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Benzene prompts recalls of spray antifungals and sunscreens
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Major insurers running billions of dollars behind on payments to hospitals and doctors
Anthem Blue Cross, the country’s second-biggest health insurance company, is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, say hospital officials in multiple states.
Anthem, like other big insurers, is using the COVID-19 crisis as cover to institute “egregious” policies that harm patients and pinch hospital finances, said Molly Smith, group vice president at the American Hospital Association. “There’s this sense of ‘Everyone’s distracted. We can get this through.’ ”
Hospitals are also dealing with a spike in retroactive claims denials by UnitedHealthcare, the biggest health insurer, for ED care, the AHA said.
Hospitals say it is hurting their finances as many cope with COVID surges – even after the industry has received tens of billions of dollars in emergency assistance from the federal government.
“We recognize there have been some challenges” to prompt payments caused by claims-processing changes and “a new set of dynamics” amid the pandemic, Anthem spokesperson Colin Manning said in an email. “We apologize for any delays or inconvenience this may have caused.”
Virginia law requires insurers to pay claims within 40 days. In a Sept. 24 letter to state insurance regulators, VCU Health, a system that operates a large teaching hospital in Richmond associated with Virginia Commonwealth University, said Anthem owes it $385 million. More than 40% of the claims are more than 90 days old, VCU said.
For all Virginia hospitals, Anthem’s late, unpaid claims amount to “hundreds of millions of dollars,” the Virginia Hospital and Healthcare Association said in a June 23 letter to state regulators.
Nationwide, the payment delays “are creating an untenable situation,” the American Hospital Association said in a Sept. 9 letter to Anthem CEO Gail Boudreaux. “Patients are facing greater hurdles to accessing care; clinicians are burning out on unnecessary administrative tasks; and the system is straining to finance the personnel and supplies” needed to fight Covid.
Complaints about Anthem extend “from sea to shining sea, from New Hampshire to California,” AHA CEO Rick Pollack told KHN.
Substantial payment delays can be seen on Anthem’s books. On June 30, 2019, before the pandemic, 43% of the insurer’s medical bills for that quarter were unpaid, according to regulatory filings. Two years later that figure had risen to 53% – a difference of $2.5 billion.
Anthem profits were $4.6 billion in 2020 and $3.5 billion in the first half of 2021.
Alexis Thurber, who lives near Seattle, was insured by Anthem when she got an $18,192 hospital bill in May for radiation therapy that doctors said was essential to treat her breast cancer.
The treatments were “experimental” and “not medically necessary,” Anthem said, according to Ms. Thurber. She spent much of the summer trying to get the insurer to pay up – placing two dozen phone calls, spending hours on hold, sending multiple emails and enduring unmeasurable stress and worry. It finally covered the claim months later.
“It’s so egregious. It’s a game they’re playing,” said Ms. Thurber, 51, whose cancer was diagnosed in November. “Trying to get true help was impossible.”
Privacy rules prevent Anthem from commenting on Ms. Thurber’s case, said Anthem spokesperson Colin Manning.
When insurers fail to promptly pay medical bills, patients are left in the lurch. They might first get a notice saying payment is pending or denied. A hospital might bill them for treatment they thought would be covered. Hospitals and doctors often sue patients whose insurance didn’t pay up.
Hospitals point to a variety of Anthem practices contributing to payment delays or denials, including new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers. “This requires providers to literally leave the patient[’s] bedside to get on the phone with Anthem,” AHA said in its letter.
Anthem often hinders coverage for outpatient surgery, specialty pharmacy and other services in health systems listed as in network, amounting to a “bait and switch” on Anthem members, AHA officials said.
“Demanding that patients be treated outside of the hospital setting, against the advice of the patient’s in-network treating physician, appears to be motivated by a desire to drive up Empire’s profits,” the Greater New York Hospital Association wrote in an April letter to Empire Blue Cross, which is owned by Anthem.
Anthem officials pushed back in a recent letter to the AHA, saying the insurer’s changing rules are intended partly to control excessive prices charged by hospitals for specialty drugs and nonemergency surgery, screening and diagnostic procedures.
Severe problems with Anthem’s new claims management system surfaced months ago and “persist without meaningful improvement,” AHA said in its letter.
Claims have gotten lost in Anthem’s computers, and in some cases VCU Health has had to print medical records and mail them to get paid, VCU said in its letter. The cash slowdown imposes “an unmanageable disruption that threatens to undermine our financial footing,” VCU said.
United denied $31,557 in claims for Emily Long’s care after she was struck in June by a motorcycle in New York City. She needed surgery to repair a fractured cheekbone. United said there was a lack of documentation for “medical necessity” – an “incredibly aggravating” response on top of the distress of the accident, Ms. Long said.
The Brooklyn hospital that treated Ms. Long was “paid appropriately under her plan and within the required time frame,” said United spokesperson Maria Gordon Shydlo. “The facility has the right to appeal the decision.”
United’s unpaid claims came to 54% as of June 30, about the same level as 2 years previously.
When Erin Conlisk initially had trouble gaining approval for a piece of medical equipment for her elderly father this summer, United employees told her the insurer’s entire prior-authorization database had gone down for weeks, said Ms. Conlisk, who lives in California.
“There was a brief issue with our prior-authorization process in mid-July, which was resolved quickly,” Gordon Shydlo said.
When asked by Wall Street analysts about the payment backups, Anthem executives said it partly reflects their decision to increase financial reserves amid the health crisis.
“Really a ton of uncertainty associated with this environment,” John Gallina, the company’s chief financial officer, said on a conference call in July. “We’ve tried to be extremely prudent and conservative in our approach.”
During the pandemic, hospitals have benefited from two extraordinary cash infusions. They and other medical providers have received more than $100 billion through the CARES Act of 2020 and the American Rescue Plan of 2021. Last year United, Anthem and other insurers accelerated billions in hospital reimbursements.
The federal payments enriched many of the biggest, wealthiest systems while poorer hospitals serving low-income patients and rural areas struggled.
Those are the systems most hurt now by insurer payment delays, hospital officials said. Federal relief funds “have been a lifeline, but they don’t make people whole in terms of the losses from increased expenses and lost revenue as a result of the COVID experience,” Mr. Pollack said.
Several health systems declined to comment about claims payment delays or didn’t respond to a reporter’s queries. Among individual hospitals “there is a deep fear of talking on the record about your largest business partner,” AHA’s Ms. Smith said.
Alexis Thurber worried she might have to pay her $18,192 radiation bill herself, and she’s not confident her Anthem policy will do a better job next time of covering the cost of her care.
“It makes me not want to go to the doctor anymore,” she said. “I’m scared to get another mammogram because you can’t rely on it.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Anthem Blue Cross, the country’s second-biggest health insurance company, is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, say hospital officials in multiple states.
Anthem, like other big insurers, is using the COVID-19 crisis as cover to institute “egregious” policies that harm patients and pinch hospital finances, said Molly Smith, group vice president at the American Hospital Association. “There’s this sense of ‘Everyone’s distracted. We can get this through.’ ”
Hospitals are also dealing with a spike in retroactive claims denials by UnitedHealthcare, the biggest health insurer, for ED care, the AHA said.
Hospitals say it is hurting their finances as many cope with COVID surges – even after the industry has received tens of billions of dollars in emergency assistance from the federal government.
“We recognize there have been some challenges” to prompt payments caused by claims-processing changes and “a new set of dynamics” amid the pandemic, Anthem spokesperson Colin Manning said in an email. “We apologize for any delays or inconvenience this may have caused.”
Virginia law requires insurers to pay claims within 40 days. In a Sept. 24 letter to state insurance regulators, VCU Health, a system that operates a large teaching hospital in Richmond associated with Virginia Commonwealth University, said Anthem owes it $385 million. More than 40% of the claims are more than 90 days old, VCU said.
For all Virginia hospitals, Anthem’s late, unpaid claims amount to “hundreds of millions of dollars,” the Virginia Hospital and Healthcare Association said in a June 23 letter to state regulators.
Nationwide, the payment delays “are creating an untenable situation,” the American Hospital Association said in a Sept. 9 letter to Anthem CEO Gail Boudreaux. “Patients are facing greater hurdles to accessing care; clinicians are burning out on unnecessary administrative tasks; and the system is straining to finance the personnel and supplies” needed to fight Covid.
Complaints about Anthem extend “from sea to shining sea, from New Hampshire to California,” AHA CEO Rick Pollack told KHN.
Substantial payment delays can be seen on Anthem’s books. On June 30, 2019, before the pandemic, 43% of the insurer’s medical bills for that quarter were unpaid, according to regulatory filings. Two years later that figure had risen to 53% – a difference of $2.5 billion.
Anthem profits were $4.6 billion in 2020 and $3.5 billion in the first half of 2021.
Alexis Thurber, who lives near Seattle, was insured by Anthem when she got an $18,192 hospital bill in May for radiation therapy that doctors said was essential to treat her breast cancer.
The treatments were “experimental” and “not medically necessary,” Anthem said, according to Ms. Thurber. She spent much of the summer trying to get the insurer to pay up – placing two dozen phone calls, spending hours on hold, sending multiple emails and enduring unmeasurable stress and worry. It finally covered the claim months later.
“It’s so egregious. It’s a game they’re playing,” said Ms. Thurber, 51, whose cancer was diagnosed in November. “Trying to get true help was impossible.”
Privacy rules prevent Anthem from commenting on Ms. Thurber’s case, said Anthem spokesperson Colin Manning.
When insurers fail to promptly pay medical bills, patients are left in the lurch. They might first get a notice saying payment is pending or denied. A hospital might bill them for treatment they thought would be covered. Hospitals and doctors often sue patients whose insurance didn’t pay up.
Hospitals point to a variety of Anthem practices contributing to payment delays or denials, including new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers. “This requires providers to literally leave the patient[’s] bedside to get on the phone with Anthem,” AHA said in its letter.
Anthem often hinders coverage for outpatient surgery, specialty pharmacy and other services in health systems listed as in network, amounting to a “bait and switch” on Anthem members, AHA officials said.
“Demanding that patients be treated outside of the hospital setting, against the advice of the patient’s in-network treating physician, appears to be motivated by a desire to drive up Empire’s profits,” the Greater New York Hospital Association wrote in an April letter to Empire Blue Cross, which is owned by Anthem.
Anthem officials pushed back in a recent letter to the AHA, saying the insurer’s changing rules are intended partly to control excessive prices charged by hospitals for specialty drugs and nonemergency surgery, screening and diagnostic procedures.
Severe problems with Anthem’s new claims management system surfaced months ago and “persist without meaningful improvement,” AHA said in its letter.
Claims have gotten lost in Anthem’s computers, and in some cases VCU Health has had to print medical records and mail them to get paid, VCU said in its letter. The cash slowdown imposes “an unmanageable disruption that threatens to undermine our financial footing,” VCU said.
United denied $31,557 in claims for Emily Long’s care after she was struck in June by a motorcycle in New York City. She needed surgery to repair a fractured cheekbone. United said there was a lack of documentation for “medical necessity” – an “incredibly aggravating” response on top of the distress of the accident, Ms. Long said.
The Brooklyn hospital that treated Ms. Long was “paid appropriately under her plan and within the required time frame,” said United spokesperson Maria Gordon Shydlo. “The facility has the right to appeal the decision.”
United’s unpaid claims came to 54% as of June 30, about the same level as 2 years previously.
When Erin Conlisk initially had trouble gaining approval for a piece of medical equipment for her elderly father this summer, United employees told her the insurer’s entire prior-authorization database had gone down for weeks, said Ms. Conlisk, who lives in California.
“There was a brief issue with our prior-authorization process in mid-July, which was resolved quickly,” Gordon Shydlo said.
When asked by Wall Street analysts about the payment backups, Anthem executives said it partly reflects their decision to increase financial reserves amid the health crisis.
“Really a ton of uncertainty associated with this environment,” John Gallina, the company’s chief financial officer, said on a conference call in July. “We’ve tried to be extremely prudent and conservative in our approach.”
During the pandemic, hospitals have benefited from two extraordinary cash infusions. They and other medical providers have received more than $100 billion through the CARES Act of 2020 and the American Rescue Plan of 2021. Last year United, Anthem and other insurers accelerated billions in hospital reimbursements.
The federal payments enriched many of the biggest, wealthiest systems while poorer hospitals serving low-income patients and rural areas struggled.
Those are the systems most hurt now by insurer payment delays, hospital officials said. Federal relief funds “have been a lifeline, but they don’t make people whole in terms of the losses from increased expenses and lost revenue as a result of the COVID experience,” Mr. Pollack said.
Several health systems declined to comment about claims payment delays or didn’t respond to a reporter’s queries. Among individual hospitals “there is a deep fear of talking on the record about your largest business partner,” AHA’s Ms. Smith said.
Alexis Thurber worried she might have to pay her $18,192 radiation bill herself, and she’s not confident her Anthem policy will do a better job next time of covering the cost of her care.
“It makes me not want to go to the doctor anymore,” she said. “I’m scared to get another mammogram because you can’t rely on it.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Anthem Blue Cross, the country’s second-biggest health insurance company, is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, say hospital officials in multiple states.
Anthem, like other big insurers, is using the COVID-19 crisis as cover to institute “egregious” policies that harm patients and pinch hospital finances, said Molly Smith, group vice president at the American Hospital Association. “There’s this sense of ‘Everyone’s distracted. We can get this through.’ ”
Hospitals are also dealing with a spike in retroactive claims denials by UnitedHealthcare, the biggest health insurer, for ED care, the AHA said.
Hospitals say it is hurting their finances as many cope with COVID surges – even after the industry has received tens of billions of dollars in emergency assistance from the federal government.
“We recognize there have been some challenges” to prompt payments caused by claims-processing changes and “a new set of dynamics” amid the pandemic, Anthem spokesperson Colin Manning said in an email. “We apologize for any delays or inconvenience this may have caused.”
Virginia law requires insurers to pay claims within 40 days. In a Sept. 24 letter to state insurance regulators, VCU Health, a system that operates a large teaching hospital in Richmond associated with Virginia Commonwealth University, said Anthem owes it $385 million. More than 40% of the claims are more than 90 days old, VCU said.
For all Virginia hospitals, Anthem’s late, unpaid claims amount to “hundreds of millions of dollars,” the Virginia Hospital and Healthcare Association said in a June 23 letter to state regulators.
Nationwide, the payment delays “are creating an untenable situation,” the American Hospital Association said in a Sept. 9 letter to Anthem CEO Gail Boudreaux. “Patients are facing greater hurdles to accessing care; clinicians are burning out on unnecessary administrative tasks; and the system is straining to finance the personnel and supplies” needed to fight Covid.
Complaints about Anthem extend “from sea to shining sea, from New Hampshire to California,” AHA CEO Rick Pollack told KHN.
Substantial payment delays can be seen on Anthem’s books. On June 30, 2019, before the pandemic, 43% of the insurer’s medical bills for that quarter were unpaid, according to regulatory filings. Two years later that figure had risen to 53% – a difference of $2.5 billion.
Anthem profits were $4.6 billion in 2020 and $3.5 billion in the first half of 2021.
Alexis Thurber, who lives near Seattle, was insured by Anthem when she got an $18,192 hospital bill in May for radiation therapy that doctors said was essential to treat her breast cancer.
The treatments were “experimental” and “not medically necessary,” Anthem said, according to Ms. Thurber. She spent much of the summer trying to get the insurer to pay up – placing two dozen phone calls, spending hours on hold, sending multiple emails and enduring unmeasurable stress and worry. It finally covered the claim months later.
“It’s so egregious. It’s a game they’re playing,” said Ms. Thurber, 51, whose cancer was diagnosed in November. “Trying to get true help was impossible.”
Privacy rules prevent Anthem from commenting on Ms. Thurber’s case, said Anthem spokesperson Colin Manning.
When insurers fail to promptly pay medical bills, patients are left in the lurch. They might first get a notice saying payment is pending or denied. A hospital might bill them for treatment they thought would be covered. Hospitals and doctors often sue patients whose insurance didn’t pay up.
Hospitals point to a variety of Anthem practices contributing to payment delays or denials, including new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers. “This requires providers to literally leave the patient[’s] bedside to get on the phone with Anthem,” AHA said in its letter.
Anthem often hinders coverage for outpatient surgery, specialty pharmacy and other services in health systems listed as in network, amounting to a “bait and switch” on Anthem members, AHA officials said.
“Demanding that patients be treated outside of the hospital setting, against the advice of the patient’s in-network treating physician, appears to be motivated by a desire to drive up Empire’s profits,” the Greater New York Hospital Association wrote in an April letter to Empire Blue Cross, which is owned by Anthem.
Anthem officials pushed back in a recent letter to the AHA, saying the insurer’s changing rules are intended partly to control excessive prices charged by hospitals for specialty drugs and nonemergency surgery, screening and diagnostic procedures.
Severe problems with Anthem’s new claims management system surfaced months ago and “persist without meaningful improvement,” AHA said in its letter.
Claims have gotten lost in Anthem’s computers, and in some cases VCU Health has had to print medical records and mail them to get paid, VCU said in its letter. The cash slowdown imposes “an unmanageable disruption that threatens to undermine our financial footing,” VCU said.
United denied $31,557 in claims for Emily Long’s care after she was struck in June by a motorcycle in New York City. She needed surgery to repair a fractured cheekbone. United said there was a lack of documentation for “medical necessity” – an “incredibly aggravating” response on top of the distress of the accident, Ms. Long said.
The Brooklyn hospital that treated Ms. Long was “paid appropriately under her plan and within the required time frame,” said United spokesperson Maria Gordon Shydlo. “The facility has the right to appeal the decision.”
United’s unpaid claims came to 54% as of June 30, about the same level as 2 years previously.
When Erin Conlisk initially had trouble gaining approval for a piece of medical equipment for her elderly father this summer, United employees told her the insurer’s entire prior-authorization database had gone down for weeks, said Ms. Conlisk, who lives in California.
