In a real-world setting, full vaccination against SARS-CoV-2 was more than 80% effective at reducing infection in people with inflammatory bowel disease (IBD) who were taking immunosuppressive medications.

The study, which examined postvaccine infection rates in a Veterans Affairs cohort, further validates the benefit of COVID-19 vaccines, particularly in a subgroup most at risk for having compromised immune systems. Furthermore, the findings “may serve to increase patient and provider willingness to pursue vaccination in these settings,” wrote study authors Nabeel Khan, MD, of the Corporal Michael J. Crescenz VA Medical Center and Nadim Mahmud, MD, of the University of Pennsylvania, both in Philadelphia. The report was published in Gastroenterology. In addition, the researchers said the findings “should provide positive reinforcement to IBD patients taking immunosuppressive agents who may otherwise be reluctant to receive vaccination.”

Since the onset of the COVID-19 pandemic, concerns have been raised regarding the possible heightened risk of SARS-CoV-2 infection among patients with IBD and other diseases associated with immune system dysregulation. Despite these fears, patients with IBD appear to have comparable rates of SARS-CoV-2 infection to that of the general population.

Pfizer’s BNT162b2 and Moderna’s RNA-1273 vaccines are the most widely used COVID-19 vaccines in the United States. These vaccines have demonstrated over 90% efficacy for preventing infection and severe disease in late-stage trials; however, few trials have examined their pooled effectiveness in immunocompromised patients and those taking immunosuppressive therapies.

To address this gap, researchers conducted a retrospective cohort study that included 14,697 patients (median age, 68 years) from the Veterans Health Administration database who had been diagnosed with IBD before the start date of the administration’s vaccination program. A total of 7,321 patients in the cohort had received at least 1 dose of either the Pfizer (45.2%) or Moderna (54.8%) vaccines.

Approximately 61.8% of patients had ulcerative colitis, while the remaining patients had Crohn’s disease. In terms of medications, vaccinated versus unvaccinated patients in the study were exposed to mesalamine alone (54.9% vs. 54.6%), thiopurines (10.8% vs. 10.5%), anti–tumor necrosis factor (anti-TNF) biologic monotherapy (18.8% vs. 20.9%), vedolizumab (7.2% vs. 6.0%), ustekinumab (1.0% vs. 1.1%), tofacitinib (0.7% vs. 0.8%), methotrexate (2.3% vs. 2.0%%), and/or corticosteroids (6.8% vs. 5.6%).

A total of 3,561 patients who received the Moderna vaccine and 3,017 patients who received the Pfizer vaccine received both doses. The median time between each dose was 21 days for Pfizer and 28 days for Moderna.

Patients who were unvaccinated had significantly fewer comorbidities (P < .001). The majority of patients in the overall cohort were men (92.2%), a group identified as having a much greater risk of worse COVID-19–related outcomes.

Unvaccinated patients in the study had a higher rate of SARS-CoV-2 infection compared with the fully vaccinated group (1.34% vs. 0.11%, respectively) in follow-up data reported through April 20, 2021. Over a median follow-up duration of 20 days, researchers found 14 infections with SARS-CoV-2 (0.28%) in partially vaccinated individuals. Seven infections (0.11%) were reported in fully vaccinated individuals over a median 38-day follow-up period.

Compared with unvaccinated patients, full vaccination status was associated with a 69% reduction in the hazard ratio of infection (HR, 0.31; 95% confidence interval, 0.17-0.56; P < .001). Corresponding vaccine efficacy rates were 25.1% for partial vaccination and 80.4% for full vaccination.

There were no significant interactions between vaccination status and exposure to steroids (P =.64), mesalamine versus immunosuppressive agents (P =.46), or anti-TNFs with immunomodulators or steroids versus other therapies (P =.34). In addition, no difference was found in the association between vaccination status and infection for patients who received the Moderna versus the Pfizer vaccines (P =.09).

Unvaccinated individuals had the highest raw proportions of severe infection with the novel coronavirus (0.32%) and all-cause mortality (0.66%), compared with people who were partially vaccinated or fully vaccinated. In adjusted Cox regression analyses, there was no significant association between vaccination status and severe SARS-CoV-2 infection (fully vaccinated vs. unvaccinated, P = .18) or all-cause mortality (fully vaccinated vs. unvaccinated, P =.11). The researchers wrote that, “future studies with larger sample size and/or longer follow-up are needed to evaluate this further.”

An important limitation of this study was the inclusion of mostly older men who were also predominantly White (80.4%). Ultimately, this population may limit the generalizability of the findings for women and patients of other races/ethnicities.

While the study received no financial support, Dr. Khan has received research grants from several pharmaceutical companies, but Dr. Mahmud disclosed no conflicts.

In a real-world setting, full vaccination against SARS-CoV-2 was more than 80% effective at reducing infection in people with inflammatory bowel disease (IBD) who were taking immunosuppressive medications.

The study, which examined postvaccine infection rates in a Veterans Affairs cohort, further validates the benefit of COVID-19 vaccines, particularly in a subgroup most at risk for having compromised immune systems. Furthermore, the findings “may serve to increase patient and provider willingness to pursue vaccination in these settings,” wrote study authors Nabeel Khan, MD, of the Corporal Michael J. Crescenz VA Medical Center and Nadim Mahmud, MD, of the University of Pennsylvania, both in Philadelphia. The report was published in Gastroenterology. In addition, the researchers said the findings “should provide positive reinforcement to IBD patients taking immunosuppressive agents who may otherwise be reluctant to receive vaccination.”

Since the onset of the COVID-19 pandemic, concerns have been raised regarding the possible heightened risk of SARS-CoV-2 infection among patients with IBD and other diseases associated with immune system dysregulation. Despite these fears, patients with IBD appear to have comparable rates of SARS-CoV-2 infection to that of the general population.

Pfizer’s BNT162b2 and Moderna’s RNA-1273 vaccines are the most widely used COVID-19 vaccines in the United States. These vaccines have demonstrated over 90% efficacy for preventing infection and severe disease in late-stage trials; however, few trials have examined their pooled effectiveness in immunocompromised patients and those taking immunosuppressive therapies.

To address this gap, researchers conducted a retrospective cohort study that included 14,697 patients (median age, 68 years) from the Veterans Health Administration database who had been diagnosed with IBD before the start date of the administration’s vaccination program. A total of 7,321 patients in the cohort had received at least 1 dose of either the Pfizer (45.2%) or Moderna (54.8%) vaccines.

Approximately 61.8% of patients had ulcerative colitis, while the remaining patients had Crohn’s disease. In terms of medications, vaccinated versus unvaccinated patients in the study were exposed to mesalamine alone (54.9% vs. 54.6%), thiopurines (10.8% vs. 10.5%), anti–tumor necrosis factor (anti-TNF) biologic monotherapy (18.8% vs. 20.9%), vedolizumab (7.2% vs. 6.0%), ustekinumab (1.0% vs. 1.1%), tofacitinib (0.7% vs. 0.8%), methotrexate (2.3% vs. 2.0%%), and/or corticosteroids (6.8% vs. 5.6%).

A total of 3,561 patients who received the Moderna vaccine and 3,017 patients who received the Pfizer vaccine received both doses. The median time between each dose was 21 days for Pfizer and 28 days for Moderna.

Patients who were unvaccinated had significantly fewer comorbidities (P < .001). The majority of patients in the overall cohort were men (92.2%), a group identified as having a much greater risk of worse COVID-19–related outcomes.

Unvaccinated patients in the study had a higher rate of SARS-CoV-2 infection compared with the fully vaccinated group (1.34% vs. 0.11%, respectively) in follow-up data reported through April 20, 2021. Over a median follow-up duration of 20 days, researchers found 14 infections with SARS-CoV-2 (0.28%) in partially vaccinated individuals. Seven infections (0.11%) were reported in fully vaccinated individuals over a median 38-day follow-up period.

Compared with unvaccinated patients, full vaccination status was associated with a 69% reduction in the hazard ratio of infection (HR, 0.31; 95% confidence interval, 0.17-0.56; P < .001). Corresponding vaccine efficacy rates were 25.1% for partial vaccination and 80.4% for full vaccination.

There were no significant interactions between vaccination status and exposure to steroids (P =.64), mesalamine versus immunosuppressive agents (P =.46), or anti-TNFs with immunomodulators or steroids versus other therapies (P =.34). In addition, no difference was found in the association between vaccination status and infection for patients who received the Moderna versus the Pfizer vaccines (P =.09).

Unvaccinated individuals had the highest raw proportions of severe infection with the novel coronavirus (0.32%) and all-cause mortality (0.66%), compared with people who were partially vaccinated or fully vaccinated. In adjusted Cox regression analyses, there was no significant association between vaccination status and severe SARS-CoV-2 infection (fully vaccinated vs. unvaccinated, P = .18) or all-cause mortality (fully vaccinated vs. unvaccinated, P =.11). The researchers wrote that, “future studies with larger sample size and/or longer follow-up are needed to evaluate this further.”

An important limitation of this study was the inclusion of mostly older men who were also predominantly White (80.4%). Ultimately, this population may limit the generalizability of the findings for women and patients of other races/ethnicities.

While the study received no financial support, Dr. Khan has received research grants from several pharmaceutical companies, but Dr. Mahmud disclosed no conflicts.

In a real-world setting, full vaccination against SARS-CoV-2 was more than 80% effective at reducing infection in people with inflammatory bowel disease (IBD) who were taking immunosuppressive medications.

The study, which examined postvaccine infection rates in a Veterans Affairs cohort, further validates the benefit of COVID-19 vaccines, particularly in a subgroup most at risk for having compromised immune systems. Furthermore, the findings “may serve to increase patient and provider willingness to pursue vaccination in these settings,” wrote study authors Nabeel Khan, MD, of the Corporal Michael J. Crescenz VA Medical Center and Nadim Mahmud, MD, of the University of Pennsylvania, both in Philadelphia. The report was published in Gastroenterology. In addition, the researchers said the findings “should provide positive reinforcement to IBD patients taking immunosuppressive agents who may otherwise be reluctant to receive vaccination.”

Since the onset of the COVID-19 pandemic, concerns have been raised regarding the possible heightened risk of SARS-CoV-2 infection among patients with IBD and other diseases associated with immune system dysregulation. Despite these fears, patients with IBD appear to have comparable rates of SARS-CoV-2 infection to that of the general population.

Pfizer’s BNT162b2 and Moderna’s RNA-1273 vaccines are the most widely used COVID-19 vaccines in the United States. These vaccines have demonstrated over 90% efficacy for preventing infection and severe disease in late-stage trials; however, few trials have examined their pooled effectiveness in immunocompromised patients and those taking immunosuppressive therapies.

To address this gap, researchers conducted a retrospective cohort study that included 14,697 patients (median age, 68 years) from the Veterans Health Administration database who had been diagnosed with IBD before the start date of the administration’s vaccination program. A total of 7,321 patients in the cohort had received at least 1 dose of either the Pfizer (45.2%) or Moderna (54.8%) vaccines.

Approximately 61.8% of patients had ulcerative colitis, while the remaining patients had Crohn’s disease. In terms of medications, vaccinated versus unvaccinated patients in the study were exposed to mesalamine alone (54.9% vs. 54.6%), thiopurines (10.8% vs. 10.5%), anti–tumor necrosis factor (anti-TNF) biologic monotherapy (18.8% vs. 20.9%), vedolizumab (7.2% vs. 6.0%), ustekinumab (1.0% vs. 1.1%), tofacitinib (0.7% vs. 0.8%), methotrexate (2.3% vs. 2.0%%), and/or corticosteroids (6.8% vs. 5.6%).

A total of 3,561 patients who received the Moderna vaccine and 3,017 patients who received the Pfizer vaccine received both doses. The median time between each dose was 21 days for Pfizer and 28 days for Moderna.

Patients who were unvaccinated had significantly fewer comorbidities (P < .001). The majority of patients in the overall cohort were men (92.2%), a group identified as having a much greater risk of worse COVID-19–related outcomes.

Unvaccinated patients in the study had a higher rate of SARS-CoV-2 infection compared with the fully vaccinated group (1.34% vs. 0.11%, respectively) in follow-up data reported through April 20, 2021. Over a median follow-up duration of 20 days, researchers found 14 infections with SARS-CoV-2 (0.28%) in partially vaccinated individuals. Seven infections (0.11%) were reported in fully vaccinated individuals over a median 38-day follow-up period.

Compared with unvaccinated patients, full vaccination status was associated with a 69% reduction in the hazard ratio of infection (HR, 0.31; 95% confidence interval, 0.17-0.56; P < .001). Corresponding vaccine efficacy rates were 25.1% for partial vaccination and 80.4% for full vaccination.

There were no significant interactions between vaccination status and exposure to steroids (P =.64), mesalamine versus immunosuppressive agents (P =.46), or anti-TNFs with immunomodulators or steroids versus other therapies (P =.34). In addition, no difference was found in the association between vaccination status and infection for patients who received the Moderna versus the Pfizer vaccines (P =.09).

Unvaccinated individuals had the highest raw proportions of severe infection with the novel coronavirus (0.32%) and all-cause mortality (0.66%), compared with people who were partially vaccinated or fully vaccinated. In adjusted Cox regression analyses, there was no significant association between vaccination status and severe SARS-CoV-2 infection (fully vaccinated vs. unvaccinated, P = .18) or all-cause mortality (fully vaccinated vs. unvaccinated, P =.11). The researchers wrote that, “future studies with larger sample size and/or longer follow-up are needed to evaluate this further.”

An important limitation of this study was the inclusion of mostly older men who were also predominantly White (80.4%). Ultimately, this population may limit the generalizability of the findings for women and patients of other races/ethnicities.

While the study received no financial support, Dr. Khan has received research grants from several pharmaceutical companies, but Dr. Mahmud disclosed no conflicts.

The future of preexposure prophylaxis (PrEP) is here, according to interim study results demonstrating the superiority of long-acting, injectable cabotegravir (CAB-LA) over the current workhorse, daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC).

In a prospective, phase 2b-3 randomized, double-blind, double-dummy, active-controlled trial among 4,566 cisgender MSM (men who have sex with men) and transgender women, CAB-LA was shown to reduce risk for HIV infection by 66%. The study was terminated early, owing to strong evidence of efficacy in the first preplanned interim endpoint analysis. The study findings were published Aug. 11 in the New England Journal of Medicine.

“The lesson is not that TDF-FTC doesn’t work or has major problems; it is a very safe, very well-tolerated agent and astonishingly effective if taken as prescribed,” Raphael J. Landovitz, MD, lead author and codirector of the Center for HIV Identification, Prevention, and Treatment Services at the University of California, Los Angeles, said in an interview.

“The reason that we were able to show that cabotegravir was superior is because we enrolled a very young, very highly at-risk, very underresourced, underrepresented, highly sexually active group who weren’t able to take PrEP the way it was prescribed,” he said.

