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Treating young adults with high LDL may be cost-effective
Treating elevated low-density lipoprotein cholesterol (LDL-C) in adults younger than 40 with statins is highly cost-effective in men, and intermediately cost-effective in women, a new report suggests.
In a simulated model based on data from the U.S. National Health and Nutrition Examination Survey (NHANES), lipid lowering with statins or lifestyle interventions in this age group would prevent or reduce the risk of atherosclerotic cardiovascular disease (ASCVD) and improve quality of life in later years.
The findings were published online Nov. 8 in the Journal of the American College of Cardiology.
“My group does epidemiologic analyses with cohort studies as well as health economic analyses like this one, and if you have long-term longitudinal observation, you see that the early exposures are important for what happens later,” senior author Andrew E. Moran, MD, Columbia University Irving Medical Center, New York, told this news organization.
“But when it comes to treatment studies that a lot of the treatment guidelines are based on, those are usually short-term, and they usually enroll older people. We saw the gap in the evidence that this paper tries to fill,” Dr. Moran said.
His group used a computer simulation model to synthesize evidence from observational cohort studies and clinical trials of statin treatment, as well as health services data on the costs of medicines and treatments.
Combining information from these sources, the investigators made their best estimates of the potential health benefits and costs of treating high cholesterol earlier in life, compared with standard care, which was statin treatment at age 40, or if LDL-C was 190 mg/dL or greater.
Lipid lowering incremental to standard care with moderate-intensity statins or intensive lifestyle interventions was simulated starting when young adult LDL-C was either ≥160 mg/dL or ≥130 mg/dL.
They found that approximately 27% of young adults who are free of ASCVD have LDL-C ≥130 mg/dL, and 9% have LDL-C of ≥160 mg/dL.
Their model projected that treating adults younger than 40 with statins or lifestyle interventions would prevent lifetime ASCVD events and increase quality-adjusted life years (QALYs) compared with standard care, which would begin treatment at age 40.
Incremental cost-effectiveness ratios (ICERs) were $31,000/QALY for statin treatment in young adult men with LDL-C ≥130 mg/dL, and $106,000/QALY for statin treatment in young women with LDL-C ≥130 mg/dL.
Intensive lifestyle intervention was more costly and less effective than statin therapy.
“We are straining to find these young adults with very high cholesterol,” Dr. Moran noted. “A lot of young adults don’t even see a doctor. This is an argument for engaging them in their health care and getting them involved in some basic screening. Atherosclerosis is a long-term process that starts in childhood for a lot of people.”
More innovative approaches may be needed, because the traditional health care system is not doing a good job of reaching young adults, he added. “Many of them may not have adequate health insurance. They need health care in nontraditional ways; convenience is really important for them. Perhaps part of the solution here is to think about ways of reaching this particular group that is not engaged with health care generally.”
Time to relax the age 40 threshold
The U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association should emphasize lifetime risk of elevated cholesterol, Paul A. Heidenreich, MD, MS, Stanford University School of Medicine, California, and colleagues write in an accompanying editorial.
“In addition to calculating 10-year risk, we should calculate years of life lost (or QALYs lost) from unhealthy LDL-C levels, and both lifestyle and pharmacologic treatment should be considered to treat high LDL-C in adults regardless of age. We also need to communicate that the mantra ‘lower is better’ applies not only to a single measurement but to lifetime exposure to LDL-C,” the editorialists write.
“I think treatment should be earlier than age 40,” Dr. Heidenreich said in an interview.
“Part of the reason that 40 was chosen as a threshold was because everyone looked at 10-year, or even 20-year risk, and thought there was no reason to worry until you get older. It’s interesting that we never accepted that with high blood pressure. But more and more, we are learning that it is a lifelong process,” he said.
“Statins are getting less and less expensive, and their safety is more and more established with every decade that goes by. I definitely agree with this paper that it would actually make sense to be starting much earlier for those with elevated CVD risk from their high cholesterol.”
The study was supported by the U.S. National Heart, Lung, and Blood Institute (NHLBI), the Medical Research Council, Swindon, U.K. Dr. Moran and Dr. Heidenreich have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Treating elevated low-density lipoprotein cholesterol (LDL-C) in adults younger than 40 with statins is highly cost-effective in men, and intermediately cost-effective in women, a new report suggests.
In a simulated model based on data from the U.S. National Health and Nutrition Examination Survey (NHANES), lipid lowering with statins or lifestyle interventions in this age group would prevent or reduce the risk of atherosclerotic cardiovascular disease (ASCVD) and improve quality of life in later years.
The findings were published online Nov. 8 in the Journal of the American College of Cardiology.
“My group does epidemiologic analyses with cohort studies as well as health economic analyses like this one, and if you have long-term longitudinal observation, you see that the early exposures are important for what happens later,” senior author Andrew E. Moran, MD, Columbia University Irving Medical Center, New York, told this news organization.
“But when it comes to treatment studies that a lot of the treatment guidelines are based on, those are usually short-term, and they usually enroll older people. We saw the gap in the evidence that this paper tries to fill,” Dr. Moran said.
His group used a computer simulation model to synthesize evidence from observational cohort studies and clinical trials of statin treatment, as well as health services data on the costs of medicines and treatments.
Combining information from these sources, the investigators made their best estimates of the potential health benefits and costs of treating high cholesterol earlier in life, compared with standard care, which was statin treatment at age 40, or if LDL-C was 190 mg/dL or greater.
Lipid lowering incremental to standard care with moderate-intensity statins or intensive lifestyle interventions was simulated starting when young adult LDL-C was either ≥160 mg/dL or ≥130 mg/dL.
They found that approximately 27% of young adults who are free of ASCVD have LDL-C ≥130 mg/dL, and 9% have LDL-C of ≥160 mg/dL.
Their model projected that treating adults younger than 40 with statins or lifestyle interventions would prevent lifetime ASCVD events and increase quality-adjusted life years (QALYs) compared with standard care, which would begin treatment at age 40.
Incremental cost-effectiveness ratios (ICERs) were $31,000/QALY for statin treatment in young adult men with LDL-C ≥130 mg/dL, and $106,000/QALY for statin treatment in young women with LDL-C ≥130 mg/dL.
Intensive lifestyle intervention was more costly and less effective than statin therapy.
“We are straining to find these young adults with very high cholesterol,” Dr. Moran noted. “A lot of young adults don’t even see a doctor. This is an argument for engaging them in their health care and getting them involved in some basic screening. Atherosclerosis is a long-term process that starts in childhood for a lot of people.”
More innovative approaches may be needed, because the traditional health care system is not doing a good job of reaching young adults, he added. “Many of them may not have adequate health insurance. They need health care in nontraditional ways; convenience is really important for them. Perhaps part of the solution here is to think about ways of reaching this particular group that is not engaged with health care generally.”
Time to relax the age 40 threshold
The U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association should emphasize lifetime risk of elevated cholesterol, Paul A. Heidenreich, MD, MS, Stanford University School of Medicine, California, and colleagues write in an accompanying editorial.
“In addition to calculating 10-year risk, we should calculate years of life lost (or QALYs lost) from unhealthy LDL-C levels, and both lifestyle and pharmacologic treatment should be considered to treat high LDL-C in adults regardless of age. We also need to communicate that the mantra ‘lower is better’ applies not only to a single measurement but to lifetime exposure to LDL-C,” the editorialists write.
“I think treatment should be earlier than age 40,” Dr. Heidenreich said in an interview.
“Part of the reason that 40 was chosen as a threshold was because everyone looked at 10-year, or even 20-year risk, and thought there was no reason to worry until you get older. It’s interesting that we never accepted that with high blood pressure. But more and more, we are learning that it is a lifelong process,” he said.
“Statins are getting less and less expensive, and their safety is more and more established with every decade that goes by. I definitely agree with this paper that it would actually make sense to be starting much earlier for those with elevated CVD risk from their high cholesterol.”
The study was supported by the U.S. National Heart, Lung, and Blood Institute (NHLBI), the Medical Research Council, Swindon, U.K. Dr. Moran and Dr. Heidenreich have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Treating elevated low-density lipoprotein cholesterol (LDL-C) in adults younger than 40 with statins is highly cost-effective in men, and intermediately cost-effective in women, a new report suggests.
In a simulated model based on data from the U.S. National Health and Nutrition Examination Survey (NHANES), lipid lowering with statins or lifestyle interventions in this age group would prevent or reduce the risk of atherosclerotic cardiovascular disease (ASCVD) and improve quality of life in later years.
The findings were published online Nov. 8 in the Journal of the American College of Cardiology.
“My group does epidemiologic analyses with cohort studies as well as health economic analyses like this one, and if you have long-term longitudinal observation, you see that the early exposures are important for what happens later,” senior author Andrew E. Moran, MD, Columbia University Irving Medical Center, New York, told this news organization.
“But when it comes to treatment studies that a lot of the treatment guidelines are based on, those are usually short-term, and they usually enroll older people. We saw the gap in the evidence that this paper tries to fill,” Dr. Moran said.
His group used a computer simulation model to synthesize evidence from observational cohort studies and clinical trials of statin treatment, as well as health services data on the costs of medicines and treatments.
Combining information from these sources, the investigators made their best estimates of the potential health benefits and costs of treating high cholesterol earlier in life, compared with standard care, which was statin treatment at age 40, or if LDL-C was 190 mg/dL or greater.
Lipid lowering incremental to standard care with moderate-intensity statins or intensive lifestyle interventions was simulated starting when young adult LDL-C was either ≥160 mg/dL or ≥130 mg/dL.
They found that approximately 27% of young adults who are free of ASCVD have LDL-C ≥130 mg/dL, and 9% have LDL-C of ≥160 mg/dL.
Their model projected that treating adults younger than 40 with statins or lifestyle interventions would prevent lifetime ASCVD events and increase quality-adjusted life years (QALYs) compared with standard care, which would begin treatment at age 40.
Incremental cost-effectiveness ratios (ICERs) were $31,000/QALY for statin treatment in young adult men with LDL-C ≥130 mg/dL, and $106,000/QALY for statin treatment in young women with LDL-C ≥130 mg/dL.
Intensive lifestyle intervention was more costly and less effective than statin therapy.
“We are straining to find these young adults with very high cholesterol,” Dr. Moran noted. “A lot of young adults don’t even see a doctor. This is an argument for engaging them in their health care and getting them involved in some basic screening. Atherosclerosis is a long-term process that starts in childhood for a lot of people.”
More innovative approaches may be needed, because the traditional health care system is not doing a good job of reaching young adults, he added. “Many of them may not have adequate health insurance. They need health care in nontraditional ways; convenience is really important for them. Perhaps part of the solution here is to think about ways of reaching this particular group that is not engaged with health care generally.”
Time to relax the age 40 threshold
The U.S. Preventive Services Task Force and the American College of Cardiology/American Heart Association should emphasize lifetime risk of elevated cholesterol, Paul A. Heidenreich, MD, MS, Stanford University School of Medicine, California, and colleagues write in an accompanying editorial.
“In addition to calculating 10-year risk, we should calculate years of life lost (or QALYs lost) from unhealthy LDL-C levels, and both lifestyle and pharmacologic treatment should be considered to treat high LDL-C in adults regardless of age. We also need to communicate that the mantra ‘lower is better’ applies not only to a single measurement but to lifetime exposure to LDL-C,” the editorialists write.