“There was a brief issue with our prior-authorization process in mid-July, which was resolved quickly,” Gordon Shydlo said.
When asked by Wall Street analysts about the payment backups, Anthem executives said it partly reflects their decision to increase financial reserves amid the health crisis.
“Really a ton of uncertainty associated with this environment,” John Gallina, the company’s chief financial officer, said on a conference call in July. “We’ve tried to be extremely prudent and conservative in our approach.”
During the pandemic, hospitals have benefited from two extraordinary cash infusions. They and other medical providers have received more than $100 billion through the CARES Act of 2020 and the American Rescue Plan of 2021. Last year United, Anthem and other insurers accelerated billions in hospital reimbursements.
The federal payments enriched many of the biggest, wealthiest systems while poorer hospitals serving low-income patients and rural areas struggled.
Those are the systems most hurt now by insurer payment delays, hospital officials said. Federal relief funds “have been a lifeline, but they don’t make people whole in terms of the losses from increased expenses and lost revenue as a result of the COVID experience,” Mr. Pollack said.
Several health systems declined to comment about claims payment delays or didn’t respond to a reporter’s queries. Among individual hospitals “there is a deep fear of talking on the record about your largest business partner,” AHA’s Ms. Smith said.
Alexis Thurber worried she might have to pay her $18,192 radiation bill herself, and she’s not confident her Anthem policy will do a better job next time of covering the cost of her care.
“It makes me not want to go to the doctor anymore,” she said. “I’m scared to get another mammogram because you can’t rely on it.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Merck’s new COVID-19 pill: ‘Game changer’ or just one more tool?
Soon after Merck announced on Oct. 1 that it would ask federal regulators for emergency use authorization (EUA) for its auspicious new COVID-19 pill, the accolades began.
Former Food and Drug Administration chief Scott Gottlieb, MD, told CNBC the drug was “a profound game changer.” Top infectious disease expert Anthony S. Fauci, MD, called the early data “impressive.” The World Health Organization termed it “certainly good news,” while saying it awaits more data.
Merck, partnering with Ridgeback Biotherapeutics on the investigational oral antiviral medicine molnupiravir, plans to submit applications to regulatory agencies worldwide, hoping to deliver the first oral antiviral medication for COVID-19.
Interim clinical trial results show that the drug may slash the risk for hospitalization or death by 50% in those with mild to moderate COVID-19.
When the results were found to be so favorable, the study was halted at the recommendation of an independent data-monitoring committee and in consultation with the FDA.
“This anticipated drug has gotten a little more hype than it deserves,” said William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn. He and others suggest a reality check.
“It’s not exactly a home run, like penicillin for strep throat,” agreed Carl Fichtenbaum, MD, professor of infectious diseases at the University of Cincinnati, who is investigating a similar pill for a rival company, Atea, partnering with Roche.
“But it is encouraging,” he said. “It will probably be an incremental improvement on what we have.” The fact that it can be taken at home is a plus: “Anything we can do to keep people from getting sicker is a good thing.”
“The data show in this higher risk group [those who were studied had at least one risk factor for severe COVID-19, such as age or a medical condition], it reduces the risk of advancing to severe disease by 50%,” Dr. Schaffner said. While that’s a clear benefit for half, it of course leaves the other half without benefit, he said.
Others critiqued the predicted cost of the drug. The U.S. government has already agreed to pay about $700 per patient, according to a new report from Harvard T. H. Chan School of Public Health, Boston, and King’s College Hospital, London. That analysis concluded that the actual cost of production for the 5-day course is $17.74.
“We fully expect that having an oral treatment that reduces the risk of hospitalizations will be significantly cost effective for society,” Melissa Moody, a Merck spokesperson, told this news organization. “We are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”
Merck expects to produce 10 million courses of treatment by the end of the year, with additional doses expected to be produced in 2022, according to a company press release. Earlier in 2021, Merck finalized its agreement with the U.S. government to supply about 1.7 million courses of the drug at the $700 price, once an EUA or FDA approval is given.
Merck also has supply and purchase agreements with other governments worldwide, pending regulatory approval.
Study details
Details about the study findings came from a Merck press release. In the planned interim analysis, Merck and Ridgeback evaluated data from 775 patients initially enrolled in the phase 3 MOVe-OUT trial.
All adults had lab-confirmed mild to moderate COVID-19, and reported onset of symptoms within 5 days of being randomly assigned to the drug or placebo. All had at least one risk factor linked with poor disease outcome (such as older age or obesity).
The drug is a ribonucleoside and works by creating mutations in the virus’s genome, halting the ability of the virus to replicate.
Through day 29 of the study, the drug reduced the risk or hospitalization or death by about 50%. While 7.3% of those who received the drug either died or were hospitalized by day 29, 14.1% of those on placebo did, a statistically significant difference (P = .0012).
Side effects were similar in both groups, with 35% of the drug-treated and 40% of the placebo group reporting some side effect, Merck reported. Adverse drug-related events were 12% in the drug group and 11% in the placebo group. While 1.3% of the drug-treated group quit the study because of an adverse event, 3.4% of the placebo group quit.
Pros, cons, and unknowns
The ability to take the drug orally, and at home, is a definite plus, Dr. Schaffner said, compared with the monoclonal antibody treatment currently approved that must be given intravenously or subcutaneously and in certain locations.
More people could be reached and helped with the option of an at-home, oral medicine, he and others agreed.
The regimen for molnupiravir is four pills, two times daily, for 5 days, even if symptoms are mild. As with other prescription drugs, “there will always be folks who don’t comply completely” with the prescribed regimen, Dr. Schaffner said. With this pill, that might be especially true if the symptoms are very mild.
The 50% reduction is not as effective as the benefit often quoted for monoclonal antibody treatment. In clinical trials of Regeneron’s monoclonal antibody treatment, the regimen reduced COVID-19–related hospitalization or death in high-risk patients by 70%.
Even so, the new pill could change the pandemic’s course, others say. “I think molnupiravir has the potential to change how we take care of people who have COVID and risk factors for developing severe disease,” Rajesh Tim Gandhi, MD, an infectious disease physician at Massachusetts General Hospital and Harvard Medical School in Boston, told this news organization.
“What we’ll need to do, however, is make sure that people get tested quickly after they develop symptoms and, if they’re confirmed to have COVID, start on the pills within 5 days of developing symptoms,” he said, while warning that more data are needed about the drug and the trial results.
Another concern is that the promise of a pill will stall vaccination rates, with some people figuring why get vaccinated when they can obtain the pill if they do get sick.
Relying on treatment alone won’t work, Dr. Schaffner said. “Let’s [also] focus on prevention, which is the vaccine. We have to keep working both sides of the street.”
Dr. Gandhi added: “It’s important to remember that even though molnupiravir reduced the likelihood of hospitalization and death, a number of people who received the drug still got sick enough to end up in the hospital.”
Also unknown, he said, is how severe their disease was and whether they will develop long COVID.
The Merck study included only unvaccinated people. Might it work for those vaccinated people who get a breakthrough infection? “From a purely scientific perspective, there is no reason to believe molnupiravir would not work in people who are vaccinated, but the overall efficacy on top of the vaccine is likely dependent on how well they were able to mount a protective immune response to the vaccine,” Ms. Moody said. Still, Merck believes the pill could be of benefit for these infections too, she added.
As for the expected cost, Ms. Moody said that the company takes into account a number of factors in setting pricing, “but fundamentally we look at the impact of the disease, the benefits that the drug delivers to patients and to society, and at supporting ongoing drug development.”
On Merck’s heels: Pfizer, Roche, Atea
Pfizer is studying an antiviral pill, PF-07321332, a protease inhibitor that blocks the protease enzymes and halts replication of the virus.
In addition to studying the drug in infected patients at high risk of severe illness and in those at typical risk, Pfizer launched a phase 2-3 study in late September that will enroll people who live in the same household as a person with a confirmed, symptomatic COVID-19 infection to see if the drug can prevent disease in those who have been exposed.
Atea and Roche’s COVID pill, AT527, is in phase 3 trials as well. AT527 is an inhibitor of polymerase, an enzyme many viruses have, to stop replications. Atea is evaluating the drug to reduce disease “burden” and for both pre- and postexposure prevention.
Big picture: Role of COVID-19 pills
It may be necessary to target the coronavirus with more than one antiviral agent, said Dr. Fichtenbaum, a principal investigator for the AT527 trials.
“Sometimes viruses require two or three active agents to control their replication,” he said, citing information gleaned from other viral research, such as HIV. For control of HIV infection, a cocktail or combination of antivirals is often recommended.
That may well be the case for COVID-19, Dr. Fichtenbaum said. The goal would be to attack the virus at more than one pathway.
A version of this article first appeared on Medscape.com.
Soon after Merck announced on Oct. 1 that it would ask federal regulators for emergency use authorization (EUA) for its auspicious new COVID-19 pill, the accolades began.
Former Food and Drug Administration chief Scott Gottlieb, MD, told CNBC the drug was “a profound game changer.” Top infectious disease expert Anthony S. Fauci, MD, called the early data “impressive.” The World Health Organization termed it “certainly good news,” while saying it awaits more data.
Merck, partnering with Ridgeback Biotherapeutics on the investigational oral antiviral medicine molnupiravir, plans to submit applications to regulatory agencies worldwide, hoping to deliver the first oral antiviral medication for COVID-19.
Interim clinical trial results show that the drug may slash the risk for hospitalization or death by 50% in those with mild to moderate COVID-19.
When the results were found to be so favorable, the study was halted at the recommendation of an independent data-monitoring committee and in consultation with the FDA.
“This anticipated drug has gotten a little more hype than it deserves,” said William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn. He and others suggest a reality check.
“It’s not exactly a home run, like penicillin for strep throat,” agreed Carl Fichtenbaum, MD, professor of infectious diseases at the University of Cincinnati, who is investigating a similar pill for a rival company, Atea, partnering with Roche.
“But it is encouraging,” he said. “It will probably be an incremental improvement on what we have.” The fact that it can be taken at home is a plus: “Anything we can do to keep people from getting sicker is a good thing.”
“The data show in this higher risk group [those who were studied had at least one risk factor for severe COVID-19, such as age or a medical condition], it reduces the risk of advancing to severe disease by 50%,” Dr. Schaffner said. While that’s a clear benefit for half, it of course leaves the other half without benefit, he said.
Others critiqued the predicted cost of the drug. The U.S. government has already agreed to pay about $700 per patient, according to a new report from Harvard T. H. Chan School of Public Health, Boston, and King’s College Hospital, London. That analysis concluded that the actual cost of production for the 5-day course is $17.74.
“We fully expect that having an oral treatment that reduces the risk of hospitalizations will be significantly cost effective for society,” Melissa Moody, a Merck spokesperson, told this news organization. “We are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”
Merck expects to produce 10 million courses of treatment by the end of the year, with additional doses expected to be produced in 2022, according to a company press release. Earlier in 2021, Merck finalized its agreement with the U.S. government to supply about 1.7 million courses of the drug at the $700 price, once an EUA or FDA approval is given.
Merck also has supply and purchase agreements with other governments worldwide, pending regulatory approval.
Study details
Details about the study findings came from a Merck press release. In the planned interim analysis, Merck and Ridgeback evaluated data from 775 patients initially enrolled in the phase 3 MOVe-OUT trial.
All adults had lab-confirmed mild to moderate COVID-19, and reported onset of symptoms within 5 days of being randomly assigned to the drug or placebo. All had at least one risk factor linked with poor disease outcome (such as older age or obesity).
The drug is a ribonucleoside and works by creating mutations in the virus’s genome, halting the ability of the virus to replicate.
Through day 29 of the study, the drug reduced the risk or hospitalization or death by about 50%. While 7.3% of those who received the drug either died or were hospitalized by day 29, 14.1% of those on placebo did, a statistically significant difference (P = .0012).
Side effects were similar in both groups, with 35% of the drug-treated and 40% of the placebo group reporting some side effect, Merck reported. Adverse drug-related events were 12% in the drug group and 11% in the placebo group. While 1.3% of the drug-treated group quit the study because of an adverse event, 3.4% of the placebo group quit.
Pros, cons, and unknowns
The ability to take the drug orally, and at home, is a definite plus, Dr. Schaffner said, compared with the monoclonal antibody treatment currently approved that must be given intravenously or subcutaneously and in certain locations.
More people could be reached and helped with the option of an at-home, oral medicine, he and others agreed.
The regimen for molnupiravir is four pills, two times daily, for 5 days, even if symptoms are mild. As with other prescription drugs, “there will always be folks who don’t comply completely” with the prescribed regimen, Dr. Schaffner said. With this pill, that might be especially true if the symptoms are very mild.
The 50% reduction is not as effective as the benefit often quoted for monoclonal antibody treatment. In clinical trials of Regeneron’s monoclonal antibody treatment, the regimen reduced COVID-19–related hospitalization or death in high-risk patients by 70%.
Even so, the new pill could change the pandemic’s course, others say. “I think molnupiravir has the potential to change how we take care of people who have COVID and risk factors for developing severe disease,” Rajesh Tim Gandhi, MD, an infectious disease physician at Massachusetts General Hospital and Harvard Medical School in Boston, told this news organization.
“What we’ll need to do, however, is make sure that people get tested quickly after they develop symptoms and, if they’re confirmed to have COVID, start on the pills within 5 days of developing symptoms,” he said, while warning that more data are needed about the drug and the trial results.
Another concern is that the promise of a pill will stall vaccination rates, with some people figuring why get vaccinated when they can obtain the pill if they do get sick.
Relying on treatment alone won’t work, Dr. Schaffner said. “Let’s [also] focus on prevention, which is the vaccine. We have to keep working both sides of the street.”
Dr. Gandhi added: “It’s important to remember that even though molnupiravir reduced the likelihood of hospitalization and death, a number of people who received the drug still got sick enough to end up in the hospital.”
Also unknown, he said, is how severe their disease was and whether they will develop long COVID.
The Merck study included only unvaccinated people. Might it work for those vaccinated people who get a breakthrough infection? “From a purely scientific perspective, there is no reason to believe molnupiravir would not work in people who are vaccinated, but the overall efficacy on top of the vaccine is likely dependent on how well they were able to mount a protective immune response to the vaccine,” Ms. Moody said. Still, Merck believes the pill could be of benefit for these infections too, she added.
As for the expected cost, Ms. Moody said that the company takes into account a number of factors in setting pricing, “but fundamentally we look at the impact of the disease, the benefits that the drug delivers to patients and to society, and at supporting ongoing drug development.”
On Merck’s heels: Pfizer, Roche, Atea
Pfizer is studying an antiviral pill, PF-07321332, a protease inhibitor that blocks the protease enzymes and halts replication of the virus.
In addition to studying the drug in infected patients at high risk of severe illness and in those at typical risk, Pfizer launched a phase 2-3 study in late September that will enroll people who live in the same household as a person with a confirmed, symptomatic COVID-19 infection to see if the drug can prevent disease in those who have been exposed.
Atea and Roche’s COVID pill, AT527, is in phase 3 trials as well. AT527 is an inhibitor of polymerase, an enzyme many viruses have, to stop replications. Atea is evaluating the drug to reduce disease “burden” and for both pre- and postexposure prevention.
Big picture: Role of COVID-19 pills
It may be necessary to target the coronavirus with more than one antiviral agent, said Dr. Fichtenbaum, a principal investigator for the AT527 trials.
“Sometimes viruses require two or three active agents to control their replication,” he said, citing information gleaned from other viral research, such as HIV. For control of HIV infection, a cocktail or combination of antivirals is often recommended.
That may well be the case for COVID-19, Dr. Fichtenbaum said. The goal would be to attack the virus at more than one pathway.
A version of this article first appeared on Medscape.com.
Soon after Merck announced on Oct. 1 that it would ask federal regulators for emergency use authorization (EUA) for its auspicious new COVID-19 pill, the accolades began.
Former Food and Drug Administration chief Scott Gottlieb, MD, told CNBC the drug was “a profound game changer.” Top infectious disease expert Anthony S. Fauci, MD, called the early data “impressive.” The World Health Organization termed it “certainly good news,” while saying it awaits more data.
Merck, partnering with Ridgeback Biotherapeutics on the investigational oral antiviral medicine molnupiravir, plans to submit applications to regulatory agencies worldwide, hoping to deliver the first oral antiviral medication for COVID-19.
Interim clinical trial results show that the drug may slash the risk for hospitalization or death by 50% in those with mild to moderate COVID-19.
When the results were found to be so favorable, the study was halted at the recommendation of an independent data-monitoring committee and in consultation with the FDA.
“This anticipated drug has gotten a little more hype than it deserves,” said William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn. He and others suggest a reality check.
“It’s not exactly a home run, like penicillin for strep throat,” agreed Carl Fichtenbaum, MD, professor of infectious diseases at the University of Cincinnati, who is investigating a similar pill for a rival company, Atea, partnering with Roche.
“But it is encouraging,” he said. “It will probably be an incremental improvement on what we have.” The fact that it can be taken at home is a plus: “Anything we can do to keep people from getting sicker is a good thing.”
“The data show in this higher risk group [those who were studied had at least one risk factor for severe COVID-19, such as age or a medical condition], it reduces the risk of advancing to severe disease by 50%,” Dr. Schaffner said. While that’s a clear benefit for half, it of course leaves the other half without benefit, he said.
Others critiqued the predicted cost of the drug. The U.S. government has already agreed to pay about $700 per patient, according to a new report from Harvard T. H. Chan School of Public Health, Boston, and King’s College Hospital, London. That analysis concluded that the actual cost of production for the 5-day course is $17.74.
“We fully expect that having an oral treatment that reduces the risk of hospitalizations will be significantly cost effective for society,” Melissa Moody, a Merck spokesperson, told this news organization. “We are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”
Merck expects to produce 10 million courses of treatment by the end of the year, with additional doses expected to be produced in 2022, according to a company press release. Earlier in 2021, Merck finalized its agreement with the U.S. government to supply about 1.7 million courses of the drug at the $700 price, once an EUA or FDA approval is given.