Study participants were assigned to receive either active CAB 600 mg intramuscularly with TDF-FTC placebo or active TDF-FTC (300 mg/200 mg) with a CAB procedure in three phases:
 

• An oral-tablet 5-week lead-in phase, a blinded injection phase beginning at week 5.
• An injection at week 9 and every 8 weeks thereafter through week 153.
• An open-label “tail” phase consisting of oral TDF/FTC to provide ongoing for participants discontinuing injections.

The median age of study participants was 26 years (interquartile range [IQR], 22-32 years); 12.5% (570) identified as transgender women; 49.8% (845/1,698) of U.S. participants were Black patients.

During follow-up, HIV infections were identified in 57 participants, including 52 who acquired HIV infections after enrollment (13 in the CAB group, incidence 0.41 per 100 person-years, vs. 39 in the TDF-FTC group, incidence 1.22 per 100 person-years). The hazard ratio for incident HIV infection was 0.34 (95% confidence interval, 0.18-0.62) CAB vs. TDF-FTC (P < .001). Consistent effects were observed across prespecified subgroups and populations.

Among participants in the CAB group, integrase strand-transfer inhibitor resistance mutations were detected in one of four of the baseline HIV infection cases. Among participants in the TDF-FTC group, 2 of 39 incident infections occurred despite drug concentration measurements that indicated good PrEP adherence.

Although injection site reactions were reported in 81.4% (1,724) of the CAB group, only 2.4% of patients (50) discontinued treatment. Most reactions began a median of 1 day (IQR, 0-2 days) post injection. They were of mild to moderate severity (60.8% pain, 23.7% tenderness) and lasted a median of 3 days (IQR, 2-6 days). Injection site reactions were reported in 31.3% of the participants in the TDF-FTC group who received at least one placebo injection.

Rates of severe adverse effects (grade 3 or higher) were similar between participants in the CAB and TDF-FTC groups. They consisted mostly of an increase in creatine kinase level (14.2% with CAB vs. 13.5% with TDF-FTC) and a decrease in creatine clearance (7.0% with CAB vs. 8.3% with TDF-FTC).

In a post hoc analysis, the mean annualized weight increase was 1.23 kg/y (95% CI, 1.05-1.42) in the CAB group, compared with 0.37 kg/y (95% CI, 0.18-0.55) in the TDF-FTC group. Most of these differences were observed during the first 40 weeks and were driven by weight loss among TDF-FTC participants; weight changes between groups were similar thereafter (~1 kg/y for both groups).
 

New modality, new challenges

“We’re constantly searching for new modalities to expand our repertoire of what we can provide patients, especially those folks with the highest need for PrEP,” Lina Rosengren-Hovee, MD, assistant professor of medicine and infectious disease specialist at UNC-Health, Chapel Hill, N.C., said in an interview. “Being able to offer an injectable option is going to be a game changer, but it will be critical to pinpoint structural factors that affect adherence,” she added.

Dr. Rosengren-Hovee also pointed to cases of integrase inhibitor resistance (both in the study and the larger clinical arena), which she believes are concerning. “It’s still a conversation that you’ll want to have with a patient; I wonder if we need more discussion about how we handle that in the clinical setting, even if it’s fairly uncommon,” she said.

When asked, Dr. Landovitz emphasized the rarity of breakthrough cases but acknowledged that there appears to be a pattern whereby the first breakthrough occurs with a trickle of virus and then bursts out with higher levels of virus at some point.

“CDC is actually thinking very hard about whether these long-acting PrEP agents obligate a change to the HIV screening process [e.g., a viral load or RNA-based test] rather than a conventional HIV test,” Dr. Landovitz said. He went on to say that in the ongoing, open-label portion of the study, investigators hope to learn whether one can avoid resistance by catching the first breakthrough earlier. That would help inform clinical implementation, he explained. He said that he challenges practitioners and health care communities to avoid some of the mistakes made with the oral PrEP rollout, namely, universal access without proper implementation of planning and testing protocols.

“By default, PrEP is much more decentralized and demedicalized, especially in primary care,” said Dr. Rosengren-Hovee. “We need more studies looking at real-world scenarios.”

Dr. Rosengren-Hovee reports no relevant financial relationships. Dr. Landovitz has consulting relationships with Gilead, Janssen, Roche, and Cepheus.

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

The future of preexposure prophylaxis (PrEP) is here, according to interim study results demonstrating the superiority of long-acting, injectable cabotegravir (CAB-LA) over the current workhorse, daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC).

In a prospective, phase 2b-3 randomized, double-blind, double-dummy, active-controlled trial among 4,566 cisgender MSM (men who have sex with men) and transgender women, CAB-LA was shown to reduce risk for HIV infection by 66%. The study was terminated early, owing to strong evidence of efficacy in the first preplanned interim endpoint analysis. The study findings were published Aug. 11 in the New England Journal of Medicine.

“The lesson is not that TDF-FTC doesn’t work or has major problems; it is a very safe, very well-tolerated agent and astonishingly effective if taken as prescribed,” Raphael J. Landovitz, MD, lead author and codirector of the Center for HIV Identification, Prevention, and Treatment Services at the University of California, Los Angeles, said in an interview.

“The reason that we were able to show that cabotegravir was superior is because we enrolled a very young, very highly at-risk, very underresourced, underrepresented, highly sexually active group who weren’t able to take PrEP the way it was prescribed,” he said.

Study participants were assigned to receive either active CAB 600 mg intramuscularly with TDF-FTC placebo or active TDF-FTC (300 mg/200 mg) with a CAB procedure in three phases:
 

• An oral-tablet 5-week lead-in phase, a blinded injection phase beginning at week 5.
• An injection at week 9 and every 8 weeks thereafter through week 153.
• An open-label “tail” phase consisting of oral TDF/FTC to provide ongoing for participants discontinuing injections.

The median age of study participants was 26 years (interquartile range [IQR], 22-32 years); 12.5% (570) identified as transgender women; 49.8% (845/1,698) of U.S. participants were Black patients.

During follow-up, HIV infections were identified in 57 participants, including 52 who acquired HIV infections after enrollment (13 in the CAB group, incidence 0.41 per 100 person-years, vs. 39 in the TDF-FTC group, incidence 1.22 per 100 person-years). The hazard ratio for incident HIV infection was 0.34 (95% confidence interval, 0.18-0.62) CAB vs. TDF-FTC (P < .001). Consistent effects were observed across prespecified subgroups and populations.

Among participants in the CAB group, integrase strand-transfer inhibitor resistance mutations were detected in one of four of the baseline HIV infection cases. Among participants in the TDF-FTC group, 2 of 39 incident infections occurred despite drug concentration measurements that indicated good PrEP adherence.

Although injection site reactions were reported in 81.4% (1,724) of the CAB group, only 2.4% of patients (50) discontinued treatment. Most reactions began a median of 1 day (IQR, 0-2 days) post injection. They were of mild to moderate severity (60.8% pain, 23.7% tenderness) and lasted a median of 3 days (IQR, 2-6 days). Injection site reactions were reported in 31.3% of the participants in the TDF-FTC group who received at least one placebo injection.

Rates of severe adverse effects (grade 3 or higher) were similar between participants in the CAB and TDF-FTC groups. They consisted mostly of an increase in creatine kinase level (14.2% with CAB vs. 13.5% with TDF-FTC) and a decrease in creatine clearance (7.0% with CAB vs. 8.3% with TDF-FTC).

In a post hoc analysis, the mean annualized weight increase was 1.23 kg/y (95% CI, 1.05-1.42) in the CAB group, compared with 0.37 kg/y (95% CI, 0.18-0.55) in the TDF-FTC group. Most of these differences were observed during the first 40 weeks and were driven by weight loss among TDF-FTC participants; weight changes between groups were similar thereafter (~1 kg/y for both groups).
 

New modality, new challenges

“We’re constantly searching for new modalities to expand our repertoire of what we can provide patients, especially those folks with the highest need for PrEP,” Lina Rosengren-Hovee, MD, assistant professor of medicine and infectious disease specialist at UNC-Health, Chapel Hill, N.C., said in an interview. “Being able to offer an injectable option is going to be a game changer, but it will be critical to pinpoint structural factors that affect adherence,” she added.

Dr. Rosengren-Hovee also pointed to cases of integrase inhibitor resistance (both in the study and the larger clinical arena), which she believes are concerning. “It’s still a conversation that you’ll want to have with a patient; I wonder if we need more discussion about how we handle that in the clinical setting, even if it’s fairly uncommon,” she said.

When asked, Dr. Landovitz emphasized the rarity of breakthrough cases but acknowledged that there appears to be a pattern whereby the first breakthrough occurs with a trickle of virus and then bursts out with higher levels of virus at some point.

“CDC is actually thinking very hard about whether these long-acting PrEP agents obligate a change to the HIV screening process [e.g., a viral load or RNA-based test] rather than a conventional HIV test,” Dr. Landovitz said. He went on to say that in the ongoing, open-label portion of the study, investigators hope to learn whether one can avoid resistance by catching the first breakthrough earlier. That would help inform clinical implementation, he explained. He said that he challenges practitioners and health care communities to avoid some of the mistakes made with the oral PrEP rollout, namely, universal access without proper implementation of planning and testing protocols.

“By default, PrEP is much more decentralized and demedicalized, especially in primary care,” said Dr. Rosengren-Hovee. “We need more studies looking at real-world scenarios.”

Dr. Rosengren-Hovee reports no relevant financial relationships. Dr. Landovitz has consulting relationships with Gilead, Janssen, Roche, and Cepheus.

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

The future of preexposure prophylaxis (PrEP) is here, according to interim study results demonstrating the superiority of long-acting, injectable cabotegravir (CAB-LA) over the current workhorse, daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC).

In a prospective, phase 2b-3 randomized, double-blind, double-dummy, active-controlled trial among 4,566 cisgender MSM (men who have sex with men) and transgender women, CAB-LA was shown to reduce risk for HIV infection by 66%. The study was terminated early, owing to strong evidence of efficacy in the first preplanned interim endpoint analysis. The study findings were published Aug. 11 in the New England Journal of Medicine.

“The lesson is not that TDF-FTC doesn’t work or has major problems; it is a very safe, very well-tolerated agent and astonishingly effective if taken as prescribed,” Raphael J. Landovitz, MD, lead author and codirector of the Center for HIV Identification, Prevention, and Treatment Services at the University of California, Los Angeles, said in an interview.

“The reason that we were able to show that cabotegravir was superior is because we enrolled a very young, very highly at-risk, very underresourced, underrepresented, highly sexually active group who weren’t able to take PrEP the way it was prescribed,” he said.

Study participants were assigned to receive either active CAB 600 mg intramuscularly with TDF-FTC placebo or active TDF-FTC (300 mg/200 mg) with a CAB procedure in three phases:
 

• An oral-tablet 5-week lead-in phase, a blinded injection phase beginning at week 5.
• An injection at week 9 and every 8 weeks thereafter through week 153.
• An open-label “tail” phase consisting of oral TDF/FTC to provide ongoing for participants discontinuing injections.

The median age of study participants was 26 years (interquartile range [IQR], 22-32 years); 12.5% (570) identified as transgender women; 49.8% (845/1,698) of U.S. participants were Black patients.

During follow-up, HIV infections were identified in 57 participants, including 52 who acquired HIV infections after enrollment (13 in the CAB group, incidence 0.41 per 100 person-years, vs. 39 in the TDF-FTC group, incidence 1.22 per 100 person-years). The hazard ratio for incident HIV infection was 0.34 (95% confidence interval, 0.18-0.62) CAB vs. TDF-FTC (P < .001). Consistent effects were observed across prespecified subgroups and populations.

Among participants in the CAB group, integrase strand-transfer inhibitor resistance mutations were detected in one of four of the baseline HIV infection cases. Among participants in the TDF-FTC group, 2 of 39 incident infections occurred despite drug concentration measurements that indicated good PrEP adherence.

Although injection site reactions were reported in 81.4% (1,724) of the CAB group, only 2.4% of patients (50) discontinued treatment. Most reactions began a median of 1 day (IQR, 0-2 days) post injection. They were of mild to moderate severity (60.8% pain, 23.7% tenderness) and lasted a median of 3 days (IQR, 2-6 days). Injection site reactions were reported in 31.3% of the participants in the TDF-FTC group who received at least one placebo injection.

Rates of severe adverse effects (grade 3 or higher) were similar between participants in the CAB and TDF-FTC groups. They consisted mostly of an increase in creatine kinase level (14.2% with CAB vs. 13.5% with TDF-FTC) and a decrease in creatine clearance (7.0% with CAB vs. 8.3% with TDF-FTC).

In a post hoc analysis, the mean annualized weight increase was 1.23 kg/y (95% CI, 1.05-1.42) in the CAB group, compared with 0.37 kg/y (95% CI, 0.18-0.55) in the TDF-FTC group. Most of these differences were observed during the first 40 weeks and were driven by weight loss among TDF-FTC participants; weight changes between groups were similar thereafter (~1 kg/y for both groups).
 

New modality, new challenges

“We’re constantly searching for new modalities to expand our repertoire of what we can provide patients, especially those folks with the highest need for PrEP,” Lina Rosengren-Hovee, MD, assistant professor of medicine and infectious disease specialist at UNC-Health, Chapel Hill, N.C., said in an interview. “Being able to offer an injectable option is going to be a game changer, but it will be critical to pinpoint structural factors that affect adherence,” she added.

Dr. Rosengren-Hovee also pointed to cases of integrase inhibitor resistance (both in the study and the larger clinical arena), which she believes are concerning. “It’s still a conversation that you’ll want to have with a patient; I wonder if we need more discussion about how we handle that in the clinical setting, even if it’s fairly uncommon,” she said.

When asked, Dr. Landovitz emphasized the rarity of breakthrough cases but acknowledged that there appears to be a pattern whereby the first breakthrough occurs with a trickle of virus and then bursts out with higher levels of virus at some point.

“CDC is actually thinking very hard about whether these long-acting PrEP agents obligate a change to the HIV screening process [e.g., a viral load or RNA-based test] rather than a conventional HIV test,” Dr. Landovitz said. He went on to say that in the ongoing, open-label portion of the study, investigators hope to learn whether one can avoid resistance by catching the first breakthrough earlier. That would help inform clinical implementation, he explained. He said that he challenges practitioners and health care communities to avoid some of the mistakes made with the oral PrEP rollout, namely, universal access without proper implementation of planning and testing protocols.

“By default, PrEP is much more decentralized and demedicalized, especially in primary care,” said Dr. Rosengren-Hovee. “We need more studies looking at real-world scenarios.”

Dr. Rosengren-Hovee reports no relevant financial relationships. Dr. Landovitz has consulting relationships with Gilead, Janssen, Roche, and Cepheus.

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

The U.S. Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next two days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis. 

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”

It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.

The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.

