Red and white blood cells

A portable device could be used to monitor patients’ white blood cell (WBC) levels at home, without the need for blood samples, according to researchers.

The team created a prototype that records video of blood cells flowing through capillaries just below the skin surface at the base of the fingernail.

The group is developing a computer algorithm that, in early testing, has been able to analyze the videos and determine if WBC levels are too low.

The researchers believe this type of device could be used to prevent infections among chemotherapy recipients.

“Our vision is that patients will have this portable device that they can take home, and they can monitor daily how they are reacting to the treatment,” said Carlos Castro-Gonzalez, PhD, of the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts.

“If they go below the [safe WBC] threshold, then preventive treatment can be deployed.”

Dr Castro-Gonzalez and his colleagues described their prototype, and the testing of it, in Scientific Reports.

The device consists of a wide-field microscope that emits blue light, which penetrates about 50 to 150 microns below the skin and is reflected back to a video camera.

The researchers decided to image the skin at the base of the nail because the capillaries there are very close to the skin surface. These capillaries are so narrow that WBCs must squeeze through one at a time, making them easier to see.

The researchers tested the device in 11 patients at various points during their chemotherapy treatment.

The device does not provide precise WBC counts but allowed the team to differentiate cases of severe neutropenia (<500 neutrophils per μL) from non-neutropenic cases (>1500 neutrophils per μL).

To obtain enough data to make these classifications, the researchers recorded 1 minute of video per patient. Three blinded human assistants then watched the videos and noted whenever a WBC passed by.

However, since submitting their paper, the researchers have been developing a computer algorithm to perform the same task automatically.

“Based on the feature-set that our human raters identified, we are now developing an AI and machine-vision algorithm, with preliminary results that indicate the same accuracy as the raters,” said study author Aurélien Bourquard, PhD, of MIT.

The researchers have applied for patents on the technology and launched a company called Leuko, which is working on commercializing the technology with help from MIT.

To move the technology further toward commercialization, the researchers are building a new automated prototype.

“Automating the measurement process is key to making a viable home-use device,” said study author Ian Butterworth, of MIT. “The imaging needs to take place in the right spot on the patient’s finger, and the operation of the device must be straightforward.”

Using this new prototype, the researchers plan to test the device with additional cancer patients. And the team is investigating whether they can get accurate results with shorter lengths of video.

They also plan to adapt the technology so it can generate more precise WBC counts, which would make it useful for monitoring bone marrow transplant recipients or people with certain infectious diseases, Dr Castro-Gonzalez said.

This could also make it possible to determine whether chemotherapy patients can receive their next dose sooner than usual.

“There is a balancing act that oncologists must do,” said study author Alvaro Sanchez-Ferro, MD, of Centro Integral en Neurociencias A.C. HM CINAC in Madrid, Spain.

“Normally, doctors want to make chemotherapy as intensive as possible but without getting people too immunosuppressed. Current 21-day cycles are based on statistics of what most patients can take, but if you are ready early, then they can potentially bring you back early, and that can translate into better survival.”

Red and white blood cells

A portable device could be used to monitor patients’ white blood cell (WBC) levels at home, without the need for blood samples, according to researchers.

The team created a prototype that records video of blood cells flowing through capillaries just below the skin surface at the base of the fingernail.

The group is developing a computer algorithm that, in early testing, has been able to analyze the videos and determine if WBC levels are too low.

The researchers believe this type of device could be used to prevent infections among chemotherapy recipients.

“Our vision is that patients will have this portable device that they can take home, and they can monitor daily how they are reacting to the treatment,” said Carlos Castro-Gonzalez, PhD, of the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts.

“If they go below the [safe WBC] threshold, then preventive treatment can be deployed.”

Dr Castro-Gonzalez and his colleagues described their prototype, and the testing of it, in Scientific Reports.

The device consists of a wide-field microscope that emits blue light, which penetrates about 50 to 150 microns below the skin and is reflected back to a video camera.

The researchers decided to image the skin at the base of the nail because the capillaries there are very close to the skin surface. These capillaries are so narrow that WBCs must squeeze through one at a time, making them easier to see.

The researchers tested the device in 11 patients at various points during their chemotherapy treatment.

The device does not provide precise WBC counts but allowed the team to differentiate cases of severe neutropenia (<500 neutrophils per μL) from non-neutropenic cases (>1500 neutrophils per μL).

To obtain enough data to make these classifications, the researchers recorded 1 minute of video per patient. Three blinded human assistants then watched the videos and noted whenever a WBC passed by.

However, since submitting their paper, the researchers have been developing a computer algorithm to perform the same task automatically.

“Based on the feature-set that our human raters identified, we are now developing an AI and machine-vision algorithm, with preliminary results that indicate the same accuracy as the raters,” said study author Aurélien Bourquard, PhD, of MIT.

The researchers have applied for patents on the technology and launched a company called Leuko, which is working on commercializing the technology with help from MIT.

To move the technology further toward commercialization, the researchers are building a new automated prototype.

“Automating the measurement process is key to making a viable home-use device,” said study author Ian Butterworth, of MIT. “The imaging needs to take place in the right spot on the patient’s finger, and the operation of the device must be straightforward.”

Using this new prototype, the researchers plan to test the device with additional cancer patients. And the team is investigating whether they can get accurate results with shorter lengths of video.

They also plan to adapt the technology so it can generate more precise WBC counts, which would make it useful for monitoring bone marrow transplant recipients or people with certain infectious diseases, Dr Castro-Gonzalez said.

This could also make it possible to determine whether chemotherapy patients can receive their next dose sooner than usual.

“There is a balancing act that oncologists must do,” said study author Alvaro Sanchez-Ferro, MD, of Centro Integral en Neurociencias A.C. HM CINAC in Madrid, Spain.

“Normally, doctors want to make chemotherapy as intensive as possible but without getting people too immunosuppressed. Current 21-day cycles are based on statistics of what most patients can take, but if you are ready early, then they can potentially bring you back early, and that can translate into better survival.”

Red and white blood cells

A portable device could be used to monitor patients’ white blood cell (WBC) levels at home, without the need for blood samples, according to researchers.

The team created a prototype that records video of blood cells flowing through capillaries just below the skin surface at the base of the fingernail.

The group is developing a computer algorithm that, in early testing, has been able to analyze the videos and determine if WBC levels are too low.

The researchers believe this type of device could be used to prevent infections among chemotherapy recipients.

“Our vision is that patients will have this portable device that they can take home, and they can monitor daily how they are reacting to the treatment,” said Carlos Castro-Gonzalez, PhD, of the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts.

“If they go below the [safe WBC] threshold, then preventive treatment can be deployed.”

Dr Castro-Gonzalez and his colleagues described their prototype, and the testing of it, in Scientific Reports.

The device consists of a wide-field microscope that emits blue light, which penetrates about 50 to 150 microns below the skin and is reflected back to a video camera.

The researchers decided to image the skin at the base of the nail because the capillaries there are very close to the skin surface. These capillaries are so narrow that WBCs must squeeze through one at a time, making them easier to see.

The researchers tested the device in 11 patients at various points during their chemotherapy treatment.

The device does not provide precise WBC counts but allowed the team to differentiate cases of severe neutropenia (<500 neutrophils per μL) from non-neutropenic cases (>1500 neutrophils per μL).

To obtain enough data to make these classifications, the researchers recorded 1 minute of video per patient. Three blinded human assistants then watched the videos and noted whenever a WBC passed by.

However, since submitting their paper, the researchers have been developing a computer algorithm to perform the same task automatically.

“Based on the feature-set that our human raters identified, we are now developing an AI and machine-vision algorithm, with preliminary results that indicate the same accuracy as the raters,” said study author Aurélien Bourquard, PhD, of MIT.

The researchers have applied for patents on the technology and launched a company called Leuko, which is working on commercializing the technology with help from MIT.

To move the technology further toward commercialization, the researchers are building a new automated prototype.

“Automating the measurement process is key to making a viable home-use device,” said study author Ian Butterworth, of MIT. “The imaging needs to take place in the right spot on the patient’s finger, and the operation of the device must be straightforward.”

Using this new prototype, the researchers plan to test the device with additional cancer patients. And the team is investigating whether they can get accurate results with shorter lengths of video.