Merck also has supply and purchase agreements with other governments worldwide, pending regulatory approval.
Study details
Details about the study findings came from a Merck press release. In the planned interim analysis, Merck and Ridgeback evaluated data from 775 patients initially enrolled in the phase 3 MOVe-OUT trial.
All adults had lab-confirmed mild to moderate COVID-19, and reported onset of symptoms within 5 days of being randomly assigned to the drug or placebo. All had at least one risk factor linked with poor disease outcome (such as older age or obesity).
The drug is a ribonucleoside and works by creating mutations in the virus’s genome, halting the ability of the virus to replicate.
Through day 29 of the study, the drug reduced the risk or hospitalization or death by about 50%. While 7.3% of those who received the drug either died or were hospitalized by day 29, 14.1% of those on placebo did, a statistically significant difference (P = .0012).
Side effects were similar in both groups, with 35% of the drug-treated and 40% of the placebo group reporting some side effect, Merck reported. Adverse drug-related events were 12% in the drug group and 11% in the placebo group. While 1.3% of the drug-treated group quit the study because of an adverse event, 3.4% of the placebo group quit.
Pros, cons, and unknowns
The ability to take the drug orally, and at home, is a definite plus, Dr. Schaffner said, compared with the monoclonal antibody treatment currently approved that must be given intravenously or subcutaneously and in certain locations.
More people could be reached and helped with the option of an at-home, oral medicine, he and others agreed.
The regimen for molnupiravir is four pills, two times daily, for 5 days, even if symptoms are mild. As with other prescription drugs, “there will always be folks who don’t comply completely” with the prescribed regimen, Dr. Schaffner said. With this pill, that might be especially true if the symptoms are very mild.
The 50% reduction is not as effective as the benefit often quoted for monoclonal antibody treatment. In clinical trials of Regeneron’s monoclonal antibody treatment, the regimen reduced COVID-19–related hospitalization or death in high-risk patients by 70%.
Even so, the new pill could change the pandemic’s course, others say. “I think molnupiravir has the potential to change how we take care of people who have COVID and risk factors for developing severe disease,” Rajesh Tim Gandhi, MD, an infectious disease physician at Massachusetts General Hospital and Harvard Medical School in Boston, told this news organization.
“What we’ll need to do, however, is make sure that people get tested quickly after they develop symptoms and, if they’re confirmed to have COVID, start on the pills within 5 days of developing symptoms,” he said, while warning that more data are needed about the drug and the trial results.
Another concern is that the promise of a pill will stall vaccination rates, with some people figuring why get vaccinated when they can obtain the pill if they do get sick.
Relying on treatment alone won’t work, Dr. Schaffner said. “Let’s [also] focus on prevention, which is the vaccine. We have to keep working both sides of the street.”
Dr. Gandhi added: “It’s important to remember that even though molnupiravir reduced the likelihood of hospitalization and death, a number of people who received the drug still got sick enough to end up in the hospital.”
Also unknown, he said, is how severe their disease was and whether they will develop long COVID.
The Merck study included only unvaccinated people. Might it work for those vaccinated people who get a breakthrough infection? “From a purely scientific perspective, there is no reason to believe molnupiravir would not work in people who are vaccinated, but the overall efficacy on top of the vaccine is likely dependent on how well they were able to mount a protective immune response to the vaccine,” Ms. Moody said. Still, Merck believes the pill could be of benefit for these infections too, she added.
As for the expected cost, Ms. Moody said that the company takes into account a number of factors in setting pricing, “but fundamentally we look at the impact of the disease, the benefits that the drug delivers to patients and to society, and at supporting ongoing drug development.”
On Merck’s heels: Pfizer, Roche, Atea
Pfizer is studying an antiviral pill, PF-07321332, a protease inhibitor that blocks the protease enzymes and halts replication of the virus.
In addition to studying the drug in infected patients at high risk of severe illness and in those at typical risk, Pfizer launched a phase 2-3 study in late September that will enroll people who live in the same household as a person with a confirmed, symptomatic COVID-19 infection to see if the drug can prevent disease in those who have been exposed.
Atea and Roche’s COVID pill, AT527, is in phase 3 trials as well. AT527 is an inhibitor of polymerase, an enzyme many viruses have, to stop replications. Atea is evaluating the drug to reduce disease “burden” and for both pre- and postexposure prevention.
Big picture: Role of COVID-19 pills
It may be necessary to target the coronavirus with more than one antiviral agent, said Dr. Fichtenbaum, a principal investigator for the AT527 trials.
“Sometimes viruses require two or three active agents to control their replication,” he said, citing information gleaned from other viral research, such as HIV. For control of HIV infection, a cocktail or combination of antivirals is often recommended.
That may well be the case for COVID-19, Dr. Fichtenbaum said. The goal would be to attack the virus at more than one pathway.
A version of this article first appeared on Medscape.com.
‘Push the bar higher’: New statement on type 1 diabetes in adults
A newly published consensus statement on the management of type 1 diabetes in adults addresses the unique clinical needs of the population compared with those of children with type 1 diabetes or adults with type 2 diabetes.
“The focus on adults is kind of new and it is important. ... I do think it’s a bit of a forgotten population. Whenever we talk about diabetes in adults it’s assumed to be about type 2,” document coauthor M. Sue Kirkman, MD, said in an interview.
The document covers diagnosis of type 1 diabetes, goals and targets, schedule of care, self-management education and lifestyle, glucose monitoring, insulin therapy, hypoglycemia, psychosocial care, diabetic ketoacidosis (DKA), pancreas transplant/islet cell transplantation, adjunctive therapies, special populations (pregnant, older, hospitalized), and emergent and future perspectives.
Initially presented in draft form in June at the American Diabetes Association (ADA) 81st scientific sessions, the final version of the joint ADA/EASD statement was presented Oct. 1 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published in Diabetologia and Diabetes Care.
“We are aware of the many and rapid advances in the diagnosis and treatment of type 1 diabetes ... However, despite these advances, there is also a growing recognition of the psychosocial burden of living with type 1 diabetes,” writing group cochair Richard I.G. Holt, MB BChir, PhD, professor of diabetes and endocrinology at the University of Southampton, England, said when introducing the 90-minute EASD session.
“Although there is guidance for the management of type 1 diabetes, the aim of this report is to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes,” he added.
Noting that the joint EASD/ADA consensus report on type 2 diabetes has been “highly influential,” Dr. Holt said, “EASD and ADA recognized the need to develop a comparable consensus report specifically addressing type 1 diabetes.”
The overriding goals, Dr. Holt said, are to “support people with type 1 diabetes to live a long and healthy life” with four specific strategies: delivery of insulin to keep glucose levels as close to target as possible to prevent complications while minimizing hypoglycemia and preventing DKA; managing cardiovascular risk factors; minimizing psychosocial burden; and promoting psychological well-being.
Diagnostic algorithm
Another coauthor, J. Hans de Vries, MD, PhD, professor of internal medicine at the University of Amsterdam, explained the recommended approach to distinguishing type 1 diabetes from type 2 diabetes or monogenic diabetes in adults, which is often a clinical challenge.
This also was the topic prompting the most questions during the EASD session.
“Especially in adults, misdiagnosis of type of diabetes is common, occurring in up to 40% of patients diagnosed after the age of 30 years,” Dr. de Vries said.
Among the many reasons for the confusion are that C-peptide levels, a reflection of endogenous insulin secretion, can still be relatively high at the time of clinical onset of type 1 diabetes, but islet antibodies don’t have 100% positive predictive value.
Obesity and type 2 diabetes are increasingly seen at younger ages, and DKA can occur in type 2 diabetes (“ketosis-prone”). In addition, monogenic forms of diabetes can be disguised as type 1 diabetes.
“So, we thought there was a need for a diagnostic algorithm,” Dr. de Vries said, adding that the algorithm – displayed as a graphic in the statement – is only for adults in whom type 1 diabetes is suspected, not other types. Also, it’s based on data from White European populations.
The first step is to test islet autoantibodies. If positive, the diagnosis of type 1 diabetes can be made. If negative and the person is younger than 35 years and without signs of type 2 diabetes, testing C-peptide is advised. If that’s below 200 pmol/L, type 1 diabetes is the diagnosis. If above 200 pmol/L, genetic testing for monogenic diabetes is advised. If there are signs of type 2 diabetes and/or the person is over age 35, type 2 diabetes is the most likely diagnosis.
And if uncertainty remains, the recommendation is to try noninsulin therapy and retest C-peptide again in 3 years, as by that time it will be below 200 pmol/L in a person with type 1 diabetes.
Dr. Kirkman commented regarding the algorithm: “It’s very much from a European population perspective. In some ways that’s a limitation, especially in the U.S. where the population is diverse, but I do think it’s still useful to help guide people through how to think about somebody who presents as an adult where it’s not obviously type 2 or type 1 ... There is a lot of in-between stuff.”
Psychosocial support: Essential but often overlooked
Frank J. Snoek, PhD, professor of psychology at Amsterdam University Medical Centers, Vrije Universiteit, presented the section on behavioral and psychosocial care. He pointed out that diabetes-related emotional distress is reported by 20%-40% of adults with type 1 diabetes, and that the risk of such distress is especially high at the time of diagnosis and when complications develop.
About 15% of people with type 1 diabetes have depression, which is linked to elevated A1c levels, increased complication risk, and mortality. Anxiety also is very common and linked with diabetes-specific fears including hypoglycemia. Eating disorders are more prevalent among people with type 1 diabetes than in the general population and can further complicate diabetes management.
Recommendations include periodic evaluation of psychological health and social barriers to self-management and having clear referral pathways and access to psychological or psychiatric care for individuals in need. “All members of the diabetes care team have a responsibility when it comes to offering psychosocial support as part of ongoing diabetes care and education.”
Dr. Kirkman had identified this section as noteworthy: “I think the focus on psychosocial care and making that an ongoing part of diabetes care and assessment is important.”
More data needed on diets, many other areas
During the discussion, several attendees asked about low-carbohydrate diets, embraced by many individuals with type 1 diabetes.
The document states: “While low-carbohydrate and very low-carbohydrate eating patterns have become increasingly popular and reduce A1c levels in the short term, it is important to incorporate these in conjunction with healthy eating guidelines. Additional components of the meal, including high fat and/or high protein, may contribute to delayed hyperglycemia and the need for insulin dose adjustments. Since this is highly variable between individuals, postprandial glucose measurements for up to 3 hours or more may be needed to determine initial dose adjustments.”
Beyond that, Tomasz Klupa, MD, PhD, of the department of metabolic diseases, Jagiellonian University, Krakow, Poland, responded: “We don’t have much data on low-carb diets in type 1 diabetes. ... Compliance to those diets is pretty poor. We don’t have long-term follow-up and the studies are simply not conclusive. Initial results do show reductions in body weight and A1c, but with time the compliance goes down dramatically.”
“Certainly, when we think of low-carb diets, we have to meet our patients where they are,” said Amy Hess-Fischl, a nutritionist and certified diabetes care and education specialist at the University of Chicago. “We don’t have enough data to really say there’s positive long-term evidence. But we can find a happy medium to find some benefits in glycemic and weight control. ... It’s really that collaboration with that person to identify what’s going to work for them in a healthy way.”
The EASD session concluded with writing group cochair Anne L. Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles, summing up the many other knowledge gaps, including personalizing use of diabetes technology, the problems of health disparities and lack of access to care, and the feasibility of prevention and/or cure. 
She observed: “There is no one-size-fits-all approach to diabetes care, and the more we can individualize our approaches, the more successful we are likely to be. ... Hopefully this consensus statement has pushed the bar a bit higher, telling the powers that be that people with type 1 diabetes need and deserve the best.
“We have a very long way to go before all of our patients reach their goals and health equity is achieved. ... We need to provide each and every person the access to the care we describe in this consensus statement, so that all can prosper and thrive and look forward to a long and healthy life lived with type 1 diabetes.”
Dr. Holt has financial relationships with Novo Nordisk, Abbott, Eli Lilly, Otsuka, and Roche. Dr. de Vries has financial relationships with Afon, Eli Lilly, Novo Nordisk, Adocia, and Zealand Pharma. Ms. Hess-Fischl has financial relationships with Abbott Diabetes Care and Xeris. Dr. Klupa has financial relationships with numerous drug and device companies. Dr. Snoek has financial relationships with Abbott, Eli Lilly, Sanofi, and Novo Nordisk. Dr. Peters has financial relationships with Abbott Diabetes Care, Dexcom, Eli Lilly, Insulet, Novo Nordisk, Medscape, and Zealand Pharmaceuticals. She holds stock options in Omada Health and Livongo and is a special government employee of the Food and Drug Administration.
A version of this article first appeared on Medscape.com.
A newly published consensus statement on the management of type 1 diabetes in adults addresses the unique clinical needs of the population compared with those of children with type 1 diabetes or adults with type 2 diabetes.
“The focus on adults is kind of new and it is important. ... I do think it’s a bit of a forgotten population. Whenever we talk about diabetes in adults it’s assumed to be about type 2,” document coauthor M. Sue Kirkman, MD, said in an interview.
The document covers diagnosis of type 1 diabetes, goals and targets, schedule of care, self-management education and lifestyle, glucose monitoring, insulin therapy, hypoglycemia, psychosocial care, diabetic ketoacidosis (DKA), pancreas transplant/islet cell transplantation, adjunctive therapies, special populations (pregnant, older, hospitalized), and emergent and future perspectives.
Initially presented in draft form in June at the American Diabetes Association (ADA) 81st scientific sessions, the final version of the joint ADA/EASD statement was presented Oct. 1 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published in Diabetologia and Diabetes Care.
“We are aware of the many and rapid advances in the diagnosis and treatment of type 1 diabetes ... However, despite these advances, there is also a growing recognition of the psychosocial burden of living with type 1 diabetes,” writing group cochair Richard I.G. Holt, MB BChir, PhD, professor of diabetes and endocrinology at the University of Southampton, England, said when introducing the 90-minute EASD session.
“Although there is guidance for the management of type 1 diabetes, the aim of this report is to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes,” he added.
Noting that the joint EASD/ADA consensus report on type 2 diabetes has been “highly influential,” Dr. Holt said, “EASD and ADA recognized the need to develop a comparable consensus report specifically addressing type 1 diabetes.”
The overriding goals, Dr. Holt said, are to “support people with type 1 diabetes to live a long and healthy life” with four specific strategies: delivery of insulin to keep glucose levels as close to target as possible to prevent complications while minimizing hypoglycemia and preventing DKA; managing cardiovascular risk factors; minimizing psychosocial burden; and promoting psychological well-being.
Diagnostic algorithm
Another coauthor, J. Hans de Vries, MD, PhD, professor of internal medicine at the University of Amsterdam, explained the recommended approach to distinguishing type 1 diabetes from type 2 diabetes or monogenic diabetes in adults, which is often a clinical challenge.
This also was the topic prompting the most questions during the EASD session.
“Especially in adults, misdiagnosis of type of diabetes is common, occurring in up to 40% of patients diagnosed after the age of 30 years,” Dr. de Vries said.
Among the many reasons for the confusion are that C-peptide levels, a reflection of endogenous insulin secretion, can still be relatively high at the time of clinical onset of type 1 diabetes, but islet antibodies don’t have 100% positive predictive value.
Obesity and type 2 diabetes are increasingly seen at younger ages, and DKA can occur in type 2 diabetes (“ketosis-prone”). In addition, monogenic forms of diabetes can be disguised as type 1 diabetes.
“So, we thought there was a need for a diagnostic algorithm,” Dr. de Vries said, adding that the algorithm – displayed as a graphic in the statement – is only for adults in whom type 1 diabetes is suspected, not other types. Also, it’s based on data from White European populations.
The first step is to test islet autoantibodies. If positive, the diagnosis of type 1 diabetes can be made. If negative and the person is younger than 35 years and without signs of type 2 diabetes, testing C-peptide is advised. If that’s below 200 pmol/L, type 1 diabetes is the diagnosis. If above 200 pmol/L, genetic testing for monogenic diabetes is advised. If there are signs of type 2 diabetes and/or the person is over age 35, type 2 diabetes is the most likely diagnosis.
And if uncertainty remains, the recommendation is to try noninsulin therapy and retest C-peptide again in 3 years, as by that time it will be below 200 pmol/L in a person with type 1 diabetes.
Dr. Kirkman commented regarding the algorithm: “It’s very much from a European population perspective. In some ways that’s a limitation, especially in the U.S. where the population is diverse, but I do think it’s still useful to help guide people through how to think about somebody who presents as an adult where it’s not obviously type 2 or type 1 ... There is a lot of in-between stuff.”
Psychosocial support: Essential but often overlooked
Frank J. Snoek, PhD, professor of psychology at Amsterdam University Medical Centers, Vrije Universiteit, presented the section on behavioral and psychosocial care. He pointed out that diabetes-related emotional distress is reported by 20%-40% of adults with type 1 diabetes, and that the risk of such distress is especially high at the time of diagnosis and when complications develop.
About 15% of people with type 1 diabetes have depression, which is linked to elevated A1c levels, increased complication risk, and mortality. Anxiety also is very common and linked with diabetes-specific fears including hypoglycemia. Eating disorders are more prevalent among people with type 1 diabetes than in the general population and can further complicate diabetes management.
Recommendations include periodic evaluation of psychological health and social barriers to self-management and having clear referral pathways and access to psychological or psychiatric care for individuals in need. “All members of the diabetes care team have a responsibility when it comes to offering psychosocial support as part of ongoing diabetes care and education.”
Dr. Kirkman had identified this section as noteworthy: “I think the focus on psychosocial care and making that an ongoing part of diabetes care and assessment is important.”
More data needed on diets, many other areas
During the discussion, several attendees asked about low-carbohydrate diets, embraced by many individuals with type 1 diabetes.