“I think treatment should be earlier than age 40,” Dr. Heidenreich said in an interview.
“Part of the reason that 40 was chosen as a threshold was because everyone looked at 10-year, or even 20-year risk, and thought there was no reason to worry until you get older. It’s interesting that we never accepted that with high blood pressure. But more and more, we are learning that it is a lifelong process,” he said.
“Statins are getting less and less expensive, and their safety is more and more established with every decade that goes by. I definitely agree with this paper that it would actually make sense to be starting much earlier for those with elevated CVD risk from their high cholesterol.”
The study was supported by the U.S. National Heart, Lung, and Blood Institute (NHLBI), the Medical Research Council, Swindon, U.K. Dr. Moran and Dr. Heidenreich have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Step right up, folks, for a public dissection
The greatest autopsy on Earth?
The LOTME staff would like to apologize in advance. The following item contains historical facts.
P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.
When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.
It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.
Oh wait.
David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.
Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.
P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
Go ahead, have that soda before math
We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?
You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.
Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.
This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
Chicken nuggets and the meat paradox
Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.
Liam: Vegetable!
Olivia: Meat!
Liam: Chicken nuggets are vegetables!
Olivia: No, dorkface! They’re meat.
Caregiver: Good news, kids. You’re both right.
Olivia: How can we both be right?
At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.
Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.
In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.
Olivia: Did our caregiver lie to us, Dr. Scientist?
Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.
Liam: What else did they say, Dr. Scientist?
Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.
Caregiver: How did you get in here anyway? And how do you know their names?
Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.
Bedtimes aren’t just for children
There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.
Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.
Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.
So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.
“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.
Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”
So bedtimes aren’t just for children.
The greatest autopsy on Earth?
The LOTME staff would like to apologize in advance. The following item contains historical facts.
P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.
When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.
It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.
Oh wait.
David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.
Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.
P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
Go ahead, have that soda before math
We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?
You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.
Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.
This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
Chicken nuggets and the meat paradox
Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.
Liam: Vegetable!
Olivia: Meat!
Liam: Chicken nuggets are vegetables!
Olivia: No, dorkface! They’re meat.
Caregiver: Good news, kids. You’re both right.
Olivia: How can we both be right?
At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.
Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.
In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.
Olivia: Did our caregiver lie to us, Dr. Scientist?
Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.
Liam: What else did they say, Dr. Scientist?
Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.
Caregiver: How did you get in here anyway? And how do you know their names?
Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.
Bedtimes aren’t just for children
There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.
Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.
Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.
So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.
“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.
Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”
So bedtimes aren’t just for children.
The greatest autopsy on Earth?
The LOTME staff would like to apologize in advance. The following item contains historical facts.
P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.
When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.
It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.
Oh wait.
David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.
Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.
P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
Go ahead, have that soda before math
We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?
You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.
Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.
This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
Chicken nuggets and the meat paradox
Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.
Liam: Vegetable!
Olivia: Meat!
Liam: Chicken nuggets are vegetables!
Olivia: No, dorkface! They’re meat.
Caregiver: Good news, kids. You’re both right.
Olivia: How can we both be right?
At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.
Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.
In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.
Olivia: Did our caregiver lie to us, Dr. Scientist?
Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.
Liam: What else did they say, Dr. Scientist?
Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.
Caregiver: How did you get in here anyway? And how do you know their names?
Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.
Bedtimes aren’t just for children
There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.
Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.
Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.
So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.
“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.
Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”
So bedtimes aren’t just for children.
AHA 2021 puts scientific dialogue, health equity center stage
Virtual platforms democratized scientific meetings during the COVID-19 pandemic but, as any meeting-goer will tell you, it’s the questions from the floor and the back-and-forth of an expert panel that often reveal the importance of and/or problems with a presentation. It’s the scrutiny that makes the science resonate, especially in this postfactual era.
The all-virtual American Heart Association Scientific Sessions 2021 is looking to recreate the engagement of an in-person meeting by offering more live interactive events. They range from seven late-breaking science (LBS) sessions to Saturday’s fireside chat on the Pfizer and Moderna COVID-19 vaccines and Monday’s dive into the controversial new AHA/American College of Cardiology Chest Pain guidelines.
To help digest the latest science, attendees will be able to have their questions answered in real-time via Slido, meet with the trialists, and hear live commentary from key opinion leaders after the live events. A networking function will also allow attendees and exhibitors to chat or meet virtually.
“In this day and age, many people pretty quickly can get access to the science but it’s what I call the IC sort of phenomenon – the presentation of the information, the context of the information, putting it into how I’m going to use it in my practice, and then the critical appraisal – that’s what most people want at the Scientific Sessions,” program committee chair Manesh R. Patel, MD, of Duke University School of Medicine, said in an interview. “We’re all craving ways in which we can interact with one another to put things in context.”
Plans for a hybrid in-person meeting in Boston were scuttled in September because of the Delta variant surge, but the theme of the meeting remained: “One World. Together for Science.” Attendees will be able to access more than 500 live and on-demand sessions including 117 oral abstracts, 286 poster sessions, 59 moderated digital posters, and over a dozen sessions focused on strategies to promote health equity.
“Last year there was a Presidential Session and a statement on structural racism, so we wanted to take the next step and say, What are the ways in which people are starting to interact and do things to make a difference?” explained Dr. Patel. “So, this year, you’ll see different versions of that from the Main Event session, which has some case vignettes and a panel discussion, to other health equity sessions that describe not just COVID care, but blood pressure care, maternal-fetal medicine, and congenital kids. Wherever we can, we’ve tried to infuse it throughout the sessions and will continue to.”
Late-breaking science
The LBS sessions kick off at 9:30 a.m. ET Saturday with AVATAR, a randomized trial of aortic valve replacement vs. watchful waiting in severe aortic stenosis proved asymptomatic through exercise testing.
“The findings of that trial, depending on what they are, could certainly impact clinical practice because it’s a very common scenario in which we have elderly patients with aortic valve stenosis that might be severe but they may not be symptomatic,” he said.
It’s followed by a randomized trial from the Cardiothoracic Surgical Trials Network, examining whether tricuspid repair at the time of mitral valve surgery leads to beneficial outcomes. “I think it’s a pretty important study,” Dr. Patel said, “because it’ll again affect how we think about our clinical practice.”
Rounding out the LBS.01 session is RAPID CABG, comparing early vs. delayed coronary bypass graft surgery (CABG) in patients with acute coronary syndromes on ticagrelor, and the pivotal U.S. VEST trial of an external support device already approved in Europe for saphenous vein grafts during CABG.
Saturday’s LBS.02 at 3:00 p.m. ET is devoted to hypertension and looks at how the COVID-19 pandemic affected blood pressure control. There’s also a study of remotely delivered hypertension and lipid management in 10,000 patients across the Partners Healthcare System and a cluster randomized trial of a village doctor–led blood pressure intervention in rural China.
Sunday’s LBS.03 at 8:00 a.m. ET is focused on atrial arrhythmias, starting with the CRAVE trial examining the effect of caffeine consumption on cardiac ectopy burden in 108 patients using an N-of-1 design and 2-day blocks on and off caffeine. “There’s an ability to identify a dose response that you get arrhythmias when you increase the amount of coffee you drink vs. not in an individual, so I think that will be likely discussed a lot and worth paying attention to,” Dr. Patel said.
The session also includes GIRAF, a comparison of cognitive outcomes with dabigatran (Pradaxa) vs. warfarin (Coumadin) in nonvalvular atrial fibrillation (AF); PALACS, a randomized trial examining whether left-sided pericardiotomy prevents AF after cardiac surgery; and AMAZE, which study sponsor AtriCure revealed missed its primary efficacy endpoint of freedom from AF with the LARIAT suture delivery device for left atrial appendage closure plus pulmonary vein isolation.
LBS.04 at 3:30 p.m. ET Sunday takes on digital health, with results from the nonrandomized Fitbit Heart Study on AF notifications from 450,000 participants wearing a single-lead ECG patch. “A lot of technologies claim that they can detect things, and we should ask that people go through the rigorous evaluation to see if they in fact do. So, in that respect, I think it›s an important step,” observed Dr. Patel.
Also on tap is I-STOP-AFib, another N-of-1 study using mobile apps and the AliveCor device to identify individual AF triggers; and REVeAL-HF, a 4,000-patient study examining whether electronic alerts that provide clinicians with prognostic information on their heart failure (HF) patients will reduce mortality and 30-day HF hospitalizations.
LBS.05 at 5:00 p.m. ET provides new information from EMPEROR-Preserved in HF with preserved ejection fraction and main results from EMPULSE, also using the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) in 530 patients hospitalized for acute HF.
The session also features CHIEF-HF, a randomized trial leveraging mobile technologies to test whether 12 weeks of another SGLT2 inhibitor, canagliflozin (Invokana), is superior to placebo for improving HF symptoms; and DREAM-HF, a comparison of transendocardial delivery of allogeneic mesenchymal precursor cells vs. a sham comparator in chronic HF as a result of left ventricular systolic dysfunction.
Monday’s LBS.06 at 8:00 a.m. ET details the safety and cholesterol-lowering efficacy of MK-0616, an investigational oral PCSK9 inhibitor. “It’s just a phase 2 [trial], but there’s interest in an oral PCSK9 inhibitor, given that the current ones are subcutaneous,” Dr. Patel said.
Results will also be presented from PREPARE-IT 2, which tested icosapent ethyl vs. placebo in outpatients with COVID-19. In the recently reported PREPARE-IT 1, a loading dose of icosapent ethyl failed to reduce the risk of hospitalization with SARS-CoV-2 infection among at-risk individuals.
LBS.07 at 11:00 a.m. Monday completes the late-breakers with new results from ASCEND, this time examining the effect of aspirin on dementia and cognitive impairment in patients with diabetes.
Next up is a look at the effectiveness of P2Y12 inhibitors in hospitalized patients with COVID-19 in the adaptive ACTIV-4a trial, followed by results of the pivotal phase 3 REVERSE-IT trial of bentracimab, a recombinant human monoclonal antibody antigen fragment designed to reverse the antiplatelet activity of ticagrelor in the event of major bleeding or when urgent surgery is needed.
Closing out the session is AXIOMATIC-TKR, a double-blind comparison of the safety and efficacy of the investigational oral factor XI anticoagulant JNJ-70033093 vs. subcutaneous enoxaparin (Lovenox) in elective total knee replacement.
For those searching for more AHA-related science online, the Resuscitation Science Symposium (ReSS) will run from this Friday through Sunday and the Quality of Care and Outcomes Research (QCOR) Scientific Sessions will take the stage next Monday, Nov. 15.
A version of this article first appeared on Medscape.com.
Virtual platforms democratized scientific meetings during the COVID-19 pandemic but, as any meeting-goer will tell you, it’s the questions from the floor and the back-and-forth of an expert panel that often reveal the importance of and/or problems with a presentation. It’s the scrutiny that makes the science resonate, especially in this postfactual era.
The all-virtual American Heart Association Scientific Sessions 2021 is looking to recreate the engagement of an in-person meeting by offering more live interactive events. They range from seven late-breaking science (LBS) sessions to Saturday’s fireside chat on the Pfizer and Moderna COVID-19 vaccines and Monday’s dive into the controversial new AHA/American College of Cardiology Chest Pain guidelines.