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

The U.S. Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next two days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis. 

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”

It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.

The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.

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

The U.S. Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next two days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis. 

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”

It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.

The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.

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

Traditionally, as the ides of August descend upon us we expect to be bombarded with advertisements encouraging parents and students to finish up their back-to-school shopping. But, this year the question on every parent and school administrator’s mind is not which color back pack will be the most popular this year but whether a mask should be a required part of the back-to-school ensemble.

The American Academy of Pediatrics has recommended that “All students older than 2 years and all school staff should wear a mask at school” (“American Academy of Pediatrics Updates Recommendations for Opening Schools in Fall 2021.” 2021 Jul 19). The academy’s statement includes a generous list of common sense caveats but it does not include a statement that masks have been shown to be protective for children in school environments. The Centers for Disease Control and Prevention “recommends” universal indoor masking along with keeping a 3-foot separation but again fails to include any references to support the effectiveness of masks (“Guidance for COVID-19 Prevention in K-12 Schools.” 2021 Aug 5).

Not surprisingly, into this void have stepped two pairs of experts – one group purporting to have evidence that masking is effective in school environments and the other warning that masks may not only be ineffective but that they also carry some significant downsides. And, where can you find these opposing positions? Not in The Lancet. Not in the New England Journal of Medicine. We don’t have time for any of that peer-reviewed monkey business. No, this is pandemic-era science where we have an abundance of opinions and paucity of facts. You will find these opposing articles on the op-ed pages of two of this country’s major newspapers.

In the Aug. 10, 2021, edition of the New York Times you will find an article (“We Studied One Million Students. This Is What We Learned About Masking”) by two pediatricians, Kanecia Zimmerman, MD, and Danny Benjamin Jr., MD, who have “studied” a million students in North Carolina school systems and tell us universal masking is “one of the most effective and efficient strategies for preventing SARS-CoV-2 transmission in schools. These investigators write that they “believe” the low rate of in school transmission they observed in North Carolina was “because of the mask-on-mask school environment.”

However, in the next paragraph the authors admit, “Because North Carolina had a mask mandate for all K-12 schools, we could not compare masked schools with unmasked schools.” They lean instead on studies from three other states with mask mandates that also had low transmission rates and a single report of an outbreak in Israel that employed neither masking nor safe distancing.

On the other side of the divide is an article in the Wall Street Journal titled “The Case Against Masks for Children” by Marty Makary, MD, and H. Cody Meissner, MD, (2021 Aug 9). The authors, one a pediatric infectious disease specialist, argue that there is “no science behind mask mandates for children.” And, observe that, of the $46 billion spent on research grants by the National Institutes of Health, “not a single grant was dedicated to studying masking in children.”

Dr. Makary and Dr. Meissner present a variety of concerns about the effects of masking including those on the development and communication skills of young children. None of their theoretical concerns of course are supported by controlled studies. They also observe that in previous studies children seem to be less likely to transmit COVID-19 than adults. Although we all know the landscape is changing with the emergence of the delta strain. In their strongest statement the authors claim, “It is abusive to force kids who struggle with them [masks] to sacrifice for the sake of unvaccinated adults.”

So there you have it. It is a situation we have come to expect over the last 2 years – plenty of opinions and too few facts supported by controlled studies. Both pairs of authors, however, agree on two things: Vaccination should continue to be considered our primary tool in prevention and control of COVID-19. and children need to be in school. Based on nothing more than a hunch and 7 decades of hunching, I tend to side with Dr. Makary and Dr. Meissner. Depending on the situation, I suggest masking but wouldn’t mandate it for children in school.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Traditionally, as the ides of August descend upon us we expect to be bombarded with advertisements encouraging parents and students to finish up their back-to-school shopping. But, this year the question on every parent and school administrator’s mind is not which color back pack will be the most popular this year but whether a mask should be a required part of the back-to-school ensemble.

The American Academy of Pediatrics has recommended that “All students older than 2 years and all school staff should wear a mask at school” (“American Academy of Pediatrics Updates Recommendations for Opening Schools in Fall 2021.” 2021 Jul 19). The academy’s statement includes a generous list of common sense caveats but it does not include a statement that masks have been shown to be protective for children in school environments. The Centers for Disease Control and Prevention “recommends” universal indoor masking along with keeping a 3-foot separation but again fails to include any references to support the effectiveness of masks (“Guidance for COVID-19 Prevention in K-12 Schools.” 2021 Aug 5).

Not surprisingly, into this void have stepped two pairs of experts – one group purporting to have evidence that masking is effective in school environments and the other warning that masks may not only be ineffective but that they also carry some significant downsides. And, where can you find these opposing positions? Not in The Lancet. Not in the New England Journal of Medicine. We don’t have time for any of that peer-reviewed monkey business. No, this is pandemic-era science where we have an abundance of opinions and paucity of facts. You will find these opposing articles on the op-ed pages of two of this country’s major newspapers.

In the Aug. 10, 2021, edition of the New York Times you will find an article (“We Studied One Million Students. This Is What We Learned About Masking”) by two pediatricians, Kanecia Zimmerman, MD, and Danny Benjamin Jr., MD, who have “studied” a million students in North Carolina school systems and tell us universal masking is “one of the most effective and efficient strategies for preventing SARS-CoV-2 transmission in schools. These investigators write that they “believe” the low rate of in school transmission they observed in North Carolina was “because of the mask-on-mask school environment.”

However, in the next paragraph the authors admit, “Because North Carolina had a mask mandate for all K-12 schools, we could not compare masked schools with unmasked schools.” They lean instead on studies from three other states with mask mandates that also had low transmission rates and a single report of an outbreak in Israel that employed neither masking nor safe distancing.

On the other side of the divide is an article in the Wall Street Journal titled “The Case Against Masks for Children” by Marty Makary, MD, and H. Cody Meissner, MD, (2021 Aug 9). The authors, one a pediatric infectious disease specialist, argue that there is “no science behind mask mandates for children.” And, observe that, of the $46 billion spent on research grants by the National Institutes of Health, “not a single grant was dedicated to studying masking in children.”

Dr. Makary and Dr. Meissner present a variety of concerns about the effects of masking including those on the development and communication skills of young children. None of their theoretical concerns of course are supported by controlled studies. They also observe that in previous studies children seem to be less likely to transmit COVID-19 than adults. Although we all know the landscape is changing with the emergence of the delta strain. In their strongest statement the authors claim, “It is abusive to force kids who struggle with them [masks] to sacrifice for the sake of unvaccinated adults.”

So there you have it. It is a situation we have come to expect over the last 2 years – plenty of opinions and too few facts supported by controlled studies. Both pairs of authors, however, agree on two things: Vaccination should continue to be considered our primary tool in prevention and control of COVID-19. and children need to be in school. Based on nothing more than a hunch and 7 decades of hunching, I tend to side with Dr. Makary and Dr. Meissner. Depending on the situation, I suggest masking but wouldn’t mandate it for children in school.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Traditionally, as the ides of August descend upon us we expect to be bombarded with advertisements encouraging parents and students to finish up their back-to-school shopping. But, this year the question on every parent and school administrator’s mind is not which color back pack will be the most popular this year but whether a mask should be a required part of the back-to-school ensemble.

The American Academy of Pediatrics has recommended that “All students older than 2 years and all school staff should wear a mask at school” (“American Academy of Pediatrics Updates Recommendations for Opening Schools in Fall 2021.” 2021 Jul 19). The academy’s statement includes a generous list of common sense caveats but it does not include a statement that masks have been shown to be protective for children in school environments. The Centers for Disease Control and Prevention “recommends” universal indoor masking along with keeping a 3-foot separation but again fails to include any references to support the effectiveness of masks (“Guidance for COVID-19 Prevention in K-12 Schools.” 2021 Aug 5).

Not surprisingly, into this void have stepped two pairs of experts – one group purporting to have evidence that masking is effective in school environments and the other warning that masks may not only be ineffective but that they also carry some significant downsides. And, where can you find these opposing positions? Not in The Lancet. Not in the New England Journal of Medicine. We don’t have time for any of that peer-reviewed monkey business. No, this is pandemic-era science where we have an abundance of opinions and paucity of facts. You will find these opposing articles on the op-ed pages of two of this country’s major newspapers.

In the Aug. 10, 2021, edition of the New York Times you will find an article (“We Studied One Million Students. This Is What We Learned About Masking”) by two pediatricians, Kanecia Zimmerman, MD, and Danny Benjamin Jr., MD, who have “studied” a million students in North Carolina school systems and tell us universal masking is “one of the most effective and efficient strategies for preventing SARS-CoV-2 transmission in schools. These investigators write that they “believe” the low rate of in school transmission they observed in North Carolina was “because of the mask-on-mask school environment.”

However, in the next paragraph the authors admit, “Because North Carolina had a mask mandate for all K-12 schools, we could not compare masked schools with unmasked schools.” They lean instead on studies from three other states with mask mandates that also had low transmission rates and a single report of an outbreak in Israel that employed neither masking nor safe distancing.

On the other side of the divide is an article in the Wall Street Journal titled “The Case Against Masks for Children” by Marty Makary, MD, and H. Cody Meissner, MD, (2021 Aug 9). The authors, one a pediatric infectious disease specialist, argue that there is “no science behind mask mandates for children.” And, observe that, of the $46 billion spent on research grants by the National Institutes of Health, “not a single grant was dedicated to studying masking in children.”

Dr. Makary and Dr. Meissner present a variety of concerns about the effects of masking including those on the development and communication skills of young children. None of their theoretical concerns of course are supported by controlled studies. They also observe that in previous studies children seem to be less likely to transmit COVID-19 than adults. Although we all know the landscape is changing with the emergence of the delta strain. In their strongest statement the authors claim, “It is abusive to force kids who struggle with them [masks] to sacrifice for the sake of unvaccinated adults.”

So there you have it. It is a situation we have come to expect over the last 2 years – plenty of opinions and too few facts supported by controlled studies. Both pairs of authors, however, agree on two things: Vaccination should continue to be considered our primary tool in prevention and control of COVID-19. and children need to be in school. Based on nothing more than a hunch and 7 decades of hunching, I tend to side with Dr. Makary and Dr. Meissner. Depending on the situation, I suggest masking but wouldn’t mandate it for children in school.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Study Overview

Objective. To update national trends in the treatment and risk factor control of diabetic patients from 1999 through 2018 in the US using data from the National Health and Nutrition Examination Survey (NHANES) with the goal of identifying population subgroups with the highest probability of having untreated risk factors.

Design. The authors conducted a cross-sectional analysis of data from NHANES focusing on adults with diabetes. They examined patient characteristics and medication use over time and estimated the prevalence of risk factor control and medication use. To minimize the effects of a small sample size, the survey years were pooled into 4-year intervals. The variables studied included glycated hemoglobin (HbA_1c), blood pressure, serum cholesterol, medication use, sociodemographic characteristics, and weight status. For statistical analysis, logistic and multinomial logistic regression models were used to examine factors associated with treatment in participants who did not achieve targets for glycemic, blood pressure, and lipid control. Temporal trends were estimated using 2-piece linear spline models with 1 knot at inflection points.

Setting and participants. The NHANES program began in the early 1960s to monitor the health of the US population. In 1999, the survey became a continuous program combining interviews and physical examinations. The survey examines a nationally representative sample of about 5000 persons each year. This study included 6653 participants who were nonpregnant, aged older than 20 years, reported a diagnosis of diabetes from a physician, and participated in NHANES from 1999 through 2018.

Main outcome measures. The main outcome measures were temporal trends in risk factor control (glycemic, blood pressure, or lipid levels) and medication use (glucose lowering, blood pressure lowering, or lipid lowering medications), and number as well as class of drug used, from 1999 through 2018 in diabetic adults from the US participating in NHANES.

Results. Sociodemographic characteristics of the studied diabetes population—The age and racial or ethnic distribution of participants with diabetes were stable from 1999 through 2018, whereas participants with a college degree, higher income, health insurance, obesity, or long-standing diabetes increased during the same period.

Trends in diabetes risk factor control—The trends for glycemic, blood pressure, and lipid control were nonlinear, with an inflection point around 2010. Glycemic control was defined as HbA_1c less than 7%, blood pressure was considered controlled if less than 140/90 mmHg, and lipid was controlled if non-HDL cholesterol level was less than 130 mg/dL. Although these chosen targets were based on the most recent clinical guidelines, the authors declared that they observed similar trends when alternative targets were used. The level of risk factor control improved in all diabetic patients from 1999 through 2010. However, the percentage of adult diabetic participants for whom glycemic control was achieved declined from 57.4% (95% CI, 52.9-61.8) in 2007-2010 to 50.5% (95% CI, 45.8-55.3) in 2015-2018. Blood pressure control was achieved in 74.2% of participants (95% CI, 70.7-77.4) in 2011-2014 but declined to 70.4% (95% CI, 66.7-73.8) in 2015-2018. Control in lipid levels improved during the entire study period; however, the rate of improvement heavily declined after 2007 with lipid target levels attained in 52.3% of participants (95% CI, 49.2-55.3) in 2007-2014 and 55.7% (95% CI, 50.8-60.5) in 2015-2018. Finally, the percentage of participants in whom targets for all 3 risk factors were simultaneously achieved plateaued after 2010 and was 22.2% (95% CI, 17.9-27.3) in 2015-2018.

Trends in diabetes treatment—The use of glucose lowering drugs increased from 74.1% in 1999-2002 to 82.7% in 2007-2010 and then stabilized. A shift toward a safer glucose lowering treatment choice was observed with a decline in the use of older glucose lowering medications such as sulfonylureas, which increases the risk of hypoglycemia, and an increase in the use of metformin, insulin, and newer agents such as sodium-glucose cotransporter 2 inhibitors.

Similarly, blood pressure lowering medication use rose from 1999-2002 to 2007-2010 and then stabilized, with increased use of first-line recommended treatments including angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers. Likewise, statin use rose from 28.4% in 1999-2002 to 56% in 2011-2014 and then stabilized. The total number of drugs used culminated in 2011-2014 with 60% of participants using more than 5 drugs and then leveled off to 57.2% in 2015-2018. Lastly, health insurance status and race or ethnicity impacted the likelihood of receiving monotherapy or combination drug therapy when targets for glycemic, blood pressure, or lipid control were not achieved.

Conclusion. Despite great progress in the control of diabetes and its associated risk factors between 1999 and 2010, this trend declined for glycemic and blood pressure control and leveled off for lipid control in adult NHANES participants with diabetes after 2010. First-line treatments for diabetes and associated risk factors remain underused, and treatment intensification may not be sufficiently considered in patients with uncontrolled risk factors despite clinical guideline recommendations. The findings of this study may portend a possible population-level increase in diabetes-related illnesses in the years to come.

