MDedge Endocrinology

Aerobic exercise may help reduce blood pressure in patients whose hypertension responds poorly to medications, a new study suggests.

A randomized controlled clinical trial showed that patients with resistant hypertension assigned to a moderate-intensity aerobic exercise training program had lower blood pressure compared with patients who received usual care.

“Resistant hypertension persists as a big clinical challenge because the available treatment options to lower blood pressure in this clinical population, namely drugs and renal denervation, show limited success,” Fernando Ribeiro, PhD, University of Aveiro, Portugal, told this news organization. “Aerobic exercise was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure.”

The findings were published online August 4 in JAMA Cardiology.

The researchers enrolled 53 patients aged 40-75 years with a diagnosis of resistant hypertension in this prospective, single-blinded trial. Nearly half (24) were women.

Resistant hypertension was defined as having a “mean systolic BP of 130 mm Hg or greater on 24-hour ambulatory BP monitoring and/or 135 mm Hg or greater during daytime hours while taking maximally tolerated doses of at least 3 antihypertensive agents, including a diuretic, or to have a controlled BP while taking 4 or more antihypertensive agents.”

From March 2017 to December 2019 at two sites in Portugal, 26 patients were randomly assigned to a 12-week aerobic exercise training program involving three 40-minute supervised sessions per week in addition to usual care. Another 27 patients in the control group were allocated to receive usual care only.

24-hour ambulatory systolic blood pressure was reduced by 7.1 mm Hg (95% confidence interval, -12.8 to -1.4; P = .02) in patients in the exercise group compared with the control group. In the exercise group, there were additional reductions of:

• -5.1 mm Hg of 24-hour ambulatory diastolic blood pressure (95% CI, -7.9 to -2.3; P = .001)
• -8.4 mm Hg of daytime systolic blood pressure (95% CI, -14.3 to -2.5, P = .006)
• -5.7 mm Hg of daytime diastolic blood pressure (95% CI, -9.0 to -2.4; P = .001)
• -10.0 mm Hg of office systolic blood pressure (95% CI, -17.6 to -2.5; P = .01)

Additionally, a significant improvement in cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5-6.6; P < .001) was observed in the exercise group compared with the control group.

Although prior research has suggested that exercise may lower blood pressure, this study is particularly useful because it “outlines very specifically what types of exercise you can recommend,” said Daniel Lackland, DrPH, Medical University of South Carolina, Charleston.

Although important, exercise is “one part of the overall management of high blood pressure. If people are being prescribed medication, they should continue taking it and work on lifestyle changes like reducing salt intake and drinking in moderation,” added Dr. Lackland, who was not involved in the research.

Also commenting on the findings, Wanpen Vongpatanasin, MD, UT Southwestern Medical Center, Dallas, pointed out that there are many potential benefits from exercise training. “It might improve endothelial function, decrease vascular stiffness and nervous system reactivity to stress, and improve quality of life for patients,” she said.

The study has several limitations, including a small sample size and a patient population that mostly has “relatively mild hypertension,” Dr. Vongpatanasin said, adding, “We don’t know whether these findings will apply to patients with more severe hypertension.”

It would also have been helpful if investigators monitored patient adherence to prescribed medications through urine or blood samples rather than a questionnaire, and to measure nighttime blood pressure, which is a more important predictor of cardiovascular outcomes, said Dr. Vongpatanasin, who was not associated with the research.

Moving forward, it will be important to “investigate why some patients are nonresponders to the exercise intervention and why some are super-responders,” study author Dr. Ribeiro said.

Dr. Ribeiro, Dr. Lackland, and Dr. Vongpatanasin have disclosed no relevant financial relationships. This study was funded by the European Union through the European Regional Development Fund Operational Competitiveness Factors Program (COMPETE) and by the Portuguese government through the Foundation for Science and Technology. The funders had no role in the study.

A version of this article first appeared on Medscape.com.

Aerobic exercise may help reduce blood pressure in patients whose hypertension responds poorly to medications, a new study suggests.

A randomized controlled clinical trial showed that patients with resistant hypertension assigned to a moderate-intensity aerobic exercise training program had lower blood pressure compared with patients who received usual care.

“Resistant hypertension persists as a big clinical challenge because the available treatment options to lower blood pressure in this clinical population, namely drugs and renal denervation, show limited success,” Fernando Ribeiro, PhD, University of Aveiro, Portugal, told this news organization. “Aerobic exercise was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure.”

The findings were published online August 4 in JAMA Cardiology.

The researchers enrolled 53 patients aged 40-75 years with a diagnosis of resistant hypertension in this prospective, single-blinded trial. Nearly half (24) were women.

Resistant hypertension was defined as having a “mean systolic BP of 130 mm Hg or greater on 24-hour ambulatory BP monitoring and/or 135 mm Hg or greater during daytime hours while taking maximally tolerated doses of at least 3 antihypertensive agents, including a diuretic, or to have a controlled BP while taking 4 or more antihypertensive agents.”

From March 2017 to December 2019 at two sites in Portugal, 26 patients were randomly assigned to a 12-week aerobic exercise training program involving three 40-minute supervised sessions per week in addition to usual care. Another 27 patients in the control group were allocated to receive usual care only.

24-hour ambulatory systolic blood pressure was reduced by 7.1 mm Hg (95% confidence interval, -12.8 to -1.4; P = .02) in patients in the exercise group compared with the control group. In the exercise group, there were additional reductions of:

• -5.1 mm Hg of 24-hour ambulatory diastolic blood pressure (95% CI, -7.9 to -2.3; P = .001)
• -8.4 mm Hg of daytime systolic blood pressure (95% CI, -14.3 to -2.5, P = .006)
• -5.7 mm Hg of daytime diastolic blood pressure (95% CI, -9.0 to -2.4; P = .001)
• -10.0 mm Hg of office systolic blood pressure (95% CI, -17.6 to -2.5; P = .01)

Additionally, a significant improvement in cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5-6.6; P < .001) was observed in the exercise group compared with the control group.

Although prior research has suggested that exercise may lower blood pressure, this study is particularly useful because it “outlines very specifically what types of exercise you can recommend,” said Daniel Lackland, DrPH, Medical University of South Carolina, Charleston.

Although important, exercise is “one part of the overall management of high blood pressure. If people are being prescribed medication, they should continue taking it and work on lifestyle changes like reducing salt intake and drinking in moderation,” added Dr. Lackland, who was not involved in the research.

Also commenting on the findings, Wanpen Vongpatanasin, MD, UT Southwestern Medical Center, Dallas, pointed out that there are many potential benefits from exercise training. “It might improve endothelial function, decrease vascular stiffness and nervous system reactivity to stress, and improve quality of life for patients,” she said.

The study has several limitations, including a small sample size and a patient population that mostly has “relatively mild hypertension,” Dr. Vongpatanasin said, adding, “We don’t know whether these findings will apply to patients with more severe hypertension.”

It would also have been helpful if investigators monitored patient adherence to prescribed medications through urine or blood samples rather than a questionnaire, and to measure nighttime blood pressure, which is a more important predictor of cardiovascular outcomes, said Dr. Vongpatanasin, who was not associated with the research.

Moving forward, it will be important to “investigate why some patients are nonresponders to the exercise intervention and why some are super-responders,” study author Dr. Ribeiro said.

Dr. Ribeiro, Dr. Lackland, and Dr. Vongpatanasin have disclosed no relevant financial relationships. This study was funded by the European Union through the European Regional Development Fund Operational Competitiveness Factors Program (COMPETE) and by the Portuguese government through the Foundation for Science and Technology. The funders had no role in the study.

A version of this article first appeared on Medscape.com.

Aerobic exercise may help reduce blood pressure in patients whose hypertension responds poorly to medications, a new study suggests.

A randomized controlled clinical trial showed that patients with resistant hypertension assigned to a moderate-intensity aerobic exercise training program had lower blood pressure compared with patients who received usual care.

“Resistant hypertension persists as a big clinical challenge because the available treatment options to lower blood pressure in this clinical population, namely drugs and renal denervation, show limited success,” Fernando Ribeiro, PhD, University of Aveiro, Portugal, told this news organization. “Aerobic exercise was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure.”

The findings were published online August 4 in JAMA Cardiology.

The researchers enrolled 53 patients aged 40-75 years with a diagnosis of resistant hypertension in this prospective, single-blinded trial. Nearly half (24) were women.

Resistant hypertension was defined as having a “mean systolic BP of 130 mm Hg or greater on 24-hour ambulatory BP monitoring and/or 135 mm Hg or greater during daytime hours while taking maximally tolerated doses of at least 3 antihypertensive agents, including a diuretic, or to have a controlled BP while taking 4 or more antihypertensive agents.”

From March 2017 to December 2019 at two sites in Portugal, 26 patients were randomly assigned to a 12-week aerobic exercise training program involving three 40-minute supervised sessions per week in addition to usual care. Another 27 patients in the control group were allocated to receive usual care only.

24-hour ambulatory systolic blood pressure was reduced by 7.1 mm Hg (95% confidence interval, -12.8 to -1.4; P = .02) in patients in the exercise group compared with the control group. In the exercise group, there were additional reductions of:

• -5.1 mm Hg of 24-hour ambulatory diastolic blood pressure (95% CI, -7.9 to -2.3; P = .001)
• -8.4 mm Hg of daytime systolic blood pressure (95% CI, -14.3 to -2.5, P = .006)
• -5.7 mm Hg of daytime diastolic blood pressure (95% CI, -9.0 to -2.4; P = .001)
• -10.0 mm Hg of office systolic blood pressure (95% CI, -17.6 to -2.5; P = .01)

Additionally, a significant improvement in cardiorespiratory fitness (5.05 mL/kg per minute of oxygen consumption; 95% CI, 3.5-6.6; P < .001) was observed in the exercise group compared with the control group.

Although prior research has suggested that exercise may lower blood pressure, this study is particularly useful because it “outlines very specifically what types of exercise you can recommend,” said Daniel Lackland, DrPH, Medical University of South Carolina, Charleston.

Although important, exercise is “one part of the overall management of high blood pressure. If people are being prescribed medication, they should continue taking it and work on lifestyle changes like reducing salt intake and drinking in moderation,” added Dr. Lackland, who was not involved in the research.

Also commenting on the findings, Wanpen Vongpatanasin, MD, UT Southwestern Medical Center, Dallas, pointed out that there are many potential benefits from exercise training. “It might improve endothelial function, decrease vascular stiffness and nervous system reactivity to stress, and improve quality of life for patients,” she said.

The study has several limitations, including a small sample size and a patient population that mostly has “relatively mild hypertension,” Dr. Vongpatanasin said, adding, “We don’t know whether these findings will apply to patients with more severe hypertension.”