They also plan to adapt the technology so it can generate more precise WBC counts, which would make it useful for monitoring bone marrow transplant recipients or people with certain infectious diseases, Dr Castro-Gonzalez said.

This could also make it possible to determine whether chemotherapy patients can receive their next dose sooner than usual.

“There is a balancing act that oncologists must do,” said study author Alvaro Sanchez-Ferro, MD, of Centro Integral en Neurociencias A.C. HM CINAC in Madrid, Spain.

“Normally, doctors want to make chemotherapy as intensive as possible but without getting people too immunosuppressed. Current 21-day cycles are based on statistics of what most patients can take, but if you are ready early, then they can potentially bring you back early, and that can translate into better survival.”

Watkins, K.E., et al, JAMA Intern Med 177(10):1480, October 1, 2017

BACKGROUND: Collaborative care has been reported to be an effective strategy for the delivery of evidence-based treatments and improving patient outcomes, but its utility for substance abuse treatment in primary care has not been evaluated.

METHODS: The Substance Use Motivation and Medication Integrated Treatment (SUMMIT) study, coordinated at RAND Corporation, included 377 adults (mean age 42 years; 80% male) attending two community health clinics for opioid and alcohol use disorders. The study excluded patients with bipolar disorder, schizophrenia, or current substance abuse treatment. Study participants were randomized to collaborative care (n=187) or usual care (n=190). Patients were assessed for their use of evidence-based treatments (brief six-session psychotherapy treatment and treatment with buprenorphine/naloxone or naltrexone) and self-reported abstinence from opioids and alcohol at six months.

RESULTS: Only 13% of the patients had received any substance abuse treatment in the previous year. After six months, more patients in the collaborative care group than controls had received psychotherapy or medications (39.0% versus 16.8%; adjusted odds ratio [OR] 3.97, 95% CI 2.32-6.79; p<0.001); the difference was explained by a higher rate of psychotherapy (35.8% versus 10.5%; OR 6.22, 95% CI 3.4-11.5; p<0.001), while rates of medication use in the two groups were similar (13.4% versus 12.6%). Self-reported abstinence at six months was also more frequent with collaborative care (32.8% versus 22.3%; adjusted effect estimate, beta = 0.12; 95% CI 0.01-0.23; p=0.03). Healthcare Effectiveness Data and Information Set (HEDIS) measures of initiation and engagement increased significantly with collaborative care (both, p<0.001).

CONCLUSIONS: A collaborative care intervention increased treatment uptake and six-month abstinence in these primary care patients with opioid and alcohol abuse disorders. 69 references ([email protected] – no reprints)

Watkins, K.E., et al, JAMA Intern Med 177(10):1480, October 1, 2017

BACKGROUND: Collaborative care has been reported to be an effective strategy for the delivery of evidence-based treatments and improving patient outcomes, but its utility for substance abuse treatment in primary care has not been evaluated.

METHODS: The Substance Use Motivation and Medication Integrated Treatment (SUMMIT) study, coordinated at RAND Corporation, included 377 adults (mean age 42 years; 80% male) attending two community health clinics for opioid and alcohol use disorders. The study excluded patients with bipolar disorder, schizophrenia, or current substance abuse treatment. Study participants were randomized to collaborative care (n=187) or usual care (n=190). Patients were assessed for their use of evidence-based treatments (brief six-session psychotherapy treatment and treatment with buprenorphine/naloxone or naltrexone) and self-reported abstinence from opioids and alcohol at six months.

RESULTS: Only 13% of the patients had received any substance abuse treatment in the previous year. After six months, more patients in the collaborative care group than controls had received psychotherapy or medications (39.0% versus 16.8%; adjusted odds ratio [OR] 3.97, 95% CI 2.32-6.79; p<0.001); the difference was explained by a higher rate of psychotherapy (35.8% versus 10.5%; OR 6.22, 95% CI 3.4-11.5; p<0.001), while rates of medication use in the two groups were similar (13.4% versus 12.6%). Self-reported abstinence at six months was also more frequent with collaborative care (32.8% versus 22.3%; adjusted effect estimate, beta = 0.12; 95% CI 0.01-0.23; p=0.03). Healthcare Effectiveness Data and Information Set (HEDIS) measures of initiation and engagement increased significantly with collaborative care (both, p<0.001).

CONCLUSIONS: A collaborative care intervention increased treatment uptake and six-month abstinence in these primary care patients with opioid and alcohol abuse disorders. 69 references ([email protected] – no reprints)

Watkins, K.E., et al, JAMA Intern Med 177(10):1480, October 1, 2017

BACKGROUND: Collaborative care has been reported to be an effective strategy for the delivery of evidence-based treatments and improving patient outcomes, but its utility for substance abuse treatment in primary care has not been evaluated.

METHODS: The Substance Use Motivation and Medication Integrated Treatment (SUMMIT) study, coordinated at RAND Corporation, included 377 adults (mean age 42 years; 80% male) attending two community health clinics for opioid and alcohol use disorders. The study excluded patients with bipolar disorder, schizophrenia, or current substance abuse treatment. Study participants were randomized to collaborative care (n=187) or usual care (n=190). Patients were assessed for their use of evidence-based treatments (brief six-session psychotherapy treatment and treatment with buprenorphine/naloxone or naltrexone) and self-reported abstinence from opioids and alcohol at six months.

RESULTS: Only 13% of the patients had received any substance abuse treatment in the previous year. After six months, more patients in the collaborative care group than controls had received psychotherapy or medications (39.0% versus 16.8%; adjusted odds ratio [OR] 3.97, 95% CI 2.32-6.79; p<0.001); the difference was explained by a higher rate of psychotherapy (35.8% versus 10.5%; OR 6.22, 95% CI 3.4-11.5; p<0.001), while rates of medication use in the two groups were similar (13.4% versus 12.6%). Self-reported abstinence at six months was also more frequent with collaborative care (32.8% versus 22.3%; adjusted effect estimate, beta = 0.12; 95% CI 0.01-0.23; p=0.03). Healthcare Effectiveness Data and Information Set (HEDIS) measures of initiation and engagement increased significantly with collaborative care (both, p<0.001).

CONCLUSIONS: A collaborative care intervention increased treatment uptake and six-month abstinence in these primary care patients with opioid and alcohol abuse disorders. 69 references ([email protected] – no reprints)

Clinical question: While it is generally thought that ICU wards are not conducive for sleep because of light and noise disruptions, are general wards any better?

Background: Hospitalized patients frequently report poor sleep, partly because of the inpatient environment. Sound level changes (SLCs), rather than the total volumes, are important in disrupting sleep. The World Health Organization recommends that nighttime baseline noise levels do not exceed 30 decibels (dB) and that nighttime noise peaks (i.e., loud noises) do not exceed 40 dB. The circadian rhythm system depends on ambient light to regulate the internal clock. Insufficient and inappropriately timed light exposure can desynchronize the biological clock, thereby negatively affecting sleep quality.

Clinical question: While it is generally thought that ICU wards are not conducive for sleep because of light and noise disruptions, are general wards any better?

Background: Hospitalized patients frequently report poor sleep, partly because of the inpatient environment. Sound level changes (SLCs), rather than the total volumes, are important in disrupting sleep. The World Health Organization recommends that nighttime baseline noise levels do not exceed 30 decibels (dB) and that nighttime noise peaks (i.e., loud noises) do not exceed 40 dB. The circadian rhythm system depends on ambient light to regulate the internal clock. Insufficient and inappropriately timed light exposure can desynchronize the biological clock, thereby negatively affecting sleep quality.

Clinical question: While it is generally thought that ICU wards are not conducive for sleep because of light and noise disruptions, are general wards any better?

Background: Hospitalized patients frequently report poor sleep, partly because of the inpatient environment. Sound level changes (SLCs), rather than the total volumes, are important in disrupting sleep. The World Health Organization recommends that nighttime baseline noise levels do not exceed 30 decibels (dB) and that nighttime noise peaks (i.e., loud noises) do not exceed 40 dB. The circadian rhythm system depends on ambient light to regulate the internal clock. Insufficient and inappropriately timed light exposure can desynchronize the biological clock, thereby negatively affecting sleep quality.

Federal agencies and leaders are taking a multipronged approach to the opioid crisis.