Commentary

The thorough understanding of trends in management of diseases is critical to inform public health policies and planning. Well designed clinical studies heavily influence the development of public health policies and clinical guidelines, which in turn drive real-world clinical practice. In a recent analysis utilizing data from NHANES, Fang et al¹ showed evidence of a general shift toward less intensive treatment of diabetes, hypertension, and hypercholesterolemia in adults living in the US during the last decade.

Similarly, in a separate study using NHANES data collected between 1999 and 2018 published in JAMA just 2 weeks after the current report, Wang et al² confirms this declining trend in diabetes management with only 21.2% of diabetic adults simultaneously attaining glycemic, blood pressure, and lipid level targets during the same period. What led to the decline in more stringent risk factor and diabetes management since 2010 observed in these studies? One possible explanation, as suggested by Fang et al, is that major clinical trials from the late 2000s­—including Action to Control Cardiovascular Risk in Diabetes, UK Prospective Diabetes Study, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, and Veterans Affairs Diabetes Trial—that assessed the effects of intensive glycemic control (with target HbA_1c < 6.5%) found that intensive treatment of diabetes compared to standard care had no cardiovascular benefit albeit increasing the risk of hypoglycemia. Thus, these trial findings may have translated into suboptimal diabetes treatment observed in some NHANES participants. Wang et al propose that effective tailored approaches are needed to improve risk factor control in diabetic patients, such as enhance and maintain adherence to medications and healthy lifestyle behaviors, as well as better access to health care and therapeutic education.

The changes in recent trends in diabetes management have immense clinical implications. The authors of this study suggest a link between the recent relaxation of glycemic targets, as well as risk factor control, and a resurgence of diabetic complications such as lower limb amputation or stroke. Indeed, several recent studies indicate an upward trend or plateau in diabetic complications which had been decreasing in prevalence prior to 2010.³ For example, lower extremity amputation has surged by more than 25% between 2010 and 2015, especially in young and middle-aged adults.⁴ Among the arguments brought forward that this recent resurgence in amputations is directly linked to worsening glycemic control is the fact that between 2007 and 2010, when glucose levels were best controlled within the previous 30-year period, amputations were also at the lowest levels. Moreover, data from the Centers for Disease Control and Prevention also show a 55% increase in mortality (from 15.7 to 24.2 per 1000) among diabetic patients between 2010 and 2015.¹⁴ On the other hand, a growing number of studies show that an increase of inappropriate treatment intensification—reaching HbA_1c levels that are way below the recommended targets—is associated with adverse consequences in diabetic patients particularly in those aged more than 65 years.^5-7 These seemingly contradictory findings highlight the importance of a personalized and thoughtful approach to the management of diabetes and its risk factors. As an example, an increase in the use of newer and safer glucose lowering drugs (eg, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase 4 inhibitors) can help achieve better HbA_1c goals with a reduced risk of hypoglycemic episodes as recently shown by a Danish study.⁸ In this study, the authors concluded that the reduction of the rate of hypoglycemic episodes leading to hospitalization in Denmark was directly linked to the use of these safer and newer glucose lowering drugs.

A discussion on the specifics of trends in diabetes treatment and control must include considerations in older adults aged more than 65 years who constitute more than 40% of the diabetic population. Despite the high prevalence of diabetes in this vulnerable population, such data are still insufficient in the literature and are critically needed to inform public health policies and clinical guidelines. In epidemiological studies focusing on diabetic complications from the last 10 years, concerning increases have been observed in younger⁹ and middle-aged adults while remaining stable in older adults. However, the risk of hypoglycemia or severe hypoglycemia remains high in older adults living in nursing facilities, even in those with an elevated HbA_1c of greater than 8%.⁷ Moreover, in light of more relaxed HbA_1c treatment goals for older frail adults as recommended by international guidelines since 2010,^10,11 recent findings from the French GERODIAB cohort show an increased mortality (hazard ratio, 1.76) in type 2 diabetics aged 70 years and older with HbA_1c greater than or equal to 8.6%.¹² Similarly, a 5-year retrospective British study from 2018 which included patients aged 70 years and older, shows an increased overall mortality in those with HbA_1c greater than 8.5%.¹³ Taken together, further age-stratified analysis utilizing data from large cohort studies including NHANES may help to clarify national trends in diabetes treatment and risk factor control as well as diabetic complications specific to the geriatric population. By being better informed of such trends, clinicians could then develop treatment strategies that minimize complications (eg, hypoglycemia, falls) while achieving favorable outcomes (eg, reduce hyperglycemic emergencies, improve survival) in frail older patients.

Applications for Clinical Practice

The understanding of population-wide trends in diabetes control is critical to planning public health approaches for the prevention and treatment of this disease and its complications. In older adults, the high risk of hypoglycemic events and insufficient epidemiological data on trends of diabetes control hinder diabetes management. Personalized treatment targets taking into account geriatric syndromes and general health status, as well as multidisciplinary management involving endocrinologists, geriatricians, and clinical pharmacists, are necessary to optimize care in older adults with diabetes.

Study Overview

Objective. To update national trends in the treatment and risk factor control of diabetic patients from 1999 through 2018 in the US using data from the National Health and Nutrition Examination Survey (NHANES) with the goal of identifying population subgroups with the highest probability of having untreated risk factors.

Design. The authors conducted a cross-sectional analysis of data from NHANES focusing on adults with diabetes. They examined patient characteristics and medication use over time and estimated the prevalence of risk factor control and medication use. To minimize the effects of a small sample size, the survey years were pooled into 4-year intervals. The variables studied included glycated hemoglobin (HbA_1c), blood pressure, serum cholesterol, medication use, sociodemographic characteristics, and weight status. For statistical analysis, logistic and multinomial logistic regression models were used to examine factors associated with treatment in participants who did not achieve targets for glycemic, blood pressure, and lipid control. Temporal trends were estimated using 2-piece linear spline models with 1 knot at inflection points.

Setting and participants. The NHANES program began in the early 1960s to monitor the health of the US population. In 1999, the survey became a continuous program combining interviews and physical examinations. The survey examines a nationally representative sample of about 5000 persons each year. This study included 6653 participants who were nonpregnant, aged older than 20 years, reported a diagnosis of diabetes from a physician, and participated in NHANES from 1999 through 2018.

Main outcome measures. The main outcome measures were temporal trends in risk factor control (glycemic, blood pressure, or lipid levels) and medication use (glucose lowering, blood pressure lowering, or lipid lowering medications), and number as well as class of drug used, from 1999 through 2018 in diabetic adults from the US participating in NHANES.

Results. Sociodemographic characteristics of the studied diabetes population—The age and racial or ethnic distribution of participants with diabetes were stable from 1999 through 2018, whereas participants with a college degree, higher income, health insurance, obesity, or long-standing diabetes increased during the same period.

Trends in diabetes risk factor control—The trends for glycemic, blood pressure, and lipid control were nonlinear, with an inflection point around 2010. Glycemic control was defined as HbA_1c less than 7%, blood pressure was considered controlled if less than 140/90 mmHg, and lipid was controlled if non-HDL cholesterol level was less than 130 mg/dL. Although these chosen targets were based on the most recent clinical guidelines, the authors declared that they observed similar trends when alternative targets were used. The level of risk factor control improved in all diabetic patients from 1999 through 2010. However, the percentage of adult diabetic participants for whom glycemic control was achieved declined from 57.4% (95% CI, 52.9-61.8) in 2007-2010 to 50.5% (95% CI, 45.8-55.3) in 2015-2018. Blood pressure control was achieved in 74.2% of participants (95% CI, 70.7-77.4) in 2011-2014 but declined to 70.4% (95% CI, 66.7-73.8) in 2015-2018. Control in lipid levels improved during the entire study period; however, the rate of improvement heavily declined after 2007 with lipid target levels attained in 52.3% of participants (95% CI, 49.2-55.3) in 2007-2014 and 55.7% (95% CI, 50.8-60.5) in 2015-2018. Finally, the percentage of participants in whom targets for all 3 risk factors were simultaneously achieved plateaued after 2010 and was 22.2% (95% CI, 17.9-27.3) in 2015-2018.

Trends in diabetes treatment—The use of glucose lowering drugs increased from 74.1% in 1999-2002 to 82.7% in 2007-2010 and then stabilized. A shift toward a safer glucose lowering treatment choice was observed with a decline in the use of older glucose lowering medications such as sulfonylureas, which increases the risk of hypoglycemia, and an increase in the use of metformin, insulin, and newer agents such as sodium-glucose cotransporter 2 inhibitors.

Similarly, blood pressure lowering medication use rose from 1999-2002 to 2007-2010 and then stabilized, with increased use of first-line recommended treatments including angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers. Likewise, statin use rose from 28.4% in 1999-2002 to 56% in 2011-2014 and then stabilized. The total number of drugs used culminated in 2011-2014 with 60% of participants using more than 5 drugs and then leveled off to 57.2% in 2015-2018. Lastly, health insurance status and race or ethnicity impacted the likelihood of receiving monotherapy or combination drug therapy when targets for glycemic, blood pressure, or lipid control were not achieved.

Conclusion. Despite great progress in the control of diabetes and its associated risk factors between 1999 and 2010, this trend declined for glycemic and blood pressure control and leveled off for lipid control in adult NHANES participants with diabetes after 2010. First-line treatments for diabetes and associated risk factors remain underused, and treatment intensification may not be sufficiently considered in patients with uncontrolled risk factors despite clinical guideline recommendations. The findings of this study may portend a possible population-level increase in diabetes-related illnesses in the years to come.

Commentary

The thorough understanding of trends in management of diseases is critical to inform public health policies and planning. Well designed clinical studies heavily influence the development of public health policies and clinical guidelines, which in turn drive real-world clinical practice. In a recent analysis utilizing data from NHANES, Fang et al¹ showed evidence of a general shift toward less intensive treatment of diabetes, hypertension, and hypercholesterolemia in adults living in the US during the last decade.

Similarly, in a separate study using NHANES data collected between 1999 and 2018 published in JAMA just 2 weeks after the current report, Wang et al² confirms this declining trend in diabetes management with only 21.2% of diabetic adults simultaneously attaining glycemic, blood pressure, and lipid level targets during the same period. What led to the decline in more stringent risk factor and diabetes management since 2010 observed in these studies? One possible explanation, as suggested by Fang et al, is that major clinical trials from the late 2000s­—including Action to Control Cardiovascular Risk in Diabetes, UK Prospective Diabetes Study, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, and Veterans Affairs Diabetes Trial—that assessed the effects of intensive glycemic control (with target HbA_1c < 6.5%) found that intensive treatment of diabetes compared to standard care had no cardiovascular benefit albeit increasing the risk of hypoglycemia. Thus, these trial findings may have translated into suboptimal diabetes treatment observed in some NHANES participants. Wang et al propose that effective tailored approaches are needed to improve risk factor control in diabetic patients, such as enhance and maintain adherence to medications and healthy lifestyle behaviors, as well as better access to health care and therapeutic education.

The changes in recent trends in diabetes management have immense clinical implications. The authors of this study suggest a link between the recent relaxation of glycemic targets, as well as risk factor control, and a resurgence of diabetic complications such as lower limb amputation or stroke. Indeed, several recent studies indicate an upward trend or plateau in diabetic complications which had been decreasing in prevalence prior to 2010.³ For example, lower extremity amputation has surged by more than 25% between 2010 and 2015, especially in young and middle-aged adults.⁴ Among the arguments brought forward that this recent resurgence in amputations is directly linked to worsening glycemic control is the fact that between 2007 and 2010, when glucose levels were best controlled within the previous 30-year period, amputations were also at the lowest levels. Moreover, data from the Centers for Disease Control and Prevention also show a 55% increase in mortality (from 15.7 to 24.2 per 1000) among diabetic patients between 2010 and 2015.¹⁴ On the other hand, a growing number of studies show that an increase of inappropriate treatment intensification—reaching HbA_1c levels that are way below the recommended targets—is associated with adverse consequences in diabetic patients particularly in those aged more than 65 years.^5-7 These seemingly contradictory findings highlight the importance of a personalized and thoughtful approach to the management of diabetes and its risk factors. As an example, an increase in the use of newer and safer glucose lowering drugs (eg, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase 4 inhibitors) can help achieve better HbA_1c goals with a reduced risk of hypoglycemic episodes as recently shown by a Danish study.⁸ In this study, the authors concluded that the reduction of the rate of hypoglycemic episodes leading to hospitalization in Denmark was directly linked to the use of these safer and newer glucose lowering drugs.

A discussion on the specifics of trends in diabetes treatment and control must include considerations in older adults aged more than 65 years who constitute more than 40% of the diabetic population. Despite the high prevalence of diabetes in this vulnerable population, such data are still insufficient in the literature and are critically needed to inform public health policies and clinical guidelines. In epidemiological studies focusing on diabetic complications from the last 10 years, concerning increases have been observed in younger⁹ and middle-aged adults while remaining stable in older adults. However, the risk of hypoglycemia or severe hypoglycemia remains high in older adults living in nursing facilities, even in those with an elevated HbA_1c of greater than 8%.⁷ Moreover, in light of more relaxed HbA_1c treatment goals for older frail adults as recommended by international guidelines since 2010,^10,11 recent findings from the French GERODIAB cohort show an increased mortality (hazard ratio, 1.76) in type 2 diabetics aged 70 years and older with HbA_1c greater than or equal to 8.6%.¹² Similarly, a 5-year retrospective British study from 2018 which included patients aged 70 years and older, shows an increased overall mortality in those with HbA_1c greater than 8.5%.¹³ Taken together, further age-stratified analysis utilizing data from large cohort studies including NHANES may help to clarify national trends in diabetes treatment and risk factor control as well as diabetic complications specific to the geriatric population. By being better informed of such trends, clinicians could then develop treatment strategies that minimize complications (eg, hypoglycemia, falls) while achieving favorable outcomes (eg, reduce hyperglycemic emergencies, improve survival) in frail older patients.

Applications for Clinical Practice

The understanding of population-wide trends in diabetes control is critical to planning public health approaches for the prevention and treatment of this disease and its complications. In older adults, the high risk of hypoglycemic events and insufficient epidemiological data on trends of diabetes control hinder diabetes management. Personalized treatment targets taking into account geriatric syndromes and general health status, as well as multidisciplinary management involving endocrinologists, geriatricians, and clinical pharmacists, are necessary to optimize care in older adults with diabetes.

Study Overview

Objective. To update national trends in the treatment and risk factor control of diabetic patients from 1999 through 2018 in the US using data from the National Health and Nutrition Examination Survey (NHANES) with the goal of identifying population subgroups with the highest probability of having untreated risk factors.