To help digest the latest science, attendees will be able to have their questions answered in real-time via Slido, meet with the trialists, and hear live commentary from key opinion leaders after the live events. A networking function will also allow attendees and exhibitors to chat or meet virtually.
“In this day and age, many people pretty quickly can get access to the science but it’s what I call the IC sort of phenomenon – the presentation of the information, the context of the information, putting it into how I’m going to use it in my practice, and then the critical appraisal – that’s what most people want at the Scientific Sessions,” program committee chair Manesh R. Patel, MD, of Duke University School of Medicine, said in an interview. “We’re all craving ways in which we can interact with one another to put things in context.”
Plans for a hybrid in-person meeting in Boston were scuttled in September because of the Delta variant surge, but the theme of the meeting remained: “One World. Together for Science.” Attendees will be able to access more than 500 live and on-demand sessions including 117 oral abstracts, 286 poster sessions, 59 moderated digital posters, and over a dozen sessions focused on strategies to promote health equity.
“Last year there was a Presidential Session and a statement on structural racism, so we wanted to take the next step and say, What are the ways in which people are starting to interact and do things to make a difference?” explained Dr. Patel. “So, this year, you’ll see different versions of that from the Main Event session, which has some case vignettes and a panel discussion, to other health equity sessions that describe not just COVID care, but blood pressure care, maternal-fetal medicine, and congenital kids. Wherever we can, we’ve tried to infuse it throughout the sessions and will continue to.”
Late-breaking science
The LBS sessions kick off at 9:30 a.m. ET Saturday with AVATAR, a randomized trial of aortic valve replacement vs. watchful waiting in severe aortic stenosis proved asymptomatic through exercise testing.
“The findings of that trial, depending on what they are, could certainly impact clinical practice because it’s a very common scenario in which we have elderly patients with aortic valve stenosis that might be severe but they may not be symptomatic,” he said.
It’s followed by a randomized trial from the Cardiothoracic Surgical Trials Network, examining whether tricuspid repair at the time of mitral valve surgery leads to beneficial outcomes. “I think it’s a pretty important study,” Dr. Patel said, “because it’ll again affect how we think about our clinical practice.”
Rounding out the LBS.01 session is RAPID CABG, comparing early vs. delayed coronary bypass graft surgery (CABG) in patients with acute coronary syndromes on ticagrelor, and the pivotal U.S. VEST trial of an external support device already approved in Europe for saphenous vein grafts during CABG.
Saturday’s LBS.02 at 3:00 p.m. ET is devoted to hypertension and looks at how the COVID-19 pandemic affected blood pressure control. There’s also a study of remotely delivered hypertension and lipid management in 10,000 patients across the Partners Healthcare System and a cluster randomized trial of a village doctor–led blood pressure intervention in rural China.
Sunday’s LBS.03 at 8:00 a.m. ET is focused on atrial arrhythmias, starting with the CRAVE trial examining the effect of caffeine consumption on cardiac ectopy burden in 108 patients using an N-of-1 design and 2-day blocks on and off caffeine. “There’s an ability to identify a dose response that you get arrhythmias when you increase the amount of coffee you drink vs. not in an individual, so I think that will be likely discussed a lot and worth paying attention to,” Dr. Patel said.
The session also includes GIRAF, a comparison of cognitive outcomes with dabigatran (Pradaxa) vs. warfarin (Coumadin) in nonvalvular atrial fibrillation (AF); PALACS, a randomized trial examining whether left-sided pericardiotomy prevents AF after cardiac surgery; and AMAZE, which study sponsor AtriCure revealed missed its primary efficacy endpoint of freedom from AF with the LARIAT suture delivery device for left atrial appendage closure plus pulmonary vein isolation.
LBS.04 at 3:30 p.m. ET Sunday takes on digital health, with results from the nonrandomized Fitbit Heart Study on AF notifications from 450,000 participants wearing a single-lead ECG patch. “A lot of technologies claim that they can detect things, and we should ask that people go through the rigorous evaluation to see if they in fact do. So, in that respect, I think it›s an important step,” observed Dr. Patel.
Also on tap is I-STOP-AFib, another N-of-1 study using mobile apps and the AliveCor device to identify individual AF triggers; and REVeAL-HF, a 4,000-patient study examining whether electronic alerts that provide clinicians with prognostic information on their heart failure (HF) patients will reduce mortality and 30-day HF hospitalizations.
LBS.05 at 5:00 p.m. ET provides new information from EMPEROR-Preserved in HF with preserved ejection fraction and main results from EMPULSE, also using the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) in 530 patients hospitalized for acute HF.
The session also features CHIEF-HF, a randomized trial leveraging mobile technologies to test whether 12 weeks of another SGLT2 inhibitor, canagliflozin (Invokana), is superior to placebo for improving HF symptoms; and DREAM-HF, a comparison of transendocardial delivery of allogeneic mesenchymal precursor cells vs. a sham comparator in chronic HF as a result of left ventricular systolic dysfunction.
Monday’s LBS.06 at 8:00 a.m. ET details the safety and cholesterol-lowering efficacy of MK-0616, an investigational oral PCSK9 inhibitor. “It’s just a phase 2 [trial], but there’s interest in an oral PCSK9 inhibitor, given that the current ones are subcutaneous,” Dr. Patel said.
Results will also be presented from PREPARE-IT 2, which tested icosapent ethyl vs. placebo in outpatients with COVID-19. In the recently reported PREPARE-IT 1, a loading dose of icosapent ethyl failed to reduce the risk of hospitalization with SARS-CoV-2 infection among at-risk individuals.
LBS.07 at 11:00 a.m. Monday completes the late-breakers with new results from ASCEND, this time examining the effect of aspirin on dementia and cognitive impairment in patients with diabetes.
Next up is a look at the effectiveness of P2Y12 inhibitors in hospitalized patients with COVID-19 in the adaptive ACTIV-4a trial, followed by results of the pivotal phase 3 REVERSE-IT trial of bentracimab, a recombinant human monoclonal antibody antigen fragment designed to reverse the antiplatelet activity of ticagrelor in the event of major bleeding or when urgent surgery is needed.
Closing out the session is AXIOMATIC-TKR, a double-blind comparison of the safety and efficacy of the investigational oral factor XI anticoagulant JNJ-70033093 vs. subcutaneous enoxaparin (Lovenox) in elective total knee replacement.
For those searching for more AHA-related science online, the Resuscitation Science Symposium (ReSS) will run from this Friday through Sunday and the Quality of Care and Outcomes Research (QCOR) Scientific Sessions will take the stage next Monday, Nov. 15.
A version of this article first appeared on Medscape.com.
Virtual platforms democratized scientific meetings during the COVID-19 pandemic but, as any meeting-goer will tell you, it’s the questions from the floor and the back-and-forth of an expert panel that often reveal the importance of and/or problems with a presentation. It’s the scrutiny that makes the science resonate, especially in this postfactual era.
The all-virtual American Heart Association Scientific Sessions 2021 is looking to recreate the engagement of an in-person meeting by offering more live interactive events. They range from seven late-breaking science (LBS) sessions to Saturday’s fireside chat on the Pfizer and Moderna COVID-19 vaccines and Monday’s dive into the controversial new AHA/American College of Cardiology Chest Pain guidelines.
To help digest the latest science, attendees will be able to have their questions answered in real-time via Slido, meet with the trialists, and hear live commentary from key opinion leaders after the live events. A networking function will also allow attendees and exhibitors to chat or meet virtually.
“In this day and age, many people pretty quickly can get access to the science but it’s what I call the IC sort of phenomenon – the presentation of the information, the context of the information, putting it into how I’m going to use it in my practice, and then the critical appraisal – that’s what most people want at the Scientific Sessions,” program committee chair Manesh R. Patel, MD, of Duke University School of Medicine, said in an interview. “We’re all craving ways in which we can interact with one another to put things in context.”
Plans for a hybrid in-person meeting in Boston were scuttled in September because of the Delta variant surge, but the theme of the meeting remained: “One World. Together for Science.” Attendees will be able to access more than 500 live and on-demand sessions including 117 oral abstracts, 286 poster sessions, 59 moderated digital posters, and over a dozen sessions focused on strategies to promote health equity.
“Last year there was a Presidential Session and a statement on structural racism, so we wanted to take the next step and say, What are the ways in which people are starting to interact and do things to make a difference?” explained Dr. Patel. “So, this year, you’ll see different versions of that from the Main Event session, which has some case vignettes and a panel discussion, to other health equity sessions that describe not just COVID care, but blood pressure care, maternal-fetal medicine, and congenital kids. Wherever we can, we’ve tried to infuse it throughout the sessions and will continue to.”
Late-breaking science
The LBS sessions kick off at 9:30 a.m. ET Saturday with AVATAR, a randomized trial of aortic valve replacement vs. watchful waiting in severe aortic stenosis proved asymptomatic through exercise testing.
“The findings of that trial, depending on what they are, could certainly impact clinical practice because it’s a very common scenario in which we have elderly patients with aortic valve stenosis that might be severe but they may not be symptomatic,” he said.
It’s followed by a randomized trial from the Cardiothoracic Surgical Trials Network, examining whether tricuspid repair at the time of mitral valve surgery leads to beneficial outcomes. “I think it’s a pretty important study,” Dr. Patel said, “because it’ll again affect how we think about our clinical practice.”
Rounding out the LBS.01 session is RAPID CABG, comparing early vs. delayed coronary bypass graft surgery (CABG) in patients with acute coronary syndromes on ticagrelor, and the pivotal U.S. VEST trial of an external support device already approved in Europe for saphenous vein grafts during CABG.
Saturday’s LBS.02 at 3:00 p.m. ET is devoted to hypertension and looks at how the COVID-19 pandemic affected blood pressure control. There’s also a study of remotely delivered hypertension and lipid management in 10,000 patients across the Partners Healthcare System and a cluster randomized trial of a village doctor–led blood pressure intervention in rural China.
Sunday’s LBS.03 at 8:00 a.m. ET is focused on atrial arrhythmias, starting with the CRAVE trial examining the effect of caffeine consumption on cardiac ectopy burden in 108 patients using an N-of-1 design and 2-day blocks on and off caffeine. “There’s an ability to identify a dose response that you get arrhythmias when you increase the amount of coffee you drink vs. not in an individual, so I think that will be likely discussed a lot and worth paying attention to,” Dr. Patel said.
The session also includes GIRAF, a comparison of cognitive outcomes with dabigatran (Pradaxa) vs. warfarin (Coumadin) in nonvalvular atrial fibrillation (AF); PALACS, a randomized trial examining whether left-sided pericardiotomy prevents AF after cardiac surgery; and AMAZE, which study sponsor AtriCure revealed missed its primary efficacy endpoint of freedom from AF with the LARIAT suture delivery device for left atrial appendage closure plus pulmonary vein isolation.
LBS.04 at 3:30 p.m. ET Sunday takes on digital health, with results from the nonrandomized Fitbit Heart Study on AF notifications from 450,000 participants wearing a single-lead ECG patch. “A lot of technologies claim that they can detect things, and we should ask that people go through the rigorous evaluation to see if they in fact do. So, in that respect, I think it›s an important step,” observed Dr. Patel.
Also on tap is I-STOP-AFib, another N-of-1 study using mobile apps and the AliveCor device to identify individual AF triggers; and REVeAL-HF, a 4,000-patient study examining whether electronic alerts that provide clinicians with prognostic information on their heart failure (HF) patients will reduce mortality and 30-day HF hospitalizations.