Efforts by the Centers for Medicare & Medicaid Services focus on changes to the Medicare Part D program and Medicare Advantage, via two policy changes issued April 2: The Part D/Medicare Advantage annual update and final calendar year 2019 guidance to insurers who provide coverage under those two programs.

The annual Part D/Medicare Advantage update implements provisions of the Comprehensive Addiction and Recovery Act of 2016 (S. 524), requiring “CMS to establish through regulation a framework that allows Part D sponsors to implement drug management programs,” according to a CMS fact sheet. “Under such programs, a sponsor can limit at-risk beneficiaries’ access to coverage for frequently abused drugs beginning with the 2019 plan year.” The update designates opioids and benzodiazepines as frequently abused drugs.

For chronic opioid users, CMS expects “all sponsors to implement an opioid care coordination edit at 90 morphine milligram equivalent (MME) per day. This formulary-level safety edit should trigger when a beneficiary’s cumulative MME per day across their opioid prescriptions reaches or exceeds 90 MME.”

There is flexibility: Pharmacists may contact prescribers and confirm that more pain medication is needed and then override the 90 MME/day threshold, if appropriate.

Finally, CMS expects “sponsors to implement additional soft safety edits to alert the pharmacist about duplicative opioid therapy and concurrent use of opioids and benzodiazepines,” according to the guidance.

The executive and legislative branches also are taking action.

President Trump in March detailed initiatives to address the opioid crisis across three domains: reducing demand through education, awareness, and prevention of overprescribing; reducing illicit drug importation and distribution; and expanding opportunities for proven treatment options.

For prescribers, the president’s plan calls for a nationwide reduction in opioid prescriptions filled by one-third within 3 years. It also looks aims to ensure that 75% of opioid prescriptions paid for by the government are “issued using best practices within 3 years, and 95% within 5 years,” a White House fact sheet notes.

When it comes to federal health care providers, those standards are to be met by half within 2 years and all within 5.

The White House also is calling on states to transition to a nationally interoperable Prescription Drug Monitoring Program (PDMP) network.

The president’s plan also calls for ensuring first-responder access to naloxone, improving overdose tracking systems, and expanding access to medication-assisted treatment. It also aims to change the Medicaid law that prohibits reimbursement of residential treatment at certain facilities with more than 16 beds.

On the legislative side, the House Energy and Commerce Committee is in the process of hosting a series of hearings and is expected to introduce a comprehensive package of bills aimed at various aspects of the opioid crisis. Across the four hearings, more than 30 pieces of individual legislation have been examined.

In the Senate, the Health, Education, Labor and Pensions Committee on April 4 released a discussion draft of the Opioid Crisis Response Act of 2018 and has scheduled a hearing for April 11 to discuss it.

The bill would spur development of nonaddictive pain killers, clarify FDA authority on small-quantity blister packs for opioids, provide states with better PDMP support; increase access to mental health services in schools, and improve substance use disorder treatment in underserved areas.

Also on April 4, the National Institutes of Health launched the HEAL Initiative (Helping to End Addiction Long-Term) to increase research to help prevent addiction through advanced pain management, and improve treatments for opioid misuse disorder and addiction. NIH is nearly doubling funding into opioid misuse/addiction research from $600 million in fiscal 2016 to $1.1 billion in fiscal 2018.

[email protected]

Federal agencies and leaders are taking a multipronged approach to the opioid crisis.

Efforts by the Centers for Medicare & Medicaid Services focus on changes to the Medicare Part D program and Medicare Advantage, via two policy changes issued April 2: The Part D/Medicare Advantage annual update and final calendar year 2019 guidance to insurers who provide coverage under those two programs.

The annual Part D/Medicare Advantage update implements provisions of the Comprehensive Addiction and Recovery Act of 2016 (S. 524), requiring “CMS to establish through regulation a framework that allows Part D sponsors to implement drug management programs,” according to a CMS fact sheet. “Under such programs, a sponsor can limit at-risk beneficiaries’ access to coverage for frequently abused drugs beginning with the 2019 plan year.” The update designates opioids and benzodiazepines as frequently abused drugs.

For chronic opioid users, CMS expects “all sponsors to implement an opioid care coordination edit at 90 morphine milligram equivalent (MME) per day. This formulary-level safety edit should trigger when a beneficiary’s cumulative MME per day across their opioid prescriptions reaches or exceeds 90 MME.”

There is flexibility: Pharmacists may contact prescribers and confirm that more pain medication is needed and then override the 90 MME/day threshold, if appropriate.

Finally, CMS expects “sponsors to implement additional soft safety edits to alert the pharmacist about duplicative opioid therapy and concurrent use of opioids and benzodiazepines,” according to the guidance.

The executive and legislative branches also are taking action.

President Trump in March detailed initiatives to address the opioid crisis across three domains: reducing demand through education, awareness, and prevention of overprescribing; reducing illicit drug importation and distribution; and expanding opportunities for proven treatment options.

For prescribers, the president’s plan calls for a nationwide reduction in opioid prescriptions filled by one-third within 3 years. It also looks aims to ensure that 75% of opioid prescriptions paid for by the government are “issued using best practices within 3 years, and 95% within 5 years,” a White House fact sheet notes.

When it comes to federal health care providers, those standards are to be met by half within 2 years and all within 5.

The White House also is calling on states to transition to a nationally interoperable Prescription Drug Monitoring Program (PDMP) network.

The president’s plan also calls for ensuring first-responder access to naloxone, improving overdose tracking systems, and expanding access to medication-assisted treatment. It also aims to change the Medicaid law that prohibits reimbursement of residential treatment at certain facilities with more than 16 beds.

On the legislative side, the House Energy and Commerce Committee is in the process of hosting a series of hearings and is expected to introduce a comprehensive package of bills aimed at various aspects of the opioid crisis. Across the four hearings, more than 30 pieces of individual legislation have been examined.

In the Senate, the Health, Education, Labor and Pensions Committee on April 4 released a discussion draft of the Opioid Crisis Response Act of 2018 and has scheduled a hearing for April 11 to discuss it.

The bill would spur development of nonaddictive pain killers, clarify FDA authority on small-quantity blister packs for opioids, provide states with better PDMP support; increase access to mental health services in schools, and improve substance use disorder treatment in underserved areas.

Also on April 4, the National Institutes of Health launched the HEAL Initiative (Helping to End Addiction Long-Term) to increase research to help prevent addiction through advanced pain management, and improve treatments for opioid misuse disorder and addiction. NIH is nearly doubling funding into opioid misuse/addiction research from $600 million in fiscal 2016 to $1.1 billion in fiscal 2018.

[email protected]

Federal agencies and leaders are taking a multipronged approach to the opioid crisis.

Efforts by the Centers for Medicare & Medicaid Services focus on changes to the Medicare Part D program and Medicare Advantage, via two policy changes issued April 2: The Part D/Medicare Advantage annual update and final calendar year 2019 guidance to insurers who provide coverage under those two programs.

The annual Part D/Medicare Advantage update implements provisions of the Comprehensive Addiction and Recovery Act of 2016 (S. 524), requiring “CMS to establish through regulation a framework that allows Part D sponsors to implement drug management programs,” according to a CMS fact sheet. “Under such programs, a sponsor can limit at-risk beneficiaries’ access to coverage for frequently abused drugs beginning with the 2019 plan year.” The update designates opioids and benzodiazepines as frequently abused drugs.

For chronic opioid users, CMS expects “all sponsors to implement an opioid care coordination edit at 90 morphine milligram equivalent (MME) per day. This formulary-level safety edit should trigger when a beneficiary’s cumulative MME per day across their opioid prescriptions reaches or exceeds 90 MME.”

There is flexibility: Pharmacists may contact prescribers and confirm that more pain medication is needed and then override the 90 MME/day threshold, if appropriate.

Finally, CMS expects “sponsors to implement additional soft safety edits to alert the pharmacist about duplicative opioid therapy and concurrent use of opioids and benzodiazepines,” according to the guidance.

The executive and legislative branches also are taking action.

President Trump in March detailed initiatives to address the opioid crisis across three domains: reducing demand through education, awareness, and prevention of overprescribing; reducing illicit drug importation and distribution; and expanding opportunities for proven treatment options.