Design. The authors conducted a cross-sectional analysis of data from NHANES focusing on adults with diabetes. They examined patient characteristics and medication use over time and estimated the prevalence of risk factor control and medication use. To minimize the effects of a small sample size, the survey years were pooled into 4-year intervals. The variables studied included glycated hemoglobin (HbA_1c), blood pressure, serum cholesterol, medication use, sociodemographic characteristics, and weight status. For statistical analysis, logistic and multinomial logistic regression models were used to examine factors associated with treatment in participants who did not achieve targets for glycemic, blood pressure, and lipid control. Temporal trends were estimated using 2-piece linear spline models with 1 knot at inflection points.

Setting and participants. The NHANES program began in the early 1960s to monitor the health of the US population. In 1999, the survey became a continuous program combining interviews and physical examinations. The survey examines a nationally representative sample of about 5000 persons each year. This study included 6653 participants who were nonpregnant, aged older than 20 years, reported a diagnosis of diabetes from a physician, and participated in NHANES from 1999 through 2018.

Main outcome measures. The main outcome measures were temporal trends in risk factor control (glycemic, blood pressure, or lipid levels) and medication use (glucose lowering, blood pressure lowering, or lipid lowering medications), and number as well as class of drug used, from 1999 through 2018 in diabetic adults from the US participating in NHANES.

Results. Sociodemographic characteristics of the studied diabetes population—The age and racial or ethnic distribution of participants with diabetes were stable from 1999 through 2018, whereas participants with a college degree, higher income, health insurance, obesity, or long-standing diabetes increased during the same period.

Trends in diabetes risk factor control—The trends for glycemic, blood pressure, and lipid control were nonlinear, with an inflection point around 2010. Glycemic control was defined as HbA_1c less than 7%, blood pressure was considered controlled if less than 140/90 mmHg, and lipid was controlled if non-HDL cholesterol level was less than 130 mg/dL. Although these chosen targets were based on the most recent clinical guidelines, the authors declared that they observed similar trends when alternative targets were used. The level of risk factor control improved in all diabetic patients from 1999 through 2010. However, the percentage of adult diabetic participants for whom glycemic control was achieved declined from 57.4% (95% CI, 52.9-61.8) in 2007-2010 to 50.5% (95% CI, 45.8-55.3) in 2015-2018. Blood pressure control was achieved in 74.2% of participants (95% CI, 70.7-77.4) in 2011-2014 but declined to 70.4% (95% CI, 66.7-73.8) in 2015-2018. Control in lipid levels improved during the entire study period; however, the rate of improvement heavily declined after 2007 with lipid target levels attained in 52.3% of participants (95% CI, 49.2-55.3) in 2007-2014 and 55.7% (95% CI, 50.8-60.5) in 2015-2018. Finally, the percentage of participants in whom targets for all 3 risk factors were simultaneously achieved plateaued after 2010 and was 22.2% (95% CI, 17.9-27.3) in 2015-2018.

Trends in diabetes treatment—The use of glucose lowering drugs increased from 74.1% in 1999-2002 to 82.7% in 2007-2010 and then stabilized. A shift toward a safer glucose lowering treatment choice was observed with a decline in the use of older glucose lowering medications such as sulfonylureas, which increases the risk of hypoglycemia, and an increase in the use of metformin, insulin, and newer agents such as sodium-glucose cotransporter 2 inhibitors.

Similarly, blood pressure lowering medication use rose from 1999-2002 to 2007-2010 and then stabilized, with increased use of first-line recommended treatments including angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers. Likewise, statin use rose from 28.4% in 1999-2002 to 56% in 2011-2014 and then stabilized. The total number of drugs used culminated in 2011-2014 with 60% of participants using more than 5 drugs and then leveled off to 57.2% in 2015-2018. Lastly, health insurance status and race or ethnicity impacted the likelihood of receiving monotherapy or combination drug therapy when targets for glycemic, blood pressure, or lipid control were not achieved.

Conclusion. Despite great progress in the control of diabetes and its associated risk factors between 1999 and 2010, this trend declined for glycemic and blood pressure control and leveled off for lipid control in adult NHANES participants with diabetes after 2010. First-line treatments for diabetes and associated risk factors remain underused, and treatment intensification may not be sufficiently considered in patients with uncontrolled risk factors despite clinical guideline recommendations. The findings of this study may portend a possible population-level increase in diabetes-related illnesses in the years to come.

Commentary

The thorough understanding of trends in management of diseases is critical to inform public health policies and planning. Well designed clinical studies heavily influence the development of public health policies and clinical guidelines, which in turn drive real-world clinical practice. In a recent analysis utilizing data from NHANES, Fang et al¹ showed evidence of a general shift toward less intensive treatment of diabetes, hypertension, and hypercholesterolemia in adults living in the US during the last decade.

Similarly, in a separate study using NHANES data collected between 1999 and 2018 published in JAMA just 2 weeks after the current report, Wang et al² confirms this declining trend in diabetes management with only 21.2% of diabetic adults simultaneously attaining glycemic, blood pressure, and lipid level targets during the same period. What led to the decline in more stringent risk factor and diabetes management since 2010 observed in these studies? One possible explanation, as suggested by Fang et al, is that major clinical trials from the late 2000s­—including Action to Control Cardiovascular Risk in Diabetes, UK Prospective Diabetes Study, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation, and Veterans Affairs Diabetes Trial—that assessed the effects of intensive glycemic control (with target HbA_1c < 6.5%) found that intensive treatment of diabetes compared to standard care had no cardiovascular benefit albeit increasing the risk of hypoglycemia. Thus, these trial findings may have translated into suboptimal diabetes treatment observed in some NHANES participants. Wang et al propose that effective tailored approaches are needed to improve risk factor control in diabetic patients, such as enhance and maintain adherence to medications and healthy lifestyle behaviors, as well as better access to health care and therapeutic education.

The changes in recent trends in diabetes management have immense clinical implications. The authors of this study suggest a link between the recent relaxation of glycemic targets, as well as risk factor control, and a resurgence of diabetic complications such as lower limb amputation or stroke. Indeed, several recent studies indicate an upward trend or plateau in diabetic complications which had been decreasing in prevalence prior to 2010.³ For example, lower extremity amputation has surged by more than 25% between 2010 and 2015, especially in young and middle-aged adults.⁴ Among the arguments brought forward that this recent resurgence in amputations is directly linked to worsening glycemic control is the fact that between 2007 and 2010, when glucose levels were best controlled within the previous 30-year period, amputations were also at the lowest levels. Moreover, data from the Centers for Disease Control and Prevention also show a 55% increase in mortality (from 15.7 to 24.2 per 1000) among diabetic patients between 2010 and 2015.¹⁴ On the other hand, a growing number of studies show that an increase of inappropriate treatment intensification—reaching HbA_1c levels that are way below the recommended targets—is associated with adverse consequences in diabetic patients particularly in those aged more than 65 years.^5-7 These seemingly contradictory findings highlight the importance of a personalized and thoughtful approach to the management of diabetes and its risk factors. As an example, an increase in the use of newer and safer glucose lowering drugs (eg, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase 4 inhibitors) can help achieve better HbA_1c goals with a reduced risk of hypoglycemic episodes as recently shown by a Danish study.⁸ In this study, the authors concluded that the reduction of the rate of hypoglycemic episodes leading to hospitalization in Denmark was directly linked to the use of these safer and newer glucose lowering drugs.

A discussion on the specifics of trends in diabetes treatment and control must include considerations in older adults aged more than 65 years who constitute more than 40% of the diabetic population. Despite the high prevalence of diabetes in this vulnerable population, such data are still insufficient in the literature and are critically needed to inform public health policies and clinical guidelines. In epidemiological studies focusing on diabetic complications from the last 10 years, concerning increases have been observed in younger⁹ and middle-aged adults while remaining stable in older adults. However, the risk of hypoglycemia or severe hypoglycemia remains high in older adults living in nursing facilities, even in those with an elevated HbA_1c of greater than 8%.⁷ Moreover, in light of more relaxed HbA_1c treatment goals for older frail adults as recommended by international guidelines since 2010,^10,11 recent findings from the French GERODIAB cohort show an increased mortality (hazard ratio, 1.76) in type 2 diabetics aged 70 years and older with HbA_1c greater than or equal to 8.6%.¹² Similarly, a 5-year retrospective British study from 2018 which included patients aged 70 years and older, shows an increased overall mortality in those with HbA_1c greater than 8.5%.¹³ Taken together, further age-stratified analysis utilizing data from large cohort studies including NHANES may help to clarify national trends in diabetes treatment and risk factor control as well as diabetic complications specific to the geriatric population. By being better informed of such trends, clinicians could then develop treatment strategies that minimize complications (eg, hypoglycemia, falls) while achieving favorable outcomes (eg, reduce hyperglycemic emergencies, improve survival) in frail older patients.

Applications for Clinical Practice

The understanding of population-wide trends in diabetes control is critical to planning public health approaches for the prevention and treatment of this disease and its complications. In older adults, the high risk of hypoglycemic events and insufficient epidemiological data on trends of diabetes control hinder diabetes management. Personalized treatment targets taking into account geriatric syndromes and general health status, as well as multidisciplinary management involving endocrinologists, geriatricians, and clinical pharmacists, are necessary to optimize care in older adults with diabetes.

The current pandemic is forcing changes throughout the health care industry. Telehealth is witnessing a surge. Hospitals are struggling without elective care, and remarkably, physicians are being laid off during a time of crisis. While some states have a surplus work force, other states go begging, and they lock the system up with delays in the processing of applications.

Considering the prevalence of noncompete clauses and a schism in state-to-state processing of complaints, patients are suffering and dying under an antiquated system. The Federation of State Medical Boards doesn’t seem to add to the solution, but instead confounds the problem with new directives. The time is nigh for the federal government to eliminate state medical licensure and replace it with a national medical license for all physicians and health care professionals.

Because physicians’ training requirements don’t vary from state to state, it makes sense. We must take national standardized exams to qualify. Locum tenens physicians must maintain licensure in as many states as they practice; this creates an unnecessary burden and expense, when there is a better alternative. Some states have arranged reciprocity licensure with other states. This is commendable but doesn’t go far enough to manage national shortages in rural areas.

Under a national licensing system, physicians and other health care professionals would not only be free to travel anywhere in the United States to practice, they can count on consistent and equal management of their license. The federal government can track regional overages and shortages and redirect physicians and other medical professionals with incentives to areas in need.

The FSMB claims that there is interstate continuity among state medical boards, but the data don’t support this.

Why is this the case? Each medical board fails to manage their charges equally. Often, action taken by one state board when reported to another state board can cause a review and readjudication. This occasionally results in the overturning of a reprimand or suspension because of differences in legislation.

Yet the physician or health care professional must bear the burden of the notification against their license. Once again, the FSMB claims there is interstate continuity in disciplinary actions, but the data do not support this.

Once someone brings a complaint against a health professional, which in this health care climate is inevitable, the medical board must institute an investigation. Even if it has no merit, the process must go forward. Under a national system, a consistent approach to dismiss and investigate issues and complaints might expedite the process. This eliminates inefficiency and delays in clearance of charges.

A report in 2006 identified fragmentation and discontinuities in the way each state medical board manages a physician or other health care personnel’s complaints. The number of hands involved in the process varies and is often onerous and redundant. Several sources may request the same information, tying it up as it moves through an inefficient and uncooperative system. With the increase in internal politics since then, this only compounds rather than improves the problem.

Yet the benefit of national licensure is not just for the health care personnel but also for insurance companies that must register and screen physicians as they move from region to region. In each state, the physician must repeat the accreditation process, delaying reimbursements and denying care. Hospitals also must repeat the credentialing task as well. This, although the physician or health care worker has a clean record with the same company or the same hospital system in their original state.

Perhaps data from one insurance group or hospital in another state get lost or altered in transfer, but under national licensing, this would not be possible. Furthermore, the current system limits the individual professional’s input. By nationalizing, record corrections would go through a federal database rather than state data banks that don’t sync.

This already partially exists with the National Practitioner Identifier. But we can take it one step further. Through nationalization, we could institute a fairer system of reporting where both the professional’s and the complainant’s summary is included. One might argue the National Physician Data Bank performs this function, but in fact, it merely reflects state assessments – which again vary.

The infrastructure is already in place to transition from a state to national system with facilities and records kept in each state’s medical board. It would simply be a matter of replacing state personnel with federal employees who all work from the same script. A national medical license simply makes sense for all parties. It reduces discontinuity and increases efficiency. A national medical license empowers the individual rather than institutions, yet benefits both.

The time is nigh to nationally certify and set physicians free, reduce paperwork and needless fees, and eliminate state supremacy.  


Dr. Raymond is an emergency physician based in Hickory, N.C., and Muckendorf an der Donau, Austria.

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

The current pandemic is forcing changes throughout the health care industry. Telehealth is witnessing a surge. Hospitals are struggling without elective care, and remarkably, physicians are being laid off during a time of crisis. While some states have a surplus work force, other states go begging, and they lock the system up with delays in the processing of applications.

Considering the prevalence of noncompete clauses and a schism in state-to-state processing of complaints, patients are suffering and dying under an antiquated system. The Federation of State Medical Boards doesn’t seem to add to the solution, but instead confounds the problem with new directives. The time is nigh for the federal government to eliminate state medical licensure and replace it with a national medical license for all physicians and health care professionals.

Because physicians’ training requirements don’t vary from state to state, it makes sense. We must take national standardized exams to qualify. Locum tenens physicians must maintain licensure in as many states as they practice; this creates an unnecessary burden and expense, when there is a better alternative. Some states have arranged reciprocity licensure with other states. This is commendable but doesn’t go far enough to manage national shortages in rural areas.

Under a national licensing system, physicians and other health care professionals would not only be free to travel anywhere in the United States to practice, they can count on consistent and equal management of their license. The federal government can track regional overages and shortages and redirect physicians and other medical professionals with incentives to areas in need.

The FSMB claims that there is interstate continuity among state medical boards, but the data don’t support this.

Why is this the case? Each medical board fails to manage their charges equally. Often, action taken by one state board when reported to another state board can cause a review and readjudication. This occasionally results in the overturning of a reprimand or suspension because of differences in legislation.

Yet the physician or health care professional must bear the burden of the notification against their license. Once again, the FSMB claims there is interstate continuity in disciplinary actions, but the data do not support this.

Once someone brings a complaint against a health professional, which in this health care climate is inevitable, the medical board must institute an investigation. Even if it has no merit, the process must go forward. Under a national system, a consistent approach to dismiss and investigate issues and complaints might expedite the process. This eliminates inefficiency and delays in clearance of charges.

A report in 2006 identified fragmentation and discontinuities in the way each state medical board manages a physician or other health care personnel’s complaints. The number of hands involved in the process varies and is often onerous and redundant. Several sources may request the same information, tying it up as it moves through an inefficient and uncooperative system. With the increase in internal politics since then, this only compounds rather than improves the problem.

Yet the benefit of national licensure is not just for the health care personnel but also for insurance companies that must register and screen physicians as they move from region to region. In each state, the physician must repeat the accreditation process, delaying reimbursements and denying care. Hospitals also must repeat the credentialing task as well. This, although the physician or health care worker has a clean record with the same company or the same hospital system in their original state.