It would also have been helpful if investigators monitored patient adherence to prescribed medications through urine or blood samples rather than a questionnaire, and to measure nighttime blood pressure, which is a more important predictor of cardiovascular outcomes, said Dr. Vongpatanasin, who was not associated with the research.

Moving forward, it will be important to “investigate why some patients are nonresponders to the exercise intervention and why some are super-responders,” study author Dr. Ribeiro said.

Dr. Ribeiro, Dr. Lackland, and Dr. Vongpatanasin have disclosed no relevant financial relationships. This study was funded by the European Union through the European Regional Development Fund Operational Competitiveness Factors Program (COMPETE) and by the Portuguese government through the Foundation for Science and Technology. The funders had no role in the study.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

A version of this article first appeared on Medscape.com.

Nearly half of adults prescribed metformin after a new diagnosis of type 2 diabetes have stopped taking it by 1 year, new data show.

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The findings, from a retrospective analysis of administrative data from Alberta, Canada, during 2012-2017, also show that the fall-off in metformin adherence was most dramatic during the first 30 days, and in most cases, there was no concomitant substitution of another glucose-lowering drug.

While the majority with newly diagnosed type 2 diabetes were prescribed metformin as first-line therapy, patients started on other agents incurred far higher medication and health care costs.

The data were recently published online in Diabetic Medicine by David J. T. Campbell, MD, PhD, of the University of Calgary (Alta.), and colleagues.

“We realized that even if someone is prescribed metformin that doesn’t mean they’re staying on metformin even for a year ... the drop-off rate is really quite abrupt,” Dr. Campbell said in an interview. Most who discontinued had A1c levels above 7.5%, so it wasn’t that they no longer needed glucose-lowering medication, he noted.
 

People don’t understand chronic use; meds don’t make you feel better

One reason for the discontinuations, he said, is that patients might not realize they need to keep taking the medication.

“When a physician is seeing a person with newly diagnosed diabetes, I think it’s important to remember that they might not know the implications of having a chronic condition. A lot of times we’re quick to prescribe metformin and forget about it. ... Physicians might write a script for 3 months and three refills and not see the patient again for a year ... We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they’re getting early diabetes education.”

Side effects are an issue, but not for most. “Any clinician who prescribes metformin knows there are side effects, such as upset stomach, diarrhea, and nausea. But certainly, it’s not half [who experience these]. ... A lot of people just aren’t accepting of having to take it lifelong, especially since they probably don’t feel any better on it,” Dr. Campbell said.  

James Flory, MD, an endocrinologist at Memorial Sloan Kettering Cancer Center, New York, said in an interview that about 25% of patients taking metformin experience gastrointestinal side effects.

Moreover, he noted that the drop-off in adherence is also seen with antihypertensive and lipid-lowering drugs that have fewer side effects than those of metformin. He pointed to a “striking example” of this, a 2011 randomized trial published in the New England Journal of Medicine, and as reported by this news organization, showing overall rates of adherence to these medications was around 50%, even among people who had already had a myocardial infarction.   

“People really don’t want to be on these medications. ... They have an aversion to being medicalized and taking pills. If they’re not being pretty consistently prompted and reminded and urged to take them, I think people will find rationalizations, reasons for stopping. ... I think people want to handle things through lifestyle and not be on a drug,” noted Dr. Flory, who has published on the subject of metformin adherence.

“These drugs don’t make people feel better. None of them do. At best they don’t make you feel worse. You have to really believe in the chronic condition and believe that it’s hurting you and that you can’t handle it without the drugs to motivate you to keep taking them,” Dr. Flory explained.

Communication with the patient is key, he added.

“I don’t have empirical data to support this, but I feel it’s helpful to acknowledge the downsides to patients. I tell them to let me know [if they’re having side effects] and we’ll work on it. Don’t just stop taking the drug and never circle back.” At the same time, he added, “I think it’s important to emphasize metformin’s safety and effectiveness.”

For patients experiencing gastrointestinal side effects, options including switching to extended-release metformin or lowering the dose.

Also, while patients are typically advised to take metformin with food, some experience diarrhea when they do that and prefer to take it at bedtime than with dinner. “If that’s what works for people, that’s what they should do,” Dr. Flory advised.

“It doesn’t take a lot of time to emphasize to patients the safety and this level of flexibility and control they should be able to exercise over how much they take and when. These things should really help.”  
 

Metformin usually prescribed, but not always taken

Dr. Campbell and colleagues analyzed 17,932 individuals with incident type 2 diabetes diagnosed between April 1, 2012, and March 31, 2017. Overall, 89% received metformin monotherapy as their initial diabetes prescription, 7.6% started metformin in combination with another glucose-lowering drug, and 3.3% were prescribed a nonmetformin diabetes medication. (Those prescribed insulin as their first diabetes medication were excluded.) 

The most commonly coprescribed drugs with metformin were sulfonylureas (in 47%) and DPP-4 inhibitors (28%). Of those initiated with only nonmetformin medications, sulfonylureas were also the most common (53%) and dipeptidyl peptidase-4 (DPP-4) inhibitors second (21%).

The metformin prescribing rate of 89% reflects current guidelines, Dr. Campbell noted.

“In hypertension, clinicians weren’t really following the guidelines ... they were prescribing more expensive drugs than the guidelines say. ... We showed that in diabetes, contrary to hypertension, clinicians really are generally following the clinical practice guidelines. ... The vast majority who are started on metformin are started on monotherapy. That was reassuring to us. We’re not paying for a bunch of expensive drugs when metformin would do just as well,” he said.

However, the proportion who had been dispensed metformin to cover the prescribed number of days dropped by about 10% after 30 days, by a further 10% after 90 days, and yet again after 100 days, resulting in just 54% remaining on the drug by 1 year.

Factors associated with higher adherence included older age, presence of comorbidities, and highest versus lowest neighborhood income quintile.

Those who had been prescribed nonmetformin monotherapy had about twice the total health care costs of those initially prescribed metformin monotherapy. Higher health care costs were seen among patients who were younger, had lower incomes, had higher baseline A1c, had more comorbidities, and were men.

How will the newer type 2 diabetes drugs change prescribing?

Dr. Campbell noted that “a lot has changed since 2017. ... At least in Canada, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists were supposed to be reserved as second-line agents in patients with cardiovascular disease, but more and more they’re being thought of as first-line agents in high-risk patients.”

“I suspect as those guidelines are transmitted to primary care colleagues who are doing the bulk of the prescribing we’ll see more and more uptake of these agents.”

Indeed, Dr. Flory said, “The metformin data at this point are very dated and the body of trials showing health benefits for it is actually very weak compared to the big trials that have been done for the newer agents, to the point where you can imagine a consensus gradually forming where people start to recommend something other than metformin for nearly everybody with type 2 diabetes. The cost implications are just huge, and I think the safety implications as well.”

According to Dr. Flory, the SGLT2 inhibitors “are fundamentally not as safe as metformin. I think they’re very safe drugs – large good studies have established that – but if you’re going to give drugs to a large number of people who are pretty healthy at baseline the safety standards have to be pretty high.”

Just the elevated risk of euglycemic diabetic ketoacidosis alone is reason for pause, Dr. Flory said. “Even though it’s manageable ... metformin just doesn’t have a safety problem like that. I’m very comfortable prescribing SGLT2 inhibitors, but If I’m going to give a drug to a million people and have nothing go wrong with any of them, that would be metformin, not an SGLT2 [inhibitor].”

Dr. Campbell and colleagues will be conducting a follow-up of prescribing data through 2019, which will of course include the newer agents. They’ll also investigate reasons for drug discontinuation and outcomes of those who discontinue versus continue metformin.

Dr. Campbell has reported no relevant financial relationships. Dr. Flory consults for a legal firm on litigation related to insulin analog pricing issues, not for or pertaining to a specific company.

A version of this article first appeared on Medscape.com.

Nearly half of adults prescribed metformin after a new diagnosis of type 2 diabetes have stopped taking it by 1 year, new data show.

SDI Productions/E+

The findings, from a retrospective analysis of administrative data from Alberta, Canada, during 2012-2017, also show that the fall-off in metformin adherence was most dramatic during the first 30 days, and in most cases, there was no concomitant substitution of another glucose-lowering drug.

While the majority with newly diagnosed type 2 diabetes were prescribed metformin as first-line therapy, patients started on other agents incurred far higher medication and health care costs.

The data were recently published online in Diabetic Medicine by David J. T. Campbell, MD, PhD, of the University of Calgary (Alta.), and colleagues.

“We realized that even if someone is prescribed metformin that doesn’t mean they’re staying on metformin even for a year ... the drop-off rate is really quite abrupt,” Dr. Campbell said in an interview. Most who discontinued had A1c levels above 7.5%, so it wasn’t that they no longer needed glucose-lowering medication, he noted.
 

People don’t understand chronic use; meds don’t make you feel better

One reason for the discontinuations, he said, is that patients might not realize they need to keep taking the medication.

“When a physician is seeing a person with newly diagnosed diabetes, I think it’s important to remember that they might not know the implications of having a chronic condition. A lot of times we’re quick to prescribe metformin and forget about it. ... Physicians might write a script for 3 months and three refills and not see the patient again for a year ... We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they’re getting early diabetes education.”

Side effects are an issue, but not for most. “Any clinician who prescribes metformin knows there are side effects, such as upset stomach, diarrhea, and nausea. But certainly, it’s not half [who experience these]. ... A lot of people just aren’t accepting of having to take it lifelong, especially since they probably don’t feel any better on it,” Dr. Campbell said.  

James Flory, MD, an endocrinologist at Memorial Sloan Kettering Cancer Center, New York, said in an interview that about 25% of patients taking metformin experience gastrointestinal side effects.

Moreover, he noted that the drop-off in adherence is also seen with antihypertensive and lipid-lowering drugs that have fewer side effects than those of metformin. He pointed to a “striking example” of this, a 2011 randomized trial published in the New England Journal of Medicine, and as reported by this news organization, showing overall rates of adherence to these medications was around 50%, even among people who had already had a myocardial infarction.   

“People really don’t want to be on these medications. ... They have an aversion to being medicalized and taking pills. If they’re not being pretty consistently prompted and reminded and urged to take them, I think people will find rationalizations, reasons for stopping. ... I think people want to handle things through lifestyle and not be on a drug,” noted Dr. Flory, who has published on the subject of metformin adherence.

“These drugs don’t make people feel better. None of them do. At best they don’t make you feel worse. You have to really believe in the chronic condition and believe that it’s hurting you and that you can’t handle it without the drugs to motivate you to keep taking them,” Dr. Flory explained.

Communication with the patient is key, he added.

“I don’t have empirical data to support this, but I feel it’s helpful to acknowledge the downsides to patients. I tell them to let me know [if they’re having side effects] and we’ll work on it. Don’t just stop taking the drug and never circle back.” At the same time, he added, “I think it’s important to emphasize metformin’s safety and effectiveness.”