The document states: “While low-carbohydrate and very low-carbohydrate eating patterns have become increasingly popular and reduce A1c levels in the short term, it is important to incorporate these in conjunction with healthy eating guidelines. Additional components of the meal, including high fat and/or high protein, may contribute to delayed hyperglycemia and the need for insulin dose adjustments. Since this is highly variable between individuals, postprandial glucose measurements for up to 3 hours or more may be needed to determine initial dose adjustments.”
Beyond that, Tomasz Klupa, MD, PhD, of the department of metabolic diseases, Jagiellonian University, Krakow, Poland, responded: “We don’t have much data on low-carb diets in type 1 diabetes. ... Compliance to those diets is pretty poor. We don’t have long-term follow-up and the studies are simply not conclusive. Initial results do show reductions in body weight and A1c, but with time the compliance goes down dramatically.”
“Certainly, when we think of low-carb diets, we have to meet our patients where they are,” said Amy Hess-Fischl, a nutritionist and certified diabetes care and education specialist at the University of Chicago. “We don’t have enough data to really say there’s positive long-term evidence. But we can find a happy medium to find some benefits in glycemic and weight control. ... It’s really that collaboration with that person to identify what’s going to work for them in a healthy way.”
The EASD session concluded with writing group cochair Anne L. Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles, summing up the many other knowledge gaps, including personalizing use of diabetes technology, the problems of health disparities and lack of access to care, and the feasibility of prevention and/or cure.
She observed: “There is no one-size-fits-all approach to diabetes care, and the more we can individualize our approaches, the more successful we are likely to be. ... Hopefully this consensus statement has pushed the bar a bit higher, telling the powers that be that people with type 1 diabetes need and deserve the best.
“We have a very long way to go before all of our patients reach their goals and health equity is achieved. ... We need to provide each and every person the access to the care we describe in this consensus statement, so that all can prosper and thrive and look forward to a long and healthy life lived with type 1 diabetes.”
Dr. Holt has financial relationships with Novo Nordisk, Abbott, Eli Lilly, Otsuka, and Roche. Dr. de Vries has financial relationships with Afon, Eli Lilly, Novo Nordisk, Adocia, and Zealand Pharma. Ms. Hess-Fischl has financial relationships with Abbott Diabetes Care and Xeris. Dr. Klupa has financial relationships with numerous drug and device companies. Dr. Snoek has financial relationships with Abbott, Eli Lilly, Sanofi, and Novo Nordisk. Dr. Peters has financial relationships with Abbott Diabetes Care, Dexcom, Eli Lilly, Insulet, Novo Nordisk, Medscape, and Zealand Pharmaceuticals. She holds stock options in Omada Health and Livongo and is a special government employee of the Food and Drug Administration.
A version of this article first appeared on Medscape.com.
A newly published consensus statement on the management of type 1 diabetes in adults addresses the unique clinical needs of the population compared with those of children with type 1 diabetes or adults with type 2 diabetes.
“The focus on adults is kind of new and it is important. ... I do think it’s a bit of a forgotten population. Whenever we talk about diabetes in adults it’s assumed to be about type 2,” document coauthor M. Sue Kirkman, MD, said in an interview.
The document covers diagnosis of type 1 diabetes, goals and targets, schedule of care, self-management education and lifestyle, glucose monitoring, insulin therapy, hypoglycemia, psychosocial care, diabetic ketoacidosis (DKA), pancreas transplant/islet cell transplantation, adjunctive therapies, special populations (pregnant, older, hospitalized), and emergent and future perspectives.
Initially presented in draft form in June at the American Diabetes Association (ADA) 81st scientific sessions, the final version of the joint ADA/EASD statement was presented Oct. 1 at the annual meeting of the European Association for the Study of Diabetes and simultaneously published in Diabetologia and Diabetes Care.
“We are aware of the many and rapid advances in the diagnosis and treatment of type 1 diabetes ... However, despite these advances, there is also a growing recognition of the psychosocial burden of living with type 1 diabetes,” writing group cochair Richard I.G. Holt, MB BChir, PhD, professor of diabetes and endocrinology at the University of Southampton, England, said when introducing the 90-minute EASD session.
“Although there is guidance for the management of type 1 diabetes, the aim of this report is to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes,” he added.
Noting that the joint EASD/ADA consensus report on type 2 diabetes has been “highly influential,” Dr. Holt said, “EASD and ADA recognized the need to develop a comparable consensus report specifically addressing type 1 diabetes.”
The overriding goals, Dr. Holt said, are to “support people with type 1 diabetes to live a long and healthy life” with four specific strategies: delivery of insulin to keep glucose levels as close to target as possible to prevent complications while minimizing hypoglycemia and preventing DKA; managing cardiovascular risk factors; minimizing psychosocial burden; and promoting psychological well-being.
Diagnostic algorithm
Another coauthor, J. Hans de Vries, MD, PhD, professor of internal medicine at the University of Amsterdam, explained the recommended approach to distinguishing type 1 diabetes from type 2 diabetes or monogenic diabetes in adults, which is often a clinical challenge.
This also was the topic prompting the most questions during the EASD session.
“Especially in adults, misdiagnosis of type of diabetes is common, occurring in up to 40% of patients diagnosed after the age of 30 years,” Dr. de Vries said.
Among the many reasons for the confusion are that C-peptide levels, a reflection of endogenous insulin secretion, can still be relatively high at the time of clinical onset of type 1 diabetes, but islet antibodies don’t have 100% positive predictive value.
Obesity and type 2 diabetes are increasingly seen at younger ages, and DKA can occur in type 2 diabetes (“ketosis-prone”). In addition, monogenic forms of diabetes can be disguised as type 1 diabetes.
“So, we thought there was a need for a diagnostic algorithm,” Dr. de Vries said, adding that the algorithm – displayed as a graphic in the statement – is only for adults in whom type 1 diabetes is suspected, not other types. Also, it’s based on data from White European populations.
The first step is to test islet autoantibodies. If positive, the diagnosis of type 1 diabetes can be made. If negative and the person is younger than 35 years and without signs of type 2 diabetes, testing C-peptide is advised. If that’s below 200 pmol/L, type 1 diabetes is the diagnosis. If above 200 pmol/L, genetic testing for monogenic diabetes is advised. If there are signs of type 2 diabetes and/or the person is over age 35, type 2 diabetes is the most likely diagnosis.
And if uncertainty remains, the recommendation is to try noninsulin therapy and retest C-peptide again in 3 years, as by that time it will be below 200 pmol/L in a person with type 1 diabetes.
Dr. Kirkman commented regarding the algorithm: “It’s very much from a European population perspective. In some ways that’s a limitation, especially in the U.S. where the population is diverse, but I do think it’s still useful to help guide people through how to think about somebody who presents as an adult where it’s not obviously type 2 or type 1 ... There is a lot of in-between stuff.”
Psychosocial support: Essential but often overlooked
Frank J. Snoek, PhD, professor of psychology at Amsterdam University Medical Centers, Vrije Universiteit, presented the section on behavioral and psychosocial care. He pointed out that diabetes-related emotional distress is reported by 20%-40% of adults with type 1 diabetes, and that the risk of such distress is especially high at the time of diagnosis and when complications develop.
About 15% of people with type 1 diabetes have depression, which is linked to elevated A1c levels, increased complication risk, and mortality. Anxiety also is very common and linked with diabetes-specific fears including hypoglycemia. Eating disorders are more prevalent among people with type 1 diabetes than in the general population and can further complicate diabetes management.
Recommendations include periodic evaluation of psychological health and social barriers to self-management and having clear referral pathways and access to psychological or psychiatric care for individuals in need. “All members of the diabetes care team have a responsibility when it comes to offering psychosocial support as part of ongoing diabetes care and education.”
Dr. Kirkman had identified this section as noteworthy: “I think the focus on psychosocial care and making that an ongoing part of diabetes care and assessment is important.”
More data needed on diets, many other areas
During the discussion, several attendees asked about low-carbohydrate diets, embraced by many individuals with type 1 diabetes.
The document states: “While low-carbohydrate and very low-carbohydrate eating patterns have become increasingly popular and reduce A1c levels in the short term, it is important to incorporate these in conjunction with healthy eating guidelines. Additional components of the meal, including high fat and/or high protein, may contribute to delayed hyperglycemia and the need for insulin dose adjustments. Since this is highly variable between individuals, postprandial glucose measurements for up to 3 hours or more may be needed to determine initial dose adjustments.”
Beyond that, Tomasz Klupa, MD, PhD, of the department of metabolic diseases, Jagiellonian University, Krakow, Poland, responded: “We don’t have much data on low-carb diets in type 1 diabetes. ... Compliance to those diets is pretty poor. We don’t have long-term follow-up and the studies are simply not conclusive. Initial results do show reductions in body weight and A1c, but with time the compliance goes down dramatically.”
“Certainly, when we think of low-carb diets, we have to meet our patients where they are,” said Amy Hess-Fischl, a nutritionist and certified diabetes care and education specialist at the University of Chicago. “We don’t have enough data to really say there’s positive long-term evidence. But we can find a happy medium to find some benefits in glycemic and weight control. ... It’s really that collaboration with that person to identify what’s going to work for them in a healthy way.”
The EASD session concluded with writing group cochair Anne L. Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles, summing up the many other knowledge gaps, including personalizing use of diabetes technology, the problems of health disparities and lack of access to care, and the feasibility of prevention and/or cure.
She observed: “There is no one-size-fits-all approach to diabetes care, and the more we can individualize our approaches, the more successful we are likely to be. ... Hopefully this consensus statement has pushed the bar a bit higher, telling the powers that be that people with type 1 diabetes need and deserve the best.
“We have a very long way to go before all of our patients reach their goals and health equity is achieved. ... We need to provide each and every person the access to the care we describe in this consensus statement, so that all can prosper and thrive and look forward to a long and healthy life lived with type 1 diabetes.”
Dr. Holt has financial relationships with Novo Nordisk, Abbott, Eli Lilly, Otsuka, and Roche. Dr. de Vries has financial relationships with Afon, Eli Lilly, Novo Nordisk, Adocia, and Zealand Pharma. Ms. Hess-Fischl has financial relationships with Abbott Diabetes Care and Xeris. Dr. Klupa has financial relationships with numerous drug and device companies. Dr. Snoek has financial relationships with Abbott, Eli Lilly, Sanofi, and Novo Nordisk. Dr. Peters has financial relationships with Abbott Diabetes Care, Dexcom, Eli Lilly, Insulet, Novo Nordisk, Medscape, and Zealand Pharmaceuticals. She holds stock options in Omada Health and Livongo and is a special government employee of the Food and Drug Administration.
A version of this article first appeared on Medscape.com.
FROM EASD 2021
Web of antimicrobials doesn’t hold water
Music plus mushrooms equals therapy
Magic mushrooms have been used recreationally and medicinally for thousands of years, but researchers have found adding music could be a game changer in antidepressant treatment.
The ingredient that makes these mushrooms so magical is psilocybin. It works well for the clinical treatment of mental health conditions and some forms of depression because the “trip” can be contained to one work day, making it easy to administer under supervision. With the accompaniment of music, scientists have found that psilocybin evokes emotion.
This recent study, presented at the European College of Neuropsychopharmacology Congress in Lisbon, tested participants’ emotional response to music before and after the psilocybin. Ketanserin, an antihypertensive drug, was used to test against the effects of psilocybin. The scientist played Mozart and Elgar and found that participants on psilocybin had an emotional response increase of 60%. That response was even greater, compared with ketanserin, which actually lessened the emotional response to music.
“This shows that combination of psilocybin and music has a strong emotional effect, and we believe that this will be important for the therapeutic application of psychedelics if they are approved for clinical use,” said lead researcher Dea Siggaard Stenbæk of the University of Copenhagen.
Professor David J. Nutt of Imperial College in London, who was not involved in the study, said that it supports the use of music for treatment efficacy with psychedelics and suggested that the next step is to “optimise this approach probably through individualising and personalising music tracks in therapy.”
Cue the 1960s LSD music montage.
Chicken ‘white striping is not a disease’
Have you ever sliced open a new pack of chicken breasts to start dinner and noticed white fatty lines running through the chicken? Maybe you thought it was just some extra fat to trim off, but the Humane League calls it “white striping disease.”
Chicken is the No. 1 meat consumed by Americans, so it’s not surprising that chickens are factory farmed and raised to be ready for slaughter quickly, according to CBSNews.com, which reported that the Humane League claims white striping is found in 70% of the chicken in popular grocery stores. The league expressed concern for the chickens’ welfare as they are bred to grow bigger quickly, which is causing the white striping and increasing the fat content of the meat by as much as 224%.
The National Chicken Council told CBS that the league’s findings were unscientific. A spokesperson said, “White striping is not a disease. It is a quality factor in chicken breast meat caused by deposits of fat in the muscle during the bird’s growth and development.” He went on to say that severe white striping happens in 3%-6% of birds, which are mostly used in further processed products, not in chicken breast packages.
Somehow, that’s not making us feel any better.
The itsy bitsy spider lets us all down
Most people do not like spiders. That’s too bad, because spiders are generally nothing but helpful little creatures that prey upon annoying flies and other pests. Then there’s the silk they produce. The ancient Romans used it to treat conditions such as warts and skin lesions. Spiders wrap their eggs in silk to protect them from harmful bacteria.
Of course, we can hardly trust the medical opinions of people from 2,000 years ago, but modern-day studies have not definitively proved whether or not spider silk has any antimicrobial properties.
To settle the matter once and for all, researchers from Denmark built a silk-harvesting machine using the most famous of Danish inventions: Legos. The contraption, sort of a paddle wheel, pulled the silk from several different species of spider pinned down by the researchers. The silk was then tested against three different bacteria species, including good old Escherichia coli.
Unfortunately for our spider friends, their silk has no antimicrobial activity. The researchers suspected that any such activity seen in previous studies was actually caused by improper control for the solvents used to extract the silk; those solvents can have antimicrobial properties on their own. As for protecting their eggs, rather than killing bacteria, the silk likely provides a physical barrier alone.
It is bad news for spiders on the benefit-to-humanity front, but look at the bright side: If their silk had antimicrobial activity, we’d have to start farming them to acquire more silk. And that’s no good. Spiders deserve to roam free, hunt as they please, and drop down on your head from the ceiling.
Anxiety and allergies: Cause, effect, confusion
We’re big fans of science, but as longtime, totally impartial (Science rules!) observers of science’s medical realm, we can see that the day-to-day process of practicing the scientific method occasionally gets a bit messy. And no, we’re not talking about COVID-19.
We’re talking allergies. We’re talking mental health. We’re talking allergic disease and mental health.
We’re talking about a pair of press releases we came across during our never-ending search for material to educate, entertain, and astound our fabulously wonderful and loyal readers. (We say that, of course, in the most impartial way possible.)
The first release was titled, “Allergies including asthma and hay fever not linked to mental health traits” and covered research from the University of Bristol (England). The investigators were trying to determine if “allergic diseases actually causes mental health traits including anxiety, depression, bipolar disorder, and schizophrenia, or vice versa,” according to the release.
What they found, however, was “little evidence of a causal relationship between the onset of allergic disease and mental health.” Again, this is the press release talking.
The second release seemed to suggest the exact opposite: “Study uncovers link between allergies and mental health conditions.” That got our attention. A little more reading revealed that “people with asthma, atopic dermatitis, and hay fever also had a higher likelihood of having depression, anxiety, bipolar disorder, or neuroticism.”
One of the investigators was quoted as saying, “Establishing whether allergic disease causes mental health problems, or vice versa, is important to ensure that resources and treatment strategies are targeted appropriately.”
Did you notice the “vice versa”? Did you notice that it appeared in quotes from both releases? We did, so we took a closer look at the source. The second release covered a group of investigators from the University of Bristol – the same group, and the same study, in fact, as the first one.
So there you have it. One study, two press releases, and one confused journalist. Thank you, science.
Music plus mushrooms equals therapy
Magic mushrooms have been used recreationally and medicinally for thousands of years, but researchers have found adding music could be a game changer in antidepressant treatment.
The ingredient that makes these mushrooms so magical is psilocybin. It works well for the clinical treatment of mental health conditions and some forms of depression because the “trip” can be contained to one work day, making it easy to administer under supervision. With the accompaniment of music, scientists have found that psilocybin evokes emotion.
This recent study, presented at the European College of Neuropsychopharmacology Congress in Lisbon, tested participants’ emotional response to music before and after the psilocybin. Ketanserin, an antihypertensive drug, was used to test against the effects of psilocybin. The scientist played Mozart and Elgar and found that participants on psilocybin had an emotional response increase of 60%. That response was even greater, compared with ketanserin, which actually lessened the emotional response to music.
“This shows that combination of psilocybin and music has a strong emotional effect, and we believe that this will be important for the therapeutic application of psychedelics if they are approved for clinical use,” said lead researcher Dea Siggaard Stenbæk of the University of Copenhagen.
Professor David J. Nutt of Imperial College in London, who was not involved in the study, said that it supports the use of music for treatment efficacy with psychedelics and suggested that the next step is to “optimise this approach probably through individualising and personalising music tracks in therapy.”
Cue the 1960s LSD music montage.
Chicken ‘white striping is not a disease’
Have you ever sliced open a new pack of chicken breasts to start dinner and noticed white fatty lines running through the chicken? Maybe you thought it was just some extra fat to trim off, but the Humane League calls it “white striping disease.”
Chicken is the No. 1 meat consumed by Americans, so it’s not surprising that chickens are factory farmed and raised to be ready for slaughter quickly, according to CBSNews.com, which reported that the Humane League claims white striping is found in 70% of the chicken in popular grocery stores. The league expressed concern for the chickens’ welfare as they are bred to grow bigger quickly, which is causing the white striping and increasing the fat content of the meat by as much as 224%.