Perhaps data from one insurance group or hospital in another state get lost or altered in transfer, but under national licensing, this would not be possible. Furthermore, the current system limits the individual professional’s input. By nationalizing, record corrections would go through a federal database rather than state data banks that don’t sync.

This already partially exists with the National Practitioner Identifier. But we can take it one step further. Through nationalization, we could institute a fairer system of reporting where both the professional’s and the complainant’s summary is included. One might argue the National Physician Data Bank performs this function, but in fact, it merely reflects state assessments – which again vary.

The infrastructure is already in place to transition from a state to national system with facilities and records kept in each state’s medical board. It would simply be a matter of replacing state personnel with federal employees who all work from the same script. A national medical license simply makes sense for all parties. It reduces discontinuity and increases efficiency. A national medical license empowers the individual rather than institutions, yet benefits both.

The time is nigh to nationally certify and set physicians free, reduce paperwork and needless fees, and eliminate state supremacy.  


Dr. Raymond is an emergency physician based in Hickory, N.C., and Muckendorf an der Donau, Austria.

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

The current pandemic is forcing changes throughout the health care industry. Telehealth is witnessing a surge. Hospitals are struggling without elective care, and remarkably, physicians are being laid off during a time of crisis. While some states have a surplus work force, other states go begging, and they lock the system up with delays in the processing of applications.

Considering the prevalence of noncompete clauses and a schism in state-to-state processing of complaints, patients are suffering and dying under an antiquated system. The Federation of State Medical Boards doesn’t seem to add to the solution, but instead confounds the problem with new directives. The time is nigh for the federal government to eliminate state medical licensure and replace it with a national medical license for all physicians and health care professionals.

Because physicians’ training requirements don’t vary from state to state, it makes sense. We must take national standardized exams to qualify. Locum tenens physicians must maintain licensure in as many states as they practice; this creates an unnecessary burden and expense, when there is a better alternative. Some states have arranged reciprocity licensure with other states. This is commendable but doesn’t go far enough to manage national shortages in rural areas.

Under a national licensing system, physicians and other health care professionals would not only be free to travel anywhere in the United States to practice, they can count on consistent and equal management of their license. The federal government can track regional overages and shortages and redirect physicians and other medical professionals with incentives to areas in need.

The FSMB claims that there is interstate continuity among state medical boards, but the data don’t support this.

Why is this the case? Each medical board fails to manage their charges equally. Often, action taken by one state board when reported to another state board can cause a review and readjudication. This occasionally results in the overturning of a reprimand or suspension because of differences in legislation.

Yet the physician or health care professional must bear the burden of the notification against their license. Once again, the FSMB claims there is interstate continuity in disciplinary actions, but the data do not support this.

Once someone brings a complaint against a health professional, which in this health care climate is inevitable, the medical board must institute an investigation. Even if it has no merit, the process must go forward. Under a national system, a consistent approach to dismiss and investigate issues and complaints might expedite the process. This eliminates inefficiency and delays in clearance of charges.

A report in 2006 identified fragmentation and discontinuities in the way each state medical board manages a physician or other health care personnel’s complaints. The number of hands involved in the process varies and is often onerous and redundant. Several sources may request the same information, tying it up as it moves through an inefficient and uncooperative system. With the increase in internal politics since then, this only compounds rather than improves the problem.

Yet the benefit of national licensure is not just for the health care personnel but also for insurance companies that must register and screen physicians as they move from region to region. In each state, the physician must repeat the accreditation process, delaying reimbursements and denying care. Hospitals also must repeat the credentialing task as well. This, although the physician or health care worker has a clean record with the same company or the same hospital system in their original state.

Perhaps data from one insurance group or hospital in another state get lost or altered in transfer, but under national licensing, this would not be possible. Furthermore, the current system limits the individual professional’s input. By nationalizing, record corrections would go through a federal database rather than state data banks that don’t sync.

This already partially exists with the National Practitioner Identifier. But we can take it one step further. Through nationalization, we could institute a fairer system of reporting where both the professional’s and the complainant’s summary is included. One might argue the National Physician Data Bank performs this function, but in fact, it merely reflects state assessments – which again vary.

The infrastructure is already in place to transition from a state to national system with facilities and records kept in each state’s medical board. It would simply be a matter of replacing state personnel with federal employees who all work from the same script. A national medical license simply makes sense for all parties. It reduces discontinuity and increases efficiency. A national medical license empowers the individual rather than institutions, yet benefits both.

The time is nigh to nationally certify and set physicians free, reduce paperwork and needless fees, and eliminate state supremacy.  


Dr. Raymond is an emergency physician based in Hickory, N.C., and Muckendorf an der Donau, Austria.

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

The four most effective treatments for long-term clearance of actinic keratosis (AK) are photodynamic therapy with aminolevulinate (ALA-PDT); imiquimod, 5%; photodynamic therapy with methyl aminolevulinate (MAL-PDT); and cryosurgery, results from a systemic review and meta-analysis suggest.

Future FamDoc/Wikimedia Commons/CC BY-SA 4.0/No changes

To date, many studies have reported that “most interventions are superior to placebo in terms of lesion clearance and improving the cosmetic image,” corresponding author Markus V. Heppt, MD, MSc, and colleagues wrote in a study published online Aug. 4, 2021, in JAMA Dermatology.

“However, most randomized clinical trials (RCTs) and meta-analyses focused on short-term outcomes that are evaluated within 3-6 months after treatment, although AK is increasingly being considered a chronic condition and reducing the incidence of cSCC [cutaneous squamous cell carcinoma] should be the ultimate goal of treatment,” they said. In addition, most treatments have been compared with placebo “and head-to-head comparisons are widely lacking, limiting the possibility to cross compare distinct active treatments. To this end, no evidence-based recommendation regarding the long-term efficacy of interventions for AK exists.”

To determine the long-term clearance rates of treatments used in adults with AK, a precursor of cSCC, Dr. Heppt, of the department of dermatology at University Hospital Erlangen (Germany), and colleagues drew from 15 randomized clinical trials that reported sustained clearance rates after at least 12 months of treatment and were published up to April 6, 2020. They conducted the review by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline and its extension for network meta-analyses (PRIMSA-NMA) and using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process to determine the certainty of the evidence for network meta-analyses.

The study population included 4,252 patients. Among 10 studies included in a network meta-analysis for the outcome of participant complete clearance, ALA-PDT showed the most favorable risk ratio profile, compared with placebo (RR, 8.06; moderate-quality evidence on GRADE), followed by imiquimod, 5% (RR, 5.98; very-low-quality evidence on GRADE); MAL-PDT (RR, 5.95; low-quality evidence on GRADE); and cryosurgery (RR, 4.76; very-low-quality evidence on GRADE).

ALA-PDT had the highest RR in the network meta-analyses for lesion-specific clearance (RR, 5.08; moderate-quality evidence on GRADE).

“Although ALA-PDT showed the most favorable RR and was ranked best among all interventions, the relative efficacy values and treatment rankings must be interpreted with caution,” because of the low certainty of evidence and few direct, head-to-head comparisons, the authors emphasized. “In particular, it remains elusive how to translate the distinct RR values into clinical relevance. We are hesitant to derive hierarchical or algorithmic treatment recommendations from our results.”

“The current meta-analysis notes that there are conflicting results in different studies,” said Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn. who was asked to comment on the study. “Sustained participant complete clearance of actinic keratoses at 12 months is used as an outcome measure, although the authors comment that prevention/reduction of squamous cell carcinoma might be the more valid outcome measure.”

In her clinical experience, Dr. Ko said that patients often have good, sustained clearance of AKs with field treatment using a topical medication like 5-fluorouracil. “Patients can also have a good result with photodynamic therapy,” she said. “The paper’s results therefore do reflect what I have seen in my own practice. I also agree with the authors that, while it is difficult to measure, a meaningful outcome for patients is reduction/prevention of squamous cell carcinoma. It would be useful to have data on which treatment of actinic keratosis is best to reduce/prevent squamous cell carcinoma.”

The authors acknowledged limitations of the study, including the fact that field-directed treatments such as imiquimod, PDT, and fluorouracil were compared with lesion-directed approaches such as cryosurgery, “which may limit the generalizability of our results.” They concluded that their analysis “provides data that might contribute to an evidence-based framework to guide the selection of interventions for AK with proven long-term efficacy and sustained AK clearance.”

The analysis did not include data on tirbanibulin, a first-in-class dual Src kinase and tubulin polymerization inhibitor that was approved by the FDA for the topical treatment of AKs on the face or scalp in December 2020.

Dr. Heppt disclosed that he has been a member of the advisory boards of Almirall Hermal and Sanofi-Aventis and has received speaker’s honoraria from Galderma and Biofrontera. Many of his coauthors also reported having relevant financial disclosures. Dr. Ko reported having no relevant disclosures.

[email protected]

The four most effective treatments for long-term clearance of actinic keratosis (AK) are photodynamic therapy with aminolevulinate (ALA-PDT); imiquimod, 5%; photodynamic therapy with methyl aminolevulinate (MAL-PDT); and cryosurgery, results from a systemic review and meta-analysis suggest.

Future FamDoc/Wikimedia Commons/CC BY-SA 4.0/No changes

To date, many studies have reported that “most interventions are superior to placebo in terms of lesion clearance and improving the cosmetic image,” corresponding author Markus V. Heppt, MD, MSc, and colleagues wrote in a study published online Aug. 4, 2021, in JAMA Dermatology.

“However, most randomized clinical trials (RCTs) and meta-analyses focused on short-term outcomes that are evaluated within 3-6 months after treatment, although AK is increasingly being considered a chronic condition and reducing the incidence of cSCC [cutaneous squamous cell carcinoma] should be the ultimate goal of treatment,” they said. In addition, most treatments have been compared with placebo “and head-to-head comparisons are widely lacking, limiting the possibility to cross compare distinct active treatments. To this end, no evidence-based recommendation regarding the long-term efficacy of interventions for AK exists.”

To determine the long-term clearance rates of treatments used in adults with AK, a precursor of cSCC, Dr. Heppt, of the department of dermatology at University Hospital Erlangen (Germany), and colleagues drew from 15 randomized clinical trials that reported sustained clearance rates after at least 12 months of treatment and were published up to April 6, 2020. They conducted the review by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline and its extension for network meta-analyses (PRIMSA-NMA) and using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process to determine the certainty of the evidence for network meta-analyses.

The study population included 4,252 patients. Among 10 studies included in a network meta-analysis for the outcome of participant complete clearance, ALA-PDT showed the most favorable risk ratio profile, compared with placebo (RR, 8.06; moderate-quality evidence on GRADE), followed by imiquimod, 5% (RR, 5.98; very-low-quality evidence on GRADE); MAL-PDT (RR, 5.95; low-quality evidence on GRADE); and cryosurgery (RR, 4.76; very-low-quality evidence on GRADE).

ALA-PDT had the highest RR in the network meta-analyses for lesion-specific clearance (RR, 5.08; moderate-quality evidence on GRADE).

“Although ALA-PDT showed the most favorable RR and was ranked best among all interventions, the relative efficacy values and treatment rankings must be interpreted with caution,” because of the low certainty of evidence and few direct, head-to-head comparisons, the authors emphasized. “In particular, it remains elusive how to translate the distinct RR values into clinical relevance. We are hesitant to derive hierarchical or algorithmic treatment recommendations from our results.”

“The current meta-analysis notes that there are conflicting results in different studies,” said Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn. who was asked to comment on the study. “Sustained participant complete clearance of actinic keratoses at 12 months is used as an outcome measure, although the authors comment that prevention/reduction of squamous cell carcinoma might be the more valid outcome measure.”

In her clinical experience, Dr. Ko said that patients often have good, sustained clearance of AKs with field treatment using a topical medication like 5-fluorouracil. “Patients can also have a good result with photodynamic therapy,” she said. “The paper’s results therefore do reflect what I have seen in my own practice. I also agree with the authors that, while it is difficult to measure, a meaningful outcome for patients is reduction/prevention of squamous cell carcinoma. It would be useful to have data on which treatment of actinic keratosis is best to reduce/prevent squamous cell carcinoma.”

The authors acknowledged limitations of the study, including the fact that field-directed treatments such as imiquimod, PDT, and fluorouracil were compared with lesion-directed approaches such as cryosurgery, “which may limit the generalizability of our results.” They concluded that their analysis “provides data that might contribute to an evidence-based framework to guide the selection of interventions for AK with proven long-term efficacy and sustained AK clearance.”

The analysis did not include data on tirbanibulin, a first-in-class dual Src kinase and tubulin polymerization inhibitor that was approved by the FDA for the topical treatment of AKs on the face or scalp in December 2020.

Dr. Heppt disclosed that he has been a member of the advisory boards of Almirall Hermal and Sanofi-Aventis and has received speaker’s honoraria from Galderma and Biofrontera. Many of his coauthors also reported having relevant financial disclosures. Dr. Ko reported having no relevant disclosures.

[email protected]

The four most effective treatments for long-term clearance of actinic keratosis (AK) are photodynamic therapy with aminolevulinate (ALA-PDT); imiquimod, 5%; photodynamic therapy with methyl aminolevulinate (MAL-PDT); and cryosurgery, results from a systemic review and meta-analysis suggest.

Future FamDoc/Wikimedia Commons/CC BY-SA 4.0/No changes

To date, many studies have reported that “most interventions are superior to placebo in terms of lesion clearance and improving the cosmetic image,” corresponding author Markus V. Heppt, MD, MSc, and colleagues wrote in a study published online Aug. 4, 2021, in JAMA Dermatology.

“However, most randomized clinical trials (RCTs) and meta-analyses focused on short-term outcomes that are evaluated within 3-6 months after treatment, although AK is increasingly being considered a chronic condition and reducing the incidence of cSCC [cutaneous squamous cell carcinoma] should be the ultimate goal of treatment,” they said. In addition, most treatments have been compared with placebo “and head-to-head comparisons are widely lacking, limiting the possibility to cross compare distinct active treatments. To this end, no evidence-based recommendation regarding the long-term efficacy of interventions for AK exists.”

To determine the long-term clearance rates of treatments used in adults with AK, a precursor of cSCC, Dr. Heppt, of the department of dermatology at University Hospital Erlangen (Germany), and colleagues drew from 15 randomized clinical trials that reported sustained clearance rates after at least 12 months of treatment and were published up to April 6, 2020. They conducted the review by following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline and its extension for network meta-analyses (PRIMSA-NMA) and using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process to determine the certainty of the evidence for network meta-analyses.

The study population included 4,252 patients. Among 10 studies included in a network meta-analysis for the outcome of participant complete clearance, ALA-PDT showed the most favorable risk ratio profile, compared with placebo (RR, 8.06; moderate-quality evidence on GRADE), followed by imiquimod, 5% (RR, 5.98; very-low-quality evidence on GRADE); MAL-PDT (RR, 5.95; low-quality evidence on GRADE); and cryosurgery (RR, 4.76; very-low-quality evidence on GRADE).