For patients experiencing gastrointestinal side effects, options including switching to extended-release metformin or lowering the dose.

Also, while patients are typically advised to take metformin with food, some experience diarrhea when they do that and prefer to take it at bedtime than with dinner. “If that’s what works for people, that’s what they should do,” Dr. Flory advised.

“It doesn’t take a lot of time to emphasize to patients the safety and this level of flexibility and control they should be able to exercise over how much they take and when. These things should really help.”  
 

Metformin usually prescribed, but not always taken

Dr. Campbell and colleagues analyzed 17,932 individuals with incident type 2 diabetes diagnosed between April 1, 2012, and March 31, 2017. Overall, 89% received metformin monotherapy as their initial diabetes prescription, 7.6% started metformin in combination with another glucose-lowering drug, and 3.3% were prescribed a nonmetformin diabetes medication. (Those prescribed insulin as their first diabetes medication were excluded.) 

The most commonly coprescribed drugs with metformin were sulfonylureas (in 47%) and DPP-4 inhibitors (28%). Of those initiated with only nonmetformin medications, sulfonylureas were also the most common (53%) and dipeptidyl peptidase-4 (DPP-4) inhibitors second (21%).

The metformin prescribing rate of 89% reflects current guidelines, Dr. Campbell noted.

“In hypertension, clinicians weren’t really following the guidelines ... they were prescribing more expensive drugs than the guidelines say. ... We showed that in diabetes, contrary to hypertension, clinicians really are generally following the clinical practice guidelines. ... The vast majority who are started on metformin are started on monotherapy. That was reassuring to us. We’re not paying for a bunch of expensive drugs when metformin would do just as well,” he said.

However, the proportion who had been dispensed metformin to cover the prescribed number of days dropped by about 10% after 30 days, by a further 10% after 90 days, and yet again after 100 days, resulting in just 54% remaining on the drug by 1 year.

Factors associated with higher adherence included older age, presence of comorbidities, and highest versus lowest neighborhood income quintile.

Those who had been prescribed nonmetformin monotherapy had about twice the total health care costs of those initially prescribed metformin monotherapy. Higher health care costs were seen among patients who were younger, had lower incomes, had higher baseline A1c, had more comorbidities, and were men.

How will the newer type 2 diabetes drugs change prescribing?

Dr. Campbell noted that “a lot has changed since 2017. ... At least in Canada, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists were supposed to be reserved as second-line agents in patients with cardiovascular disease, but more and more they’re being thought of as first-line agents in high-risk patients.”

“I suspect as those guidelines are transmitted to primary care colleagues who are doing the bulk of the prescribing we’ll see more and more uptake of these agents.”

Indeed, Dr. Flory said, “The metformin data at this point are very dated and the body of trials showing health benefits for it is actually very weak compared to the big trials that have been done for the newer agents, to the point where you can imagine a consensus gradually forming where people start to recommend something other than metformin for nearly everybody with type 2 diabetes. The cost implications are just huge, and I think the safety implications as well.”

According to Dr. Flory, the SGLT2 inhibitors “are fundamentally not as safe as metformin. I think they’re very safe drugs – large good studies have established that – but if you’re going to give drugs to a large number of people who are pretty healthy at baseline the safety standards have to be pretty high.”

Just the elevated risk of euglycemic diabetic ketoacidosis alone is reason for pause, Dr. Flory said. “Even though it’s manageable ... metformin just doesn’t have a safety problem like that. I’m very comfortable prescribing SGLT2 inhibitors, but If I’m going to give a drug to a million people and have nothing go wrong with any of them, that would be metformin, not an SGLT2 [inhibitor].”

Dr. Campbell and colleagues will be conducting a follow-up of prescribing data through 2019, which will of course include the newer agents. They’ll also investigate reasons for drug discontinuation and outcomes of those who discontinue versus continue metformin.

Dr. Campbell has reported no relevant financial relationships. Dr. Flory consults for a legal firm on litigation related to insulin analog pricing issues, not for or pertaining to a specific company.

A version of this article first appeared on Medscape.com.

Nearly half of adults prescribed metformin after a new diagnosis of type 2 diabetes have stopped taking it by 1 year, new data show.

SDI Productions/E+

The findings, from a retrospective analysis of administrative data from Alberta, Canada, during 2012-2017, also show that the fall-off in metformin adherence was most dramatic during the first 30 days, and in most cases, there was no concomitant substitution of another glucose-lowering drug.

While the majority with newly diagnosed type 2 diabetes were prescribed metformin as first-line therapy, patients started on other agents incurred far higher medication and health care costs.

The data were recently published online in Diabetic Medicine by David J. T. Campbell, MD, PhD, of the University of Calgary (Alta.), and colleagues.

“We realized that even if someone is prescribed metformin that doesn’t mean they’re staying on metformin even for a year ... the drop-off rate is really quite abrupt,” Dr. Campbell said in an interview. Most who discontinued had A1c levels above 7.5%, so it wasn’t that they no longer needed glucose-lowering medication, he noted.
 

People don’t understand chronic use; meds don’t make you feel better

One reason for the discontinuations, he said, is that patients might not realize they need to keep taking the medication.

“When a physician is seeing a person with newly diagnosed diabetes, I think it’s important to remember that they might not know the implications of having a chronic condition. A lot of times we’re quick to prescribe metformin and forget about it. ... Physicians might write a script for 3 months and three refills and not see the patient again for a year ... We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they’re getting early diabetes education.”

Side effects are an issue, but not for most. “Any clinician who prescribes metformin knows there are side effects, such as upset stomach, diarrhea, and nausea. But certainly, it’s not half [who experience these]. ... A lot of people just aren’t accepting of having to take it lifelong, especially since they probably don’t feel any better on it,” Dr. Campbell said.  

James Flory, MD, an endocrinologist at Memorial Sloan Kettering Cancer Center, New York, said in an interview that about 25% of patients taking metformin experience gastrointestinal side effects.

Moreover, he noted that the drop-off in adherence is also seen with antihypertensive and lipid-lowering drugs that have fewer side effects than those of metformin. He pointed to a “striking example” of this, a 2011 randomized trial published in the New England Journal of Medicine, and as reported by this news organization, showing overall rates of adherence to these medications was around 50%, even among people who had already had a myocardial infarction.   

“People really don’t want to be on these medications. ... They have an aversion to being medicalized and taking pills. If they’re not being pretty consistently prompted and reminded and urged to take them, I think people will find rationalizations, reasons for stopping. ... I think people want to handle things through lifestyle and not be on a drug,” noted Dr. Flory, who has published on the subject of metformin adherence.

“These drugs don’t make people feel better. None of them do. At best they don’t make you feel worse. You have to really believe in the chronic condition and believe that it’s hurting you and that you can’t handle it without the drugs to motivate you to keep taking them,” Dr. Flory explained.

Communication with the patient is key, he added.

“I don’t have empirical data to support this, but I feel it’s helpful to acknowledge the downsides to patients. I tell them to let me know [if they’re having side effects] and we’ll work on it. Don’t just stop taking the drug and never circle back.” At the same time, he added, “I think it’s important to emphasize metformin’s safety and effectiveness.”

For patients experiencing gastrointestinal side effects, options including switching to extended-release metformin or lowering the dose.

Also, while patients are typically advised to take metformin with food, some experience diarrhea when they do that and prefer to take it at bedtime than with dinner. “If that’s what works for people, that’s what they should do,” Dr. Flory advised.

“It doesn’t take a lot of time to emphasize to patients the safety and this level of flexibility and control they should be able to exercise over how much they take and when. These things should really help.”  
 

Metformin usually prescribed, but not always taken

Dr. Campbell and colleagues analyzed 17,932 individuals with incident type 2 diabetes diagnosed between April 1, 2012, and March 31, 2017. Overall, 89% received metformin monotherapy as their initial diabetes prescription, 7.6% started metformin in combination with another glucose-lowering drug, and 3.3% were prescribed a nonmetformin diabetes medication. (Those prescribed insulin as their first diabetes medication were excluded.) 

The most commonly coprescribed drugs with metformin were sulfonylureas (in 47%) and DPP-4 inhibitors (28%). Of those initiated with only nonmetformin medications, sulfonylureas were also the most common (53%) and dipeptidyl peptidase-4 (DPP-4) inhibitors second (21%).

The metformin prescribing rate of 89% reflects current guidelines, Dr. Campbell noted.

“In hypertension, clinicians weren’t really following the guidelines ... they were prescribing more expensive drugs than the guidelines say. ... We showed that in diabetes, contrary to hypertension, clinicians really are generally following the clinical practice guidelines. ... The vast majority who are started on metformin are started on monotherapy. That was reassuring to us. We’re not paying for a bunch of expensive drugs when metformin would do just as well,” he said.

However, the proportion who had been dispensed metformin to cover the prescribed number of days dropped by about 10% after 30 days, by a further 10% after 90 days, and yet again after 100 days, resulting in just 54% remaining on the drug by 1 year.

Factors associated with higher adherence included older age, presence of comorbidities, and highest versus lowest neighborhood income quintile.

Those who had been prescribed nonmetformin monotherapy had about twice the total health care costs of those initially prescribed metformin monotherapy. Higher health care costs were seen among patients who were younger, had lower incomes, had higher baseline A1c, had more comorbidities, and were men.

How will the newer type 2 diabetes drugs change prescribing?

Dr. Campbell noted that “a lot has changed since 2017. ... At least in Canada, the sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 receptor agonists were supposed to be reserved as second-line agents in patients with cardiovascular disease, but more and more they’re being thought of as first-line agents in high-risk patients.”

“I suspect as those guidelines are transmitted to primary care colleagues who are doing the bulk of the prescribing we’ll see more and more uptake of these agents.”

Indeed, Dr. Flory said, “The metformin data at this point are very dated and the body of trials showing health benefits for it is actually very weak compared to the big trials that have been done for the newer agents, to the point where you can imagine a consensus gradually forming where people start to recommend something other than metformin for nearly everybody with type 2 diabetes. The cost implications are just huge, and I think the safety implications as well.”

According to Dr. Flory, the SGLT2 inhibitors “are fundamentally not as safe as metformin. I think they’re very safe drugs – large good studies have established that – but if you’re going to give drugs to a large number of people who are pretty healthy at baseline the safety standards have to be pretty high.”

Just the elevated risk of euglycemic diabetic ketoacidosis alone is reason for pause, Dr. Flory said. “Even though it’s manageable ... metformin just doesn’t have a safety problem like that. I’m very comfortable prescribing SGLT2 inhibitors, but If I’m going to give a drug to a million people and have nothing go wrong with any of them, that would be metformin, not an SGLT2 [inhibitor].”

Dr. Campbell and colleagues will be conducting a follow-up of prescribing data through 2019, which will of course include the newer agents. They’ll also investigate reasons for drug discontinuation and outcomes of those who discontinue versus continue metformin.