For prescribers, the president’s plan calls for a nationwide reduction in opioid prescriptions filled by one-third within 3 years. It also looks aims to ensure that 75% of opioid prescriptions paid for by the government are “issued using best practices within 3 years, and 95% within 5 years,” a White House fact sheet notes.

When it comes to federal health care providers, those standards are to be met by half within 2 years and all within 5.

The White House also is calling on states to transition to a nationally interoperable Prescription Drug Monitoring Program (PDMP) network.

The president’s plan also calls for ensuring first-responder access to naloxone, improving overdose tracking systems, and expanding access to medication-assisted treatment. It also aims to change the Medicaid law that prohibits reimbursement of residential treatment at certain facilities with more than 16 beds.

On the legislative side, the House Energy and Commerce Committee is in the process of hosting a series of hearings and is expected to introduce a comprehensive package of bills aimed at various aspects of the opioid crisis. Across the four hearings, more than 30 pieces of individual legislation have been examined.

In the Senate, the Health, Education, Labor and Pensions Committee on April 4 released a discussion draft of the Opioid Crisis Response Act of 2018 and has scheduled a hearing for April 11 to discuss it.

The bill would spur development of nonaddictive pain killers, clarify FDA authority on small-quantity blister packs for opioids, provide states with better PDMP support; increase access to mental health services in schools, and improve substance use disorder treatment in underserved areas.

Also on April 4, the National Institutes of Health launched the HEAL Initiative (Helping to End Addiction Long-Term) to increase research to help prevent addiction through advanced pain management, and improve treatments for opioid misuse disorder and addiction. NIH is nearly doubling funding into opioid misuse/addiction research from $600 million in fiscal 2016 to $1.1 billion in fiscal 2018.

[email protected]

SAN DIEGO – Think beyond the foot: Fungal infections are just the beginning when it comes to skin disorders in athletes, which include ringworm in wrestlers, “jogger’s nipple” in runners, and more serious conditions – like skin cancer.

“Skin ailments are some of the most common conditions of athletes,” affecting all levels of sports enthusiasts, “from weekend warriors to professional athletes,” said Brian B. Adams, MD, MPH, professor and chair of the department of dermatology at the University of Cincinnati.

Skin cancer: Risk seems clear, but data are sparse

“Athletes in general appear to be at increased risk in the long term for skin cancer” since they often play and practice during the hours between 10 a.m. and 4 p.m., when the danger of sun exposure is at its highest, he said. In addition, “sweating removes the sunscreen that athletes put on, and there is evidence that sweating actually increases the chance of burning,” he said.

Skiers and snowboarders face unique sun exposure risks, he added. “Snow reflects up to 100% of UV, so even though they may be in shade, they experience UV. And mountain athletes experience greater amounts of UV as the altitude of the mountain increases: At higher altitudes, the atmosphere has less chance of filtering out the damaging rays.”

While it’s obvious that many athletes face extra sun exposure, Dr. Adams pointed out, “very little is definitively known about the actual degree of risk of athletic activities.”

Still, the research that does exist provides plenty of hints about risk. “Large epidemiological studies showed that recreational activities such as sun exposure on the beach or during water sports were associated with an increased risk of basal cell carcinoma, whereas skiing has been shown to be at increased risk for squamous cell carcinoma,” according to a 2008 report on outdoor sports and skin cancer (Clin Dermatol. 2008 Jan-Feb;26[1]:12-5).

“Risk factors of cutaneous melanoma, such as the number of melanocytic nevi and solar lentigines, have been found to be more frequent in subjects practicing endurance outdoor sports. An increased risk for cutaneous melanoma may be assumed for these athletes,” Dr. Adams commented.

Another study, this one published in 2006, found more atypical melanocytic nevi, solar lentigines, and lesions suggestive of nonmelanoma skin cancer in marathon runners, compared with a control group, and the risk was associated with the level of training intensity. The control subjects were more sensitive to the sun and had more common melanocytic nevi (Arch Dermatol. 2006 Nov;142[11]:1471-4).

Counseling about sunscreen may actually work

One strategy to reduce sun exposure is to advise athletes to avoid peak sun hours. However, “the key to caring for the athletes is not only recognizing that their sport may play a role in their disease but also realizing that your therapeutic approach must be tailored to minimize disruption to their practices and competitions,” Dr. Adams said.

Watch for other conditions, from jogger’s nipple to ringworm

Dr. Adams offered advice about detection, treatment, and prevention of other skin disorders that affect athletes:

• “Jogger’s nipples” and other kinds of chafing. He has learned to recognize the “red eleven” – two vertical streaks of blood on a runner’s shirt – that represent a case of “jogger’s nipples” caused by chafing. Antibacterial ointment or petroleum jelly are useful treatments, he said, and an application of plenty of petroleum jelly on the nipples prior to a run can be helpful. Cotton shirts should be avoided, he said, in favor of synthetic, moisture-wicking shirts and bras. Chafing can also occur in the underarms and inner thighs, he said, and the same treatments and preventive techniques are useful.
• Callused and bleeding “jogger’s toes.” This can strike runners, especially on the second toe, which is often the longest and most likely to strike the toe box of a shoe. Specialty shoes can help prevent this condition, he said.
• Tinea corporis (ringworm) and herpes gladiatorum. In wrestlers, ringworm is known as tinea corporis gladiatorum because the intensity of skin-to-skin contact in wrestling makes the condition especially common in these athletes. Lesions don’t develop as rings at first; instead, they first appear as relatively nonspecific red round lesions and are most likely to be found in the head, neck, and upper extremities, Dr. Adams noted. Herpes gladiatorum is caused by herpes simplex virus 1; it is also seen in wrestlers and caused by skin-to-skin contact. Topical and oral antifungals clear ringworm, while oral antiviral agents are appropriate for herpes gladiatorum, Dr. Adams said. While herpes gladiatorum clears up and is no longer contagious after 4-5 days, he said, it’s not clear how long wrestlers with ringworm should be disqualified from playing.

Dr. Adams disclosed advising Mission, a company that focuses on sunscreen designed by and for athletes.

SAN DIEGO – Think beyond the foot: Fungal infections are just the beginning when it comes to skin disorders in athletes, which include ringworm in wrestlers, “jogger’s nipple” in runners, and more serious conditions – like skin cancer.

“Skin ailments are some of the most common conditions of athletes,” affecting all levels of sports enthusiasts, “from weekend warriors to professional athletes,” said Brian B. Adams, MD, MPH, professor and chair of the department of dermatology at the University of Cincinnati.

Skin cancer: Risk seems clear, but data are sparse

“Athletes in general appear to be at increased risk in the long term for skin cancer” since they often play and practice during the hours between 10 a.m. and 4 p.m., when the danger of sun exposure is at its highest, he said. In addition, “sweating removes the sunscreen that athletes put on, and there is evidence that sweating actually increases the chance of burning,” he said.

Skiers and snowboarders face unique sun exposure risks, he added. “Snow reflects up to 100% of UV, so even though they may be in shade, they experience UV. And mountain athletes experience greater amounts of UV as the altitude of the mountain increases: At higher altitudes, the atmosphere has less chance of filtering out the damaging rays.”

While it’s obvious that many athletes face extra sun exposure, Dr. Adams pointed out, “very little is definitively known about the actual degree of risk of athletic activities.”

Still, the research that does exist provides plenty of hints about risk. “Large epidemiological studies showed that recreational activities such as sun exposure on the beach or during water sports were associated with an increased risk of basal cell carcinoma, whereas skiing has been shown to be at increased risk for squamous cell carcinoma,” according to a 2008 report on outdoor sports and skin cancer (Clin Dermatol. 2008 Jan-Feb;26[1]:12-5).

“Risk factors of cutaneous melanoma, such as the number of melanocytic nevi and solar lentigines, have been found to be more frequent in subjects practicing endurance outdoor sports. An increased risk for cutaneous melanoma may be assumed for these athletes,” Dr. Adams commented.

Another study, this one published in 2006, found more atypical melanocytic nevi, solar lentigines, and lesions suggestive of nonmelanoma skin cancer in marathon runners, compared with a control group, and the risk was associated with the level of training intensity. The control subjects were more sensitive to the sun and had more common melanocytic nevi (Arch Dermatol. 2006 Nov;142[11]:1471-4).