The National Chicken Council told CBS that the league’s findings were unscientific. A spokesperson said, “White striping is not a disease. It is a quality factor in chicken breast meat caused by deposits of fat in the muscle during the bird’s growth and development.” He went on to say that severe white striping happens in 3%-6% of birds, which are mostly used in further processed products, not in chicken breast packages.
Somehow, that’s not making us feel any better.
The itsy bitsy spider lets us all down
Most people do not like spiders. That’s too bad, because spiders are generally nothing but helpful little creatures that prey upon annoying flies and other pests. Then there’s the silk they produce. The ancient Romans used it to treat conditions such as warts and skin lesions. Spiders wrap their eggs in silk to protect them from harmful bacteria.
Of course, we can hardly trust the medical opinions of people from 2,000 years ago, but modern-day studies have not definitively proved whether or not spider silk has any antimicrobial properties.
To settle the matter once and for all, researchers from Denmark built a silk-harvesting machine using the most famous of Danish inventions: Legos. The contraption, sort of a paddle wheel, pulled the silk from several different species of spider pinned down by the researchers. The silk was then tested against three different bacteria species, including good old Escherichia coli.
Unfortunately for our spider friends, their silk has no antimicrobial activity. The researchers suspected that any such activity seen in previous studies was actually caused by improper control for the solvents used to extract the silk; those solvents can have antimicrobial properties on their own. As for protecting their eggs, rather than killing bacteria, the silk likely provides a physical barrier alone.
It is bad news for spiders on the benefit-to-humanity front, but look at the bright side: If their silk had antimicrobial activity, we’d have to start farming them to acquire more silk. And that’s no good. Spiders deserve to roam free, hunt as they please, and drop down on your head from the ceiling.
Anxiety and allergies: Cause, effect, confusion
We’re big fans of science, but as longtime, totally impartial (Science rules!) observers of science’s medical realm, we can see that the day-to-day process of practicing the scientific method occasionally gets a bit messy. And no, we’re not talking about COVID-19.
We’re talking allergies. We’re talking mental health. We’re talking allergic disease and mental health.
We’re talking about a pair of press releases we came across during our never-ending search for material to educate, entertain, and astound our fabulously wonderful and loyal readers. (We say that, of course, in the most impartial way possible.)
The first release was titled, “Allergies including asthma and hay fever not linked to mental health traits” and covered research from the University of Bristol (England). The investigators were trying to determine if “allergic diseases actually causes mental health traits including anxiety, depression, bipolar disorder, and schizophrenia, or vice versa,” according to the release.
What they found, however, was “little evidence of a causal relationship between the onset of allergic disease and mental health.” Again, this is the press release talking.
The second release seemed to suggest the exact opposite: “Study uncovers link between allergies and mental health conditions.” That got our attention. A little more reading revealed that “people with asthma, atopic dermatitis, and hay fever also had a higher likelihood of having depression, anxiety, bipolar disorder, or neuroticism.”
One of the investigators was quoted as saying, “Establishing whether allergic disease causes mental health problems, or vice versa, is important to ensure that resources and treatment strategies are targeted appropriately.”
Did you notice the “vice versa”? Did you notice that it appeared in quotes from both releases? We did, so we took a closer look at the source. The second release covered a group of investigators from the University of Bristol – the same group, and the same study, in fact, as the first one.
So there you have it. One study, two press releases, and one confused journalist. Thank you, science.
Music plus mushrooms equals therapy
Magic mushrooms have been used recreationally and medicinally for thousands of years, but researchers have found adding music could be a game changer in antidepressant treatment.
The ingredient that makes these mushrooms so magical is psilocybin. It works well for the clinical treatment of mental health conditions and some forms of depression because the “trip” can be contained to one work day, making it easy to administer under supervision. With the accompaniment of music, scientists have found that psilocybin evokes emotion.
This recent study, presented at the European College of Neuropsychopharmacology Congress in Lisbon, tested participants’ emotional response to music before and after the psilocybin. Ketanserin, an antihypertensive drug, was used to test against the effects of psilocybin. The scientist played Mozart and Elgar and found that participants on psilocybin had an emotional response increase of 60%. That response was even greater, compared with ketanserin, which actually lessened the emotional response to music.
“This shows that combination of psilocybin and music has a strong emotional effect, and we believe that this will be important for the therapeutic application of psychedelics if they are approved for clinical use,” said lead researcher Dea Siggaard Stenbæk of the University of Copenhagen.
Professor David J. Nutt of Imperial College in London, who was not involved in the study, said that it supports the use of music for treatment efficacy with psychedelics and suggested that the next step is to “optimise this approach probably through individualising and personalising music tracks in therapy.”
Cue the 1960s LSD music montage.
Chicken ‘white striping is not a disease’
Have you ever sliced open a new pack of chicken breasts to start dinner and noticed white fatty lines running through the chicken? Maybe you thought it was just some extra fat to trim off, but the Humane League calls it “white striping disease.”
Chicken is the No. 1 meat consumed by Americans, so it’s not surprising that chickens are factory farmed and raised to be ready for slaughter quickly, according to CBSNews.com, which reported that the Humane League claims white striping is found in 70% of the chicken in popular grocery stores. The league expressed concern for the chickens’ welfare as they are bred to grow bigger quickly, which is causing the white striping and increasing the fat content of the meat by as much as 224%.
The National Chicken Council told CBS that the league’s findings were unscientific. A spokesperson said, “White striping is not a disease. It is a quality factor in chicken breast meat caused by deposits of fat in the muscle during the bird’s growth and development.” He went on to say that severe white striping happens in 3%-6% of birds, which are mostly used in further processed products, not in chicken breast packages.
Somehow, that’s not making us feel any better.
The itsy bitsy spider lets us all down
Most people do not like spiders. That’s too bad, because spiders are generally nothing but helpful little creatures that prey upon annoying flies and other pests. Then there’s the silk they produce. The ancient Romans used it to treat conditions such as warts and skin lesions. Spiders wrap their eggs in silk to protect them from harmful bacteria.
Of course, we can hardly trust the medical opinions of people from 2,000 years ago, but modern-day studies have not definitively proved whether or not spider silk has any antimicrobial properties.
To settle the matter once and for all, researchers from Denmark built a silk-harvesting machine using the most famous of Danish inventions: Legos. The contraption, sort of a paddle wheel, pulled the silk from several different species of spider pinned down by the researchers. The silk was then tested against three different bacteria species, including good old Escherichia coli.
Unfortunately for our spider friends, their silk has no antimicrobial activity. The researchers suspected that any such activity seen in previous studies was actually caused by improper control for the solvents used to extract the silk; those solvents can have antimicrobial properties on their own. As for protecting their eggs, rather than killing bacteria, the silk likely provides a physical barrier alone.
It is bad news for spiders on the benefit-to-humanity front, but look at the bright side: If their silk had antimicrobial activity, we’d have to start farming them to acquire more silk. And that’s no good. Spiders deserve to roam free, hunt as they please, and drop down on your head from the ceiling.
Anxiety and allergies: Cause, effect, confusion
We’re big fans of science, but as longtime, totally impartial (Science rules!) observers of science’s medical realm, we can see that the day-to-day process of practicing the scientific method occasionally gets a bit messy. And no, we’re not talking about COVID-19.
We’re talking allergies. We’re talking mental health. We’re talking allergic disease and mental health.
We’re talking about a pair of press releases we came across during our never-ending search for material to educate, entertain, and astound our fabulously wonderful and loyal readers. (We say that, of course, in the most impartial way possible.)
The first release was titled, “Allergies including asthma and hay fever not linked to mental health traits” and covered research from the University of Bristol (England). The investigators were trying to determine if “allergic diseases actually causes mental health traits including anxiety, depression, bipolar disorder, and schizophrenia, or vice versa,” according to the release.
What they found, however, was “little evidence of a causal relationship between the onset of allergic disease and mental health.” Again, this is the press release talking.
The second release seemed to suggest the exact opposite: “Study uncovers link between allergies and mental health conditions.” That got our attention. A little more reading revealed that “people with asthma, atopic dermatitis, and hay fever also had a higher likelihood of having depression, anxiety, bipolar disorder, or neuroticism.”
One of the investigators was quoted as saying, “Establishing whether allergic disease causes mental health problems, or vice versa, is important to ensure that resources and treatment strategies are targeted appropriately.”
Did you notice the “vice versa”? Did you notice that it appeared in quotes from both releases? We did, so we took a closer look at the source. The second release covered a group of investigators from the University of Bristol – the same group, and the same study, in fact, as the first one.
So there you have it. One study, two press releases, and one confused journalist. Thank you, science.
Cut risedronate drug holiday to under 2 years in older patients
Any pause in taking the osteoporosis drug risedronate (Actonel) should last no longer than 2 years rather than the 2-3 years currently recommended for bisphosphonates, new research suggests.
In a cohort of patients aged 66 and older in Ontario, Canada, those who had been taking risedronate had a 34% greater risk of a hip fracture during year 2 to year 3 of a pause in taking the drug – a drug holiday – compared with those who had been taking alendronate (Fosamax).
The study showed that “risedronate, which has a shorter half-life, confers relatively less hip fracture protection than alendronate during drug holidays longer than 2 years and careful monitoring and follow-up after 2 years is likely warranted,” Kaley (Kaleen) N. Hayes, Pharm D, PhD, summarized in an oral presentation at the annual meeting of the American Society for Bone and Mineral Research. Dr. Hayes is an assistant professor in the department of health services, policy, and practice at Brown University School of Public Health, Providence, R.I.
“Although alendronate and risedronate have similar effectiveness for preventing fractures on treatment, our findings suggest that older patients on a risedronate drug holiday may benefit from assessment to consider resuming therapy after 2 years to prevent hip fractures,” she elaborated in an email.
Juliet Compston, MD, identified this study as one of the meeting’s clinical science highlights.
“This is the first study to directly compare fracture incidence during a drug holiday after treatment with the two most commonly prescribed oral bisphosphonates, alendronate and risedronate,” she told this news organization in an email.
The difference in fracture incidence during the 3-year drug holiday is “consistent with the known difference in pharmacokinetic properties of the two drugs,” noted Dr. Compston, professor of bone medicine and honorary consultant physician at the University of Cambridge (England) School of Clinical Medicine.
Since the increased risk of fracture after stopping risedronate vs. alendronate was seen by 2 years, “reevaluation of risk in risedronate-treated patients should therefore be considered earlier than the recommended period of 2-3 years after discontinuation,” she said.
“The study does not provide information about the optimal duration of drug holiday for either risedronate or alendronate, but it supports a shorter duration for the former of up to 2 years,” according to Dr. Compston.
Study rationale and findings
“The question of whether people treated for osteoporosis with oral bisphosphonates should have drug holidays is controversial,” Dr. Compston noted, “but many guidelines recommend that in lower-risk individuals who have received bisphosphonates for 5 years, a break from treatment of 2-3 years should be considered.”
Five or more years of bisphosphonate treatment for osteoporosis has been associated with rare adverse effects such as atypical femoral fractures, and these drugs appear to have fracture protection effects that linger for a while, so a drug holiday is recommended for most patients, Dr. Hayes added.
Guidelines such as the 2016 ASBMR task force report on long-term bisphosphonates for osteoporosis, she continued, “acknowledge that evidence for this recommendation comes primarily from the extension trial for alendronate, and patients undergoing a risedronate drug holiday may need to be reassessed earlier because of risedronate’s shorter half-life.”
Compared with alendronate, risedronate accumulates less in the bone and is eliminated more quickly from the body, so its fracture protection during drug holidays may be shorter.
The researchers aimed to estimate the 3-year fracture risk after discontinuing long-term (3 or more years) risedronate vs. alendronate therapy among older adults in Ontario.
From health care administrative data, they identified 120,368 patients aged 66 years and older who had started taking risedronate or alendronate as initial therapy for osteoporosis during the period 2000-2016. They had taken the therapy for 3 or more years (with at least 80% adherence) before stopping it for 120 days or longer.
The researchers found that 45% of patients were taking risedronate and 55% were taking alendronate, which are the main bisphosphonates used in Ontario, Dr. Hayes noted. Etidronate (Didronel) is recommended as second-line therapy and accounts for less than 2% of patients starting oral bisphosphonate therapy.
In an earlier study, the researchers identified a shift toward greater use of risedronate than alendronate since 2008, likely related to newer formulations (for example, monthly and weekly delayed-release formulations of risedronate vs. only weekly alendronate formulations).
The researchers matched 25,077 patients taking alendronate with 25,077 patients taking risedronate, based on fracture risk–related characteristics, including demographics, diagnoses, medication use, and health care use.
The patients had a mean age of 74 when they started taking an oral bisphosphonate; 82% were women and most were White.
Most patients (78%) had received a prescription from a general practitioner and, on average, they took the bisphosphonate therapy for 5.9 years before the drug holiday.
The primary outcome of incident hip fracture during a 3-year drug holiday occurred in 915 patients. There were 12.4 events per 1,000 patients in the risedronate group vs. 10.6 events per 1,000 patients in the alendronate group (hazard ratio, 1.18; 95% confidence interval, 1.04-1.34).
The risks were not significantly higher during year 1 or year 2 of the drug holiday, but the curves began to diverge after 2 years, coauthor Suzanne Cadarette, PhD, of the Leslie Dan Faculty of Pharmacy at the University of Toronto, explained when replying to a question after the presentation. Dr. Cadarette supervised this PhD dissertation research by Dr. Hayes.
The researchers acknowledged that the limitations of their study include a lack of information about race or bone mineral density, and the findings may not apply to a younger, more racially diverse population.
The research was supported by the University of Toronto Dalla Lana School of Public Health and the Leslie Dan Faculty of Pharmacy, a Canadian Institutes of Health Research grant, and a doctoral research award. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Any pause in taking the osteoporosis drug risedronate (Actonel) should last no longer than 2 years rather than the 2-3 years currently recommended for bisphosphonates, new research suggests.
In a cohort of patients aged 66 and older in Ontario, Canada, those who had been taking risedronate had a 34% greater risk of a hip fracture during year 2 to year 3 of a pause in taking the drug – a drug holiday – compared with those who had been taking alendronate (Fosamax).
The study showed that “risedronate, which has a shorter half-life, confers relatively less hip fracture protection than alendronate during drug holidays longer than 2 years and careful monitoring and follow-up after 2 years is likely warranted,” Kaley (Kaleen) N. Hayes, Pharm D, PhD, summarized in an oral presentation at the annual meeting of the American Society for Bone and Mineral Research. Dr. Hayes is an assistant professor in the department of health services, policy, and practice at Brown University School of Public Health, Providence, R.I.
“Although alendronate and risedronate have similar effectiveness for preventing fractures on treatment, our findings suggest that older patients on a risedronate drug holiday may benefit from assessment to consider resuming therapy after 2 years to prevent hip fractures,” she elaborated in an email.
Juliet Compston, MD, identified this study as one of the meeting’s clinical science highlights.
“This is the first study to directly compare fracture incidence during a drug holiday after treatment with the two most commonly prescribed oral bisphosphonates, alendronate and risedronate,” she told this news organization in an email.
The difference in fracture incidence during the 3-year drug holiday is “consistent with the known difference in pharmacokinetic properties of the two drugs,” noted Dr. Compston, professor of bone medicine and honorary consultant physician at the University of Cambridge (England) School of Clinical Medicine.
Since the increased risk of fracture after stopping risedronate vs. alendronate was seen by 2 years, “reevaluation of risk in risedronate-treated patients should therefore be considered earlier than the recommended period of 2-3 years after discontinuation,” she said.
“The study does not provide information about the optimal duration of drug holiday for either risedronate or alendronate, but it supports a shorter duration for the former of up to 2 years,” according to Dr. Compston.
Study rationale and findings
“The question of whether people treated for osteoporosis with oral bisphosphonates should have drug holidays is controversial,” Dr. Compston noted, “but many guidelines recommend that in lower-risk individuals who have received bisphosphonates for 5 years, a break from treatment of 2-3 years should be considered.”
Five or more years of bisphosphonate treatment for osteoporosis has been associated with rare adverse effects such as atypical femoral fractures, and these drugs appear to have fracture protection effects that linger for a while, so a drug holiday is recommended for most patients, Dr. Hayes added.
Guidelines such as the 2016 ASBMR task force report on long-term bisphosphonates for osteoporosis, she continued, “acknowledge that evidence for this recommendation comes primarily from the extension trial for alendronate, and patients undergoing a risedronate drug holiday may need to be reassessed earlier because of risedronate’s shorter half-life.”
Compared with alendronate, risedronate accumulates less in the bone and is eliminated more quickly from the body, so its fracture protection during drug holidays may be shorter.
The researchers aimed to estimate the 3-year fracture risk after discontinuing long-term (3 or more years) risedronate vs. alendronate therapy among older adults in Ontario.
From health care administrative data, they identified 120,368 patients aged 66 years and older who had started taking risedronate or alendronate as initial therapy for osteoporosis during the period 2000-2016. They had taken the therapy for 3 or more years (with at least 80% adherence) before stopping it for 120 days or longer.
The researchers found that 45% of patients were taking risedronate and 55% were taking alendronate, which are the main bisphosphonates used in Ontario, Dr. Hayes noted. Etidronate (Didronel) is recommended as second-line therapy and accounts for less than 2% of patients starting oral bisphosphonate therapy.
In an earlier study, the researchers identified a shift toward greater use of risedronate than alendronate since 2008, likely related to newer formulations (for example, monthly and weekly delayed-release formulations of risedronate vs. only weekly alendronate formulations).
The researchers matched 25,077 patients taking alendronate with 25,077 patients taking risedronate, based on fracture risk–related characteristics, including demographics, diagnoses, medication use, and health care use.
The patients had a mean age of 74 when they started taking an oral bisphosphonate; 82% were women and most were White.
Most patients (78%) had received a prescription from a general practitioner and, on average, they took the bisphosphonate therapy for 5.9 years before the drug holiday.