Dr. Campbell has reported no relevant financial relationships. Dr. Flory consults for a legal firm on litigation related to insulin analog pricing issues, not for or pertaining to a specific company.

A version of this article first appeared on Medscape.com.

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

A version of this article first appeared on WebMD.com.

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

A version of this article first appeared on WebMD.com.

Moderna says neutralizing antibodies generated by its COVID-19 vaccine against three variants of the virus that causes the disease waned substantially 6 months after the second dose.

Because of this, the company expects an increase in breakthrough infections with a need for boosters before winter.

In an experiment, a 50-mg dose of the vaccine, given as a third shot, boosted levels of antibodies in 20 previously vaccinated people by 32 times against the Beta variant, by 44 times against the Gamma variant, and by 42 times against Delta.

The new data was presented in an earnings call to investors and is based on a small study that hasn’t yet been published in medical literature.

The company also said its vaccine remained highly effective at preventing severe COVID outcomes through 6 months.

Last week, Pfizer released early data suggesting a similar drop in protection from its vaccine. The company also showed a third dose substantially boosted protection, including against the Delta variant.

The new results come just 1 day after the World Health Organization implored wealthy nations to hold off on third doses until more of the world’s population could get a first dose.

More than 80% of the 4 billion vaccine doses given around the world have been distributed to high-income countries.

A version of this article first appeared on WebMD.com.

A retracted study on the safety of blood pressure medications in patients with COVID-19 continues to be cited nearly a year later, new research shows.

Floaria Bicher/iStock/Getty Images Plus

The study in question, published on May 1, 2020, in the New England Journal of Medicine, showed no increased risk for in-hospital death with the use of ACE inhibitors or angiotensin-receptor blockers (ARBs) in hospitalized patients with COVID-19.

Concerns about the veracity of the Surgisphere database used for the study, however, led to a June 4 retraction and to the June 13 retraction of a second study, published in the Lancet, that focused on hydroxychloroquine as a COVID-19 treatment.

Although the Surgisphere scandal caused a global reckoning of COVID-19 scientific studies, the new analysis identified 652 citations of the NEJM article as of May 31.

More than a third of the citations occurred in the first 2 months after the retraction, 54% were at least 3 months later, and 2.8% at least 6 months later. In May, 11 months after the article was retracted, it was cited 21 times, senior author Emily G. McDonald, MD, MSc, McGill University, Montreal, and colleagues reported in a research letter in JAMA Internal Medicine.

“In early May and June there were already more than 200 citations in one of the world’s leading scientific journals, so I do believe it was a highly influential article early on and had an impact on different types of studies or research taking place,” she said in an interview.

Dr. McDonald said she’s also “certain that it impacted patient care,” observing that when there are no guidelines available on how to manage patients, physicians will turn to the most recent evidence in the most reputable journals.

“In the case of ACE [inhibitors] and ARBs, although the study was based on fraudulent data, we were lucky that the overall message was in the end probably correct, but that might not have been the case for another study or dataset,” she said.

Early in the pandemic, concerns existed that ACE inhibitors and ARBs could be harmful, increasing the expression of ACE2 receptors, which the SARS-CoV-2 virus uses to gain entry into cells. The first randomized trial to examine the issue, BRACE CORONA, showed no clinical benefit to interrupting use of the agents in hospitalized patients. An observational study suggested ACE inhibitors may even be protective.

Of two high-profile retractions, McDonald said they chose to bypass the hydroxychloroquine study, which had an eye-popping Altmetric attention score of 23,084, compared with 3,727 for the NEJM paper, because it may have been cited for “other” reasons. “We wanted to focus less on the politics and more on the problem of retracted work.”

The team found that researchers across the globe were citing the retracted ACE/ARB paper (18.7% in the United States, 8.1% in Italy, and 44% other countries). Most citations were used to support a statement in the main text of a study, but in nearly 3% of cases, the data were incorporated into new analyses.

Just 17.6% of the studies cited or noted the retraction. “For sure, that was surprising to us. We suspected it, but our study confirmed it,” Dr. McDonald said.

Although retracted articles can be identified by a watermark or line of text, in some cases that can be easily missed, she noted. What’s more, not all citation software points out when a study has been retracted, a fate shared by the copyediting process.

“There are a lot of mechanisms in place and, in general, what’s happening is rare but there isn’t a perfect automated system solution to absolutely prevent this from happening,” she said. “It’s still subject to human error.”

The findings also have to be taken in the context of a rapidly emerging pandemic and the unprecedented torrent of scientific papers released over the past year.

“That might have contributed to why this happened, but the takeaway message is that this can happen despite our best efforts, and we need to challenge ourselves to come up with a system solution to prevent this from happening in the future,” Dr. McDonald said. “Current mechanisms are probably capturing 95% of it, but we need to do better.”

Limitations of the present analysis are that it was limited to the single retracted study; used only a single search engine, Google Scholar, to identify the citing works; and that additional citations may have been missed, the authors noted.

McDonald and coauthor Todd C. Lee, MD, report being signatories on a public letter calling for the retraction of the Surgisphere papers. Dr. Lee also reported receiving research support from Fonds De Recherche du Quebec-Sante during the conduct of the study.

A version of this article first appeared on Medscape.com.

A retracted study on the safety of blood pressure medications in patients with COVID-19 continues to be cited nearly a year later, new research shows.

Floaria Bicher/iStock/Getty Images Plus

The study in question, published on May 1, 2020, in the New England Journal of Medicine, showed no increased risk for in-hospital death with the use of ACE inhibitors or angiotensin-receptor blockers (ARBs) in hospitalized patients with COVID-19.

Concerns about the veracity of the Surgisphere database used for the study, however, led to a June 4 retraction and to the June 13 retraction of a second study, published in the Lancet, that focused on hydroxychloroquine as a COVID-19 treatment.

Although the Surgisphere scandal caused a global reckoning of COVID-19 scientific studies, the new analysis identified 652 citations of the NEJM article as of May 31.

More than a third of the citations occurred in the first 2 months after the retraction, 54% were at least 3 months later, and 2.8% at least 6 months later. In May, 11 months after the article was retracted, it was cited 21 times, senior author Emily G. McDonald, MD, MSc, McGill University, Montreal, and colleagues reported in a research letter in JAMA Internal Medicine.

“In early May and June there were already more than 200 citations in one of the world’s leading scientific journals, so I do believe it was a highly influential article early on and had an impact on different types of studies or research taking place,” she said in an interview.

Dr. McDonald said she’s also “certain that it impacted patient care,” observing that when there are no guidelines available on how to manage patients, physicians will turn to the most recent evidence in the most reputable journals.

“In the case of ACE [inhibitors] and ARBs, although the study was based on fraudulent data, we were lucky that the overall message was in the end probably correct, but that might not have been the case for another study or dataset,” she said.

Early in the pandemic, concerns existed that ACE inhibitors and ARBs could be harmful, increasing the expression of ACE2 receptors, which the SARS-CoV-2 virus uses to gain entry into cells. The first randomized trial to examine the issue, BRACE CORONA, showed no clinical benefit to interrupting use of the agents in hospitalized patients. An observational study suggested ACE inhibitors may even be protective.

Of two high-profile retractions, McDonald said they chose to bypass the hydroxychloroquine study, which had an eye-popping Altmetric attention score of 23,084, compared with 3,727 for the NEJM paper, because it may have been cited for “other” reasons. “We wanted to focus less on the politics and more on the problem of retracted work.”

The team found that researchers across the globe were citing the retracted ACE/ARB paper (18.7% in the United States, 8.1% in Italy, and 44% other countries). Most citations were used to support a statement in the main text of a study, but in nearly 3% of cases, the data were incorporated into new analyses.

Just 17.6% of the studies cited or noted the retraction. “For sure, that was surprising to us. We suspected it, but our study confirmed it,” Dr. McDonald said.

Although retracted articles can be identified by a watermark or line of text, in some cases that can be easily missed, she noted. What’s more, not all citation software points out when a study has been retracted, a fate shared by the copyediting process.

“There are a lot of mechanisms in place and, in general, what’s happening is rare but there isn’t a perfect automated system solution to absolutely prevent this from happening,” she said. “It’s still subject to human error.”

The findings also have to be taken in the context of a rapidly emerging pandemic and the unprecedented torrent of scientific papers released over the past year.

“That might have contributed to why this happened, but the takeaway message is that this can happen despite our best efforts, and we need to challenge ourselves to come up with a system solution to prevent this from happening in the future,” Dr. McDonald said. “Current mechanisms are probably capturing 95% of it, but we need to do better.”

Limitations of the present analysis are that it was limited to the single retracted study; used only a single search engine, Google Scholar, to identify the citing works; and that additional citations may have been missed, the authors noted.

McDonald and coauthor Todd C. Lee, MD, report being signatories on a public letter calling for the retraction of the Surgisphere papers. Dr. Lee also reported receiving research support from Fonds De Recherche du Quebec-Sante during the conduct of the study.

A version of this article first appeared on Medscape.com.

A retracted study on the safety of blood pressure medications in patients with COVID-19 continues to be cited nearly a year later, new research shows.

Floaria Bicher/iStock/Getty Images Plus

The study in question, published on May 1, 2020, in the New England Journal of Medicine, showed no increased risk for in-hospital death with the use of ACE inhibitors or angiotensin-receptor blockers (ARBs) in hospitalized patients with COVID-19.

Concerns about the veracity of the Surgisphere database used for the study, however, led to a June 4 retraction and to the June 13 retraction of a second study, published in the Lancet, that focused on hydroxychloroquine as a COVID-19 treatment.

Although the Surgisphere scandal caused a global reckoning of COVID-19 scientific studies, the new analysis identified 652 citations of the NEJM article as of May 31.

More than a third of the citations occurred in the first 2 months after the retraction, 54% were at least 3 months later, and 2.8% at least 6 months later. In May, 11 months after the article was retracted, it was cited 21 times, senior author Emily G. McDonald, MD, MSc, McGill University, Montreal, and colleagues reported in a research letter in JAMA Internal Medicine.

“In early May and June there were already more than 200 citations in one of the world’s leading scientific journals, so I do believe it was a highly influential article early on and had an impact on different types of studies or research taking place,” she said in an interview.

Dr. McDonald said she’s also “certain that it impacted patient care,” observing that when there are no guidelines available on how to manage patients, physicians will turn to the most recent evidence in the most reputable journals.

“In the case of ACE [inhibitors] and ARBs, although the study was based on fraudulent data, we were lucky that the overall message was in the end probably correct, but that might not have been the case for another study or dataset,” she said.

Early in the pandemic, concerns existed that ACE inhibitors and ARBs could be harmful, increasing the expression of ACE2 receptors, which the SARS-CoV-2 virus uses to gain entry into cells. The first randomized trial to examine the issue, BRACE CORONA, showed no clinical benefit to interrupting use of the agents in hospitalized patients. An observational study suggested ACE inhibitors may even be protective.