Counseling about sunscreen may actually work

One strategy to reduce sun exposure is to advise athletes to avoid peak sun hours. However, “the key to caring for the athletes is not only recognizing that their sport may play a role in their disease but also realizing that your therapeutic approach must be tailored to minimize disruption to their practices and competitions,” Dr. Adams said.

Watch for other conditions, from jogger’s nipple to ringworm

Dr. Adams offered advice about detection, treatment, and prevention of other skin disorders that affect athletes:

• “Jogger’s nipples” and other kinds of chafing. He has learned to recognize the “red eleven” – two vertical streaks of blood on a runner’s shirt – that represent a case of “jogger’s nipples” caused by chafing. Antibacterial ointment or petroleum jelly are useful treatments, he said, and an application of plenty of petroleum jelly on the nipples prior to a run can be helpful. Cotton shirts should be avoided, he said, in favor of synthetic, moisture-wicking shirts and bras. Chafing can also occur in the underarms and inner thighs, he said, and the same treatments and preventive techniques are useful.
• Callused and bleeding “jogger’s toes.” This can strike runners, especially on the second toe, which is often the longest and most likely to strike the toe box of a shoe. Specialty shoes can help prevent this condition, he said.
• Tinea corporis (ringworm) and herpes gladiatorum. In wrestlers, ringworm is known as tinea corporis gladiatorum because the intensity of skin-to-skin contact in wrestling makes the condition especially common in these athletes. Lesions don’t develop as rings at first; instead, they first appear as relatively nonspecific red round lesions and are most likely to be found in the head, neck, and upper extremities, Dr. Adams noted. Herpes gladiatorum is caused by herpes simplex virus 1; it is also seen in wrestlers and caused by skin-to-skin contact. Topical and oral antifungals clear ringworm, while oral antiviral agents are appropriate for herpes gladiatorum, Dr. Adams said. While herpes gladiatorum clears up and is no longer contagious after 4-5 days, he said, it’s not clear how long wrestlers with ringworm should be disqualified from playing.

Dr. Adams disclosed advising Mission, a company that focuses on sunscreen designed by and for athletes.

SAN DIEGO – Think beyond the foot: Fungal infections are just the beginning when it comes to skin disorders in athletes, which include ringworm in wrestlers, “jogger’s nipple” in runners, and more serious conditions – like skin cancer.

“Skin ailments are some of the most common conditions of athletes,” affecting all levels of sports enthusiasts, “from weekend warriors to professional athletes,” said Brian B. Adams, MD, MPH, professor and chair of the department of dermatology at the University of Cincinnati.

Skin cancer: Risk seems clear, but data are sparse

“Athletes in general appear to be at increased risk in the long term for skin cancer” since they often play and practice during the hours between 10 a.m. and 4 p.m., when the danger of sun exposure is at its highest, he said. In addition, “sweating removes the sunscreen that athletes put on, and there is evidence that sweating actually increases the chance of burning,” he said.

Skiers and snowboarders face unique sun exposure risks, he added. “Snow reflects up to 100% of UV, so even though they may be in shade, they experience UV. And mountain athletes experience greater amounts of UV as the altitude of the mountain increases: At higher altitudes, the atmosphere has less chance of filtering out the damaging rays.”

While it’s obvious that many athletes face extra sun exposure, Dr. Adams pointed out, “very little is definitively known about the actual degree of risk of athletic activities.”

Still, the research that does exist provides plenty of hints about risk. “Large epidemiological studies showed that recreational activities such as sun exposure on the beach or during water sports were associated with an increased risk of basal cell carcinoma, whereas skiing has been shown to be at increased risk for squamous cell carcinoma,” according to a 2008 report on outdoor sports and skin cancer (Clin Dermatol. 2008 Jan-Feb;26[1]:12-5).

“Risk factors of cutaneous melanoma, such as the number of melanocytic nevi and solar lentigines, have been found to be more frequent in subjects practicing endurance outdoor sports. An increased risk for cutaneous melanoma may be assumed for these athletes,” Dr. Adams commented.

Another study, this one published in 2006, found more atypical melanocytic nevi, solar lentigines, and lesions suggestive of nonmelanoma skin cancer in marathon runners, compared with a control group, and the risk was associated with the level of training intensity. The control subjects were more sensitive to the sun and had more common melanocytic nevi (Arch Dermatol. 2006 Nov;142[11]:1471-4).

Counseling about sunscreen may actually work

One strategy to reduce sun exposure is to advise athletes to avoid peak sun hours. However, “the key to caring for the athletes is not only recognizing that their sport may play a role in their disease but also realizing that your therapeutic approach must be tailored to minimize disruption to their practices and competitions,” Dr. Adams said.

Watch for other conditions, from jogger’s nipple to ringworm

Dr. Adams offered advice about detection, treatment, and prevention of other skin disorders that affect athletes:

• “Jogger’s nipples” and other kinds of chafing. He has learned to recognize the “red eleven” – two vertical streaks of blood on a runner’s shirt – that represent a case of “jogger’s nipples” caused by chafing. Antibacterial ointment or petroleum jelly are useful treatments, he said, and an application of plenty of petroleum jelly on the nipples prior to a run can be helpful. Cotton shirts should be avoided, he said, in favor of synthetic, moisture-wicking shirts and bras. Chafing can also occur in the underarms and inner thighs, he said, and the same treatments and preventive techniques are useful.
• Callused and bleeding “jogger’s toes.” This can strike runners, especially on the second toe, which is often the longest and most likely to strike the toe box of a shoe. Specialty shoes can help prevent this condition, he said.
• Tinea corporis (ringworm) and herpes gladiatorum. In wrestlers, ringworm is known as tinea corporis gladiatorum because the intensity of skin-to-skin contact in wrestling makes the condition especially common in these athletes. Lesions don’t develop as rings at first; instead, they first appear as relatively nonspecific red round lesions and are most likely to be found in the head, neck, and upper extremities, Dr. Adams noted. Herpes gladiatorum is caused by herpes simplex virus 1; it is also seen in wrestlers and caused by skin-to-skin contact. Topical and oral antifungals clear ringworm, while oral antiviral agents are appropriate for herpes gladiatorum, Dr. Adams said. While herpes gladiatorum clears up and is no longer contagious after 4-5 days, he said, it’s not clear how long wrestlers with ringworm should be disqualified from playing.

Dr. Adams disclosed advising Mission, a company that focuses on sunscreen designed by and for athletes.

ORLANDO – Women exposed to statin treatment during the first trimester of pregnancy had a doubled rate of delivering neonates with a cardiac anomaly, and a nearly 400% increased rate of delivering a baby with a ventricular septal defect, compared with infants born to unexposed women in a case-control review of nearly 400,000 U.S. births during 2003-2014.

A similar, parallel analysis of the same cohort also showed that exposure to an ACE inhibitor at any time during pregnancy linked with roughly tripled rates of premature delivery, low birth weight, and neonatal cardiac anomaly, compared with unexposed women, Ming-Sum Lee, MD, and her associates reported in two posters presented at the annual meeting of the American College of Cardiology.

Kaiser Permanente Southern California

The review showed a 2.1% incidence of fetal cardiac anomalies in the infants born to the unexposed women and a 5.0% rate among the exposed women; the hazard ratio was 2.5, which was statistically significant. More detailed analysis showed that the increased incidence of cardiac anomalies was primarily caused by ventricular septal defects, which occurred at a 4.3% rate among the infants born to exposed mothers, a rate 370% higher than among the unexposed pregnancies. No other types of cardiac anomaly examined showed a significant increase among the exposed infants.

Assessment of links with ACE-inhibitor use focused on 404 women who had exposure to the drug class at any time during pregnancy. The most commonly used drug was lisinopril, by 98% of the women. The researchers compared these links against all the other women with exposure to an ACE inhibitor who delivered in the database without propensity score matching or in general any adjustment for clinical features or comorbidities. The analysis showed premature birth (less than 37 weeks’ gestational age) occurred at a 24% rate among the ACE inhibitor–exposed infants and 8% of the unexposed; low birth weight (less than 2,500 g) occurred in 15% of the exposed infants and in 5% of those not exposed, and any type of cardiac anomaly occurred in 4.5% of the exposed neonates and in 1.4% of the unexposed.