ALA-PDT had the highest RR in the network meta-analyses for lesion-specific clearance (RR, 5.08; moderate-quality evidence on GRADE).

“Although ALA-PDT showed the most favorable RR and was ranked best among all interventions, the relative efficacy values and treatment rankings must be interpreted with caution,” because of the low certainty of evidence and few direct, head-to-head comparisons, the authors emphasized. “In particular, it remains elusive how to translate the distinct RR values into clinical relevance. We are hesitant to derive hierarchical or algorithmic treatment recommendations from our results.”

“The current meta-analysis notes that there are conflicting results in different studies,” said Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn. who was asked to comment on the study. “Sustained participant complete clearance of actinic keratoses at 12 months is used as an outcome measure, although the authors comment that prevention/reduction of squamous cell carcinoma might be the more valid outcome measure.”

In her clinical experience, Dr. Ko said that patients often have good, sustained clearance of AKs with field treatment using a topical medication like 5-fluorouracil. “Patients can also have a good result with photodynamic therapy,” she said. “The paper’s results therefore do reflect what I have seen in my own practice. I also agree with the authors that, while it is difficult to measure, a meaningful outcome for patients is reduction/prevention of squamous cell carcinoma. It would be useful to have data on which treatment of actinic keratosis is best to reduce/prevent squamous cell carcinoma.”

The authors acknowledged limitations of the study, including the fact that field-directed treatments such as imiquimod, PDT, and fluorouracil were compared with lesion-directed approaches such as cryosurgery, “which may limit the generalizability of our results.” They concluded that their analysis “provides data that might contribute to an evidence-based framework to guide the selection of interventions for AK with proven long-term efficacy and sustained AK clearance.”

The analysis did not include data on tirbanibulin, a first-in-class dual Src kinase and tubulin polymerization inhibitor that was approved by the FDA for the topical treatment of AKs on the face or scalp in December 2020.

Dr. Heppt disclosed that he has been a member of the advisory boards of Almirall Hermal and Sanofi-Aventis and has received speaker’s honoraria from Galderma and Biofrontera. Many of his coauthors also reported having relevant financial disclosures. Dr. Ko reported having no relevant disclosures.

[email protected]

Killer babies and their aging mommies

The joys of new parenthood are endless, like the long nights and functioning on 4 hours of sleep. But those babies sure are sweet, and deadly. That’s right, little Johnny junior is shaving years off of your life.

LWA/Dann Tardif/Getty Images

Investigators at the University of California, Los Angeles, found that new mothers who slept less than 7 hours a night 6 months after giving birth were, biologically, 3-7 years older than were those who slept 7 or more hours. But hold on, that doesn’t mean mothers need to update their driver licenses. There’s a difference between biological and chronological age.

Biological aging is measured by epigenetics, which analyzes changes in DNA over time by determining whether coding for certain proteins is turned on or off. The process acts as a sort of clock, lead author Judith E. Carroll, PhD, said in a separate statement, allowing scientists to estimate a person’s biological age.

Although loss of sleep may accelerate biological aging and increase health risks, the researchers don’t want people to think that lack of sleep during infant care is going to automatically cause permanent damage. The jury is still out on whether the effects are long lasting. Instead, they emphasized the importance of prioritizing sleep needs and getting some help from others to do it.

“With every hour of additional sleep, the mother’s biological age was younger,” Dr. Carroll said. “I, and many other sleep scientists, consider sleep health to be just as vital to overall health as diet and exercise.”

So, new moms, fix that gourmet dinner after you go for that run because you’re already up at 4 a.m. anyway. It’s all about balance.
 

Me and my phone-y phriends

It’s been months since you’ve seen your friends in person. You got your vaccine and so, after all this time, you can finally meet with your friends in real life. No more Zoom. It’s a strange dream come true.

nemke/E+

The problem is that half your friends barely seem interested, spending much of your time together staring at their phones. Naturally, there’s a clever term for this: You’ve just been the victim of phubbing, specifically friend phubbing or fphubbing (we’re not sure there are enough “f” sounds at the beginning of that word), and it’s been the focus of a new study from the University of Georgia.

So who are these fphubbers? Researchers found that neurotic and depressed individuals are more likely to fphub, as were those with social anxiety, since they may actually prefer online interaction over face-to-face conversation. On the flip side, people with agreeable traits were less likely to fphub, as they felt doing so would be rude and impolite. Quite a bold stance right there, we know.

The researchers noted the complete ordinariness of people pulling their phones out while with friends, and the rapid acceptance of something many people may still consider rude. It could speak to casual smartphone addiction and the urge we all get when we hear that notification in our pocket. Maybe what we need when we see friends is the equivalent of those PSAs before movies telling you to turn off your cell phones. Then you can all go down to the lobby and get yourselves a treat.
 

Who needs a vaccine when there’s horse paste?

It’s not the first time, and it won’t be the last, that some people think they know best when it comes to COVID-19 safety.

Mario Olaya/Pixabay

What is the newest “trend” for prevention and treatment? Enter, ivermectin, a Food and Drug Administration–approved drug for treating conditions caused by parasitic worms. The prescription form is hard to find these days, so some folks have been “raiding rural tractor supply stores in search of ivermectin horse paste (packed with ‘apple flavor’!) and [weighing] the benefits of taking ivermectin ‘sheep drench’,” according to the Daily Beast.

The FDA does not condone the use of ivermectin for COVID-19 and warns that the types meant for animals can be harmful to humans if taken in large doses. Facebook has played its part, as groups are forming to share conflicting information about how the drug can be used for COVID-19. The medication often comes from sketchy sources, and it’s seemingly causing more harm than good. Pharmacies are even starting to treat ivermectin as if it’s an opioid.

“My ‘horse’ had no negative side effects, and now he tells me he feels like a million bucks and is now COVID free,” one social media poster wrote in code, according to the Daily Beast.
 

When the card fits, COVID-19 will take a hit

Good news! We have figured out the problem behind the whole COVID-19 vaccine-denial business.

Richard Franki/MDedge

And by “we,” of course, we mean someone else. But we’re telling you about it, and isn’t that really the important part?

Anyway, back to the problem. It’s not the vaccines themselves, it’s the vaccine cards. They’re the wrong size.

The Atlantic’s Amanda Mull explains: “When I got my first shot, in late February, I sat in the mandatory waiting area, holding my new card in one hand and my wallet in the other, trying to understand why the two objects weren’t compatible.”

She didn’t get very far with the CDC, but Chelsea Cirruzzo, a public-health reporter at U.S. News & World Report who has been tweeting about the vaccine cards, suggested that “someone just printed out a bunch of cards that are easy to write your name and vaccine brand on, without thinking about wallets.”

The evidence does fit the nobody-really-gave-it-any-thought argument. The template was available to the public on some state government websites when the vaccine was approved and can still be found on Florida’s, Ms. Mull notes. “Try to imagine governments freely distributing their templates for driver’s licenses, passports, or other documents intended to certify a particular identity or status.” The FBI, we understand, frowns upon this sort of thing.

Well, there you have it, America. When the card fits in a wallet, the vaccine problem will go away. Just remember where you read it, not where we read it.

Killer babies and their aging mommies

The joys of new parenthood are endless, like the long nights and functioning on 4 hours of sleep. But those babies sure are sweet, and deadly. That’s right, little Johnny junior is shaving years off of your life.

LWA/Dann Tardif/Getty Images

Investigators at the University of California, Los Angeles, found that new mothers who slept less than 7 hours a night 6 months after giving birth were, biologically, 3-7 years older than were those who slept 7 or more hours. But hold on, that doesn’t mean mothers need to update their driver licenses. There’s a difference between biological and chronological age.

Biological aging is measured by epigenetics, which analyzes changes in DNA over time by determining whether coding for certain proteins is turned on or off. The process acts as a sort of clock, lead author Judith E. Carroll, PhD, said in a separate statement, allowing scientists to estimate a person’s biological age.

Although loss of sleep may accelerate biological aging and increase health risks, the researchers don’t want people to think that lack of sleep during infant care is going to automatically cause permanent damage. The jury is still out on whether the effects are long lasting. Instead, they emphasized the importance of prioritizing sleep needs and getting some help from others to do it.

“With every hour of additional sleep, the mother’s biological age was younger,” Dr. Carroll said. “I, and many other sleep scientists, consider sleep health to be just as vital to overall health as diet and exercise.”

So, new moms, fix that gourmet dinner after you go for that run because you’re already up at 4 a.m. anyway. It’s all about balance.
 

Me and my phone-y phriends

It’s been months since you’ve seen your friends in person. You got your vaccine and so, after all this time, you can finally meet with your friends in real life. No more Zoom. It’s a strange dream come true.

nemke/E+

The problem is that half your friends barely seem interested, spending much of your time together staring at their phones. Naturally, there’s a clever term for this: You’ve just been the victim of phubbing, specifically friend phubbing or fphubbing (we’re not sure there are enough “f” sounds at the beginning of that word), and it’s been the focus of a new study from the University of Georgia.

So who are these fphubbers? Researchers found that neurotic and depressed individuals are more likely to fphub, as were those with social anxiety, since they may actually prefer online interaction over face-to-face conversation. On the flip side, people with agreeable traits were less likely to fphub, as they felt doing so would be rude and impolite. Quite a bold stance right there, we know.

The researchers noted the complete ordinariness of people pulling their phones out while with friends, and the rapid acceptance of something many people may still consider rude. It could speak to casual smartphone addiction and the urge we all get when we hear that notification in our pocket. Maybe what we need when we see friends is the equivalent of those PSAs before movies telling you to turn off your cell phones. Then you can all go down to the lobby and get yourselves a treat.
 

Who needs a vaccine when there’s horse paste?

It’s not the first time, and it won’t be the last, that some people think they know best when it comes to COVID-19 safety.

Mario Olaya/Pixabay

What is the newest “trend” for prevention and treatment? Enter, ivermectin, a Food and Drug Administration–approved drug for treating conditions caused by parasitic worms. The prescription form is hard to find these days, so some folks have been “raiding rural tractor supply stores in search of ivermectin horse paste (packed with ‘apple flavor’!) and [weighing] the benefits of taking ivermectin ‘sheep drench’,” according to the Daily Beast.

The FDA does not condone the use of ivermectin for COVID-19 and warns that the types meant for animals can be harmful to humans if taken in large doses. Facebook has played its part, as groups are forming to share conflicting information about how the drug can be used for COVID-19. The medication often comes from sketchy sources, and it’s seemingly causing more harm than good. Pharmacies are even starting to treat ivermectin as if it’s an opioid.

“My ‘horse’ had no negative side effects, and now he tells me he feels like a million bucks and is now COVID free,” one social media poster wrote in code, according to the Daily Beast.
 

When the card fits, COVID-19 will take a hit

Good news! We have figured out the problem behind the whole COVID-19 vaccine-denial business.

Richard Franki/MDedge

And by “we,” of course, we mean someone else. But we’re telling you about it, and isn’t that really the important part?

Anyway, back to the problem. It’s not the vaccines themselves, it’s the vaccine cards. They’re the wrong size.

The Atlantic’s Amanda Mull explains: “When I got my first shot, in late February, I sat in the mandatory waiting area, holding my new card in one hand and my wallet in the other, trying to understand why the two objects weren’t compatible.”

She didn’t get very far with the CDC, but Chelsea Cirruzzo, a public-health reporter at U.S. News & World Report who has been tweeting about the vaccine cards, suggested that “someone just printed out a bunch of cards that are easy to write your name and vaccine brand on, without thinking about wallets.”

The evidence does fit the nobody-really-gave-it-any-thought argument. The template was available to the public on some state government websites when the vaccine was approved and can still be found on Florida’s, Ms. Mull notes. “Try to imagine governments freely distributing their templates for driver’s licenses, passports, or other documents intended to certify a particular identity or status.” The FBI, we understand, frowns upon this sort of thing.

Well, there you have it, America. When the card fits in a wallet, the vaccine problem will go away. Just remember where you read it, not where we read it.

Killer babies and their aging mommies

The joys of new parenthood are endless, like the long nights and functioning on 4 hours of sleep. But those babies sure are sweet, and deadly. That’s right, little Johnny junior is shaving years off of your life.

LWA/Dann Tardif/Getty Images

Investigators at the University of California, Los Angeles, found that new mothers who slept less than 7 hours a night 6 months after giving birth were, biologically, 3-7 years older than were those who slept 7 or more hours. But hold on, that doesn’t mean mothers need to update their driver licenses. There’s a difference between biological and chronological age.

Biological aging is measured by epigenetics, which analyzes changes in DNA over time by determining whether coding for certain proteins is turned on or off. The process acts as a sort of clock, lead author Judith E. Carroll, PhD, said in a separate statement, allowing scientists to estimate a person’s biological age.

Although loss of sleep may accelerate biological aging and increase health risks, the researchers don’t want people to think that lack of sleep during infant care is going to automatically cause permanent damage. The jury is still out on whether the effects are long lasting. Instead, they emphasized the importance of prioritizing sleep needs and getting some help from others to do it.

“With every hour of additional sleep, the mother’s biological age was younger,” Dr. Carroll said. “I, and many other sleep scientists, consider sleep health to be just as vital to overall health as diet and exercise.”

So, new moms, fix that gourmet dinner after you go for that run because you’re already up at 4 a.m. anyway. It’s all about balance.
 

Me and my phone-y phriends

It’s been months since you’ve seen your friends in person. You got your vaccine and so, after all this time, you can finally meet with your friends in real life. No more Zoom. It’s a strange dream come true.

nemke/E+

The problem is that half your friends barely seem interested, spending much of your time together staring at their phones. Naturally, there’s a clever term for this: You’ve just been the victim of phubbing, specifically friend phubbing or fphubbing (we’re not sure there are enough “f” sounds at the beginning of that word), and it’s been the focus of a new study from the University of Georgia.

So who are these fphubbers? Researchers found that neurotic and depressed individuals are more likely to fphub, as were those with social anxiety, since they may actually prefer online interaction over face-to-face conversation. On the flip side, people with agreeable traits were less likely to fphub, as they felt doing so would be rude and impolite. Quite a bold stance right there, we know.

The researchers noted the complete ordinariness of people pulling their phones out while with friends, and the rapid acceptance of something many people may still consider rude. It could speak to casual smartphone addiction and the urge we all get when we hear that notification in our pocket. Maybe what we need when we see friends is the equivalent of those PSAs before movies telling you to turn off your cell phones. Then you can all go down to the lobby and get yourselves a treat.
 

Who needs a vaccine when there’s horse paste?

It’s not the first time, and it won’t be the last, that some people think they know best when it comes to COVID-19 safety.