LBS.05 at 5:00 p.m. ET provides new information from EMPEROR-Preserved in HF with preserved ejection fraction and main results from EMPULSE, also using the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) in 530 patients hospitalized for acute HF.
The session also features CHIEF-HF, a randomized trial leveraging mobile technologies to test whether 12 weeks of another SGLT2 inhibitor, canagliflozin (Invokana), is superior to placebo for improving HF symptoms; and DREAM-HF, a comparison of transendocardial delivery of allogeneic mesenchymal precursor cells vs. a sham comparator in chronic HF as a result of left ventricular systolic dysfunction.
Monday’s LBS.06 at 8:00 a.m. ET details the safety and cholesterol-lowering efficacy of MK-0616, an investigational oral PCSK9 inhibitor. “It’s just a phase 2 [trial], but there’s interest in an oral PCSK9 inhibitor, given that the current ones are subcutaneous,” Dr. Patel said.
Results will also be presented from PREPARE-IT 2, which tested icosapent ethyl vs. placebo in outpatients with COVID-19. In the recently reported PREPARE-IT 1, a loading dose of icosapent ethyl failed to reduce the risk of hospitalization with SARS-CoV-2 infection among at-risk individuals.
LBS.07 at 11:00 a.m. Monday completes the late-breakers with new results from ASCEND, this time examining the effect of aspirin on dementia and cognitive impairment in patients with diabetes.
Next up is a look at the effectiveness of P2Y12 inhibitors in hospitalized patients with COVID-19 in the adaptive ACTIV-4a trial, followed by results of the pivotal phase 3 REVERSE-IT trial of bentracimab, a recombinant human monoclonal antibody antigen fragment designed to reverse the antiplatelet activity of ticagrelor in the event of major bleeding or when urgent surgery is needed.
Closing out the session is AXIOMATIC-TKR, a double-blind comparison of the safety and efficacy of the investigational oral factor XI anticoagulant JNJ-70033093 vs. subcutaneous enoxaparin (Lovenox) in elective total knee replacement.
For those searching for more AHA-related science online, the Resuscitation Science Symposium (ReSS) will run from this Friday through Sunday and the Quality of Care and Outcomes Research (QCOR) Scientific Sessions will take the stage next Monday, Nov. 15.
A version of this article first appeared on Medscape.com.
FROM AHA 2021
Hormone blocker sticker shock – again – as patients lose cheaper drug option
In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development – often years earlier than one’s peers. KHN and NPR wrote about Dr. Taksali and his family as part of the Bill of the Month series.
The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.
Dr. Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 mg of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.
Vantas can be prescribed off label for the condition, and after much back-and-forth dialogue, Dr. Taksali finally got the insurer to cover it.
Then this summer, it was time to replace the implant.
“I thought we would just get a Vantas replacement,” Dr. Taksali said. “In my mind, I was like: ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”
But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.
Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, said in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”
In August, Endo’s president and CEO, Blaise Coleman, told investors Supprelin was doing particularly well for the company. Revenue had grown by 79%, compared with the same quarter the year before. The growth was driven in part, Mr. Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.
What competitor product shortage? Could that be Vantas?
Asked about this, Ms. Zoumas Lubeski said Mr. Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Mr. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Ms. Zoumas Lubeski said.
Dr. Taksali was skeptical.
“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.
Then, in September, Endo told the FDA it stopped making Vantas for good.
Ms. Zoumas Lubeski said that, when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”
“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”
Dr. Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.
The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said Erin Fox, who directs drug information and support services at University of Utah Health hospitals.
“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything ... at any time for any reason.”
Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption 6 months before it affects consumers or “as soon as practicable” after that. But their true deadline is 5 business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Ms. Fox said. “There’s no teeth in that law. ... Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Ms. Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know – or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Erica Eugster, MD, a professor of pediatrics at Indiana University, Indianapolis, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
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.
In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development – often years earlier than one’s peers. KHN and NPR wrote about Dr. Taksali and his family as part of the Bill of the Month series.
The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.
Dr. Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 mg of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.
Vantas can be prescribed off label for the condition, and after much back-and-forth dialogue, Dr. Taksali finally got the insurer to cover it.
Then this summer, it was time to replace the implant.
“I thought we would just get a Vantas replacement,” Dr. Taksali said. “In my mind, I was like: ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”
But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.
Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, said in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”
In August, Endo’s president and CEO, Blaise Coleman, told investors Supprelin was doing particularly well for the company. Revenue had grown by 79%, compared with the same quarter the year before. The growth was driven in part, Mr. Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.
What competitor product shortage? Could that be Vantas?
Asked about this, Ms. Zoumas Lubeski said Mr. Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Mr. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Ms. Zoumas Lubeski said.
Dr. Taksali was skeptical.
“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.
Then, in September, Endo told the FDA it stopped making Vantas for good.
Ms. Zoumas Lubeski said that, when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”
“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”
Dr. Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.
The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said Erin Fox, who directs drug information and support services at University of Utah Health hospitals.
“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything ... at any time for any reason.”
Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption 6 months before it affects consumers or “as soon as practicable” after that. But their true deadline is 5 business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Ms. Fox said. “There’s no teeth in that law. ... Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Ms. Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know – or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Erica Eugster, MD, a professor of pediatrics at Indiana University, Indianapolis, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
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.
In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development – often years earlier than one’s peers. KHN and NPR wrote about Dr. Taksali and his family as part of the Bill of the Month series.
The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.
Dr. Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 mg of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.
Vantas can be prescribed off label for the condition, and after much back-and-forth dialogue, Dr. Taksali finally got the insurer to cover it.
Then this summer, it was time to replace the implant.
“I thought we would just get a Vantas replacement,” Dr. Taksali said. “In my mind, I was like: ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”
But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.
Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, said in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”
In August, Endo’s president and CEO, Blaise Coleman, told investors Supprelin was doing particularly well for the company. Revenue had grown by 79%, compared with the same quarter the year before. The growth was driven in part, Mr. Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.
What competitor product shortage? Could that be Vantas?
Asked about this, Ms. Zoumas Lubeski said Mr. Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Mr. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Ms. Zoumas Lubeski said.
Dr. Taksali was skeptical.
“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.
Then, in September, Endo told the FDA it stopped making Vantas for good.
Ms. Zoumas Lubeski said that, when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”
“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”
Dr. Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.
The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said Erin Fox, who directs drug information and support services at University of Utah Health hospitals.
“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything ... at any time for any reason.”
Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.
“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”
But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption 6 months before it affects consumers or “as soon as practicable” after that. But their true deadline is 5 business days after manufacturing stops, according to the FDA website.
“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Ms. Fox said. “There’s no teeth in that law. ... Their name can go on the FDA naughty list. That’s pretty much it.”
In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only five times since 2015. There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.
Concerned about potential drug shortages caused by COVID-19 in March 2020, a bipartisan group of legislators introduced the Preventing Drug Shortages Act, which aimed to increase transparency around shortages. But the legislation gained no traction.
As a result of limited FDA power, the intricacies of drug shortages remain opaque, Ms. Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.
“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know – or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”
It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.
Erica Eugster, MD, a professor of pediatrics at Indiana University, Indianapolis, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.
“I immediately thought about our transgender population,” she said. “They’re the ones that are really going to suffer from this.”
No medications have been FDA approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.
The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the Journal of Pediatric Endocrinology and Metabolism.
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.
Should you tell your doctor that you’re a doctor?
The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”
She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”
The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.
“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.”
“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.
“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”
Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:
“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.
Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”
“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.
Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.
For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”
@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”
Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”
Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.
“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.
Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”
Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”
Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.
“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.
To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.
Still others offered suggestions on how to broach the subject more directly when presenting as a patient:
‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.
@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”
A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.
“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.
Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”
That’s typically a sign that the Tweet is relatable for a lot of people, she said.
“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.
The debate begs the question: Is there a duty or ethical reason to disclose?
“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”
If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.
“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”
Knowing how to share the information is another story.
“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”
“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested.
A version of this article first appeared on Medscape.com.
The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”
She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”
The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.
“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.”
“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.
“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”
Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:
“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.
Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”
“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.
Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.
For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”
@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”
Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”
Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.
“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.
Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”
Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”
Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.
“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.
To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.
Still others offered suggestions on how to broach the subject more directly when presenting as a patient:
‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.
@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”
A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.
“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.
Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”
That’s typically a sign that the Tweet is relatable for a lot of people, she said.
“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.
The debate begs the question: Is there a duty or ethical reason to disclose?
“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”
If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.
“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”
Knowing how to share the information is another story.
“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”
“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested.
A version of this article first appeared on Medscape.com.
The question drew spirited debate when urologist Ashley Winter, MD, made a simple, straightforward request on Twitter: “If you are a doctor & you come to an appointment please tell me you are a doctor, not because I will treat you differently but because it’s easier to speak in jargon.”
She later added, “This doesn’t’ mean I would be less patient-focused or emotional with a physician or other [healthcare worker]. Just means that, instead of saying ‘you will have a catheter draining your urine to a bag,’ I can say, ‘you will have a Foley.’ ”
The Tweet followed an encounter with a patient who told Dr. Winter that he was a doctor only after she had gone to some length explaining a surgical procedure in lay terms.
“I explained the surgery, obviously assuming he was an intelligent adult, but using fully layman’s terms,” she said in an interview. The patient then told her that he was a doctor. “I guess I felt this embarrassment — I wouldn’t have treated him differently, but I just could have discussed the procedure with him in more professional terms.”
“To some extent, it was my own fault,” she commented in an interview. “I didn’t take the time to ask [about his work] at the beginning of the consultation, but that’s a fine line, also,” added Dr. Winter, a urologist and sexual medicine physician in Portland, Ore.
“You know that patient is there because they want care from you and it’s not necessarily always at the forefront of importance to be asking them what they do for their work, but alternatively, if you don’t ask then you put them in this position where they have to find a way to go ahead and tell you.”
Several people chimed in on the thread to voice their thoughts on the matter. Some commiserated with Dr. Winter’s experience:
“I took care of a retired cardiologist in the hospital as a second-year resident and honest to god he let me ramble on ‘explaining’ his echo result and never told me. I found out a couple days later and wanted to die,” posted @MaddyAndrewsMD.
Another recalled a similarly embarrassing experience when she “went on and on” discussing headaches with a patient whose husband “was in the corner smirking.”
“They told my attending later [that the] husband was a retired FM doc who practiced medicine longer than I’ve been alive. I wanted to die,” posted @JSinghDO.
Many on the thread, though, were doctors and other healthcare professionals speaking as patients. Some said they didn’t want to disclose their status as a healthcare provider because they felt it affected the care they received.
For example, @drhelenrainford commented: “In my experience my care is less ‘caring’ when they know I am a [doctor]. I get spoken to like they are discussing a patient with me — no empathy just facts and difficult results just blurted out without consideration. Awful awful time as an inpatient …but that’s another story!”
@Dr_B_Ring said: “Nope – You and I speak different jargon – I would want you to speak to me like a human that doesn’t know your jargon. My ego would get in the way of asking about the acronyms I don’t know if you knew I was a fellow physician.”
Conversely, @lozzlemcfozzle said: “Honestly I prefer not to tell my Doctors — I’ve found people skip explanations assuming I ‘know,’ or seem a little nervous when I tell them!”