Dr. Lee and her associates reported the results of one adjusted analysis that factored maternal comorbidities into the calculation of the relative risk for delivering a neonate with any cardiac anomaly. After adjustment, the incremental risk linked with ACE inhibitor exposure any time during gestation was a statistically significant 80% increase.

Dr. Lee had no disclosures.

[email protected]

SOURCES: Hekimian A et al. ACC 18, Poster 1124-366. Chintamaneni S et al. ACC 18, Poster 1124-365.

ORLANDO – Women exposed to statin treatment during the first trimester of pregnancy had a doubled rate of delivering neonates with a cardiac anomaly, and a nearly 400% increased rate of delivering a baby with a ventricular septal defect, compared with infants born to unexposed women in a case-control review of nearly 400,000 U.S. births during 2003-2014.

A similar, parallel analysis of the same cohort also showed that exposure to an ACE inhibitor at any time during pregnancy linked with roughly tripled rates of premature delivery, low birth weight, and neonatal cardiac anomaly, compared with unexposed women, Ming-Sum Lee, MD, and her associates reported in two posters presented at the annual meeting of the American College of Cardiology.

Kaiser Permanente Southern California

The review showed a 2.1% incidence of fetal cardiac anomalies in the infants born to the unexposed women and a 5.0% rate among the exposed women; the hazard ratio was 2.5, which was statistically significant. More detailed analysis showed that the increased incidence of cardiac anomalies was primarily caused by ventricular septal defects, which occurred at a 4.3% rate among the infants born to exposed mothers, a rate 370% higher than among the unexposed pregnancies. No other types of cardiac anomaly examined showed a significant increase among the exposed infants.

Assessment of links with ACE-inhibitor use focused on 404 women who had exposure to the drug class at any time during pregnancy. The most commonly used drug was lisinopril, by 98% of the women. The researchers compared these links against all the other women with exposure to an ACE inhibitor who delivered in the database without propensity score matching or in general any adjustment for clinical features or comorbidities. The analysis showed premature birth (less than 37 weeks’ gestational age) occurred at a 24% rate among the ACE inhibitor–exposed infants and 8% of the unexposed; low birth weight (less than 2,500 g) occurred in 15% of the exposed infants and in 5% of those not exposed, and any type of cardiac anomaly occurred in 4.5% of the exposed neonates and in 1.4% of the unexposed.

Dr. Lee and her associates reported the results of one adjusted analysis that factored maternal comorbidities into the calculation of the relative risk for delivering a neonate with any cardiac anomaly. After adjustment, the incremental risk linked with ACE inhibitor exposure any time during gestation was a statistically significant 80% increase.

Dr. Lee had no disclosures.

[email protected]

SOURCES: Hekimian A et al. ACC 18, Poster 1124-366. Chintamaneni S et al. ACC 18, Poster 1124-365.

ORLANDO – Women exposed to statin treatment during the first trimester of pregnancy had a doubled rate of delivering neonates with a cardiac anomaly, and a nearly 400% increased rate of delivering a baby with a ventricular septal defect, compared with infants born to unexposed women in a case-control review of nearly 400,000 U.S. births during 2003-2014.

A similar, parallel analysis of the same cohort also showed that exposure to an ACE inhibitor at any time during pregnancy linked with roughly tripled rates of premature delivery, low birth weight, and neonatal cardiac anomaly, compared with unexposed women, Ming-Sum Lee, MD, and her associates reported in two posters presented at the annual meeting of the American College of Cardiology.

Kaiser Permanente Southern California

The review showed a 2.1% incidence of fetal cardiac anomalies in the infants born to the unexposed women and a 5.0% rate among the exposed women; the hazard ratio was 2.5, which was statistically significant. More detailed analysis showed that the increased incidence of cardiac anomalies was primarily caused by ventricular septal defects, which occurred at a 4.3% rate among the infants born to exposed mothers, a rate 370% higher than among the unexposed pregnancies. No other types of cardiac anomaly examined showed a significant increase among the exposed infants.

Assessment of links with ACE-inhibitor use focused on 404 women who had exposure to the drug class at any time during pregnancy. The most commonly used drug was lisinopril, by 98% of the women. The researchers compared these links against all the other women with exposure to an ACE inhibitor who delivered in the database without propensity score matching or in general any adjustment for clinical features or comorbidities. The analysis showed premature birth (less than 37 weeks’ gestational age) occurred at a 24% rate among the ACE inhibitor–exposed infants and 8% of the unexposed; low birth weight (less than 2,500 g) occurred in 15% of the exposed infants and in 5% of those not exposed, and any type of cardiac anomaly occurred in 4.5% of the exposed neonates and in 1.4% of the unexposed.

Dr. Lee and her associates reported the results of one adjusted analysis that factored maternal comorbidities into the calculation of the relative risk for delivering a neonate with any cardiac anomaly. After adjustment, the incremental risk linked with ACE inhibitor exposure any time during gestation was a statistically significant 80% increase.

Dr. Lee had no disclosures.

[email protected]

SOURCES: Hekimian A et al. ACC 18, Poster 1124-366. Chintamaneni S et al. ACC 18, Poster 1124-365.

About 11.8 million Americans selected or were automatically reenrolled in plans on the health insurance exchanges during the 2018 open enrollment, the Centers for Medicare & Medicaid Services reported.

That’s a drop of 3.3%, compared with the 12.2 million enrollees for 2017, and a drop of 7.1% from the peak year of 2016, according to the 2018 open enrollment final report.

About 11.8 million Americans selected or were automatically reenrolled in plans on the health insurance exchanges during the 2018 open enrollment, the Centers for Medicare & Medicaid Services reported.

That’s a drop of 3.3%, compared with the 12.2 million enrollees for 2017, and a drop of 7.1% from the peak year of 2016, according to the 2018 open enrollment final report.

About 11.8 million Americans selected or were automatically reenrolled in plans on the health insurance exchanges during the 2018 open enrollment, the Centers for Medicare & Medicaid Services reported.

That’s a drop of 3.3%, compared with the 12.2 million enrollees for 2017, and a drop of 7.1% from the peak year of 2016, according to the 2018 open enrollment final report.

LOS ANGELES – Results from recent trials suggest that sodium-glucose cotransporter 2 (SGLT2) inhibitors decrease urinary albumin-to-creatinine ratio in type 2 diabetes, independent of hemoglobin A¹c lowering.

“Despite optimal care around blood pressure control, glycemic control, and control of other risk factors, our patients still have a significant risk of both cardiovascular disease progression and renal disease progression,” David Cherney, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “In fact, when we have a narrow focus on glycemia, there is a lot of additional residual risk, and that A¹c lowering by itself does not negate that risk and in fact has very little effect on clinical outcomes. That brings us to the newer hyperglycemic therapies, including the SGLT2 inhibitors. While these agents do indeed block the reabsorption of glucose in the kidney, they also have an effect on other nonglycemic risk factors.”

“Inside the kidney, there are direct effects on reducing intraglomerular hypertension, leading to reductions in proteinuria,” he said. “These agents are interesting because of the way that they influence how the kidney handles sodium. As a consequence, they impact on glomerular hypertension.”

Under normal physiological conditions, humans who become volume depleted or hypotensive experience a reduction in sodium delivery to the kidney by the afferent arteriole, he explained. If less sodium is delivered to the afferent arteriole, less is filtered and delivered to the macula densa, which is the sodium-sensing area of the kidney.

“If less sodium is delivered to the macula densa, less sodium will be reabsorbed, which is an energy-requiring process that leads to the breakdown of ATP [adenosine triphosphate],” Dr. Cherney said. “If less ATP is broken down to adenosine, then less adenosine is produced. Adenosine is a vasoconstrictor in this area. So, under conditions of hypervolemia or hypotension, that’s great, because we want to maintain blood flow to the kidney; that’s a protective autoregulatory response that all of us have called tubular glomerular feedback. It’s through sodium delivery to the macula densa.”

He went on to note that hyperglycemic patients who are not taking an SGLT2 inhibitor experience an increase in sodium absorption proximally, which decreases sodium delivery to the macula densa. As a result, this causes afferent dilation, which leads to a rise in glomerular pressure, glomerular hypertension, hyperfiltration, and an increased risk of renal disease progression.