The primary outcome of incident hip fracture during a 3-year drug holiday occurred in 915 patients. There were 12.4 events per 1,000 patients in the risedronate group vs. 10.6 events per 1,000 patients in the alendronate group (hazard ratio, 1.18; 95% confidence interval, 1.04-1.34).
The risks were not significantly higher during year 1 or year 2 of the drug holiday, but the curves began to diverge after 2 years, coauthor Suzanne Cadarette, PhD, of the Leslie Dan Faculty of Pharmacy at the University of Toronto, explained when replying to a question after the presentation. Dr. Cadarette supervised this PhD dissertation research by Dr. Hayes.
The researchers acknowledged that the limitations of their study include a lack of information about race or bone mineral density, and the findings may not apply to a younger, more racially diverse population.
The research was supported by the University of Toronto Dalla Lana School of Public Health and the Leslie Dan Faculty of Pharmacy, a Canadian Institutes of Health Research grant, and a doctoral research award. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Any pause in taking the osteoporosis drug risedronate (Actonel) should last no longer than 2 years rather than the 2-3 years currently recommended for bisphosphonates, new research suggests.
In a cohort of patients aged 66 and older in Ontario, Canada, those who had been taking risedronate had a 34% greater risk of a hip fracture during year 2 to year 3 of a pause in taking the drug – a drug holiday – compared with those who had been taking alendronate (Fosamax).
The study showed that “risedronate, which has a shorter half-life, confers relatively less hip fracture protection than alendronate during drug holidays longer than 2 years and careful monitoring and follow-up after 2 years is likely warranted,” Kaley (Kaleen) N. Hayes, Pharm D, PhD, summarized in an oral presentation at the annual meeting of the American Society for Bone and Mineral Research. Dr. Hayes is an assistant professor in the department of health services, policy, and practice at Brown University School of Public Health, Providence, R.I.
“Although alendronate and risedronate have similar effectiveness for preventing fractures on treatment, our findings suggest that older patients on a risedronate drug holiday may benefit from assessment to consider resuming therapy after 2 years to prevent hip fractures,” she elaborated in an email.
Juliet Compston, MD, identified this study as one of the meeting’s clinical science highlights.
“This is the first study to directly compare fracture incidence during a drug holiday after treatment with the two most commonly prescribed oral bisphosphonates, alendronate and risedronate,” she told this news organization in an email.
The difference in fracture incidence during the 3-year drug holiday is “consistent with the known difference in pharmacokinetic properties of the two drugs,” noted Dr. Compston, professor of bone medicine and honorary consultant physician at the University of Cambridge (England) School of Clinical Medicine.
Since the increased risk of fracture after stopping risedronate vs. alendronate was seen by 2 years, “reevaluation of risk in risedronate-treated patients should therefore be considered earlier than the recommended period of 2-3 years after discontinuation,” she said.
“The study does not provide information about the optimal duration of drug holiday for either risedronate or alendronate, but it supports a shorter duration for the former of up to 2 years,” according to Dr. Compston.
Study rationale and findings
“The question of whether people treated for osteoporosis with oral bisphosphonates should have drug holidays is controversial,” Dr. Compston noted, “but many guidelines recommend that in lower-risk individuals who have received bisphosphonates for 5 years, a break from treatment of 2-3 years should be considered.”
Five or more years of bisphosphonate treatment for osteoporosis has been associated with rare adverse effects such as atypical femoral fractures, and these drugs appear to have fracture protection effects that linger for a while, so a drug holiday is recommended for most patients, Dr. Hayes added.
Guidelines such as the 2016 ASBMR task force report on long-term bisphosphonates for osteoporosis, she continued, “acknowledge that evidence for this recommendation comes primarily from the extension trial for alendronate, and patients undergoing a risedronate drug holiday may need to be reassessed earlier because of risedronate’s shorter half-life.”
Compared with alendronate, risedronate accumulates less in the bone and is eliminated more quickly from the body, so its fracture protection during drug holidays may be shorter.
The researchers aimed to estimate the 3-year fracture risk after discontinuing long-term (3 or more years) risedronate vs. alendronate therapy among older adults in Ontario.
From health care administrative data, they identified 120,368 patients aged 66 years and older who had started taking risedronate or alendronate as initial therapy for osteoporosis during the period 2000-2016. They had taken the therapy for 3 or more years (with at least 80% adherence) before stopping it for 120 days or longer.
The researchers found that 45% of patients were taking risedronate and 55% were taking alendronate, which are the main bisphosphonates used in Ontario, Dr. Hayes noted. Etidronate (Didronel) is recommended as second-line therapy and accounts for less than 2% of patients starting oral bisphosphonate therapy.
In an earlier study, the researchers identified a shift toward greater use of risedronate than alendronate since 2008, likely related to newer formulations (for example, monthly and weekly delayed-release formulations of risedronate vs. only weekly alendronate formulations).
The researchers matched 25,077 patients taking alendronate with 25,077 patients taking risedronate, based on fracture risk–related characteristics, including demographics, diagnoses, medication use, and health care use.
The patients had a mean age of 74 when they started taking an oral bisphosphonate; 82% were women and most were White.
Most patients (78%) had received a prescription from a general practitioner and, on average, they took the bisphosphonate therapy for 5.9 years before the drug holiday.
The primary outcome of incident hip fracture during a 3-year drug holiday occurred in 915 patients. There were 12.4 events per 1,000 patients in the risedronate group vs. 10.6 events per 1,000 patients in the alendronate group (hazard ratio, 1.18; 95% confidence interval, 1.04-1.34).
The risks were not significantly higher during year 1 or year 2 of the drug holiday, but the curves began to diverge after 2 years, coauthor Suzanne Cadarette, PhD, of the Leslie Dan Faculty of Pharmacy at the University of Toronto, explained when replying to a question after the presentation. Dr. Cadarette supervised this PhD dissertation research by Dr. Hayes.
The researchers acknowledged that the limitations of their study include a lack of information about race or bone mineral density, and the findings may not apply to a younger, more racially diverse population.
The research was supported by the University of Toronto Dalla Lana School of Public Health and the Leslie Dan Faculty of Pharmacy, a Canadian Institutes of Health Research grant, and a doctoral research award. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASBMR 2021
Men die more often than women after bariatric surgery
Men had a much higher rate of death following bariatric surgery performed in Austria during 2010-2018, compared with women in a retrospective analysis of nearly 20,000 patients based on health insurance records.
The reason may be that men undergoing bariatric surgery have “worse overall health at the time of surgery” than women, Hannes Beiglböck, MD, suggested at the annual meeting of the European Association for the Study of Diabetes.
The results also showed that “men tend to be older [at time of surgery] and that might have the biggest impact on outcomes after bariatric surgery,” said Dr. Beiglböck, a researcher in the division of endocrinology and metabolism at the Medical University of Vienna.
The findings confirm those of prior studies in various worldwide locations, he noted; that is, men undergoing bariatric surgery tend to be older than women and have more comorbidities and perioperative mortality.
Dr. Beiglböck also highlighted earlier reports that indicate “profound” sex-specific differences in why patients undergo bariatric surgery, with men often driven by a medical condition and women motivated by appearance.
Hence, for men, it may be important to focus on preoperative counseling to try to get them to think about bariatric surgery earlier, “which may improve their postsurgical mortality rate,” he observed.
Nearly threefold higher mortality among men
Dr. Beiglböck and associates used medical claims data filed with the Austrian health system, which includes nearly all residents. In 2010-2018, 19,901 Austrian patients underwent bariatric surgery, and researchers tracked their outcomes for a median of 5.4 years, through April 2020.
During the 9-year period, 74% of patients who underwent bariatric surgery were women, again, a finding consistent with prior reports from other countries.
The 5,220 men were an average of 41.8 years old, with 65% undergoing gastric bypass and 30% gastric banding. The 14,681 women were an average of 40.1 years old, with 70% undergoing gastric bypass and 22% gastric banding.
During follow-up, 367 patients (1.8%) died. Among men, the overall mortality rate was 2.6-fold higher, compared with women (1.3% vs. 3.4%) and average mortality per year was 2.8-fold higher (0.64% vs. 0.24%).
The rate of death on the day of surgery among men also substantially exceeded that of women (0.29% vs. 0.05%), as did death within 30 days of surgery (0.48% vs. 0.08%). All of these between-sex differences were significant.
Baseline prevalence of four categories of comorbidities and how these differed by sex among patients who died during follow-up was also examined. Underlying cardiovascular disease was prevalent in 299 patients (81% of the deceased group), 200 (54%) had a psychiatric disorder, 138 (38%) had diabetes, and 132 (36%) had a malignancy.
The prevalence of cardiovascular disease and psychiatric disorders was roughly the same in men and women. Men had a significantly higher prevalence of diabetes, and a higher proportion of women had a malignancy.
Consistent with U.S. studies
A U.S. report in 2015 documented a higher prevalence of comorbidities and more severe illness among men undergoing bariatric surgery, compared with women, noted session chair Zhila Semnani-Azad, PhD, a researcher in the department of nutrition at Harvard School of Public Health in Boston.
“I think the [Austrian] data presented have relevance to the U.S. population,” Dr. Semnani-Azad said in an interview.
“The main limitation of these univariate analyses is they don’t account for potential confounding variables that could affect the association, such as lifestyle variables, age, and family history. There is always potential for other variables” to influence apparent sex-specific associations, she commented. Another limitation is the small total number of deaths analyzed, at 367.
“These results are a good starting point for future studies. More work is needed to better understand the impact of comorbidities and sex on postsurgical mortality,” Dr. Semnani-Azad concluded.
Dr. Beiglböck and Dr. Semnani-Azad have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Men had a much higher rate of death following bariatric surgery performed in Austria during 2010-2018, compared with women in a retrospective analysis of nearly 20,000 patients based on health insurance records.
The reason may be that men undergoing bariatric surgery have “worse overall health at the time of surgery” than women, Hannes Beiglböck, MD, suggested at the annual meeting of the European Association for the Study of Diabetes.
The results also showed that “men tend to be older [at time of surgery] and that might have the biggest impact on outcomes after bariatric surgery,” said Dr. Beiglböck, a researcher in the division of endocrinology and metabolism at the Medical University of Vienna.
The findings confirm those of prior studies in various worldwide locations, he noted; that is, men undergoing bariatric surgery tend to be older than women and have more comorbidities and perioperative mortality.
Dr. Beiglböck also highlighted earlier reports that indicate “profound” sex-specific differences in why patients undergo bariatric surgery, with men often driven by a medical condition and women motivated by appearance.
Hence, for men, it may be important to focus on preoperative counseling to try to get them to think about bariatric surgery earlier, “which may improve their postsurgical mortality rate,” he observed.
Nearly threefold higher mortality among men
Dr. Beiglböck and associates used medical claims data filed with the Austrian health system, which includes nearly all residents. In 2010-2018, 19,901 Austrian patients underwent bariatric surgery, and researchers tracked their outcomes for a median of 5.4 years, through April 2020.
During the 9-year period, 74% of patients who underwent bariatric surgery were women, again, a finding consistent with prior reports from other countries.
The 5,220 men were an average of 41.8 years old, with 65% undergoing gastric bypass and 30% gastric banding. The 14,681 women were an average of 40.1 years old, with 70% undergoing gastric bypass and 22% gastric banding.
During follow-up, 367 patients (1.8%) died. Among men, the overall mortality rate was 2.6-fold higher, compared with women (1.3% vs. 3.4%) and average mortality per year was 2.8-fold higher (0.64% vs. 0.24%).
The rate of death on the day of surgery among men also substantially exceeded that of women (0.29% vs. 0.05%), as did death within 30 days of surgery (0.48% vs. 0.08%). All of these between-sex differences were significant.
Baseline prevalence of four categories of comorbidities and how these differed by sex among patients who died during follow-up was also examined. Underlying cardiovascular disease was prevalent in 299 patients (81% of the deceased group), 200 (54%) had a psychiatric disorder, 138 (38%) had diabetes, and 132 (36%) had a malignancy.
The prevalence of cardiovascular disease and psychiatric disorders was roughly the same in men and women. Men had a significantly higher prevalence of diabetes, and a higher proportion of women had a malignancy.
Consistent with U.S. studies
A U.S. report in 2015 documented a higher prevalence of comorbidities and more severe illness among men undergoing bariatric surgery, compared with women, noted session chair Zhila Semnani-Azad, PhD, a researcher in the department of nutrition at Harvard School of Public Health in Boston.
“I think the [Austrian] data presented have relevance to the U.S. population,” Dr. Semnani-Azad said in an interview.
“The main limitation of these univariate analyses is they don’t account for potential confounding variables that could affect the association, such as lifestyle variables, age, and family history. There is always potential for other variables” to influence apparent sex-specific associations, she commented. Another limitation is the small total number of deaths analyzed, at 367.
“These results are a good starting point for future studies. More work is needed to better understand the impact of comorbidities and sex on postsurgical mortality,” Dr. Semnani-Azad concluded.
Dr. Beiglböck and Dr. Semnani-Azad have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Men had a much higher rate of death following bariatric surgery performed in Austria during 2010-2018, compared with women in a retrospective analysis of nearly 20,000 patients based on health insurance records.
The reason may be that men undergoing bariatric surgery have “worse overall health at the time of surgery” than women, Hannes Beiglböck, MD, suggested at the annual meeting of the European Association for the Study of Diabetes.
The results also showed that “men tend to be older [at time of surgery] and that might have the biggest impact on outcomes after bariatric surgery,” said Dr. Beiglböck, a researcher in the division of endocrinology and metabolism at the Medical University of Vienna.
The findings confirm those of prior studies in various worldwide locations, he noted; that is, men undergoing bariatric surgery tend to be older than women and have more comorbidities and perioperative mortality.
Dr. Beiglböck also highlighted earlier reports that indicate “profound” sex-specific differences in why patients undergo bariatric surgery, with men often driven by a medical condition and women motivated by appearance.
Hence, for men, it may be important to focus on preoperative counseling to try to get them to think about bariatric surgery earlier, “which may improve their postsurgical mortality rate,” he observed.
Nearly threefold higher mortality among men
Dr. Beiglböck and associates used medical claims data filed with the Austrian health system, which includes nearly all residents. In 2010-2018, 19,901 Austrian patients underwent bariatric surgery, and researchers tracked their outcomes for a median of 5.4 years, through April 2020.
During the 9-year period, 74% of patients who underwent bariatric surgery were women, again, a finding consistent with prior reports from other countries.
The 5,220 men were an average of 41.8 years old, with 65% undergoing gastric bypass and 30% gastric banding. The 14,681 women were an average of 40.1 years old, with 70% undergoing gastric bypass and 22% gastric banding.
During follow-up, 367 patients (1.8%) died. Among men, the overall mortality rate was 2.6-fold higher, compared with women (1.3% vs. 3.4%) and average mortality per year was 2.8-fold higher (0.64% vs. 0.24%).
The rate of death on the day of surgery among men also substantially exceeded that of women (0.29% vs. 0.05%), as did death within 30 days of surgery (0.48% vs. 0.08%). All of these between-sex differences were significant.
Baseline prevalence of four categories of comorbidities and how these differed by sex among patients who died during follow-up was also examined. Underlying cardiovascular disease was prevalent in 299 patients (81% of the deceased group), 200 (54%) had a psychiatric disorder, 138 (38%) had diabetes, and 132 (36%) had a malignancy.
The prevalence of cardiovascular disease and psychiatric disorders was roughly the same in men and women. Men had a significantly higher prevalence of diabetes, and a higher proportion of women had a malignancy.
Consistent with U.S. studies
A U.S. report in 2015 documented a higher prevalence of comorbidities and more severe illness among men undergoing bariatric surgery, compared with women, noted session chair Zhila Semnani-Azad, PhD, a researcher in the department of nutrition at Harvard School of Public Health in Boston.
“I think the [Austrian] data presented have relevance to the U.S. population,” Dr. Semnani-Azad said in an interview.
“The main limitation of these univariate analyses is they don’t account for potential confounding variables that could affect the association, such as lifestyle variables, age, and family history. There is always potential for other variables” to influence apparent sex-specific associations, she commented. Another limitation is the small total number of deaths analyzed, at 367.
“These results are a good starting point for future studies. More work is needed to better understand the impact of comorbidities and sex on postsurgical mortality,” Dr. Semnani-Azad concluded.
Dr. Beiglböck and Dr. Semnani-Azad have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM EASD 2021
Exercise appears to improve bone structure, not density
“Postmenopausal women with low bone mass should obtain adequate calcium and vitamin D and participate in bone-loading exercises,” researchers noted in a recent study published in Osteoporosis International.
“Additional use of bisphosphonates will increase bone mineral density (BMD), especially at the spine,” wrote Nancy Waltman, PhD, College of Nursing, University of Nebraska Medical Center, Omaha, and colleagues.
The findings are partial results from the Heartland Osteoporosis Prevention Study (HOPS), which randomized women who had entered menopause within the previous 6 months and had osteopenia (low bone mass, T score –1.0 to –2.49) to receive one of three treatments for 12 months:
- Bone-loading and resistance exercise plus calcium and vitamin D supplements.
- Risedronate plus calcium and vitamin D supplements.
- Calcium and vitamin D supplements alone (control).
At 1 year, “risedronate significantly increased BMD at the spine, compared to exercise and control, and serum biomarkers of bone turnover also significantly reduced in the risedronate group,” Laura Bilek, PT, PhD, said during an oral presentation of the research at the annual meeting of the American Society for Bone and Mineral Research.
However, the results also showed that, importantly, “in postmenopausal women, exercise appears to improve strength at the hip through changes in structure, not BMD,” stressed Dr. Bilek, of the College of Allied Health Professionals, University of Nebraska Medical Center.
Bone health is about more than just bone mineral density
“The key takeaway for clinicians is that bone health is about more than just density!” she noted in an email.
Current guidelines don’t recommend prescribing risedronate until a woman has overt osteoporosis, she said.
On the other hand, many studies have shown that, to be most effective, bone-loading exercises should be a lifelong habit and women should begin to do them at least during menopause and should not wait until bone loss occurs.