Others said they felt uncomfortable — pretentious, even — in announcing their status, or worried that they might come across as expecting special care.
“It’s such a tough needle to thread. Want to tell people early but not come off as demanding special treatment, but don’t want to wait too long and it seems like a trap,” said @MDaware.
Twitter user @MsBabyCatcher wrote: “I have a hard time doing this because I don’t want people to think I’m being pretentious or going to micromanage/dictate care.”
Replying to @MsBabyCatcher, @RedStethoscope wrote: “I used to think this too until I got [very poor] care a few times, and was advised by other doctor moms to ‘play the doctor card.’ I have gotten better/more compassionate care by making sure it’s clear that I’m a physician (which is junk, but here we are).”
Several of those responding used the words “tricky” and “awkward,” suggesting a common theme for doctors presenting as patients.
“I struggle with this. My 5-year-old broke her arm this weekend, we spent hours in the ED, of my own hospital, I never mentioned it because I didn’t want to get preferential care. But as they were explaining her type of fracture, it felt awkward and inefficient,” said @lindsay_petty.
To avoid the awkwardness, a number of respondents said they purposefully use medical jargon to open up a conversation rather than just offering up the information that they are a doctor.
Still others offered suggestions on how to broach the subject more directly when presenting as a patient:
‘”Just FYI I’m a X doc but I’m here because I really want your help and advice!” That’s what I usually do,” wrote @drcakefm.
@BeeSting14618 Tweeted: “I usually say ‘I know some of this but I’m here because I want YOUR guidance. Also I may ask dumb questions, and I’ll tell you if a question is asking your opinion or making a request.’”
A few others injected a bit of humor: “I just do the 14-part handshake that only doctors know. Is that not customary?” quipped @Branmiz25.
“Ah yes, that transmits the entire [history of present illness],” replied Dr. Winter.
Jokes aside, the topic is obviously one that touched on a shared experience among healthcare providers, Dr. Winter commented. The Twitter thread she started just “blew up.”
That’s typically a sign that the Tweet is relatable for a lot of people, she said.
“It’s definitely something that all of us as care providers and as patients understand. It’s a funny, awkward thing that can really change an interaction, so we probably all feel pretty strongly about our experiences related to that,” she added.
The debate begs the question: Is there a duty or ethical reason to disclose?
“I definitely think it is very reasonable to disclose that one is a medical professional to another doctor,” medical ethicist Charlotte Blease, PhD, said in an interview. “There are good reasons to believe doing so might make a difference to the quality of communication and transparency.”
If the ability to use medical terminology or jargon more freely improves patient understanding, autonomy, and shared decision-making, then it may be of benefit, said Dr. Blease, a Keane OpenNotes Scholar at Beth Israel Deaconess Medical Center in Boston.
“Since doctors should strive to communicate effectively with every patient and to respect their unique needs and level of understanding, then I see no reason to deny that one is a medic,” she added.”
Knowing how to share the information is another story.
“This is something that affects all of us as physicians — we’re going to be patients at some point, right?” Dr. Winter commented. “But I don’t think how to disclose that is something that was ever brought up in my medical training.”
“Maybe there should just be a discussion of this one day when people are in medical school — maybe in a professionalism course — to broach this topic or look at if there’s any literature on outcomes related to disclosure of status or what are best practices,” she suggested.
A version of this article first appeared on Medscape.com.
Fast foods contain endocrine-disrupting chemicals
, such as chicken nuggets, hamburgers, and cheese pizza, new research suggests.
The first-of-its-kind study, which measured concentrations of chemicals such as phthalates in foods and gloves from U.S. fast food chains, is also the first to detect the plasticizer DEHT in fast foods.
“We knew from prior research that fast food consumption is linked to higher levels of phthalates in people’s bodies, but our study was novel because we actually collected these food items from fast food places and measured them,” said study author Lariah Edwards, PhD, a postdoctoral research scientist at the Milken Institute School of Public Health, George Washington University, Washington.
“Our research added an additional piece of information to the puzzle,” Dr. Edwards said in an interview.
A class of chemicals used in food packaging and food processing equipment, phthalates such as DEHP and DnBP, can leach out of these items and interfere with hormone production, Dr. Edwards said. They are linked with a wide variety of reproductive, developmental, brain, and immune effects, as well as with childhood obesity, asthma, cancer, and cardiovascular problems.
Meanwhile, nonphthalate or replacement plasticizers have been used in place of phthalates, some of which have been banned in certain products. But these plasticizers aren’t well studied, Dr. Edwards said, making the detection of DEHT in fast foods particularly concerning.
“There’s very limited research out there to understand the human health effects” of DEHT in food, she said, “so we’re being exposed before we understand what it’s doing to our health. It’s almost like we’re setting ourselves up for a big experiment.”
The study was recently published in the Journal of Exposure Science & Environmental Epidemiology .
Fast foods containing meat had highest concentrations of chemicals
Dr. Edwards and colleagues obtained 64 food samples, including hamburgers, fries, chicken nuggets, chicken burritos, and cheese pizza, as well as three pairs of unused gloves from six different fast food restaurants in San Antonio.
Using gas chromatography–mass spectrometry, they analyzed the samples for 11 chemicals, including eight phthalates and three replacement plasticizers.
The researchers detected 10 of the 11 chemicals in fast food samples: 81% of foods contained DnBP (di-n-butyl phthalate), and 70% contained DEHP (di(2-ethylhexyl phthalate)). Meanwhile 86% of samples contained replacement plasticizer DEHT (di(2-ethylhexyl terephthalate)).
Overall, fast food samples containing meat — including chicken nuggets, chicken burritos, and hamburgers — contained higher levels of these chemicals, Dr. Edwards noted.
“We know fast food is not the most nutritious, and now we’re seeing these chemicals in it we shouldn’t be exposed to,” she said.
The results also create implications for health equity, Dr. Edwards said, as Black people in the United States report eating more fast foods than other racial and ethnic groups for many reasons, such as longstanding residential segregation.
Many advocacy groups are pushing for stronger regulations on phthalates in foods, she said, and the study can be used to fuel those efforts.
“We’re hoping our findings help people understand what they’re eating and what’s in food,” Dr. Edwards said. “If they want to reduce exposure to phthalates in fast food, they can choose foods without meat in them. But not everyone has the option of reducing fast food consumption — personal choice is important, but policy is what’s going to protect us.”
Dr. Edwards noted that the research was limited by small sample sizes gathered in one U.S. city. Limitations in extraction methods also meant the researchers were able to detect chemicals in gloves only at high concentrations.
“That being said, I do think our results are fairly generalizable,” she added, “because the way fast foods are prepared at these restaurants is fairly consistent.”
The study was funded by the Passport Foundation, Forsythia Foundation, and Marisla Foundation. Dr. Edwards has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, such as chicken nuggets, hamburgers, and cheese pizza, new research suggests.
The first-of-its-kind study, which measured concentrations of chemicals such as phthalates in foods and gloves from U.S. fast food chains, is also the first to detect the plasticizer DEHT in fast foods.
“We knew from prior research that fast food consumption is linked to higher levels of phthalates in people’s bodies, but our study was novel because we actually collected these food items from fast food places and measured them,” said study author Lariah Edwards, PhD, a postdoctoral research scientist at the Milken Institute School of Public Health, George Washington University, Washington.
“Our research added an additional piece of information to the puzzle,” Dr. Edwards said in an interview.
A class of chemicals used in food packaging and food processing equipment, phthalates such as DEHP and DnBP, can leach out of these items and interfere with hormone production, Dr. Edwards said. They are linked with a wide variety of reproductive, developmental, brain, and immune effects, as well as with childhood obesity, asthma, cancer, and cardiovascular problems.
Meanwhile, nonphthalate or replacement plasticizers have been used in place of phthalates, some of which have been banned in certain products. But these plasticizers aren’t well studied, Dr. Edwards said, making the detection of DEHT in fast foods particularly concerning.
“There’s very limited research out there to understand the human health effects” of DEHT in food, she said, “so we’re being exposed before we understand what it’s doing to our health. It’s almost like we’re setting ourselves up for a big experiment.”
The study was recently published in the Journal of Exposure Science & Environmental Epidemiology .
Fast foods containing meat had highest concentrations of chemicals
Dr. Edwards and colleagues obtained 64 food samples, including hamburgers, fries, chicken nuggets, chicken burritos, and cheese pizza, as well as three pairs of unused gloves from six different fast food restaurants in San Antonio.
Using gas chromatography–mass spectrometry, they analyzed the samples for 11 chemicals, including eight phthalates and three replacement plasticizers.
The researchers detected 10 of the 11 chemicals in fast food samples: 81% of foods contained DnBP (di-n-butyl phthalate), and 70% contained DEHP (di(2-ethylhexyl phthalate)). Meanwhile 86% of samples contained replacement plasticizer DEHT (di(2-ethylhexyl terephthalate)).
Overall, fast food samples containing meat — including chicken nuggets, chicken burritos, and hamburgers — contained higher levels of these chemicals, Dr. Edwards noted.
“We know fast food is not the most nutritious, and now we’re seeing these chemicals in it we shouldn’t be exposed to,” she said.
The results also create implications for health equity, Dr. Edwards said, as Black people in the United States report eating more fast foods than other racial and ethnic groups for many reasons, such as longstanding residential segregation.
Many advocacy groups are pushing for stronger regulations on phthalates in foods, she said, and the study can be used to fuel those efforts.
“We’re hoping our findings help people understand what they’re eating and what’s in food,” Dr. Edwards said. “If they want to reduce exposure to phthalates in fast food, they can choose foods without meat in them. But not everyone has the option of reducing fast food consumption — personal choice is important, but policy is what’s going to protect us.”
Dr. Edwards noted that the research was limited by small sample sizes gathered in one U.S. city. Limitations in extraction methods also meant the researchers were able to detect chemicals in gloves only at high concentrations.
“That being said, I do think our results are fairly generalizable,” she added, “because the way fast foods are prepared at these restaurants is fairly consistent.”
The study was funded by the Passport Foundation, Forsythia Foundation, and Marisla Foundation. Dr. Edwards has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, such as chicken nuggets, hamburgers, and cheese pizza, new research suggests.
The first-of-its-kind study, which measured concentrations of chemicals such as phthalates in foods and gloves from U.S. fast food chains, is also the first to detect the plasticizer DEHT in fast foods.
“We knew from prior research that fast food consumption is linked to higher levels of phthalates in people’s bodies, but our study was novel because we actually collected these food items from fast food places and measured them,” said study author Lariah Edwards, PhD, a postdoctoral research scientist at the Milken Institute School of Public Health, George Washington University, Washington.
“Our research added an additional piece of information to the puzzle,” Dr. Edwards said in an interview.
A class of chemicals used in food packaging and food processing equipment, phthalates such as DEHP and DnBP, can leach out of these items and interfere with hormone production, Dr. Edwards said. They are linked with a wide variety of reproductive, developmental, brain, and immune effects, as well as with childhood obesity, asthma, cancer, and cardiovascular problems.
Meanwhile, nonphthalate or replacement plasticizers have been used in place of phthalates, some of which have been banned in certain products. But these plasticizers aren’t well studied, Dr. Edwards said, making the detection of DEHT in fast foods particularly concerning.
“There’s very limited research out there to understand the human health effects” of DEHT in food, she said, “so we’re being exposed before we understand what it’s doing to our health. It’s almost like we’re setting ourselves up for a big experiment.”