Of two high-profile retractions, McDonald said they chose to bypass the hydroxychloroquine study, which had an eye-popping Altmetric attention score of 23,084, compared with 3,727 for the NEJM paper, because it may have been cited for “other” reasons. “We wanted to focus less on the politics and more on the problem of retracted work.”

The team found that researchers across the globe were citing the retracted ACE/ARB paper (18.7% in the United States, 8.1% in Italy, and 44% other countries). Most citations were used to support a statement in the main text of a study, but in nearly 3% of cases, the data were incorporated into new analyses.

Just 17.6% of the studies cited or noted the retraction. “For sure, that was surprising to us. We suspected it, but our study confirmed it,” Dr. McDonald said.

Although retracted articles can be identified by a watermark or line of text, in some cases that can be easily missed, she noted. What’s more, not all citation software points out when a study has been retracted, a fate shared by the copyediting process.

“There are a lot of mechanisms in place and, in general, what’s happening is rare but there isn’t a perfect automated system solution to absolutely prevent this from happening,” she said. “It’s still subject to human error.”

The findings also have to be taken in the context of a rapidly emerging pandemic and the unprecedented torrent of scientific papers released over the past year.

“That might have contributed to why this happened, but the takeaway message is that this can happen despite our best efforts, and we need to challenge ourselves to come up with a system solution to prevent this from happening in the future,” Dr. McDonald said. “Current mechanisms are probably capturing 95% of it, but we need to do better.”

Limitations of the present analysis are that it was limited to the single retracted study; used only a single search engine, Google Scholar, to identify the citing works; and that additional citations may have been missed, the authors noted.

McDonald and coauthor Todd C. Lee, MD, report being signatories on a public letter calling for the retraction of the Surgisphere papers. Dr. Lee also reported receiving research support from Fonds De Recherche du Quebec-Sante during the conduct of the study.

A version of this article first appeared on Medscape.com.

While cases of pericarditis or myocarditis temporally linked to COVID-19 vaccination remain rare, they may happen more often than reported, according to a large review of electronic medical records (EMRs).

peterschreiber_media/iStock/Getty Images

They also appear to represent two “distinct syndromes,” George Diaz, MD, Providence Regional Medical Center Everett (Washington), said in an interview.

Myocarditis typically occurs soon after vaccination in younger patients and mostly after the second dose, while pericarditis occurs later in older patients, after the first or second dose.

Dr. Diaz and colleagues reported their analysis in a research letter published online August 4 in JAMA.

They reviewed the records of 2,000,287 people who received at least one COVID-19 vaccination at 40 hospitals in Washington, Oregon, Montana, and California that are part of the Providence health care system and use the same EMRs.

The median age of the cohort was 57 years and 59% were women.

A little more than three quarters (77%) received more than one dose; most received the mRNA vaccines made by Pfizer (53%) and Moderna (44%); 3% received the Johnson & Johnson vaccine.

The records showed that 20 people had vaccine-related myocarditis (1.0 per 100,000) and 37 had pericarditis (1.8 per 100,000).

A recent report, based on data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System, suggested an incidence of myocarditis of about 4.8 cases per 1 million following receipt of mRNA COVID-19 vaccine.

The new study shows a “similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. In addition, pericarditis may be more common than myocarditis among older patients,” the study team wrote.

“Our study resulted in higher numbers of cases probably because we searched the EMR, and VAERS requires doctors to report suspected cases voluntarily,” Dr. Diaz said in an interview.

Also, in the governments’ statistics, pericarditis and myocarditis were “lumped together,” he noted.
 

Myocarditis cases

The 20 myocarditis cases occurred a median of 3.5 days after vaccination (11 after the Moderna vaccine and 9 after the Pfizer vaccine), 15 of the patients (75%) were men, and the median age was 36 years.

Four individuals (20%) developed myocarditis symptoms after the first vaccination and 16 (80%) after the second dose. Nineteen of the patients (95%) were admitted to the hospital and all were discharged after a median of 2 days.

None of the 20 patients were readmitted or died. Two received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days after symptom onset), 13 patients (65%) had a resolution of their myocarditis symptoms and seven (35%) were improving.
 

Pericarditis cases

The 37 pericarditis cases occurred a median of 20 days after the most recent COVID-19 vaccination: 23 (62%) with Pfizer, 12 (32%) with Moderna, and 2 (5%) with the J&J vaccine. Fifteen developed pericarditis after the first vaccine dose (41%) and 22 (59%) after the second.

Twenty-seven (73%) of the cases occurred in men; the median age was 59 years.

Thirteen patients (35%) were admitted to the hospital, none to intensive care. The median hospital stay was 1 day. Seven patients with pericarditis received a second vaccination. No patient died.

At last available follow-up (median, 28 days), 7 patients (19%) had resolved symptoms and 23 (62%) were improving.

The researchers also calculate that the average monthly number of cases of myocarditis or myopericarditis during the prevaccine period of January 2019 through January 2021 was 16.9 (95% confidence interval, 15.3-18.6) compared with 27.3 (95% CI, 22.4-32.9) during the vaccine period of February through May 2021 (P < .001).

The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).

The authors say limitations of their analysis include potential missed cases outside care settings and missed diagnoses of myocarditis or pericarditis, which would underestimate the incidence, as well as inaccurate EMR vaccination information.

“Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship,” they wrote.

In late June, the Food and Drug Administration added a warning to the fact sheets accompanying the Pfizer and Moderna mRNA COVID-19 vaccines, flagging the rare risk of heart inflammation after their use.  

Dr. Diaz cautioned that myocarditis and pericarditis events remain “a rare occurrence” after COVID-19 vaccination.

“When discussing vaccination with patients, [health care providers] can advise them that patients generally recover in the rare event they get pericarditis or myocarditis and no deaths were found, and that the vaccines are safe and effective,” Dr. Diaz said.

The study had no specific funding. Dr. Diaz reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, and Edesa Biotech and scientific advisory board membership for Safeology.

A version of this article first appeared on Medscape.com.

While cases of pericarditis or myocarditis temporally linked to COVID-19 vaccination remain rare, they may happen more often than reported, according to a large review of electronic medical records (EMRs).

peterschreiber_media/iStock/Getty Images

They also appear to represent two “distinct syndromes,” George Diaz, MD, Providence Regional Medical Center Everett (Washington), said in an interview.

Myocarditis typically occurs soon after vaccination in younger patients and mostly after the second dose, while pericarditis occurs later in older patients, after the first or second dose.

Dr. Diaz and colleagues reported their analysis in a research letter published online August 4 in JAMA.

They reviewed the records of 2,000,287 people who received at least one COVID-19 vaccination at 40 hospitals in Washington, Oregon, Montana, and California that are part of the Providence health care system and use the same EMRs.

The median age of the cohort was 57 years and 59% were women.

A little more than three quarters (77%) received more than one dose; most received the mRNA vaccines made by Pfizer (53%) and Moderna (44%); 3% received the Johnson & Johnson vaccine.

The records showed that 20 people had vaccine-related myocarditis (1.0 per 100,000) and 37 had pericarditis (1.8 per 100,000).

A recent report, based on data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System, suggested an incidence of myocarditis of about 4.8 cases per 1 million following receipt of mRNA COVID-19 vaccine.

The new study shows a “similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. In addition, pericarditis may be more common than myocarditis among older patients,” the study team wrote.

“Our study resulted in higher numbers of cases probably because we searched the EMR, and VAERS requires doctors to report suspected cases voluntarily,” Dr. Diaz said in an interview.

Also, in the governments’ statistics, pericarditis and myocarditis were “lumped together,” he noted.
 

Myocarditis cases

The 20 myocarditis cases occurred a median of 3.5 days after vaccination (11 after the Moderna vaccine and 9 after the Pfizer vaccine), 15 of the patients (75%) were men, and the median age was 36 years.

Four individuals (20%) developed myocarditis symptoms after the first vaccination and 16 (80%) after the second dose. Nineteen of the patients (95%) were admitted to the hospital and all were discharged after a median of 2 days.

None of the 20 patients were readmitted or died. Two received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days after symptom onset), 13 patients (65%) had a resolution of their myocarditis symptoms and seven (35%) were improving.
 

Pericarditis cases

The 37 pericarditis cases occurred a median of 20 days after the most recent COVID-19 vaccination: 23 (62%) with Pfizer, 12 (32%) with Moderna, and 2 (5%) with the J&J vaccine. Fifteen developed pericarditis after the first vaccine dose (41%) and 22 (59%) after the second.

Twenty-seven (73%) of the cases occurred in men; the median age was 59 years.

Thirteen patients (35%) were admitted to the hospital, none to intensive care. The median hospital stay was 1 day. Seven patients with pericarditis received a second vaccination. No patient died.

At last available follow-up (median, 28 days), 7 patients (19%) had resolved symptoms and 23 (62%) were improving.

The researchers also calculate that the average monthly number of cases of myocarditis or myopericarditis during the prevaccine period of January 2019 through January 2021 was 16.9 (95% confidence interval, 15.3-18.6) compared with 27.3 (95% CI, 22.4-32.9) during the vaccine period of February through May 2021 (P < .001).

The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).

The authors say limitations of their analysis include potential missed cases outside care settings and missed diagnoses of myocarditis or pericarditis, which would underestimate the incidence, as well as inaccurate EMR vaccination information.

“Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship,” they wrote.

In late June, the Food and Drug Administration added a warning to the fact sheets accompanying the Pfizer and Moderna mRNA COVID-19 vaccines, flagging the rare risk of heart inflammation after their use.  

Dr. Diaz cautioned that myocarditis and pericarditis events remain “a rare occurrence” after COVID-19 vaccination.

“When discussing vaccination with patients, [health care providers] can advise them that patients generally recover in the rare event they get pericarditis or myocarditis and no deaths were found, and that the vaccines are safe and effective,” Dr. Diaz said.

The study had no specific funding. Dr. Diaz reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, and Edesa Biotech and scientific advisory board membership for Safeology.

A version of this article first appeared on Medscape.com.

While cases of pericarditis or myocarditis temporally linked to COVID-19 vaccination remain rare, they may happen more often than reported, according to a large review of electronic medical records (EMRs).

peterschreiber_media/iStock/Getty Images

They also appear to represent two “distinct syndromes,” George Diaz, MD, Providence Regional Medical Center Everett (Washington), said in an interview.

Myocarditis typically occurs soon after vaccination in younger patients and mostly after the second dose, while pericarditis occurs later in older patients, after the first or second dose.

Dr. Diaz and colleagues reported their analysis in a research letter published online August 4 in JAMA.