Other studies have shown that exercise changes bone structure (size or geometry), which improves bone strength. The current study supports both prior observations.
And exercise also improves muscle strength and decreases the risk of falls and fractures, Dr. Bilek noted.
Invited to comment, Pauline M. Camacho, MD, cochair of the task force for the American Association of Clinical Endocrinologists (AACE) guidelines for osteoporosis, noted that all three measures – pharmacotherapy, exercise, and calcium/vitamin D – are important in the successful management of osteoporosis.
This study showed that risedronate is superior to calcium/vitamin D supplementation as well as exercise for BMD and for bone turnover in these women with osteopenia, said Dr. Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center, Loyola University Medical Center, Chicago.
“Most women with osteopenia do not receive pharmacologic therapy,” she noted, and receive it only “if there is a history of fractures or they have other features that change that diagnosis to osteoporosis.
“There is no downside to exercise, and this needs to be advised to all patients,” she said. “The other aspect of exercise that was not assessed in this study is its effect on balance. Patients who exercise will have improved balance, which should translate into fewer falls, and thus fewer fractures.”
How can women with osteopenia maintain bone health?
In their article, Dr. Waltman and colleagues say the Lifting Intervention for Training Muscle and Osteoporosis Rehabilitation (LIFTMOR) clinical trial is one of the first to address clinician concerns about the safety and effectiveness of exercise to improve bone health.
In that trial of 101 postmenopausal women with low bone mass, 8 months of 30-minute, twice-weekly, supervised high-intensity resistance and impact training was safe and BMD increased by 2.9% at the lumbar spine and 0.3% at the femoral neck.
“Our [HOPS] study,” Dr. Waltman and colleagues explained, “builds on the LIFTMOR clinical trial and adds further data to inform whether postmenopausal women with low bone mass can effectively maintain or even improve BMD with bone-loading exercises prior to prescriptions for medication.
“Our long-term goal is to contribute to the development of clinical practice guidelines for the prevention of fractures in postmenopausal women with low bone mass,” they said.
They randomized 276 postmenopausal women who were a mean age of 54 (range, 44-63); most were White (78%) or Hispanic (6%).
Women were excluded from the study if they had a diagnosis of osteoporosis (T-score < −2.5); had an increased risk of a major fracture or hip fracture; had been on bisphosphonates within the last 6 months; were currently on estrogen, tamoxifen, or aromatase inhibitors; had a serum vitamin D level < 10 mg/mL or > 100 mg/mL; had any conditions that prohibited prescriptions for calcium and vitamin D supplements, risedronate, or exercise; or weighed more than 300 pounds.
All women received 1,200 mg/day of calcium (from supplements or diet) and 1,000-3,000 IU/day of vitamin D supplements, based on their serum 25(OH) vitamin D levels.
The exercise program consisted of visiting a gym three times a week for 45 minutes of bone-loading exercise – jogging with a weighted vest – and resistance exercises, which were supervised by a trainer for the first 2 weeks.
Women in the risedronate group received a 150-mg tablet of risedronate every 4 weeks.
At baseline, 6 months, and 12 months, the women had DXA scans to determine BMD and hip structure, and had blood tests to determine levels of serum markers for bone formation (bone specific alkaline phosphatase [Alkphase B]) and bone resorption (N-terminal telopeptide [NTx]).
Compared with baseline, at 12 months, the women had the following changes in BMD at the following sites:
- Spine: +1.9%, +0.9%, and –0.4%, in the risedronate, exercise, and control groups.
- Total hip: +0.9%, +0.5%, and +0.5%, in the risedronate, exercise, and control groups.
- Femoral neck: +0.09%, –0.4%, and –0.5%, in the risedronate, exercise, and control groups.
These improvements in BMD were significantly greater in the risedronate group than in the exercise or control groups (P < .01 for both).
The decreases in serum levels of NtX and Alkphase B were also greater with risedronate than in the exercise or control groups (P < .01 for all).
The most frequent adverse effect with the calcium supplement was constipation (n = 4). Some women taking risedronate had gastrointestinal disturbances (n = 4), muscle or joint pain (n = 11), or chest pain and dizziness (n = 2). None of the women had adverse effects from vitamin D. A few women had muscle soreness from exercise that went away after the exercises were adapted. None of the women had a serious injury or fracture from exercise.
More women in the exercise group withdrew from the study (n = 20), with most citing lack of time as the reason; 13 women withdrew from the risedronate group, and 16 withdrew from the control group.
Of the 276 participants who completed the 12-month study, treatment adherence was 92% for calcium, 94% for vitamin D, 75% for risedronate, and 59% for exercise.
Exercise was associated with positive changes in intertrochanter hip structural analysis measures, which will be described in an upcoming study, Dr. Bilek said.
The study was funded by the National Institute of Nursing Research of the National Institutes of Health. The researchers have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“Postmenopausal women with low bone mass should obtain adequate calcium and vitamin D and participate in bone-loading exercises,” researchers noted in a recent study published in Osteoporosis International.
“Additional use of bisphosphonates will increase bone mineral density (BMD), especially at the spine,” wrote Nancy Waltman, PhD, College of Nursing, University of Nebraska Medical Center, Omaha, and colleagues.
The findings are partial results from the Heartland Osteoporosis Prevention Study (HOPS), which randomized women who had entered menopause within the previous 6 months and had osteopenia (low bone mass, T score –1.0 to –2.49) to receive one of three treatments for 12 months:
- Bone-loading and resistance exercise plus calcium and vitamin D supplements.
- Risedronate plus calcium and vitamin D supplements.
- Calcium and vitamin D supplements alone (control).
At 1 year, “risedronate significantly increased BMD at the spine, compared to exercise and control, and serum biomarkers of bone turnover also significantly reduced in the risedronate group,” Laura Bilek, PT, PhD, said during an oral presentation of the research at the annual meeting of the American Society for Bone and Mineral Research.
However, the results also showed that, importantly, “in postmenopausal women, exercise appears to improve strength at the hip through changes in structure, not BMD,” stressed Dr. Bilek, of the College of Allied Health Professionals, University of Nebraska Medical Center.
Bone health is about more than just bone mineral density
“The key takeaway for clinicians is that bone health is about more than just density!” she noted in an email.
Current guidelines don’t recommend prescribing risedronate until a woman has overt osteoporosis, she said.
On the other hand, many studies have shown that, to be most effective, bone-loading exercises should be a lifelong habit and women should begin to do them at least during menopause and should not wait until bone loss occurs.
Other studies have shown that exercise changes bone structure (size or geometry), which improves bone strength. The current study supports both prior observations.
And exercise also improves muscle strength and decreases the risk of falls and fractures, Dr. Bilek noted.
Invited to comment, Pauline M. Camacho, MD, cochair of the task force for the American Association of Clinical Endocrinologists (AACE) guidelines for osteoporosis, noted that all three measures – pharmacotherapy, exercise, and calcium/vitamin D – are important in the successful management of osteoporosis.
This study showed that risedronate is superior to calcium/vitamin D supplementation as well as exercise for BMD and for bone turnover in these women with osteopenia, said Dr. Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center, Loyola University Medical Center, Chicago.
“Most women with osteopenia do not receive pharmacologic therapy,” she noted, and receive it only “if there is a history of fractures or they have other features that change that diagnosis to osteoporosis.
“There is no downside to exercise, and this needs to be advised to all patients,” she said. “The other aspect of exercise that was not assessed in this study is its effect on balance. Patients who exercise will have improved balance, which should translate into fewer falls, and thus fewer fractures.”
How can women with osteopenia maintain bone health?
In their article, Dr. Waltman and colleagues say the Lifting Intervention for Training Muscle and Osteoporosis Rehabilitation (LIFTMOR) clinical trial is one of the first to address clinician concerns about the safety and effectiveness of exercise to improve bone health.
In that trial of 101 postmenopausal women with low bone mass, 8 months of 30-minute, twice-weekly, supervised high-intensity resistance and impact training was safe and BMD increased by 2.9% at the lumbar spine and 0.3% at the femoral neck.
“Our [HOPS] study,” Dr. Waltman and colleagues explained, “builds on the LIFTMOR clinical trial and adds further data to inform whether postmenopausal women with low bone mass can effectively maintain or even improve BMD with bone-loading exercises prior to prescriptions for medication.
“Our long-term goal is to contribute to the development of clinical practice guidelines for the prevention of fractures in postmenopausal women with low bone mass,” they said.
They randomized 276 postmenopausal women who were a mean age of 54 (range, 44-63); most were White (78%) or Hispanic (6%).
Women were excluded from the study if they had a diagnosis of osteoporosis (T-score < −2.5); had an increased risk of a major fracture or hip fracture; had been on bisphosphonates within the last 6 months; were currently on estrogen, tamoxifen, or aromatase inhibitors; had a serum vitamin D level < 10 mg/mL or > 100 mg/mL; had any conditions that prohibited prescriptions for calcium and vitamin D supplements, risedronate, or exercise; or weighed more than 300 pounds.
All women received 1,200 mg/day of calcium (from supplements or diet) and 1,000-3,000 IU/day of vitamin D supplements, based on their serum 25(OH) vitamin D levels.
The exercise program consisted of visiting a gym three times a week for 45 minutes of bone-loading exercise – jogging with a weighted vest – and resistance exercises, which were supervised by a trainer for the first 2 weeks.
Women in the risedronate group received a 150-mg tablet of risedronate every 4 weeks.
At baseline, 6 months, and 12 months, the women had DXA scans to determine BMD and hip structure, and had blood tests to determine levels of serum markers for bone formation (bone specific alkaline phosphatase [Alkphase B]) and bone resorption (N-terminal telopeptide [NTx]).
Compared with baseline, at 12 months, the women had the following changes in BMD at the following sites:
- Spine: +1.9%, +0.9%, and –0.4%, in the risedronate, exercise, and control groups.
- Total hip: +0.9%, +0.5%, and +0.5%, in the risedronate, exercise, and control groups.
- Femoral neck: +0.09%, –0.4%, and –0.5%, in the risedronate, exercise, and control groups.
These improvements in BMD were significantly greater in the risedronate group than in the exercise or control groups (P < .01 for both).
The decreases in serum levels of NtX and Alkphase B were also greater with risedronate than in the exercise or control groups (P < .01 for all).
The most frequent adverse effect with the calcium supplement was constipation (n = 4). Some women taking risedronate had gastrointestinal disturbances (n = 4), muscle or joint pain (n = 11), or chest pain and dizziness (n = 2). None of the women had adverse effects from vitamin D. A few women had muscle soreness from exercise that went away after the exercises were adapted. None of the women had a serious injury or fracture from exercise.
More women in the exercise group withdrew from the study (n = 20), with most citing lack of time as the reason; 13 women withdrew from the risedronate group, and 16 withdrew from the control group.
Of the 276 participants who completed the 12-month study, treatment adherence was 92% for calcium, 94% for vitamin D, 75% for risedronate, and 59% for exercise.
Exercise was associated with positive changes in intertrochanter hip structural analysis measures, which will be described in an upcoming study, Dr. Bilek said.
The study was funded by the National Institute of Nursing Research of the National Institutes of Health. The researchers have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“Postmenopausal women with low bone mass should obtain adequate calcium and vitamin D and participate in bone-loading exercises,” researchers noted in a recent study published in Osteoporosis International.
“Additional use of bisphosphonates will increase bone mineral density (BMD), especially at the spine,” wrote Nancy Waltman, PhD, College of Nursing, University of Nebraska Medical Center, Omaha, and colleagues.
The findings are partial results from the Heartland Osteoporosis Prevention Study (HOPS), which randomized women who had entered menopause within the previous 6 months and had osteopenia (low bone mass, T score –1.0 to –2.49) to receive one of three treatments for 12 months:
- Bone-loading and resistance exercise plus calcium and vitamin D supplements.
- Risedronate plus calcium and vitamin D supplements.
- Calcium and vitamin D supplements alone (control).
At 1 year, “risedronate significantly increased BMD at the spine, compared to exercise and control, and serum biomarkers of bone turnover also significantly reduced in the risedronate group,” Laura Bilek, PT, PhD, said during an oral presentation of the research at the annual meeting of the American Society for Bone and Mineral Research.
However, the results also showed that, importantly, “in postmenopausal women, exercise appears to improve strength at the hip through changes in structure, not BMD,” stressed Dr. Bilek, of the College of Allied Health Professionals, University of Nebraska Medical Center.
Bone health is about more than just bone mineral density
“The key takeaway for clinicians is that bone health is about more than just density!” she noted in an email.
Current guidelines don’t recommend prescribing risedronate until a woman has overt osteoporosis, she said.
On the other hand, many studies have shown that, to be most effective, bone-loading exercises should be a lifelong habit and women should begin to do them at least during menopause and should not wait until bone loss occurs.
Other studies have shown that exercise changes bone structure (size or geometry), which improves bone strength. The current study supports both prior observations.
And exercise also improves muscle strength and decreases the risk of falls and fractures, Dr. Bilek noted.
Invited to comment, Pauline M. Camacho, MD, cochair of the task force for the American Association of Clinical Endocrinologists (AACE) guidelines for osteoporosis, noted that all three measures – pharmacotherapy, exercise, and calcium/vitamin D – are important in the successful management of osteoporosis.
This study showed that risedronate is superior to calcium/vitamin D supplementation as well as exercise for BMD and for bone turnover in these women with osteopenia, said Dr. Camacho, professor of medicine and director of the Osteoporosis and Metabolic Bone Disease Center, Loyola University Medical Center, Chicago.
“Most women with osteopenia do not receive pharmacologic therapy,” she noted, and receive it only “if there is a history of fractures or they have other features that change that diagnosis to osteoporosis.
“There is no downside to exercise, and this needs to be advised to all patients,” she said. “The other aspect of exercise that was not assessed in this study is its effect on balance. Patients who exercise will have improved balance, which should translate into fewer falls, and thus fewer fractures.”
How can women with osteopenia maintain bone health?
In their article, Dr. Waltman and colleagues say the Lifting Intervention for Training Muscle and Osteoporosis Rehabilitation (LIFTMOR) clinical trial is one of the first to address clinician concerns about the safety and effectiveness of exercise to improve bone health.
In that trial of 101 postmenopausal women with low bone mass, 8 months of 30-minute, twice-weekly, supervised high-intensity resistance and impact training was safe and BMD increased by 2.9% at the lumbar spine and 0.3% at the femoral neck.
“Our [HOPS] study,” Dr. Waltman and colleagues explained, “builds on the LIFTMOR clinical trial and adds further data to inform whether postmenopausal women with low bone mass can effectively maintain or even improve BMD with bone-loading exercises prior to prescriptions for medication.
“Our long-term goal is to contribute to the development of clinical practice guidelines for the prevention of fractures in postmenopausal women with low bone mass,” they said.
They randomized 276 postmenopausal women who were a mean age of 54 (range, 44-63); most were White (78%) or Hispanic (6%).
Women were excluded from the study if they had a diagnosis of osteoporosis (T-score < −2.5); had an increased risk of a major fracture or hip fracture; had been on bisphosphonates within the last 6 months; were currently on estrogen, tamoxifen, or aromatase inhibitors; had a serum vitamin D level < 10 mg/mL or > 100 mg/mL; had any conditions that prohibited prescriptions for calcium and vitamin D supplements, risedronate, or exercise; or weighed more than 300 pounds.
All women received 1,200 mg/day of calcium (from supplements or diet) and 1,000-3,000 IU/day of vitamin D supplements, based on their serum 25(OH) vitamin D levels.
The exercise program consisted of visiting a gym three times a week for 45 minutes of bone-loading exercise – jogging with a weighted vest – and resistance exercises, which were supervised by a trainer for the first 2 weeks.
Women in the risedronate group received a 150-mg tablet of risedronate every 4 weeks.
At baseline, 6 months, and 12 months, the women had DXA scans to determine BMD and hip structure, and had blood tests to determine levels of serum markers for bone formation (bone specific alkaline phosphatase [Alkphase B]) and bone resorption (N-terminal telopeptide [NTx]).
Compared with baseline, at 12 months, the women had the following changes in BMD at the following sites:
- Spine: +1.9%, +0.9%, and –0.4%, in the risedronate, exercise, and control groups.
- Total hip: +0.9%, +0.5%, and +0.5%, in the risedronate, exercise, and control groups.
- Femoral neck: +0.09%, –0.4%, and –0.5%, in the risedronate, exercise, and control groups.
These improvements in BMD were significantly greater in the risedronate group than in the exercise or control groups (P < .01 for both).
The decreases in serum levels of NtX and Alkphase B were also greater with risedronate than in the exercise or control groups (P < .01 for all).
The most frequent adverse effect with the calcium supplement was constipation (n = 4). Some women taking risedronate had gastrointestinal disturbances (n = 4), muscle or joint pain (n = 11), or chest pain and dizziness (n = 2). None of the women had adverse effects from vitamin D. A few women had muscle soreness from exercise that went away after the exercises were adapted. None of the women had a serious injury or fracture from exercise.
More women in the exercise group withdrew from the study (n = 20), with most citing lack of time as the reason; 13 women withdrew from the risedronate group, and 16 withdrew from the control group.
Of the 276 participants who completed the 12-month study, treatment adherence was 92% for calcium, 94% for vitamin D, 75% for risedronate, and 59% for exercise.
Exercise was associated with positive changes in intertrochanter hip structural analysis measures, which will be described in an upcoming study, Dr. Bilek said.
The study was funded by the National Institute of Nursing Research of the National Institutes of Health. The researchers have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASBMR 2021
New York’s largest health care provider fires 1,400 unvaccinated employees
The employees represented less than 2% of Northwell’s 76,000 employees, who are now all fully vaccinated against COVID-19, Joe Kemp, the assistant vice president of public relations for the company, told The Hill.
“Northwell Health is proud to announce that our workforce -- the largest in New York State -- is 100% vaccinated,” the company said in a statement to several news outlets.