The study was recently published in the Journal of Exposure Science & Environmental Epidemiology .
Fast foods containing meat had highest concentrations of chemicals
Dr. Edwards and colleagues obtained 64 food samples, including hamburgers, fries, chicken nuggets, chicken burritos, and cheese pizza, as well as three pairs of unused gloves from six different fast food restaurants in San Antonio.
Using gas chromatography–mass spectrometry, they analyzed the samples for 11 chemicals, including eight phthalates and three replacement plasticizers.
The researchers detected 10 of the 11 chemicals in fast food samples: 81% of foods contained DnBP (di-n-butyl phthalate), and 70% contained DEHP (di(2-ethylhexyl phthalate)). Meanwhile 86% of samples contained replacement plasticizer DEHT (di(2-ethylhexyl terephthalate)).
Overall, fast food samples containing meat — including chicken nuggets, chicken burritos, and hamburgers — contained higher levels of these chemicals, Dr. Edwards noted.
“We know fast food is not the most nutritious, and now we’re seeing these chemicals in it we shouldn’t be exposed to,” she said.
The results also create implications for health equity, Dr. Edwards said, as Black people in the United States report eating more fast foods than other racial and ethnic groups for many reasons, such as longstanding residential segregation.
Many advocacy groups are pushing for stronger regulations on phthalates in foods, she said, and the study can be used to fuel those efforts.
“We’re hoping our findings help people understand what they’re eating and what’s in food,” Dr. Edwards said. “If they want to reduce exposure to phthalates in fast food, they can choose foods without meat in them. But not everyone has the option of reducing fast food consumption — personal choice is important, but policy is what’s going to protect us.”
Dr. Edwards noted that the research was limited by small sample sizes gathered in one U.S. city. Limitations in extraction methods also meant the researchers were able to detect chemicals in gloves only at high concentrations.
“That being said, I do think our results are fairly generalizable,” she added, “because the way fast foods are prepared at these restaurants is fairly consistent.”
The study was funded by the Passport Foundation, Forsythia Foundation, and Marisla Foundation. Dr. Edwards has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF EXPOSURE SCIENCE & ENVIRONMENTAL EPIDEMIOLOGY
Unvaccinated people 20 times more likely to die from COVID: Texas study
During the month of September, , according to a new study from the Texas Department of State Health Services.
The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.
“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.
“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”
As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.
The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.
In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.
Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.
“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”
About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.
A version of this article first appeared on WebMD.com.
During the month of September, , according to a new study from the Texas Department of State Health Services.
The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.
“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.
“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”
As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.
The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.
In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.
Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.
“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”
About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.
A version of this article first appeared on WebMD.com.
During the month of September, , according to a new study from the Texas Department of State Health Services.
The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.
“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.
“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”
As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.
The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.
In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.
Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.
“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”
About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.
A version of this article first appeared on WebMD.com.
Liraglutide effective against weight regain after gastric bypass
The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.
That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.
After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.
“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.
Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.
“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”
It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.
The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.
Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).
“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.
This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.
However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
Weight regain common, repeat surgery entails risk
Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.
The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.
At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m2. None of the patients had diabetes.
The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.
They were a mean age of 48 years, and about 59% were White and 25% were Black.
All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.
At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.
There were no significant between-group differences in cardiometabolic variables.
None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.
The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.
Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.
That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.
After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.
“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.
Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.
“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”
It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.
The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.
Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).
“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.
This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.
However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
Weight regain common, repeat surgery entails risk
Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.
The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.
At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m2. None of the patients had diabetes.
The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.
They were a mean age of 48 years, and about 59% were White and 25% were Black.
All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.
At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.
There were no significant between-group differences in cardiometabolic variables.
None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.
The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.
Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.
That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.
After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.
“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.
Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.
“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”
It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.
The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.
Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).
“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.
This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.
However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
Weight regain common, repeat surgery entails risk
Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.
The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.
At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m2. None of the patients had diabetes.
The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.
They were a mean age of 48 years, and about 59% were White and 25% were Black.
All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.
At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.
There were no significant between-group differences in cardiometabolic variables.
None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.
The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.
Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM OBESITY WEEK 2021
Statins’ effects on CVD outweigh risk for diabetes in RA
The use of statins by patients with rheumatoid arthritis appears to provide an overall net benefit on cardiovascular disease outcomes that outweighs the risk of type 2 diabetes mellitus (T2DM) seen with the drugs in the general population, according to evidence from a cohort study of more than 16,000 people in the United Kingdom that was presented at the virtual annual meeting of the American College of Rheumatology.
“Our study emphasizes that RA patients should be assessed for statin initiation to improve CVD risk,” lead study author Gulsen Ozen, MD, a third-year resident at the University of Nebraska, Omaha, said in an interview. Because the risk of T2DM with statin use is no worse in patients with RA than in the general population, statin initiation “is actually a great opportunity to address the risk factors for T2DM such as activity and exercise, obesity and weight loss, and [use of glucocorticoids], which have other important health effects,” she said.
“Also, importantly, even if [patients] develop T2DM, statins still work on CVD and mortality outcomes as in patients without diabetes,” Dr. Ozen added. “Given all, the benefits of statins way outweigh the hazards.”
Dr. Ozen said this was the first large cohort study to evaluate CVD mortality and T2DM risks with statins in patients with RA, a claim with which rheumatologist Elena Myasoedova, MD, PhD, of the Mayo Clinic in Rochester, Minn., concurred.
Dr. Myasoedova, professor of rheumatology and epidemiology at Mayo, said in an interview that the study was “methodologically rigorous” using time-conditional propensity score (TCPS) matching and a prevalent new-user design, “thus addressing the immortal time bias” found in the design of studies in which patients enter a cohort but do not start a treatment before developing the outcome of interest and are assigned to the untreated group or when the period of delay from when patients enter the cohort to when they are treated is excluded from the analysis. An earlier study from the same authors did not use TCPS matching, she said.
“The study findings suggest that patients with RA can benefit from statin use in terms of CVD outcomes and mortality but physicians should use vigilance regarding increased T2DM risk and discuss this possibility with patients,” Dr. Myasoedova said. “Identifying patients who are at higher risk of developing T2DM after statin initiation would be important to personalize the approach to statin therapy.”
Study details
The study accessed records from the U.K. Clinical Practice Research Datalink and linked Hospital Episode Statistics and Office of National Statistics databases. It analyzed adult patients with RA who were diagnosed during 1989-2018 in two cohorts: One for CVD and all-cause mortality, consisting of 1,768 statin initiators and 3,528 TCPS-matched nonusers; and a T2DM cohort with 3,608 statin initiators and 7,208 TCPS-matched nonusers.
In the entire cohort, statin use was associated with a 32% reduction in CV events (composite endpoint of the nonfatal or fatal MI, stroke, hospitalized heart failure, or CVD mortality), a 54% reduction in all-cause mortality, and a 33% increase in risk for T2DM, Dr. Ozen said. Results were similar in both sexes, although CV event reduction with statins in men did not reach statistical significance, likely because of a smaller sample size, she said.
Patients with and without a history of CVD had a similar reduction in CV events and all-cause mortality, and risk for T2DM increased with statins, but the latter reached statistical significance only in patients without a history of CVD, Dr. Ozen said.
Patients with RA who are at risk for T2DM and who are taking statins require blood glucose monitoring, which is typically done in patients with RA on disease-modifying antirheumatic drugs, and hemoglobin A1c testing when glucose levels are impaired, she said. “Any concerns for T2DM would be also communicated by the primary care providers of the patients to initiate further assessment and management,” she said.
But Dr. Ozen noted that confusion exists among primary care physicians and rheumatologists about who’s responsible for prescribing statins in these patients. “I would like to remind you that instead of assigning this role to a certain specialty, just good communication could improve this care gap of statin underutilization in RA,” she said. “Also, for rheumatologists, given that all-cause mortality reduction with statins was as high as CV event reduction, statins may be reducing other causes of mortality through improving disease activity.”
Bristol-Myers Squibb provided funding for the study. Dr. Ozen and Dr. Myasoedova have no relevant disclosures.
The use of statins by patients with rheumatoid arthritis appears to provide an overall net benefit on cardiovascular disease outcomes that outweighs the risk of type 2 diabetes mellitus (T2DM) seen with the drugs in the general population, according to evidence from a cohort study of more than 16,000 people in the United Kingdom that was presented at the virtual annual meeting of the American College of Rheumatology.
“Our study emphasizes that RA patients should be assessed for statin initiation to improve CVD risk,” lead study author Gulsen Ozen, MD, a third-year resident at the University of Nebraska, Omaha, said in an interview. Because the risk of T2DM with statin use is no worse in patients with RA than in the general population, statin initiation “is actually a great opportunity to address the risk factors for T2DM such as activity and exercise, obesity and weight loss, and [use of glucocorticoids], which have other important health effects,” she said.
“Also, importantly, even if [patients] develop T2DM, statins still work on CVD and mortality outcomes as in patients without diabetes,” Dr. Ozen added. “Given all, the benefits of statins way outweigh the hazards.”
Dr. Ozen said this was the first large cohort study to evaluate CVD mortality and T2DM risks with statins in patients with RA, a claim with which rheumatologist Elena Myasoedova, MD, PhD, of the Mayo Clinic in Rochester, Minn., concurred.
Dr. Myasoedova, professor of rheumatology and epidemiology at Mayo, said in an interview that the study was “methodologically rigorous” using time-conditional propensity score (TCPS) matching and a prevalent new-user design, “thus addressing the immortal time bias” found in the design of studies in which patients enter a cohort but do not start a treatment before developing the outcome of interest and are assigned to the untreated group or when the period of delay from when patients enter the cohort to when they are treated is excluded from the analysis. An earlier study from the same authors did not use TCPS matching, she said.
“The study findings suggest that patients with RA can benefit from statin use in terms of CVD outcomes and mortality but physicians should use vigilance regarding increased T2DM risk and discuss this possibility with patients,” Dr. Myasoedova said. “Identifying patients who are at higher risk of developing T2DM after statin initiation would be important to personalize the approach to statin therapy.”
Study details
The study accessed records from the U.K. Clinical Practice Research Datalink and linked Hospital Episode Statistics and Office of National Statistics databases. It analyzed adult patients with RA who were diagnosed during 1989-2018 in two cohorts: One for CVD and all-cause mortality, consisting of 1,768 statin initiators and 3,528 TCPS-matched nonusers; and a T2DM cohort with 3,608 statin initiators and 7,208 TCPS-matched nonusers.
In the entire cohort, statin use was associated with a 32% reduction in CV events (composite endpoint of the nonfatal or fatal MI, stroke, hospitalized heart failure, or CVD mortality), a 54% reduction in all-cause mortality, and a 33% increase in risk for T2DM, Dr. Ozen said. Results were similar in both sexes, although CV event reduction with statins in men did not reach statistical significance, likely because of a smaller sample size, she said.
Patients with and without a history of CVD had a similar reduction in CV events and all-cause mortality, and risk for T2DM increased with statins, but the latter reached statistical significance only in patients without a history of CVD, Dr. Ozen said.
Patients with RA who are at risk for T2DM and who are taking statins require blood glucose monitoring, which is typically done in patients with RA on disease-modifying antirheumatic drugs, and hemoglobin A1c testing when glucose levels are impaired, she said. “Any concerns for T2DM would be also communicated by the primary care providers of the patients to initiate further assessment and management,” she said.