“This leads to all the effects that we see clinically, including the GFR [glomerular filtration rate] dip and the reduction in proteinuria that these agents cause either when used alone or with an ACE or ARB [angiotensin II receptor blocker],” Dr. Cherney said. “SGLT2s constrict the afferent arterial and reduce glomerular hypertension and proteinuria, whereas ACE inhibitors dilate the efferent arterial, which also reduces glomerular hypertension and proteinuria.”

An analysis of renal data from the multicenter EMPA-REG OUTCOME trial (Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes) found that the use of empagliflozin was associated with slower progression of kidney disease than was placebo when added to standard care. Empagliflozin was also associated with a significantly lower risk of clinically relevant renal events, including a 40%-50% reduction in microalbuminuria in patients with micro- or macroalbuminuria (N Engl J Med. 2016 Jul 28;375:323-34).

In a recent study of EMPA-REG OUTCOME patients, Dr. Cherney and his associates examined the effects of empagliflozin on the urinary albumin to creatinine ratio in patients with type 2 diabetes and established cardiovascular disease (Lancet Diabetes Endocrinol. 2017 Aug;5[8]:610-21). They found that even in patients with normal albuminuria at baseline, by the end of the trial at about 3 years there was a modest but statistically significant 15% reduction in urinary albumin secretion. “That reduction was greater in patients with microalbuminuria at baseline,” Dr. Cherney said. “There was a more than 40% reduction in microalbuminuric patients, and almost a 50% in patients who had macroalbuminuria at baseline, suggesting that the effect is greater in patients with higher levels of albuminuria.”

Meanwhile, results from the CANVAS program, which integrated data from two trials of more than 10,000 patients with type 2 diabetes and high cardiovascular disease risk, showed that those who received canagliflozin had a 14% reduced risk of 3-point major adverse cardiovascular events (3P-MACE), compared with those who received placebo. (N Engl J Med. 2017 Aug;377:644-57). “There was a curious increased risk of amputation and fracture in the canagliflozin group, which has not been seen in other trials,” Dr. Cherney said. “That certainly merits further thought and investigation, to better understand how significant this risk is.”

Upcoming trials of renal endpoints to look out for, he said, include the CREDENCE study (results expected in 2019), DAPA-CKD, which is in the recruitment stage, and a new outcome study to evaluate the effect of empagliflozin for the treatment of people with chronic kidney disease. “This is an expanding area in the renal and cardiovascular world that we will hear a lot more about in the next 3-5 years,” he said.

Dr. Cherney reported consulting fees and/or honoraria from AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Merck, Mitsubishi Tanabe, and Sanofi.

[email protected]

LOS ANGELES – Results from recent trials suggest that sodium-glucose cotransporter 2 (SGLT2) inhibitors decrease urinary albumin-to-creatinine ratio in type 2 diabetes, independent of hemoglobin A¹c lowering.

“Despite optimal care around blood pressure control, glycemic control, and control of other risk factors, our patients still have a significant risk of both cardiovascular disease progression and renal disease progression,” David Cherney, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “In fact, when we have a narrow focus on glycemia, there is a lot of additional residual risk, and that A¹c lowering by itself does not negate that risk and in fact has very little effect on clinical outcomes. That brings us to the newer hyperglycemic therapies, including the SGLT2 inhibitors. While these agents do indeed block the reabsorption of glucose in the kidney, they also have an effect on other nonglycemic risk factors.”

“Inside the kidney, there are direct effects on reducing intraglomerular hypertension, leading to reductions in proteinuria,” he said. “These agents are interesting because of the way that they influence how the kidney handles sodium. As a consequence, they impact on glomerular hypertension.”

Under normal physiological conditions, humans who become volume depleted or hypotensive experience a reduction in sodium delivery to the kidney by the afferent arteriole, he explained. If less sodium is delivered to the afferent arteriole, less is filtered and delivered to the macula densa, which is the sodium-sensing area of the kidney.

“If less sodium is delivered to the macula densa, less sodium will be reabsorbed, which is an energy-requiring process that leads to the breakdown of ATP [adenosine triphosphate],” Dr. Cherney said. “If less ATP is broken down to adenosine, then less adenosine is produced. Adenosine is a vasoconstrictor in this area. So, under conditions of hypervolemia or hypotension, that’s great, because we want to maintain blood flow to the kidney; that’s a protective autoregulatory response that all of us have called tubular glomerular feedback. It’s through sodium delivery to the macula densa.”

He went on to note that hyperglycemic patients who are not taking an SGLT2 inhibitor experience an increase in sodium absorption proximally, which decreases sodium delivery to the macula densa. As a result, this causes afferent dilation, which leads to a rise in glomerular pressure, glomerular hypertension, hyperfiltration, and an increased risk of renal disease progression.

“This leads to all the effects that we see clinically, including the GFR [glomerular filtration rate] dip and the reduction in proteinuria that these agents cause either when used alone or with an ACE or ARB [angiotensin II receptor blocker],” Dr. Cherney said. “SGLT2s constrict the afferent arterial and reduce glomerular hypertension and proteinuria, whereas ACE inhibitors dilate the efferent arterial, which also reduces glomerular hypertension and proteinuria.”

An analysis of renal data from the multicenter EMPA-REG OUTCOME trial (Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes) found that the use of empagliflozin was associated with slower progression of kidney disease than was placebo when added to standard care. Empagliflozin was also associated with a significantly lower risk of clinically relevant renal events, including a 40%-50% reduction in microalbuminuria in patients with micro- or macroalbuminuria (N Engl J Med. 2016 Jul 28;375:323-34).

In a recent study of EMPA-REG OUTCOME patients, Dr. Cherney and his associates examined the effects of empagliflozin on the urinary albumin to creatinine ratio in patients with type 2 diabetes and established cardiovascular disease (Lancet Diabetes Endocrinol. 2017 Aug;5[8]:610-21). They found that even in patients with normal albuminuria at baseline, by the end of the trial at about 3 years there was a modest but statistically significant 15% reduction in urinary albumin secretion. “That reduction was greater in patients with microalbuminuria at baseline,” Dr. Cherney said. “There was a more than 40% reduction in microalbuminuric patients, and almost a 50% in patients who had macroalbuminuria at baseline, suggesting that the effect is greater in patients with higher levels of albuminuria.”

Meanwhile, results from the CANVAS program, which integrated data from two trials of more than 10,000 patients with type 2 diabetes and high cardiovascular disease risk, showed that those who received canagliflozin had a 14% reduced risk of 3-point major adverse cardiovascular events (3P-MACE), compared with those who received placebo. (N Engl J Med. 2017 Aug;377:644-57). “There was a curious increased risk of amputation and fracture in the canagliflozin group, which has not been seen in other trials,” Dr. Cherney said. “That certainly merits further thought and investigation, to better understand how significant this risk is.”

Upcoming trials of renal endpoints to look out for, he said, include the CREDENCE study (results expected in 2019), DAPA-CKD, which is in the recruitment stage, and a new outcome study to evaluate the effect of empagliflozin for the treatment of people with chronic kidney disease. “This is an expanding area in the renal and cardiovascular world that we will hear a lot more about in the next 3-5 years,” he said.

Dr. Cherney reported consulting fees and/or honoraria from AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Merck, Mitsubishi Tanabe, and Sanofi.

[email protected]

LOS ANGELES – Results from recent trials suggest that sodium-glucose cotransporter 2 (SGLT2) inhibitors decrease urinary albumin-to-creatinine ratio in type 2 diabetes, independent of hemoglobin A¹c lowering.

“Despite optimal care around blood pressure control, glycemic control, and control of other risk factors, our patients still have a significant risk of both cardiovascular disease progression and renal disease progression,” David Cherney, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “In fact, when we have a narrow focus on glycemia, there is a lot of additional residual risk, and that A¹c lowering by itself does not negate that risk and in fact has very little effect on clinical outcomes. That brings us to the newer hyperglycemic therapies, including the SGLT2 inhibitors. While these agents do indeed block the reabsorption of glucose in the kidney, they also have an effect on other nonglycemic risk factors.”

“Inside the kidney, there are direct effects on reducing intraglomerular hypertension, leading to reductions in proteinuria,” he said. “These agents are interesting because of the way that they influence how the kidney handles sodium. As a consequence, they impact on glomerular hypertension.”