“This allows us to continue to provide exceptional care at all of our facilities, without interruption and remain open and fully operational,” Northwell Health said.
Having a fully vaccinated workforce is part of the health system’s duty to protect others, the company said. Northwell Health includes 23 hospitals and more than 830 outpatient facilities, according to ABC News.
“Northwell regrets losing any employee under such circumstances,” the company said. “We owe it to our staff, our patients, and the communities we serve to be 100% vaccinated against COVID-19.”
Former New York Gov. Andrew Cuomo announced in August that the state would require health care workers to receive at least one COVID-19 vaccine shot by Sept. 27. Employees didn’t have the option for weekly testing or religious exemptions, which is being challenged in several lawsuits, according to The New York Times.
The order went into effect last week, prompting tens of thousands of employees to get vaccinated. As of last week, 87% of hospital staff were fully vaccinated, and 92% of hospital and retirement home workers had received at least one dose, according to state health data.
Northwell announced its own vaccine mandate in August as well, which sparked protests among some workers. The order applied to both clinical and non-clinical staff.
A few thousand Northwell employees got vaccinated as the deadline approached, Mr. Kemp told The New York Times. Some who lost their jobs at first were able to return to work, and those who have been terminated can interview for reinstatement for 30 days. The hospital system is also “openly recruiting” for the vacant positions.
“The goal was to get people vaccinated, not to get people terminated,” Mr. Kemp said.
Hospitalized COVID-19 patients in New York hit a low of 350 in mid-July, according to state hospitalization data. Now, about 2,200 people are hospitalized throughout the state, most of whom are unvaccinated.
As of Oct. 3, nearly 72% of New York residents had received at least one vaccine dose, according to the latest state data. About 64% are fully vaccinated.
A version of this article first appeared on WebMD.com.
The employees represented less than 2% of Northwell’s 76,000 employees, who are now all fully vaccinated against COVID-19, Joe Kemp, the assistant vice president of public relations for the company, told The Hill.
“Northwell Health is proud to announce that our workforce -- the largest in New York State -- is 100% vaccinated,” the company said in a statement to several news outlets.
“This allows us to continue to provide exceptional care at all of our facilities, without interruption and remain open and fully operational,” Northwell Health said.
Having a fully vaccinated workforce is part of the health system’s duty to protect others, the company said. Northwell Health includes 23 hospitals and more than 830 outpatient facilities, according to ABC News.
“Northwell regrets losing any employee under such circumstances,” the company said. “We owe it to our staff, our patients, and the communities we serve to be 100% vaccinated against COVID-19.”
Former New York Gov. Andrew Cuomo announced in August that the state would require health care workers to receive at least one COVID-19 vaccine shot by Sept. 27. Employees didn’t have the option for weekly testing or religious exemptions, which is being challenged in several lawsuits, according to The New York Times.
The order went into effect last week, prompting tens of thousands of employees to get vaccinated. As of last week, 87% of hospital staff were fully vaccinated, and 92% of hospital and retirement home workers had received at least one dose, according to state health data.
Northwell announced its own vaccine mandate in August as well, which sparked protests among some workers. The order applied to both clinical and non-clinical staff.
A few thousand Northwell employees got vaccinated as the deadline approached, Mr. Kemp told The New York Times. Some who lost their jobs at first were able to return to work, and those who have been terminated can interview for reinstatement for 30 days. The hospital system is also “openly recruiting” for the vacant positions.
“The goal was to get people vaccinated, not to get people terminated,” Mr. Kemp said.
Hospitalized COVID-19 patients in New York hit a low of 350 in mid-July, according to state hospitalization data. Now, about 2,200 people are hospitalized throughout the state, most of whom are unvaccinated.
As of Oct. 3, nearly 72% of New York residents had received at least one vaccine dose, according to the latest state data. About 64% are fully vaccinated.
A version of this article first appeared on WebMD.com.
The employees represented less than 2% of Northwell’s 76,000 employees, who are now all fully vaccinated against COVID-19, Joe Kemp, the assistant vice president of public relations for the company, told The Hill.
“Northwell Health is proud to announce that our workforce -- the largest in New York State -- is 100% vaccinated,” the company said in a statement to several news outlets.
“This allows us to continue to provide exceptional care at all of our facilities, without interruption and remain open and fully operational,” Northwell Health said.
Having a fully vaccinated workforce is part of the health system’s duty to protect others, the company said. Northwell Health includes 23 hospitals and more than 830 outpatient facilities, according to ABC News.
“Northwell regrets losing any employee under such circumstances,” the company said. “We owe it to our staff, our patients, and the communities we serve to be 100% vaccinated against COVID-19.”
Former New York Gov. Andrew Cuomo announced in August that the state would require health care workers to receive at least one COVID-19 vaccine shot by Sept. 27. Employees didn’t have the option for weekly testing or religious exemptions, which is being challenged in several lawsuits, according to The New York Times.
The order went into effect last week, prompting tens of thousands of employees to get vaccinated. As of last week, 87% of hospital staff were fully vaccinated, and 92% of hospital and retirement home workers had received at least one dose, according to state health data.
Northwell announced its own vaccine mandate in August as well, which sparked protests among some workers. The order applied to both clinical and non-clinical staff.
A few thousand Northwell employees got vaccinated as the deadline approached, Mr. Kemp told The New York Times. Some who lost their jobs at first were able to return to work, and those who have been terminated can interview for reinstatement for 30 days. The hospital system is also “openly recruiting” for the vacant positions.
“The goal was to get people vaccinated, not to get people terminated,” Mr. Kemp said.
Hospitalized COVID-19 patients in New York hit a low of 350 in mid-July, according to state hospitalization data. Now, about 2,200 people are hospitalized throughout the state, most of whom are unvaccinated.
As of Oct. 3, nearly 72% of New York residents had received at least one vaccine dose, according to the latest state data. About 64% are fully vaccinated.
A version of this article first appeared on WebMD.com.
Statins tied to diabetes progression
Statin use is associated with increased likelihood of diabetes progression, according to a new matched cohort analysis of data from the Department of Veteran Affairs.
Patients with diabetes who were on statins were more likely to begin taking insulin, become hyperglycemic, and to develop acute glycemic complications, and they were also more likely to be prescribed medications from more glucose-lowering drug classes.
Although previous observational and randomized, controlled trials suggested a link between statin use and diabetes progression, they typically relied on measures like insulin resistance, hemoglobin A1c, or fasting blood glucose levels. The new work, however, outlines changes in glycemic control.
The differences between fasting glucose levels and A1c levels were generally smaller than the differences in insulin sensitivity. But A1c and fasting glucose may underestimate a potential effect of statins, since physicians may escalate antidiabetes therapy in response to changes.
Insulin sensitivity is also rarely measured in real-world settings. “This study translated findings reported on academic studies of increased insulin resistance associated with statin use in research papers into everyday language of patient care. That is, patients on statins may need to escalate their antidiabetes therapy and there may have higher occurrences of uncontrolled diabetes events,” lead author Ishak Mansi, MD, said in an interview.
The study was published online in JAMA Internal Medicine.
Dr. Mansi, who is staff internist at the VA North Texas Health System and a professor of medicine and data and population science at the University of Texas, both in Dallas, cautioned about overinterpretation of the findings. “This is an observational study; therefore, it can establish association, but not causation.”
No reason to turn down statins
Dr. Mansi noted that it’s important to distinguish between those being prescribed statins as a primary preventive measurement against cardiovascular disease, and those starting statins with preexisting cardiovascular disease for secondary prevention. Statins are a key therapeutic class for secondary prevention. “Their benefits are tremendous, and we should emphasize that no patient should stop taking their statins based on our study – rather, they should talk to their doctors,” said Dr. Mansi.
The study is one of few to look at statin use and diabetes progression in patients who already have diabetes, and the first with a propensity-matched design, according to Om Ganda, MD, who was asked for comment. The results should not deter physicians from prescribing and patients from accepting statins. “Statins should not be withheld in people with high risk of cardiovascular disease, even for primary prevention, as the risk of progression of glucose levels is relatively much smaller and manageable, rather than risking cardiovascular events by stopping or not initiating when indicated by current guidelines,” said Dr. Ganda, who is the medical director of the Lipid Clinic at the Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston.
It’s possible that statins could increase risk of diabetes progression through promoting insulin resistance, and they may also reduce beta-cell function, which could in turn reduce insulin secretion, according to Dr. Ganda.
The study group included 83,022 pairs of statin users and matched controls, of whom 95% were men; 68.2% were White; 22% were Black; 2.1% were Native American, Pacific Islander, or Alaska Native; and 0.8% were Asian. The mean age was 60 years.
Some 56% of statin users experienced diabetes progression, compared with 48% of control patients (odds ratio, 1.37; P < .001). Progression was defined as intensification of diabetes therapy through new use of insulin or increase in the number of medication classes, new onset chronic hyperglycemia, or acute complications from hyperglycemia.
The association was seen in the component measures, including an increased number of glucose-lowering medication classes (OR, 1.41; P < .001), the frequency of new insulin use (OR, 1.16; P < .001), persistent glycemia (OR, 1.13; P < .001), and a new diagnosis of ketoacidosis or uncontrolled diabetes (OR, 1.24; P < .001).
There was also a dose-response relationship between the intensity of LDL cholesterol–lowering medication and diabetes progression.
More research needed
The findings don’t necessarily have a strong clinical impact, but the researchers hope it pushes toward greater personalization of statin treatment. The benefits of statins have been well studied, but their potential harms have not received the same attention. Dr. Mansi hopes to learn more about which populations stand to gain the most for primary cardiovascular disease prevention, such as older versus younger populations, healthier or sicker patients, and those with well-controlled versus uncontrolled diabetes. “Answering these questions [would] impact hundreds of millions of patients and cannot be postponed,” said Dr. Mansi. He also called for dedicated funding for research into the adverse events of frequently used medications.
Dr. Mansi and Dr. Ganda have no relevant financial disclosures.
Statin use is associated with increased likelihood of diabetes progression, according to a new matched cohort analysis of data from the Department of Veteran Affairs.
Patients with diabetes who were on statins were more likely to begin taking insulin, become hyperglycemic, and to develop acute glycemic complications, and they were also more likely to be prescribed medications from more glucose-lowering drug classes.
Although previous observational and randomized, controlled trials suggested a link between statin use and diabetes progression, they typically relied on measures like insulin resistance, hemoglobin A1c, or fasting blood glucose levels. The new work, however, outlines changes in glycemic control.
The differences between fasting glucose levels and A1c levels were generally smaller than the differences in insulin sensitivity. But A1c and fasting glucose may underestimate a potential effect of statins, since physicians may escalate antidiabetes therapy in response to changes.
Insulin sensitivity is also rarely measured in real-world settings. “This study translated findings reported on academic studies of increased insulin resistance associated with statin use in research papers into everyday language of patient care. That is, patients on statins may need to escalate their antidiabetes therapy and there may have higher occurrences of uncontrolled diabetes events,” lead author Ishak Mansi, MD, said in an interview.
The study was published online in JAMA Internal Medicine.
Dr. Mansi, who is staff internist at the VA North Texas Health System and a professor of medicine and data and population science at the University of Texas, both in Dallas, cautioned about overinterpretation of the findings. “This is an observational study; therefore, it can establish association, but not causation.”
No reason to turn down statins
Dr. Mansi noted that it’s important to distinguish between those being prescribed statins as a primary preventive measurement against cardiovascular disease, and those starting statins with preexisting cardiovascular disease for secondary prevention. Statins are a key therapeutic class for secondary prevention. “Their benefits are tremendous, and we should emphasize that no patient should stop taking their statins based on our study – rather, they should talk to their doctors,” said Dr. Mansi.
The study is one of few to look at statin use and diabetes progression in patients who already have diabetes, and the first with a propensity-matched design, according to Om Ganda, MD, who was asked for comment. The results should not deter physicians from prescribing and patients from accepting statins. “Statins should not be withheld in people with high risk of cardiovascular disease, even for primary prevention, as the risk of progression of glucose levels is relatively much smaller and manageable, rather than risking cardiovascular events by stopping or not initiating when indicated by current guidelines,” said Dr. Ganda, who is the medical director of the Lipid Clinic at the Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston.
It’s possible that statins could increase risk of diabetes progression through promoting insulin resistance, and they may also reduce beta-cell function, which could in turn reduce insulin secretion, according to Dr. Ganda.
The study group included 83,022 pairs of statin users and matched controls, of whom 95% were men; 68.2% were White; 22% were Black; 2.1% were Native American, Pacific Islander, or Alaska Native; and 0.8% were Asian. The mean age was 60 years.
Some 56% of statin users experienced diabetes progression, compared with 48% of control patients (odds ratio, 1.37; P < .001). Progression was defined as intensification of diabetes therapy through new use of insulin or increase in the number of medication classes, new onset chronic hyperglycemia, or acute complications from hyperglycemia.
The association was seen in the component measures, including an increased number of glucose-lowering medication classes (OR, 1.41; P < .001), the frequency of new insulin use (OR, 1.16; P < .001), persistent glycemia (OR, 1.13; P < .001), and a new diagnosis of ketoacidosis or uncontrolled diabetes (OR, 1.24; P < .001).
There was also a dose-response relationship between the intensity of LDL cholesterol–lowering medication and diabetes progression.
More research needed
The findings don’t necessarily have a strong clinical impact, but the researchers hope it pushes toward greater personalization of statin treatment. The benefits of statins have been well studied, but their potential harms have not received the same attention. Dr. Mansi hopes to learn more about which populations stand to gain the most for primary cardiovascular disease prevention, such as older versus younger populations, healthier or sicker patients, and those with well-controlled versus uncontrolled diabetes. “Answering these questions [would] impact hundreds of millions of patients and cannot be postponed,” said Dr. Mansi. He also called for dedicated funding for research into the adverse events of frequently used medications.
Dr. Mansi and Dr. Ganda have no relevant financial disclosures.
Statin use is associated with increased likelihood of diabetes progression, according to a new matched cohort analysis of data from the Department of Veteran Affairs.
Patients with diabetes who were on statins were more likely to begin taking insulin, become hyperglycemic, and to develop acute glycemic complications, and they were also more likely to be prescribed medications from more glucose-lowering drug classes.
Although previous observational and randomized, controlled trials suggested a link between statin use and diabetes progression, they typically relied on measures like insulin resistance, hemoglobin A1c, or fasting blood glucose levels. The new work, however, outlines changes in glycemic control.
The differences between fasting glucose levels and A1c levels were generally smaller than the differences in insulin sensitivity. But A1c and fasting glucose may underestimate a potential effect of statins, since physicians may escalate antidiabetes therapy in response to changes.
Insulin sensitivity is also rarely measured in real-world settings. “This study translated findings reported on academic studies of increased insulin resistance associated with statin use in research papers into everyday language of patient care. That is, patients on statins may need to escalate their antidiabetes therapy and there may have higher occurrences of uncontrolled diabetes events,” lead author Ishak Mansi, MD, said in an interview.
The study was published online in JAMA Internal Medicine.
Dr. Mansi, who is staff internist at the VA North Texas Health System and a professor of medicine and data and population science at the University of Texas, both in Dallas, cautioned about overinterpretation of the findings. “This is an observational study; therefore, it can establish association, but not causation.”
No reason to turn down statins
Dr. Mansi noted that it’s important to distinguish between those being prescribed statins as a primary preventive measurement against cardiovascular disease, and those starting statins with preexisting cardiovascular disease for secondary prevention. Statins are a key therapeutic class for secondary prevention. “Their benefits are tremendous, and we should emphasize that no patient should stop taking their statins based on our study – rather, they should talk to their doctors,” said Dr. Mansi.
The study is one of few to look at statin use and diabetes progression in patients who already have diabetes, and the first with a propensity-matched design, according to Om Ganda, MD, who was asked for comment. The results should not deter physicians from prescribing and patients from accepting statins. “Statins should not be withheld in people with high risk of cardiovascular disease, even for primary prevention, as the risk of progression of glucose levels is relatively much smaller and manageable, rather than risking cardiovascular events by stopping or not initiating when indicated by current guidelines,” said Dr. Ganda, who is the medical director of the Lipid Clinic at the Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston.
It’s possible that statins could increase risk of diabetes progression through promoting insulin resistance, and they may also reduce beta-cell function, which could in turn reduce insulin secretion, according to Dr. Ganda.
The study group included 83,022 pairs of statin users and matched controls, of whom 95% were men; 68.2% were White; 22% were Black; 2.1% were Native American, Pacific Islander, or Alaska Native; and 0.8% were Asian. The mean age was 60 years.
Some 56% of statin users experienced diabetes progression, compared with 48% of control patients (odds ratio, 1.37; P < .001). Progression was defined as intensification of diabetes therapy through new use of insulin or increase in the number of medication classes, new onset chronic hyperglycemia, or acute complications from hyperglycemia.
The association was seen in the component measures, including an increased number of glucose-lowering medication classes (OR, 1.41; P < .001), the frequency of new insulin use (OR, 1.16; P < .001), persistent glycemia (OR, 1.13; P < .001), and a new diagnosis of ketoacidosis or uncontrolled diabetes (OR, 1.24; P < .001).
There was also a dose-response relationship between the intensity of LDL cholesterol–lowering medication and diabetes progression.
More research needed
The findings don’t necessarily have a strong clinical impact, but the researchers hope it pushes toward greater personalization of statin treatment. The benefits of statins have been well studied, but their potential harms have not received the same attention. Dr. Mansi hopes to learn more about which populations stand to gain the most for primary cardiovascular disease prevention, such as older versus younger populations, healthier or sicker patients, and those with well-controlled versus uncontrolled diabetes. “Answering these questions [would] impact hundreds of millions of patients and cannot be postponed,” said Dr. Mansi. He also called for dedicated funding for research into the adverse events of frequently used medications.
Dr. Mansi and Dr. Ganda have no relevant financial disclosures.
FROM JAMA INTERNAL MEDICINE