They reviewed the records of 2,000,287 people who received at least one COVID-19 vaccination at 40 hospitals in Washington, Oregon, Montana, and California that are part of the Providence health care system and use the same EMRs.

The median age of the cohort was 57 years and 59% were women.

A little more than three quarters (77%) received more than one dose; most received the mRNA vaccines made by Pfizer (53%) and Moderna (44%); 3% received the Johnson & Johnson vaccine.

The records showed that 20 people had vaccine-related myocarditis (1.0 per 100,000) and 37 had pericarditis (1.8 per 100,000).

A recent report, based on data from the Centers for Disease Control and Prevention’s Vaccine Adverse Events Reporting System, suggested an incidence of myocarditis of about 4.8 cases per 1 million following receipt of mRNA COVID-19 vaccine.

The new study shows a “similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. In addition, pericarditis may be more common than myocarditis among older patients,” the study team wrote.

“Our study resulted in higher numbers of cases probably because we searched the EMR, and VAERS requires doctors to report suspected cases voluntarily,” Dr. Diaz said in an interview.

Also, in the governments’ statistics, pericarditis and myocarditis were “lumped together,” he noted.
 

Myocarditis cases

The 20 myocarditis cases occurred a median of 3.5 days after vaccination (11 after the Moderna vaccine and 9 after the Pfizer vaccine), 15 of the patients (75%) were men, and the median age was 36 years.

Four individuals (20%) developed myocarditis symptoms after the first vaccination and 16 (80%) after the second dose. Nineteen of the patients (95%) were admitted to the hospital and all were discharged after a median of 2 days.

None of the 20 patients were readmitted or died. Two received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days after symptom onset), 13 patients (65%) had a resolution of their myocarditis symptoms and seven (35%) were improving.
 

Pericarditis cases

The 37 pericarditis cases occurred a median of 20 days after the most recent COVID-19 vaccination: 23 (62%) with Pfizer, 12 (32%) with Moderna, and 2 (5%) with the J&J vaccine. Fifteen developed pericarditis after the first vaccine dose (41%) and 22 (59%) after the second.

Twenty-seven (73%) of the cases occurred in men; the median age was 59 years.

Thirteen patients (35%) were admitted to the hospital, none to intensive care. The median hospital stay was 1 day. Seven patients with pericarditis received a second vaccination. No patient died.

At last available follow-up (median, 28 days), 7 patients (19%) had resolved symptoms and 23 (62%) were improving.

The researchers also calculate that the average monthly number of cases of myocarditis or myopericarditis during the prevaccine period of January 2019 through January 2021 was 16.9 (95% confidence interval, 15.3-18.6) compared with 27.3 (95% CI, 22.4-32.9) during the vaccine period of February through May 2021 (P < .001).

The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).

The authors say limitations of their analysis include potential missed cases outside care settings and missed diagnoses of myocarditis or pericarditis, which would underestimate the incidence, as well as inaccurate EMR vaccination information.

“Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship,” they wrote.

In late June, the Food and Drug Administration added a warning to the fact sheets accompanying the Pfizer and Moderna mRNA COVID-19 vaccines, flagging the rare risk of heart inflammation after their use.  

Dr. Diaz cautioned that myocarditis and pericarditis events remain “a rare occurrence” after COVID-19 vaccination.

“When discussing vaccination with patients, [health care providers] can advise them that patients generally recover in the rare event they get pericarditis or myocarditis and no deaths were found, and that the vaccines are safe and effective,” Dr. Diaz said.

The study had no specific funding. Dr. Diaz reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, and Edesa Biotech and scientific advisory board membership for Safeology.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones.

The new app works with the FreeStyle Libre 2 with optional glucose alarms, which was approved in the United States in June 2020 for people with diabetes aged 4 years and older.

Until now, it was only a reader device with no app compatibility. The older FreeStyle Libre 14-day, available in the United States since July 2018, has both a reader and an app, but not optional alarms.

The new app, which will soon be available for download from the App Store, enables users to view glucose readings on their iPhones and allows for caregivers or other individuals to remotely monitor the patient’s glucose levels and receive real-time alarms via the LibreLinkUp app.

Worn for 14 days before replacement is needed, the FreeStyle Libre 2 is the longest-lasting integrated continuous glucose monitoring (iCGM) sensor currently on the market. The first iCGM, the Dexcom G6, is worn for 10 days.

The Libre 2 is available at pharmacies, typically at a lower cost than other CGM systems based on a list price comparison. The actual cost for patients varies depending on insurance coverage.

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada, France, Germany, Japan, the United Kingdom, and the United States.

The FreeStyle Libre 3 is approved for use in the European Union.

A version of this article first appeared on Medscape.com.

Transgender adults are more likely to experience subjective cognitive decline (SCD) than their cisgender peers, and at an earlier age, new research shows.

Investigators found transgender adults – individuals who identify with a gender different than the one assigned to them at birth – were nearly twice as likely to report subjective cognitive decline and more than twice as likely to report SCD-related functional limitations – such as reduced ability to work, volunteer, or be social – than cisgender adults.

‘Alarming’ finding

SCD is a self-reported experience of worsening memory or thinking and is one of the first clinical manifestations of Alzheimer’s disease and related dementia (ADRD). Yet there is limited research into cognitive impairment among transgender adults.

The researchers examined SCD and associated functional limitations among transgender and cisgender adults older than age 45 years who provided health and health behavior data as part of the Behavioral Risk Factor Surveillance System (BRFSS) surveys (2015-2019). 

The sample included 386,529 adults of whom 1,302 identified as transgender and 385,227 as cisgender.

Roughly 17% of transgender adults reported SCD, which is significantly higher than the 10.6% rate for cisgender adults (P < .001).

Compared with cisgender adults reporting SCD, transgender adults reporting SCD were younger (mean age 61.9 vs. 65.2 years, P = .0005), more likely to be in a racial/ethnic minority group (37.3% vs. 19.5%, P < .0001), have a high school degree or less (59.6% vs. 43.4%, P = .0003), be uninsured (17% vs. 5.5%, P = .0007) and have a depressive disorder (58.8% vs. 45.7%, P = .0028).

The fact that transgender people who reported SCD were about 3 years younger than cisgender people who reported SCD is “somewhat alarming and a red flag to ask middle-aged trans adults about their brain health and not just older or elderly trans adults,” said Dr. Cicero.

The study also showed that transgender adults reporting SCD were 2.3 times more likely to report related social and self-care limitations when compared with cisgender adults reporting SCD.

The findings align with a study reported at AAIC 2019, which showed that sexual or gender minorities (SGM) are almost 30% more likely to report subjective cognitive decline compared with the non-SGM population.
 

Cause unclear

“We are not certain what may be causing the elevated subjective cognitive decline rates among transgender adults. We postulate that it may be in part due to anti-transgender stigma and prejudice that expose transgender people to high rates of mistreatment and discrimination where they live, work, learn, seek health care, and age,” Dr. Cicero said.

“More research is needed to identify and target preventive intervention strategies, develop culturally relevant screenings, and shape policies to improve the health and well-being of the transgender population,” he added.

Weighing in on the study, Rebecca Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said “researchers have only just started to explore the experiences of dementia within the lesbian, gay, and bisexual community, but this is the first time we are seeing some specific research that’s looking at cognition in transgender individuals and gender nonbinary individuals.”

“We don’t know exactly why transgender and gender nonbinary individuals experience greater rates of subjective cognitive decline, but we do know that they have greater rates of health disparities that are considered risk factors for dementia, including higher rates of cardiovascular disease, depression, diabetes, tobacco and alcohol use, and obesity,” Dr. Edelmayer said. 

“Alzheimer’s and dementia do not discriminate. Neither can we,” Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said in a statement.

“The Alzheimer’s Association advocates for more research to better understand the cognitive and emotional needs of transgender and nonbinary individuals so that our nation’s health care providers can offer them culturally sensitive care,” said Dr. Carrillo.

The study had no specific funding. Dr. Cicero, Dr. Carrillo, and Dr. Edelmayer have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Transgender adults are more likely to experience subjective cognitive decline (SCD) than their cisgender peers, and at an earlier age, new research shows.

Investigators found transgender adults – individuals who identify with a gender different than the one assigned to them at birth – were nearly twice as likely to report subjective cognitive decline and more than twice as likely to report SCD-related functional limitations – such as reduced ability to work, volunteer, or be social – than cisgender adults.

‘Alarming’ finding

SCD is a self-reported experience of worsening memory or thinking and is one of the first clinical manifestations of Alzheimer’s disease and related dementia (ADRD). Yet there is limited research into cognitive impairment among transgender adults.

The researchers examined SCD and associated functional limitations among transgender and cisgender adults older than age 45 years who provided health and health behavior data as part of the Behavioral Risk Factor Surveillance System (BRFSS) surveys (2015-2019). 

The sample included 386,529 adults of whom 1,302 identified as transgender and 385,227 as cisgender.

Roughly 17% of transgender adults reported SCD, which is significantly higher than the 10.6% rate for cisgender adults (P < .001).

Compared with cisgender adults reporting SCD, transgender adults reporting SCD were younger (mean age 61.9 vs. 65.2 years, P = .0005), more likely to be in a racial/ethnic minority group (37.3% vs. 19.5%, P < .0001), have a high school degree or less (59.6% vs. 43.4%, P = .0003), be uninsured (17% vs. 5.5%, P = .0007) and have a depressive disorder (58.8% vs. 45.7%, P = .0028).

The fact that transgender people who reported SCD were about 3 years younger than cisgender people who reported SCD is “somewhat alarming and a red flag to ask middle-aged trans adults about their brain health and not just older or elderly trans adults,” said Dr. Cicero.

The study also showed that transgender adults reporting SCD were 2.3 times more likely to report related social and self-care limitations when compared with cisgender adults reporting SCD.

The findings align with a study reported at AAIC 2019, which showed that sexual or gender minorities (SGM) are almost 30% more likely to report subjective cognitive decline compared with the non-SGM population.
 

Cause unclear

“We are not certain what may be causing the elevated subjective cognitive decline rates among transgender adults. We postulate that it may be in part due to anti-transgender stigma and prejudice that expose transgender people to high rates of mistreatment and discrimination where they live, work, learn, seek health care, and age,” Dr. Cicero said.

“More research is needed to identify and target preventive intervention strategies, develop culturally relevant screenings, and shape policies to improve the health and well-being of the transgender population,” he added.

Weighing in on the study, Rebecca Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said “researchers have only just started to explore the experiences of dementia within the lesbian, gay, and bisexual community, but this is the first time we are seeing some specific research that’s looking at cognition in transgender individuals and gender nonbinary individuals.”

“We don’t know exactly why transgender and gender nonbinary individuals experience greater rates of subjective cognitive decline, but we do know that they have greater rates of health disparities that are considered risk factors for dementia, including higher rates of cardiovascular disease, depression, diabetes, tobacco and alcohol use, and obesity,” Dr. Edelmayer said. 