But Dr. Ozen noted that confusion exists among primary care physicians and rheumatologists about who’s responsible for prescribing statins in these patients. “I would like to remind you that instead of assigning this role to a certain specialty, just good communication could improve this care gap of statin underutilization in RA,” she said. “Also, for rheumatologists, given that all-cause mortality reduction with statins was as high as CV event reduction, statins may be reducing other causes of mortality through improving disease activity.”
Bristol-Myers Squibb provided funding for the study. Dr. Ozen and Dr. Myasoedova have no relevant disclosures.
The use of statins by patients with rheumatoid arthritis appears to provide an overall net benefit on cardiovascular disease outcomes that outweighs the risk of type 2 diabetes mellitus (T2DM) seen with the drugs in the general population, according to evidence from a cohort study of more than 16,000 people in the United Kingdom that was presented at the virtual annual meeting of the American College of Rheumatology.
“Our study emphasizes that RA patients should be assessed for statin initiation to improve CVD risk,” lead study author Gulsen Ozen, MD, a third-year resident at the University of Nebraska, Omaha, said in an interview. Because the risk of T2DM with statin use is no worse in patients with RA than in the general population, statin initiation “is actually a great opportunity to address the risk factors for T2DM such as activity and exercise, obesity and weight loss, and [use of glucocorticoids], which have other important health effects,” she said.
“Also, importantly, even if [patients] develop T2DM, statins still work on CVD and mortality outcomes as in patients without diabetes,” Dr. Ozen added. “Given all, the benefits of statins way outweigh the hazards.”
Dr. Ozen said this was the first large cohort study to evaluate CVD mortality and T2DM risks with statins in patients with RA, a claim with which rheumatologist Elena Myasoedova, MD, PhD, of the Mayo Clinic in Rochester, Minn., concurred.
Dr. Myasoedova, professor of rheumatology and epidemiology at Mayo, said in an interview that the study was “methodologically rigorous” using time-conditional propensity score (TCPS) matching and a prevalent new-user design, “thus addressing the immortal time bias” found in the design of studies in which patients enter a cohort but do not start a treatment before developing the outcome of interest and are assigned to the untreated group or when the period of delay from when patients enter the cohort to when they are treated is excluded from the analysis. An earlier study from the same authors did not use TCPS matching, she said.
“The study findings suggest that patients with RA can benefit from statin use in terms of CVD outcomes and mortality but physicians should use vigilance regarding increased T2DM risk and discuss this possibility with patients,” Dr. Myasoedova said. “Identifying patients who are at higher risk of developing T2DM after statin initiation would be important to personalize the approach to statin therapy.”
Study details
The study accessed records from the U.K. Clinical Practice Research Datalink and linked Hospital Episode Statistics and Office of National Statistics databases. It analyzed adult patients with RA who were diagnosed during 1989-2018 in two cohorts: One for CVD and all-cause mortality, consisting of 1,768 statin initiators and 3,528 TCPS-matched nonusers; and a T2DM cohort with 3,608 statin initiators and 7,208 TCPS-matched nonusers.
In the entire cohort, statin use was associated with a 32% reduction in CV events (composite endpoint of the nonfatal or fatal MI, stroke, hospitalized heart failure, or CVD mortality), a 54% reduction in all-cause mortality, and a 33% increase in risk for T2DM, Dr. Ozen said. Results were similar in both sexes, although CV event reduction with statins in men did not reach statistical significance, likely because of a smaller sample size, she said.
Patients with and without a history of CVD had a similar reduction in CV events and all-cause mortality, and risk for T2DM increased with statins, but the latter reached statistical significance only in patients without a history of CVD, Dr. Ozen said.
Patients with RA who are at risk for T2DM and who are taking statins require blood glucose monitoring, which is typically done in patients with RA on disease-modifying antirheumatic drugs, and hemoglobin A1c testing when glucose levels are impaired, she said. “Any concerns for T2DM would be also communicated by the primary care providers of the patients to initiate further assessment and management,” she said.
But Dr. Ozen noted that confusion exists among primary care physicians and rheumatologists about who’s responsible for prescribing statins in these patients. “I would like to remind you that instead of assigning this role to a certain specialty, just good communication could improve this care gap of statin underutilization in RA,” she said. “Also, for rheumatologists, given that all-cause mortality reduction with statins was as high as CV event reduction, statins may be reducing other causes of mortality through improving disease activity.”
Bristol-Myers Squibb provided funding for the study. Dr. Ozen and Dr. Myasoedova have no relevant disclosures.
FROM ACR 2021
‘If obesity were diabetes or cancer, how would you approach it?’
“When considering the challenges of obesity, ask yourself: ‘If it were diabetes, cancer, HIV, or Alzheimer’s, how would you discuss it, approach it, assess it, treat it?’” Lee M. Kaplan, MD, PhD, asked the audience of health care professionals during ObesityWeek®, the annual meeting of The Obesity Society.
“And then do it for obesity, using the full spectrum of tools at our disposal,” he advised.
This was the takeaway that Dr. Kaplan, director of the Obesity, Metabolism, and Nutrition Institute at Massachusetts General Hospital and associate professor, Harvard Medical School, Boston, left the audience with at the end of his lecture entitled, “What does the future of obesity care look like?”
Invited to summarize his main points, Dr. Kaplan told this news organization in an interview that practitioners caring for patients with obesity need to first “recognize that obesity is a disease” caused by dysfunction of the metabolic system that regulates body fat – in the same way immune dysregulation can lead to asthma.
Second, “we are finally developing noninvasive therapies that are more effective,” he noted, referring to the recently approved semaglutide, and even more potent weight-loss therapies that could be on the market within 3 years, so that weight-loss outcomes with pharmacotherapy are approaching those with bariatric surgery.
Third, it is important that patients with obesity get “broad and equitable access” to treatment, and health care practitioners need to be on the same page and have a “shared understanding” of which treatments are appropriate for individual patients, “just as we do for other diseases.”
Need for a shared understanding
“Dr. Kaplan really brought home the idea that we all need a shared understanding of what obesity is – and what it is not,” agreed symposium moderator Donna H. Ryan, MD, in an email.
“He underscored the biologic basis of obesity,” noted Dr. Ryan, professor emerita at Pennington Biomedical Research Center in Baton Rouge, Louisiana, and associate editor-in-chief of Obesity, the official journal of The Obesity Society.
“It is a dysregulation of the body’s weight (especially adipose tissue) regulatory system,” she continued. “The body responds to powerful environmental pressures that produce excess energy balance, and we store that as fat and defend our highest fat mass. This makes obesity a disease, a chronic disease that requires a medical approach to reverse. It’s not a cosmetic problem, it’s a medical problem,” she emphasized.
There is so much misinformation out there about obesity, according to Dr. Ryan.
“People think it’s a lack of willpower, and even patients blame themselves for not being able to lose weight and keep it off. It’s not their fault! It’s biology.”
Although the supplement industry and fad diets falsely promise fast results, there is no magic diet, she continued.
“But we have made progress based on understanding the biologic basis of obesity and have new medications that offer real hope for patients.”
“With 42% of U.S. adults having a BMI that qualifies as obesity, we need a concerted and broad effort to address this problem, and that starts with everybody on the same page as to what obesity is ... a shared understanding of the biologic basis of obesity. It’s time to take obesity seriously,” she summarized, echoing Dr. Kaplan.
A question of biology
“Obesity results from inappropriate pathophysiological regulation of body fat mass,” when the body defends adiposity, Dr. Kaplan explained at the start of his lecture.
The treatment strategy for obesity has always been a stepwise approach starting with lifestyle changes, then pharmacotherapy, then possibly bariatric surgery – each step with a potentially greater chance of weight loss. But now, he explained, medicine is on the verge of having an armamentarium of more potent weight-loss medications.
Compared with phentermine/topiramate, orlistat, naltrexone/bupropion, and liraglutide – which roughly might provide 5% to 10% weight loss, the glucagon-like peptide-1 (GLP-1) agonist semaglutide 2.4 mg/week (Wegovy, Novo Nordisk), approved by the U.S. Food and Drug Association in June, provides almost double this potential weight loss.
And two new agents that could provide “never seen before weight loss” of 25% could potentially enter the marketplace by 2025: the amylin agonist cagrilintide (Novo Nordisk) and the twincretin tirzepatide (Eli Lilly) (a combined glucose-dependent insulinotropic polypeptide [GIP] and GLP-1 receptor agonist).
In addition, when liraglutide comes off patent, a generic version could potentially be introduced, and combined generic liraglutide plus generic phentermine/topiramate could be a less expensive weight-loss treatment option in the future, he noted.
One size does not fit all
Importantly, weight loss varies widely among individual patients.
A graph of potential weight loss with different treatments (for example, bariatric surgery or liraglutide) versus the percentage of patients that attain the weight losses is roughly bell-shaped, Dr. Kaplan explained. For example, in the STEP1 trial of semaglutide, roughly 7.1% of patients lost less than 5% of their initial weight, 25% of patients lost 20% to 30%, and 10.8% of patients lost 30% or more; that is, patients at the higher end had weight loss comparable to that seen with bariatric surgery
Adding pharmacotherapy after bariatric surgery could be synergistic. For example, in the GRAVITAS study of patients with type 2 diabetes who had gastric bypass surgery, those who received liraglutide after surgery had augmented weight loss compared with those who received placebo.
People at a cocktail party might come up to him and say, “I’d like to lose 5 pounds, 10 pounds,” Dr. Kaplan related in the Q&A session.
“That’s not obesity,” he emphasized. Obesity is excess body fat that poses a risk to health. A person with obesity may have 50 or more excess pounds, and the body is trying to defend this weight.
“If we want to treat obesity more effectively, we have to fully understand why it is a disease and how that disease differs from the cultural desire for thinness,” he reiterated.
“We have to keep the needs and goals of all people living with obesity foremost in our minds, even if many of them have been previously misled by the bias, stigma, blame, and discrimination that surrounds them.”
“We need to re-evaluate what we think we know about obesity and open our minds to new ideas,” he added.
Dr. Kaplan has reported financial ties to Eli Lilly, Gelesis, GI Dynamics, IntelliHealth, Johnson & Johnson, Novo Nordisk, Pfizer, and Rhythm Pharmaceuticals. Dr. Ryan has ties to numerous Novo Nordisk, Pfizer, and several other pharmaceutical companies, including having an ownership interest in Gila Therapeutics, Xeno Biosciences, Epitomee, Calibrate, Roman, and Scientific Intake.
A version of this article first appeared on Medscape.com.
“When considering the challenges of obesity, ask yourself: ‘If it were diabetes, cancer, HIV, or Alzheimer’s, how would you discuss it, approach it, assess it, treat it?’” Lee M. Kaplan, MD, PhD, asked the audience of health care professionals during ObesityWeek®, the annual meeting of The Obesity Society.
“And then do it for obesity, using the full spectrum of tools at our disposal,” he advised.
This was the takeaway that Dr. Kaplan, director of the Obesity, Metabolism, and Nutrition Institute at Massachusetts General Hospital and associate professor, Harvard Medical School, Boston, left the audience with at the end of his lecture entitled, “What does the future of obesity care look like?”