Under normal physiological conditions, humans who become volume depleted or hypotensive experience a reduction in sodium delivery to the kidney by the afferent arteriole, he explained. If less sodium is delivered to the afferent arteriole, less is filtered and delivered to the macula densa, which is the sodium-sensing area of the kidney.

“If less sodium is delivered to the macula densa, less sodium will be reabsorbed, which is an energy-requiring process that leads to the breakdown of ATP [adenosine triphosphate],” Dr. Cherney said. “If less ATP is broken down to adenosine, then less adenosine is produced. Adenosine is a vasoconstrictor in this area. So, under conditions of hypervolemia or hypotension, that’s great, because we want to maintain blood flow to the kidney; that’s a protective autoregulatory response that all of us have called tubular glomerular feedback. It’s through sodium delivery to the macula densa.”

He went on to note that hyperglycemic patients who are not taking an SGLT2 inhibitor experience an increase in sodium absorption proximally, which decreases sodium delivery to the macula densa. As a result, this causes afferent dilation, which leads to a rise in glomerular pressure, glomerular hypertension, hyperfiltration, and an increased risk of renal disease progression.

“This leads to all the effects that we see clinically, including the GFR [glomerular filtration rate] dip and the reduction in proteinuria that these agents cause either when used alone or with an ACE or ARB [angiotensin II receptor blocker],” Dr. Cherney said. “SGLT2s constrict the afferent arterial and reduce glomerular hypertension and proteinuria, whereas ACE inhibitors dilate the efferent arterial, which also reduces glomerular hypertension and proteinuria.”

An analysis of renal data from the multicenter EMPA-REG OUTCOME trial (Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes) found that the use of empagliflozin was associated with slower progression of kidney disease than was placebo when added to standard care. Empagliflozin was also associated with a significantly lower risk of clinically relevant renal events, including a 40%-50% reduction in microalbuminuria in patients with micro- or macroalbuminuria (N Engl J Med. 2016 Jul 28;375:323-34).

In a recent study of EMPA-REG OUTCOME patients, Dr. Cherney and his associates examined the effects of empagliflozin on the urinary albumin to creatinine ratio in patients with type 2 diabetes and established cardiovascular disease (Lancet Diabetes Endocrinol. 2017 Aug;5[8]:610-21). They found that even in patients with normal albuminuria at baseline, by the end of the trial at about 3 years there was a modest but statistically significant 15% reduction in urinary albumin secretion. “That reduction was greater in patients with microalbuminuria at baseline,” Dr. Cherney said. “There was a more than 40% reduction in microalbuminuric patients, and almost a 50% in patients who had macroalbuminuria at baseline, suggesting that the effect is greater in patients with higher levels of albuminuria.”

Meanwhile, results from the CANVAS program, which integrated data from two trials of more than 10,000 patients with type 2 diabetes and high cardiovascular disease risk, showed that those who received canagliflozin had a 14% reduced risk of 3-point major adverse cardiovascular events (3P-MACE), compared with those who received placebo. (N Engl J Med. 2017 Aug;377:644-57). “There was a curious increased risk of amputation and fracture in the canagliflozin group, which has not been seen in other trials,” Dr. Cherney said. “That certainly merits further thought and investigation, to better understand how significant this risk is.”

Upcoming trials of renal endpoints to look out for, he said, include the CREDENCE study (results expected in 2019), DAPA-CKD, which is in the recruitment stage, and a new outcome study to evaluate the effect of empagliflozin for the treatment of people with chronic kidney disease. “This is an expanding area in the renal and cardiovascular world that we will hear a lot more about in the next 3-5 years,” he said.

Dr. Cherney reported consulting fees and/or honoraria from AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Merck, Mitsubishi Tanabe, and Sanofi.

[email protected]

ORLANDO – A fast-track approach to urinary catheter management after benign gynecologic surgery reduced catheter dwell time, but did not significantly improve outcomes or patient satisfaction in a prospective, randomized trial.

Catheter dwell times in 200 women randomized 1:1 to receive either fast-track catheter management with planned catheter removal at 4 hours after surgery, or conventional catheter management with planned catheter removal 1 day after surgery, were 650 minutes versus 1,196 minutes in the groups, respectively, Patrick Lang, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Overall, 93% of patients had a successful voiding trial for catheter removal, but failures occurred more often in the fast-track management group than in the conventional management group (12% vs. 2%), said Dr. Lang, a fellow at the Christ Hospital Health Network, Cincinnati.

Furthermore, the reduction in Urogenital Distress Inventory short form scores after surgery was significant overall but did not differ significantly in the fast-track and conventional management groups, and there was a trend toward less of a reduction in Urogenital Distress Inventory scores among those who failed the voiding trial versus those who passed, he noted.

Follow-up patient surveys at 2-3 weeks after surgery showed no significant difference between the groups in the rates of reported urinary tract infections (13% and 19% with fast-track and conventional management, respectively) and antibiotic exposure, or in lower urinary tract symptoms (P = .24 and .92), he said.

Patients also had a positive overall impression of their catheter management, with no significant difference between the groups in the percentage of patients who strongly agreed that their catheter was well managed (80% and 87%, respectively).

[email protected]

SOURCE: Lang P et al. SGS 2018, Oral Poster 20.

ORLANDO – A fast-track approach to urinary catheter management after benign gynecologic surgery reduced catheter dwell time, but did not significantly improve outcomes or patient satisfaction in a prospective, randomized trial.

Catheter dwell times in 200 women randomized 1:1 to receive either fast-track catheter management with planned catheter removal at 4 hours after surgery, or conventional catheter management with planned catheter removal 1 day after surgery, were 650 minutes versus 1,196 minutes in the groups, respectively, Patrick Lang, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Overall, 93% of patients had a successful voiding trial for catheter removal, but failures occurred more often in the fast-track management group than in the conventional management group (12% vs. 2%), said Dr. Lang, a fellow at the Christ Hospital Health Network, Cincinnati.

Furthermore, the reduction in Urogenital Distress Inventory short form scores after surgery was significant overall but did not differ significantly in the fast-track and conventional management groups, and there was a trend toward less of a reduction in Urogenital Distress Inventory scores among those who failed the voiding trial versus those who passed, he noted.

Follow-up patient surveys at 2-3 weeks after surgery showed no significant difference between the groups in the rates of reported urinary tract infections (13% and 19% with fast-track and conventional management, respectively) and antibiotic exposure, or in lower urinary tract symptoms (P = .24 and .92), he said.

Patients also had a positive overall impression of their catheter management, with no significant difference between the groups in the percentage of patients who strongly agreed that their catheter was well managed (80% and 87%, respectively).

[email protected]

SOURCE: Lang P et al. SGS 2018, Oral Poster 20.

ORLANDO – A fast-track approach to urinary catheter management after benign gynecologic surgery reduced catheter dwell time, but did not significantly improve outcomes or patient satisfaction in a prospective, randomized trial.

Catheter dwell times in 200 women randomized 1:1 to receive either fast-track catheter management with planned catheter removal at 4 hours after surgery, or conventional catheter management with planned catheter removal 1 day after surgery, were 650 minutes versus 1,196 minutes in the groups, respectively, Patrick Lang, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

Overall, 93% of patients had a successful voiding trial for catheter removal, but failures occurred more often in the fast-track management group than in the conventional management group (12% vs. 2%), said Dr. Lang, a fellow at the Christ Hospital Health Network, Cincinnati.

Furthermore, the reduction in Urogenital Distress Inventory short form scores after surgery was significant overall but did not differ significantly in the fast-track and conventional management groups, and there was a trend toward less of a reduction in Urogenital Distress Inventory scores among those who failed the voiding trial versus those who passed, he noted.

Follow-up patient surveys at 2-3 weeks after surgery showed no significant difference between the groups in the rates of reported urinary tract infections (13% and 19% with fast-track and conventional management, respectively) and antibiotic exposure, or in lower urinary tract symptoms (P = .24 and .92), he said.

Patients also had a positive overall impression of their catheter management, with no significant difference between the groups in the percentage of patients who strongly agreed that their catheter was well managed (80% and 87%, respectively).

[email protected]

SOURCE: Lang P et al. SGS 2018, Oral Poster 20.