“Alzheimer’s and dementia do not discriminate. Neither can we,” Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said in a statement.

“The Alzheimer’s Association advocates for more research to better understand the cognitive and emotional needs of transgender and nonbinary individuals so that our nation’s health care providers can offer them culturally sensitive care,” said Dr. Carrillo.

The study had no specific funding. Dr. Cicero, Dr. Carrillo, and Dr. Edelmayer have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Transgender adults are more likely to experience subjective cognitive decline (SCD) than their cisgender peers, and at an earlier age, new research shows.

Investigators found transgender adults – individuals who identify with a gender different than the one assigned to them at birth – were nearly twice as likely to report subjective cognitive decline and more than twice as likely to report SCD-related functional limitations – such as reduced ability to work, volunteer, or be social – than cisgender adults.

‘Alarming’ finding

SCD is a self-reported experience of worsening memory or thinking and is one of the first clinical manifestations of Alzheimer’s disease and related dementia (ADRD). Yet there is limited research into cognitive impairment among transgender adults.

The researchers examined SCD and associated functional limitations among transgender and cisgender adults older than age 45 years who provided health and health behavior data as part of the Behavioral Risk Factor Surveillance System (BRFSS) surveys (2015-2019). 

The sample included 386,529 adults of whom 1,302 identified as transgender and 385,227 as cisgender.

Roughly 17% of transgender adults reported SCD, which is significantly higher than the 10.6% rate for cisgender adults (P < .001).

Compared with cisgender adults reporting SCD, transgender adults reporting SCD were younger (mean age 61.9 vs. 65.2 years, P = .0005), more likely to be in a racial/ethnic minority group (37.3% vs. 19.5%, P < .0001), have a high school degree or less (59.6% vs. 43.4%, P = .0003), be uninsured (17% vs. 5.5%, P = .0007) and have a depressive disorder (58.8% vs. 45.7%, P = .0028).

The fact that transgender people who reported SCD were about 3 years younger than cisgender people who reported SCD is “somewhat alarming and a red flag to ask middle-aged trans adults about their brain health and not just older or elderly trans adults,” said Dr. Cicero.

The study also showed that transgender adults reporting SCD were 2.3 times more likely to report related social and self-care limitations when compared with cisgender adults reporting SCD.

The findings align with a study reported at AAIC 2019, which showed that sexual or gender minorities (SGM) are almost 30% more likely to report subjective cognitive decline compared with the non-SGM population.
 

Cause unclear

“We are not certain what may be causing the elevated subjective cognitive decline rates among transgender adults. We postulate that it may be in part due to anti-transgender stigma and prejudice that expose transgender people to high rates of mistreatment and discrimination where they live, work, learn, seek health care, and age,” Dr. Cicero said.

“More research is needed to identify and target preventive intervention strategies, develop culturally relevant screenings, and shape policies to improve the health and well-being of the transgender population,” he added.

Weighing in on the study, Rebecca Edelmayer, PhD, senior director of scientific engagement at the Alzheimer’s Association, said “researchers have only just started to explore the experiences of dementia within the lesbian, gay, and bisexual community, but this is the first time we are seeing some specific research that’s looking at cognition in transgender individuals and gender nonbinary individuals.”

“We don’t know exactly why transgender and gender nonbinary individuals experience greater rates of subjective cognitive decline, but we do know that they have greater rates of health disparities that are considered risk factors for dementia, including higher rates of cardiovascular disease, depression, diabetes, tobacco and alcohol use, and obesity,” Dr. Edelmayer said. 

“Alzheimer’s and dementia do not discriminate. Neither can we,” Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association, said in a statement.

“The Alzheimer’s Association advocates for more research to better understand the cognitive and emotional needs of transgender and nonbinary individuals so that our nation’s health care providers can offer them culturally sensitive care,” said Dr. Carrillo.

The study had no specific funding. Dr. Cicero, Dr. Carrillo, and Dr. Edelmayer have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. health care system ranked last overall among 11 high-income countries in an analysis by the nonprofit Commonwealth Fund, according to a report released on Aug. 4.

The report is the seventh international comparison of countries’ health systems by the Commonwealth Fund since 2004, and the United States has ranked last in every edition, David Blumenthal, MD, president of the Commonwealth Fund, told reporters during a press briefing.

Researchers analyzed survey answers from tens of thousands of patients and physicians in 11 countries. They analyzed performance on 71 measures across five categories – access to care, care process, administrative efficiency, equity, and health care outcomes. Administrative data were gathered from the Organisation for Economic Cooperation and Development and the World Health Organization.

Among contributors to the poor showing by the United States is that half (50%) of lower-income U.S. adults and 27% of higher-income U.S. adults say costs keep them from getting needed health care.

“In no other country does income inequality so profoundly limit access to care,” Dr. Blumenthal said.

In the United Kingdom, only 12% with lower incomes and 7% with higher incomes said costs kept them from care.

In a stark comparison, the researchers found that “a high-income person in the U.S. was more likely to report financial barriers than a low-income person in nearly all the other countries surveyed: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the U.K.”

Norway, the Netherlands, and Australia were ranked at the top overall in that order. Rounding out the 11 in overall ranking were the U.K., Germany, New Zealand, Sweden, France, Switzerland, Canada, and the United States.

“What this report tells us is that our health care system is not working for Americans, particularly those with lower incomes, who are at a severe disadvantage compared to citizens of other countries. And they are paying the price with their health and their lives,” Dr. Blumenthal said in a press release.

“To catch up with other high-income countries, the administration and Congress would have to expand access to health care, equitably, to all Americans, act aggressively to control costs, and invest in the social services we know can lead to a healthier population.”
 

High infant mortality, low life expectancy in U.S.

Several factors contributed to the U.S. ranking at the bottom of the outcomes category. Among them are that the United States has the highest infant mortality rate (5.7 deaths per 1,000 live births) and lowest life expectancy at age 60 (living on average 23.1 years after age 60), compared with the other countries surveyed. The U.S. rate of preventable mortality (177 deaths per 100,000 population) is more than double that of the best-performing country, Switzerland.

Lead author Eric Schneider, MD, senior vice president for policy and research at the Commonwealth Fund, pointed out that, in terms of the change in avoidable mortality over a decade, not only did the United States have the highest rate, compared with the other countries surveyed, “it also experienced the smallest decline in avoidable mortality over that 10-year period.”

The U.S. maternal mortality rate of 17.4 deaths per 100,000 live births is twice that of France, the country with the next-highest rate (7.6 deaths per 100,000 live births).
 

U.S. excelled in only one category

The only category in which the United States did not rank last was in “care process,” where it ranked second behind only New Zealand.

The care process category combines preventive care, safe care, coordinated care, and patient engagement and preferences. The category includes indicators such as mammography screening and influenza vaccination for older adults as well as the percentage of adults counseled by a health care provider about nutrition, smoking, or alcohol use.

The United States and Germany performed best on engagement and patient preferences, although U.S. adults have the lowest rates of continuity with the same doctor.

New Zealand and the United States ranked highest in the safe care category, with higher reported use of computerized alerts and routine review of medications.
 

‘Too little, too late’: Key recommendations for U.S. to improve

Reginald Williams, vice president of International Health Policy and Practice Innovations at the Commonwealth Fund, pointed out that the U.S. shortcomings in health care come despite spending more than twice as much of its GDP (17% in 2019) as the average OECD country.

“It appears that the US delivers too little of the care that is most needed and often delivers that care too late, especially for people with chronic illnesses,” he said.

He then summarized the team’s recommendations on how the United States can change course.

First is expanding insurance coverage, he said, noting that the United States is the only one of the 11 countries that lacks universal coverage and nearly 30 million people remain uninsured.

Top-performing countries in the survey have universal coverage, annual out-of-pocket caps on covered benefits, and full coverage for primary care and treatment for chronic conditions, he said.

The United States must also improve access to care, he said.

“Top-ranking countries like the Netherlands and Norway ensure timely availability to care by telephone on nights and weekends, and in-person follow-up at home, if needed,” he said.

Mr. Williams said reducing administrative burdens is also critical to free up resources for improving health. He gave an example: “Norway determines patient copayments or physician fees on a regional basis, applying standardized copayments to all physicians within a specialty in a geographic area.”

Reducing income-related barriers is important as well, he said.

The fear of unpredictably high bills and other issues prevent people in the United States from getting the care they ultimately need, he said, adding that top-performing countries invest more in social services to reduce health risks.

That could have implications for the COVID-19 response.

Responding effectively to COVID-19 requires that patients can access affordable health care services, Mr. Williams noted.

“We know from our research that more than two-thirds of U.S. adults say their potential out-of-pocket costs would figure prominently in their decisions to get care if they had coronavirus symptoms,” he said.

Dr. Schneider summed up in the press release: “This study makes clear that higher U.S. spending on health care is not producing better health especially as the U.S. continues on a path of deepening inequality. A country that spends as much as we do should have the best health system in the world. We should adapt what works in other high-income countries to build a better health care system that provides affordable, high-quality health care for everyone.”

Dr. Blumenthal, Dr. Schneider, and Mr. Williams reported no relevant financial relationships outside their employment with the Commonwealth Fund. 

A version of this article first appeared on Medscape.com.

The U.S. health care system ranked last overall among 11 high-income countries in an analysis by the nonprofit Commonwealth Fund, according to a report released on Aug. 4.

The report is the seventh international comparison of countries’ health systems by the Commonwealth Fund since 2004, and the United States has ranked last in every edition, David Blumenthal, MD, president of the Commonwealth Fund, told reporters during a press briefing.

Researchers analyzed survey answers from tens of thousands of patients and physicians in 11 countries. They analyzed performance on 71 measures across five categories – access to care, care process, administrative efficiency, equity, and health care outcomes. Administrative data were gathered from the Organisation for Economic Cooperation and Development and the World Health Organization.

Among contributors to the poor showing by the United States is that half (50%) of lower-income U.S. adults and 27% of higher-income U.S. adults say costs keep them from getting needed health care.

“In no other country does income inequality so profoundly limit access to care,” Dr. Blumenthal said.

In the United Kingdom, only 12% with lower incomes and 7% with higher incomes said costs kept them from care.

In a stark comparison, the researchers found that “a high-income person in the U.S. was more likely to report financial barriers than a low-income person in nearly all the other countries surveyed: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the U.K.”

Norway, the Netherlands, and Australia were ranked at the top overall in that order. Rounding out the 11 in overall ranking were the U.K., Germany, New Zealand, Sweden, France, Switzerland, Canada, and the United States.

“What this report tells us is that our health care system is not working for Americans, particularly those with lower incomes, who are at a severe disadvantage compared to citizens of other countries. And they are paying the price with their health and their lives,” Dr. Blumenthal said in a press release.