Invited to summarize his main points, Dr. Kaplan told this news organization in an interview that practitioners caring for patients with obesity need to first “recognize that obesity is a disease” caused by dysfunction of the metabolic system that regulates body fat – in the same way immune dysregulation can lead to asthma.
Second, “we are finally developing noninvasive therapies that are more effective,” he noted, referring to the recently approved semaglutide, and even more potent weight-loss therapies that could be on the market within 3 years, so that weight-loss outcomes with pharmacotherapy are approaching those with bariatric surgery.
Third, it is important that patients with obesity get “broad and equitable access” to treatment, and health care practitioners need to be on the same page and have a “shared understanding” of which treatments are appropriate for individual patients, “just as we do for other diseases.”
Need for a shared understanding
“Dr. Kaplan really brought home the idea that we all need a shared understanding of what obesity is – and what it is not,” agreed symposium moderator Donna H. Ryan, MD, in an email.
“He underscored the biologic basis of obesity,” noted Dr. Ryan, professor emerita at Pennington Biomedical Research Center in Baton Rouge, Louisiana, and associate editor-in-chief of Obesity, the official journal of The Obesity Society.
“It is a dysregulation of the body’s weight (especially adipose tissue) regulatory system,” she continued. “The body responds to powerful environmental pressures that produce excess energy balance, and we store that as fat and defend our highest fat mass. This makes obesity a disease, a chronic disease that requires a medical approach to reverse. It’s not a cosmetic problem, it’s a medical problem,” she emphasized.
There is so much misinformation out there about obesity, according to Dr. Ryan.
“People think it’s a lack of willpower, and even patients blame themselves for not being able to lose weight and keep it off. It’s not their fault! It’s biology.”
Although the supplement industry and fad diets falsely promise fast results, there is no magic diet, she continued.
“But we have made progress based on understanding the biologic basis of obesity and have new medications that offer real hope for patients.”
“With 42% of U.S. adults having a BMI that qualifies as obesity, we need a concerted and broad effort to address this problem, and that starts with everybody on the same page as to what obesity is ... a shared understanding of the biologic basis of obesity. It’s time to take obesity seriously,” she summarized, echoing Dr. Kaplan.
A question of biology
“Obesity results from inappropriate pathophysiological regulation of body fat mass,” when the body defends adiposity, Dr. Kaplan explained at the start of his lecture.
The treatment strategy for obesity has always been a stepwise approach starting with lifestyle changes, then pharmacotherapy, then possibly bariatric surgery – each step with a potentially greater chance of weight loss. But now, he explained, medicine is on the verge of having an armamentarium of more potent weight-loss medications.
Compared with phentermine/topiramate, orlistat, naltrexone/bupropion, and liraglutide – which roughly might provide 5% to 10% weight loss, the glucagon-like peptide-1 (GLP-1) agonist semaglutide 2.4 mg/week (Wegovy, Novo Nordisk), approved by the U.S. Food and Drug Association in June, provides almost double this potential weight loss.
And two new agents that could provide “never seen before weight loss” of 25% could potentially enter the marketplace by 2025: the amylin agonist cagrilintide (Novo Nordisk) and the twincretin tirzepatide (Eli Lilly) (a combined glucose-dependent insulinotropic polypeptide [GIP] and GLP-1 receptor agonist).
In addition, when liraglutide comes off patent, a generic version could potentially be introduced, and combined generic liraglutide plus generic phentermine/topiramate could be a less expensive weight-loss treatment option in the future, he noted.
One size does not fit all
Importantly, weight loss varies widely among individual patients.
A graph of potential weight loss with different treatments (for example, bariatric surgery or liraglutide) versus the percentage of patients that attain the weight losses is roughly bell-shaped, Dr. Kaplan explained. For example, in the STEP1 trial of semaglutide, roughly 7.1% of patients lost less than 5% of their initial weight, 25% of patients lost 20% to 30%, and 10.8% of patients lost 30% or more; that is, patients at the higher end had weight loss comparable to that seen with bariatric surgery
Adding pharmacotherapy after bariatric surgery could be synergistic. For example, in the GRAVITAS study of patients with type 2 diabetes who had gastric bypass surgery, those who received liraglutide after surgery had augmented weight loss compared with those who received placebo.
People at a cocktail party might come up to him and say, “I’d like to lose 5 pounds, 10 pounds,” Dr. Kaplan related in the Q&A session.
“That’s not obesity,” he emphasized. Obesity is excess body fat that poses a risk to health. A person with obesity may have 50 or more excess pounds, and the body is trying to defend this weight.
“If we want to treat obesity more effectively, we have to fully understand why it is a disease and how that disease differs from the cultural desire for thinness,” he reiterated.
“We have to keep the needs and goals of all people living with obesity foremost in our minds, even if many of them have been previously misled by the bias, stigma, blame, and discrimination that surrounds them.”
“We need to re-evaluate what we think we know about obesity and open our minds to new ideas,” he added.
Dr. Kaplan has reported financial ties to Eli Lilly, Gelesis, GI Dynamics, IntelliHealth, Johnson & Johnson, Novo Nordisk, Pfizer, and Rhythm Pharmaceuticals. Dr. Ryan has ties to numerous Novo Nordisk, Pfizer, and several other pharmaceutical companies, including having an ownership interest in Gila Therapeutics, Xeno Biosciences, Epitomee, Calibrate, Roman, and Scientific Intake.
A version of this article first appeared on Medscape.com.
“When considering the challenges of obesity, ask yourself: ‘If it were diabetes, cancer, HIV, or Alzheimer’s, how would you discuss it, approach it, assess it, treat it?’” Lee M. Kaplan, MD, PhD, asked the audience of health care professionals during ObesityWeek®, the annual meeting of The Obesity Society.
“And then do it for obesity, using the full spectrum of tools at our disposal,” he advised.
This was the takeaway that Dr. Kaplan, director of the Obesity, Metabolism, and Nutrition Institute at Massachusetts General Hospital and associate professor, Harvard Medical School, Boston, left the audience with at the end of his lecture entitled, “What does the future of obesity care look like?”
Invited to summarize his main points, Dr. Kaplan told this news organization in an interview that practitioners caring for patients with obesity need to first “recognize that obesity is a disease” caused by dysfunction of the metabolic system that regulates body fat – in the same way immune dysregulation can lead to asthma.
Second, “we are finally developing noninvasive therapies that are more effective,” he noted, referring to the recently approved semaglutide, and even more potent weight-loss therapies that could be on the market within 3 years, so that weight-loss outcomes with pharmacotherapy are approaching those with bariatric surgery.
Third, it is important that patients with obesity get “broad and equitable access” to treatment, and health care practitioners need to be on the same page and have a “shared understanding” of which treatments are appropriate for individual patients, “just as we do for other diseases.”
Need for a shared understanding
“Dr. Kaplan really brought home the idea that we all need a shared understanding of what obesity is – and what it is not,” agreed symposium moderator Donna H. Ryan, MD, in an email.
“He underscored the biologic basis of obesity,” noted Dr. Ryan, professor emerita at Pennington Biomedical Research Center in Baton Rouge, Louisiana, and associate editor-in-chief of Obesity, the official journal of The Obesity Society.
“It is a dysregulation of the body’s weight (especially adipose tissue) regulatory system,” she continued. “The body responds to powerful environmental pressures that produce excess energy balance, and we store that as fat and defend our highest fat mass. This makes obesity a disease, a chronic disease that requires a medical approach to reverse. It’s not a cosmetic problem, it’s a medical problem,” she emphasized.
There is so much misinformation out there about obesity, according to Dr. Ryan.
“People think it’s a lack of willpower, and even patients blame themselves for not being able to lose weight and keep it off. It’s not their fault! It’s biology.”
Although the supplement industry and fad diets falsely promise fast results, there is no magic diet, she continued.
“But we have made progress based on understanding the biologic basis of obesity and have new medications that offer real hope for patients.”
“With 42% of U.S. adults having a BMI that qualifies as obesity, we need a concerted and broad effort to address this problem, and that starts with everybody on the same page as to what obesity is ... a shared understanding of the biologic basis of obesity. It’s time to take obesity seriously,” she summarized, echoing Dr. Kaplan.
A question of biology
“Obesity results from inappropriate pathophysiological regulation of body fat mass,” when the body defends adiposity, Dr. Kaplan explained at the start of his lecture.
The treatment strategy for obesity has always been a stepwise approach starting with lifestyle changes, then pharmacotherapy, then possibly bariatric surgery – each step with a potentially greater chance of weight loss. But now, he explained, medicine is on the verge of having an armamentarium of more potent weight-loss medications.
Compared with phentermine/topiramate, orlistat, naltrexone/bupropion, and liraglutide – which roughly might provide 5% to 10% weight loss, the glucagon-like peptide-1 (GLP-1) agonist semaglutide 2.4 mg/week (Wegovy, Novo Nordisk), approved by the U.S. Food and Drug Association in June, provides almost double this potential weight loss.
And two new agents that could provide “never seen before weight loss” of 25% could potentially enter the marketplace by 2025: the amylin agonist cagrilintide (Novo Nordisk) and the twincretin tirzepatide (Eli Lilly) (a combined glucose-dependent insulinotropic polypeptide [GIP] and GLP-1 receptor agonist).
In addition, when liraglutide comes off patent, a generic version could potentially be introduced, and combined generic liraglutide plus generic phentermine/topiramate could be a less expensive weight-loss treatment option in the future, he noted.
One size does not fit all
Importantly, weight loss varies widely among individual patients.
A graph of potential weight loss with different treatments (for example, bariatric surgery or liraglutide) versus the percentage of patients that attain the weight losses is roughly bell-shaped, Dr. Kaplan explained. For example, in the STEP1 trial of semaglutide, roughly 7.1% of patients lost less than 5% of their initial weight, 25% of patients lost 20% to 30%, and 10.8% of patients lost 30% or more; that is, patients at the higher end had weight loss comparable to that seen with bariatric surgery
Adding pharmacotherapy after bariatric surgery could be synergistic. For example, in the GRAVITAS study of patients with type 2 diabetes who had gastric bypass surgery, those who received liraglutide after surgery had augmented weight loss compared with those who received placebo.
People at a cocktail party might come up to him and say, “I’d like to lose 5 pounds, 10 pounds,” Dr. Kaplan related in the Q&A session.
“That’s not obesity,” he emphasized. Obesity is excess body fat that poses a risk to health. A person with obesity may have 50 or more excess pounds, and the body is trying to defend this weight.
“If we want to treat obesity more effectively, we have to fully understand why it is a disease and how that disease differs from the cultural desire for thinness,” he reiterated.
“We have to keep the needs and goals of all people living with obesity foremost in our minds, even if many of them have been previously misled by the bias, stigma, blame, and discrimination that surrounds them.”
“We need to re-evaluate what we think we know about obesity and open our minds to new ideas,” he added.
Dr. Kaplan has reported financial ties to Eli Lilly, Gelesis, GI Dynamics, IntelliHealth, Johnson & Johnson, Novo Nordisk, Pfizer, and Rhythm Pharmaceuticals. Dr. Ryan has ties to numerous Novo Nordisk, Pfizer, and several other pharmaceutical companies, including having an ownership interest in Gila Therapeutics, Xeno Biosciences, Epitomee, Calibrate, Roman, and Scientific Intake.
A version of this article first appeared on Medscape.com.
FROM OBESITY WEEK 2020