“To catch up with other high-income countries, the administration and Congress would have to expand access to health care, equitably, to all Americans, act aggressively to control costs, and invest in the social services we know can lead to a healthier population.”
 

High infant mortality, low life expectancy in U.S.

Several factors contributed to the U.S. ranking at the bottom of the outcomes category. Among them are that the United States has the highest infant mortality rate (5.7 deaths per 1,000 live births) and lowest life expectancy at age 60 (living on average 23.1 years after age 60), compared with the other countries surveyed. The U.S. rate of preventable mortality (177 deaths per 100,000 population) is more than double that of the best-performing country, Switzerland.

Lead author Eric Schneider, MD, senior vice president for policy and research at the Commonwealth Fund, pointed out that, in terms of the change in avoidable mortality over a decade, not only did the United States have the highest rate, compared with the other countries surveyed, “it also experienced the smallest decline in avoidable mortality over that 10-year period.”

The U.S. maternal mortality rate of 17.4 deaths per 100,000 live births is twice that of France, the country with the next-highest rate (7.6 deaths per 100,000 live births).
 

U.S. excelled in only one category

The only category in which the United States did not rank last was in “care process,” where it ranked second behind only New Zealand.

The care process category combines preventive care, safe care, coordinated care, and patient engagement and preferences. The category includes indicators such as mammography screening and influenza vaccination for older adults as well as the percentage of adults counseled by a health care provider about nutrition, smoking, or alcohol use.

The United States and Germany performed best on engagement and patient preferences, although U.S. adults have the lowest rates of continuity with the same doctor.

New Zealand and the United States ranked highest in the safe care category, with higher reported use of computerized alerts and routine review of medications.
 

‘Too little, too late’: Key recommendations for U.S. to improve

Reginald Williams, vice president of International Health Policy and Practice Innovations at the Commonwealth Fund, pointed out that the U.S. shortcomings in health care come despite spending more than twice as much of its GDP (17% in 2019) as the average OECD country.

“It appears that the US delivers too little of the care that is most needed and often delivers that care too late, especially for people with chronic illnesses,” he said.

He then summarized the team’s recommendations on how the United States can change course.

First is expanding insurance coverage, he said, noting that the United States is the only one of the 11 countries that lacks universal coverage and nearly 30 million people remain uninsured.

Top-performing countries in the survey have universal coverage, annual out-of-pocket caps on covered benefits, and full coverage for primary care and treatment for chronic conditions, he said.

The United States must also improve access to care, he said.

“Top-ranking countries like the Netherlands and Norway ensure timely availability to care by telephone on nights and weekends, and in-person follow-up at home, if needed,” he said.

Mr. Williams said reducing administrative burdens is also critical to free up resources for improving health. He gave an example: “Norway determines patient copayments or physician fees on a regional basis, applying standardized copayments to all physicians within a specialty in a geographic area.”

Reducing income-related barriers is important as well, he said.

The fear of unpredictably high bills and other issues prevent people in the United States from getting the care they ultimately need, he said, adding that top-performing countries invest more in social services to reduce health risks.

That could have implications for the COVID-19 response.

Responding effectively to COVID-19 requires that patients can access affordable health care services, Mr. Williams noted.

“We know from our research that more than two-thirds of U.S. adults say their potential out-of-pocket costs would figure prominently in their decisions to get care if they had coronavirus symptoms,” he said.

Dr. Schneider summed up in the press release: “This study makes clear that higher U.S. spending on health care is not producing better health especially as the U.S. continues on a path of deepening inequality. A country that spends as much as we do should have the best health system in the world. We should adapt what works in other high-income countries to build a better health care system that provides affordable, high-quality health care for everyone.”

Dr. Blumenthal, Dr. Schneider, and Mr. Williams reported no relevant financial relationships outside their employment with the Commonwealth Fund. 

A version of this article first appeared on Medscape.com.

The U.S. health care system ranked last overall among 11 high-income countries in an analysis by the nonprofit Commonwealth Fund, according to a report released on Aug. 4.

The report is the seventh international comparison of countries’ health systems by the Commonwealth Fund since 2004, and the United States has ranked last in every edition, David Blumenthal, MD, president of the Commonwealth Fund, told reporters during a press briefing.

Researchers analyzed survey answers from tens of thousands of patients and physicians in 11 countries. They analyzed performance on 71 measures across five categories – access to care, care process, administrative efficiency, equity, and health care outcomes. Administrative data were gathered from the Organisation for Economic Cooperation and Development and the World Health Organization.

Among contributors to the poor showing by the United States is that half (50%) of lower-income U.S. adults and 27% of higher-income U.S. adults say costs keep them from getting needed health care.

“In no other country does income inequality so profoundly limit access to care,” Dr. Blumenthal said.

In the United Kingdom, only 12% with lower incomes and 7% with higher incomes said costs kept them from care.

In a stark comparison, the researchers found that “a high-income person in the U.S. was more likely to report financial barriers than a low-income person in nearly all the other countries surveyed: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the U.K.”

Norway, the Netherlands, and Australia were ranked at the top overall in that order. Rounding out the 11 in overall ranking were the U.K., Germany, New Zealand, Sweden, France, Switzerland, Canada, and the United States.

“What this report tells us is that our health care system is not working for Americans, particularly those with lower incomes, who are at a severe disadvantage compared to citizens of other countries. And they are paying the price with their health and their lives,” Dr. Blumenthal said in a press release.

“To catch up with other high-income countries, the administration and Congress would have to expand access to health care, equitably, to all Americans, act aggressively to control costs, and invest in the social services we know can lead to a healthier population.”
 

High infant mortality, low life expectancy in U.S.

Several factors contributed to the U.S. ranking at the bottom of the outcomes category. Among them are that the United States has the highest infant mortality rate (5.7 deaths per 1,000 live births) and lowest life expectancy at age 60 (living on average 23.1 years after age 60), compared with the other countries surveyed. The U.S. rate of preventable mortality (177 deaths per 100,000 population) is more than double that of the best-performing country, Switzerland.

Lead author Eric Schneider, MD, senior vice president for policy and research at the Commonwealth Fund, pointed out that, in terms of the change in avoidable mortality over a decade, not only did the United States have the highest rate, compared with the other countries surveyed, “it also experienced the smallest decline in avoidable mortality over that 10-year period.”

The U.S. maternal mortality rate of 17.4 deaths per 100,000 live births is twice that of France, the country with the next-highest rate (7.6 deaths per 100,000 live births).
 

U.S. excelled in only one category

The only category in which the United States did not rank last was in “care process,” where it ranked second behind only New Zealand.

The care process category combines preventive care, safe care, coordinated care, and patient engagement and preferences. The category includes indicators such as mammography screening and influenza vaccination for older adults as well as the percentage of adults counseled by a health care provider about nutrition, smoking, or alcohol use.

The United States and Germany performed best on engagement and patient preferences, although U.S. adults have the lowest rates of continuity with the same doctor.

New Zealand and the United States ranked highest in the safe care category, with higher reported use of computerized alerts and routine review of medications.
 

‘Too little, too late’: Key recommendations for U.S. to improve

Reginald Williams, vice president of International Health Policy and Practice Innovations at the Commonwealth Fund, pointed out that the U.S. shortcomings in health care come despite spending more than twice as much of its GDP (17% in 2019) as the average OECD country.

“It appears that the US delivers too little of the care that is most needed and often delivers that care too late, especially for people with chronic illnesses,” he said.

He then summarized the team’s recommendations on how the United States can change course.

First is expanding insurance coverage, he said, noting that the United States is the only one of the 11 countries that lacks universal coverage and nearly 30 million people remain uninsured.

Top-performing countries in the survey have universal coverage, annual out-of-pocket caps on covered benefits, and full coverage for primary care and treatment for chronic conditions, he said.

The United States must also improve access to care, he said.

“Top-ranking countries like the Netherlands and Norway ensure timely availability to care by telephone on nights and weekends, and in-person follow-up at home, if needed,” he said.

Mr. Williams said reducing administrative burdens is also critical to free up resources for improving health. He gave an example: “Norway determines patient copayments or physician fees on a regional basis, applying standardized copayments to all physicians within a specialty in a geographic area.”

Reducing income-related barriers is important as well, he said.

The fear of unpredictably high bills and other issues prevent people in the United States from getting the care they ultimately need, he said, adding that top-performing countries invest more in social services to reduce health risks.

That could have implications for the COVID-19 response.

Responding effectively to COVID-19 requires that patients can access affordable health care services, Mr. Williams noted.

“We know from our research that more than two-thirds of U.S. adults say their potential out-of-pocket costs would figure prominently in their decisions to get care if they had coronavirus symptoms,” he said.

Dr. Schneider summed up in the press release: “This study makes clear that higher U.S. spending on health care is not producing better health especially as the U.S. continues on a path of deepening inequality. A country that spends as much as we do should have the best health system in the world. We should adapt what works in other high-income countries to build a better health care system that provides affordable, high-quality health care for everyone.”

Dr. Blumenthal, Dr. Schneider, and Mr. Williams reported no relevant financial relationships outside their employment with the Commonwealth Fund. 

A version of this article first appeared on Medscape.com.

When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.

Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.

Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.

Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.

The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.

So the question of the summer has become: “When will Delta burn out here?”

Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:

• Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
• Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
• September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
• Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
• Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”

The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
 

What a difference vaccination may make

An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)

But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.

Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.

Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.

“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.

It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?

That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
 

Roles of public policy, individual behavior

Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.

“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.

The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”

Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.

Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.

“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
 

Once the Delta variant subsides, what’s next?

It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.

There’s also Delta-plus, just found in two people in South Korea.

Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
 

On the horizon: Variant-proof vaccines

What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.

Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.

The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

A version of this article first appeared on WebMD.com.

When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.

Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.

Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.

Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.

The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.

So the question of the summer has become: “When will Delta burn out here?”

Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:

• Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
• Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
• September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
• Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
• Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”

The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
 

What a difference vaccination may make

An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)

But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.

Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.

Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.

“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.

It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?

That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
 

Roles of public policy, individual behavior

Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.

“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.

The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”

Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.

Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.

“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
 

Once the Delta variant subsides, what’s next?

It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.

There’s also Delta-plus, just found in two people in South Korea.

Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
 

On the horizon: Variant-proof vaccines

What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.

Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.

The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

A version of this article first appeared on WebMD.com.

When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.

Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.

Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.

Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.

The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.

So the question of the summer has become: “When will Delta burn out here?”

Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:

• Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
• Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
• September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
• Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
• Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”

The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
 

What a difference vaccination may make

An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)

But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.

Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.

Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.

“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.

It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?

That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
 

Roles of public policy, individual behavior

Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.

“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.

The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”

Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.

Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.

“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
 

Once the Delta variant subsides, what’s next?

It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.

There’s also Delta-plus, just found in two people in South Korea.

Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
 

On the horizon: Variant-proof vaccines

What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.

Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.

The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

A version of this article first appeared on WebMD.com.