Mario Olaya/Pixabay

What is the newest “trend” for prevention and treatment? Enter, ivermectin, a Food and Drug Administration–approved drug for treating conditions caused by parasitic worms. The prescription form is hard to find these days, so some folks have been “raiding rural tractor supply stores in search of ivermectin horse paste (packed with ‘apple flavor’!) and [weighing] the benefits of taking ivermectin ‘sheep drench’,” according to the Daily Beast.

The FDA does not condone the use of ivermectin for COVID-19 and warns that the types meant for animals can be harmful to humans if taken in large doses. Facebook has played its part, as groups are forming to share conflicting information about how the drug can be used for COVID-19. The medication often comes from sketchy sources, and it’s seemingly causing more harm than good. Pharmacies are even starting to treat ivermectin as if it’s an opioid.

“My ‘horse’ had no negative side effects, and now he tells me he feels like a million bucks and is now COVID free,” one social media poster wrote in code, according to the Daily Beast.
 

When the card fits, COVID-19 will take a hit

Good news! We have figured out the problem behind the whole COVID-19 vaccine-denial business.

Richard Franki/MDedge

And by “we,” of course, we mean someone else. But we’re telling you about it, and isn’t that really the important part?

Anyway, back to the problem. It’s not the vaccines themselves, it’s the vaccine cards. They’re the wrong size.

The Atlantic’s Amanda Mull explains: “When I got my first shot, in late February, I sat in the mandatory waiting area, holding my new card in one hand and my wallet in the other, trying to understand why the two objects weren’t compatible.”

She didn’t get very far with the CDC, but Chelsea Cirruzzo, a public-health reporter at U.S. News & World Report who has been tweeting about the vaccine cards, suggested that “someone just printed out a bunch of cards that are easy to write your name and vaccine brand on, without thinking about wallets.”

The evidence does fit the nobody-really-gave-it-any-thought argument. The template was available to the public on some state government websites when the vaccine was approved and can still be found on Florida’s, Ms. Mull notes. “Try to imagine governments freely distributing their templates for driver’s licenses, passports, or other documents intended to certify a particular identity or status.” The FBI, we understand, frowns upon this sort of thing.

Well, there you have it, America. When the card fits in a wallet, the vaccine problem will go away. Just remember where you read it, not where we read it.

This patient was given a diagnosis of erythema dyschromicum perstans (EDP), also known as ashy dermatosis because of the hyperpigmented macules that come together into confluent patches that look like burned wood. There is often an inflammatory erythematous aspect to EDP.

The etiology of EDP is unknown. It is not related to sun exposure and occurs most commonly on the trunk. Although there are case reports implicating medications or infections, no clear connection has been found. This patient’s chemotherapy may have been an inciting factor, based on her history, but it is not likely that cancer caused the EDP.

EDP tends to be chronic and difficult to treat. Fortunately, other than the itching and skin discoloration, it is usually asymptomatic and benign. Large-scale trials are lacking, but there are case reports showing benefit from narrow beam UVB treatments and topical tacrolimus.¹ Laser has not proven very helpful, and the hyperpigmentation can recur.

Based on the clinical appearance of this patient’s lesion, and the fact that a previous biopsy in the same location was consistent with her diagnosis, no further testing was performed. The patient was advised to apply topical diphenhydramine to her back 4 times daily for a 2-week trial. If the diphenhydramine failed to provide relief, the next step in her treatment would have been topical tacrolimus.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

This patient was given a diagnosis of erythema dyschromicum perstans (EDP), also known as ashy dermatosis because of the hyperpigmented macules that come together into confluent patches that look like burned wood. There is often an inflammatory erythematous aspect to EDP.

The etiology of EDP is unknown. It is not related to sun exposure and occurs most commonly on the trunk. Although there are case reports implicating medications or infections, no clear connection has been found. This patient’s chemotherapy may have been an inciting factor, based on her history, but it is not likely that cancer caused the EDP.

EDP tends to be chronic and difficult to treat. Fortunately, other than the itching and skin discoloration, it is usually asymptomatic and benign. Large-scale trials are lacking, but there are case reports showing benefit from narrow beam UVB treatments and topical tacrolimus.¹ Laser has not proven very helpful, and the hyperpigmentation can recur.

Based on the clinical appearance of this patient’s lesion, and the fact that a previous biopsy in the same location was consistent with her diagnosis, no further testing was performed. The patient was advised to apply topical diphenhydramine to her back 4 times daily for a 2-week trial. If the diphenhydramine failed to provide relief, the next step in her treatment would have been topical tacrolimus.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

This patient was given a diagnosis of erythema dyschromicum perstans (EDP), also known as ashy dermatosis because of the hyperpigmented macules that come together into confluent patches that look like burned wood. There is often an inflammatory erythematous aspect to EDP.

The etiology of EDP is unknown. It is not related to sun exposure and occurs most commonly on the trunk. Although there are case reports implicating medications or infections, no clear connection has been found. This patient’s chemotherapy may have been an inciting factor, based on her history, but it is not likely that cancer caused the EDP.

EDP tends to be chronic and difficult to treat. Fortunately, other than the itching and skin discoloration, it is usually asymptomatic and benign. Large-scale trials are lacking, but there are case reports showing benefit from narrow beam UVB treatments and topical tacrolimus.¹ Laser has not proven very helpful, and the hyperpigmentation can recur.

Based on the clinical appearance of this patient’s lesion, and the fact that a previous biopsy in the same location was consistent with her diagnosis, no further testing was performed. The patient was advised to apply topical diphenhydramine to her back 4 times daily for a 2-week trial. If the diphenhydramine failed to provide relief, the next step in her treatment would have been topical tacrolimus.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

State laws capping initial opioid prescriptions to 7 days or less have led to a reduction in opioid prescribing, a new analysis of Medicare data shows.

While overall opioid prescribing has decreased, the reduction in states with legislation restricting opioid prescribing was “significantly greater than in states without such legislation,” study investigator Michael Brenner, MD, University of Michigan, Ann Arbor, said in an interview.

The study was published online August 9 in JAMA Internal Medicine.
 

Significant but limited effect

Because of rising concern around the opioid crisis, 23 states representing 43% of the U.S. population passed laws from 2016 through 2018 limiting initial opioid prescription to 7 days or less.

Using Medicare data from 2013 through 2018, Dr. Brenner and colleagues conducted a before-and-after study to assess the effect of these laws.

They found that on average, the number of days an opioid was prescribed for each Medicare beneficiary decreased by 11.6 days (from 44.2 days in 2013 to 32.7 days in 2018) in states that imposed duration limits, compared with 10.1 days in states without these laws (from 43.4 days in 2013 to 33.3 days in 2018).

Prior to the start of duration limits in 2016, days an opioid was prescribed were comparable among states.

After adjusting for state-level differences in race, urbanization, median income, tobacco and alcohol use, serious mental illness, and other factors, state laws limiting opioid prescriptions to 7 days or less were associated with a reduction in prescribing of 1.7 days per enrollee, “suggesting a significant but limited outcome” for these laws, the researchers note.

The largest decrease in opioid prescribing occurred in primary care, but this was not significantly different in states with limit laws versus those without. However, state laws limiting duration led to a significant reduction in days of opioid prescribed among surgeons, dentists, pain specialists, and other specialists.
 

Inadequate pain control?

The researchers note the study was limited to Medicare beneficiaries; however, excess opioid prescribing is prevalent across all patient populations.

In addition, it’s not possible to tell from the data whether acute pain was adequately controlled with fewer pills.

“The question of adequacy of pain control is a crucial one that has been investigated extensively in prior work but was not possible to evaluate in this particular study,” said Dr. Brenner.

However, “ample evidence supports a role for reducing opioid prescribing and that such reduction can be achieved while ensuring that pain is adequately controlled with fewer pills,” he noted.

“A persistent misconception is that opioids are uniquely powerful and effective for controlling pain. Patients may perceive that effective analgesia is being withheld when opioids are not included in a regimen,” Dr. Brenner added.

“Yet, the evidence from meta-analyses derived from large numbers of randomized clinical trials finds that [nonsteroidal anti-inflammatory drugs] NSAIDS combined with acetaminophen provide similar or improved acute pain when compared to commonly prescribed opioid regimens, based on number-needed-to-treat analyses,” he added.

In a related editorial, Deborah Grady, MD, MPH, with University of California, San Francisco, and Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, say the decrease in opioid prescribing with duration limits was “small but probably meaningful.” 

Restricting initial prescriptions to seven or fewer days is “reasonable because patients with new onset of pain should be re-evaluated in a week if the pain continues,” they write. 

However, Dr. Grady and Dr. Katz “worry” that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as has occurred in six states, “may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief.”

In their view, the data from this study suggest that limiting initial prescriptions to seven or fewer days is “helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

The study had no specific funding. Dr. Brenner, Dr. Grady, and Dr. Katz have disclosed no relevant financial relationships.

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

State laws capping initial opioid prescriptions to 7 days or less have led to a reduction in opioid prescribing, a new analysis of Medicare data shows.

While overall opioid prescribing has decreased, the reduction in states with legislation restricting opioid prescribing was “significantly greater than in states without such legislation,” study investigator Michael Brenner, MD, University of Michigan, Ann Arbor, said in an interview.

The study was published online August 9 in JAMA Internal Medicine.
 

Significant but limited effect

Because of rising concern around the opioid crisis, 23 states representing 43% of the U.S. population passed laws from 2016 through 2018 limiting initial opioid prescription to 7 days or less.

Using Medicare data from 2013 through 2018, Dr. Brenner and colleagues conducted a before-and-after study to assess the effect of these laws.

They found that on average, the number of days an opioid was prescribed for each Medicare beneficiary decreased by 11.6 days (from 44.2 days in 2013 to 32.7 days in 2018) in states that imposed duration limits, compared with 10.1 days in states without these laws (from 43.4 days in 2013 to 33.3 days in 2018).

Prior to the start of duration limits in 2016, days an opioid was prescribed were comparable among states.

After adjusting for state-level differences in race, urbanization, median income, tobacco and alcohol use, serious mental illness, and other factors, state laws limiting opioid prescriptions to 7 days or less were associated with a reduction in prescribing of 1.7 days per enrollee, “suggesting a significant but limited outcome” for these laws, the researchers note.

The largest decrease in opioid prescribing occurred in primary care, but this was not significantly different in states with limit laws versus those without. However, state laws limiting duration led to a significant reduction in days of opioid prescribed among surgeons, dentists, pain specialists, and other specialists.
 

Inadequate pain control?

The researchers note the study was limited to Medicare beneficiaries; however, excess opioid prescribing is prevalent across all patient populations.

In addition, it’s not possible to tell from the data whether acute pain was adequately controlled with fewer pills.

“The question of adequacy of pain control is a crucial one that has been investigated extensively in prior work but was not possible to evaluate in this particular study,” said Dr. Brenner.

However, “ample evidence supports a role for reducing opioid prescribing and that such reduction can be achieved while ensuring that pain is adequately controlled with fewer pills,” he noted.

“A persistent misconception is that opioids are uniquely powerful and effective for controlling pain. Patients may perceive that effective analgesia is being withheld when opioids are not included in a regimen,” Dr. Brenner added.

“Yet, the evidence from meta-analyses derived from large numbers of randomized clinical trials finds that [nonsteroidal anti-inflammatory drugs] NSAIDS combined with acetaminophen provide similar or improved acute pain when compared to commonly prescribed opioid regimens, based on number-needed-to-treat analyses,” he added.

In a related editorial, Deborah Grady, MD, MPH, with University of California, San Francisco, and Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, say the decrease in opioid prescribing with duration limits was “small but probably meaningful.” 

Restricting initial prescriptions to seven or fewer days is “reasonable because patients with new onset of pain should be re-evaluated in a week if the pain continues,” they write. 

However, Dr. Grady and Dr. Katz “worry” that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as has occurred in six states, “may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief.”

In their view, the data from this study suggest that limiting initial prescriptions to seven or fewer days is “helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

The study had no specific funding. Dr. Brenner, Dr. Grady, and Dr. Katz have disclosed no relevant financial relationships.

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

State laws capping initial opioid prescriptions to 7 days or less have led to a reduction in opioid prescribing, a new analysis of Medicare data shows.

While overall opioid prescribing has decreased, the reduction in states with legislation restricting opioid prescribing was “significantly greater than in states without such legislation,” study investigator Michael Brenner, MD, University of Michigan, Ann Arbor, said in an interview.

The study was published online August 9 in JAMA Internal Medicine.
 

Significant but limited effect

Because of rising concern around the opioid crisis, 23 states representing 43% of the U.S. population passed laws from 2016 through 2018 limiting initial opioid prescription to 7 days or less.

Using Medicare data from 2013 through 2018, Dr. Brenner and colleagues conducted a before-and-after study to assess the effect of these laws.

They found that on average, the number of days an opioid was prescribed for each Medicare beneficiary decreased by 11.6 days (from 44.2 days in 2013 to 32.7 days in 2018) in states that imposed duration limits, compared with 10.1 days in states without these laws (from 43.4 days in 2013 to 33.3 days in 2018).

Prior to the start of duration limits in 2016, days an opioid was prescribed were comparable among states.

After adjusting for state-level differences in race, urbanization, median income, tobacco and alcohol use, serious mental illness, and other factors, state laws limiting opioid prescriptions to 7 days or less were associated with a reduction in prescribing of 1.7 days per enrollee, “suggesting a significant but limited outcome” for these laws, the researchers note.

The largest decrease in opioid prescribing occurred in primary care, but this was not significantly different in states with limit laws versus those without. However, state laws limiting duration led to a significant reduction in days of opioid prescribed among surgeons, dentists, pain specialists, and other specialists.
 

Inadequate pain control?

The researchers note the study was limited to Medicare beneficiaries; however, excess opioid prescribing is prevalent across all patient populations.

In addition, it’s not possible to tell from the data whether acute pain was adequately controlled with fewer pills.

“The question of adequacy of pain control is a crucial one that has been investigated extensively in prior work but was not possible to evaluate in this particular study,” said Dr. Brenner.

However, “ample evidence supports a role for reducing opioid prescribing and that such reduction can be achieved while ensuring that pain is adequately controlled with fewer pills,” he noted.

“A persistent misconception is that opioids are uniquely powerful and effective for controlling pain. Patients may perceive that effective analgesia is being withheld when opioids are not included in a regimen,” Dr. Brenner added.

“Yet, the evidence from meta-analyses derived from large numbers of randomized clinical trials finds that [nonsteroidal anti-inflammatory drugs] NSAIDS combined with acetaminophen provide similar or improved acute pain when compared to commonly prescribed opioid regimens, based on number-needed-to-treat analyses,” he added.

In a related editorial, Deborah Grady, MD, MPH, with University of California, San Francisco, and Mitchell H. Katz, MD, president and CEO of NYC Health + Hospitals, say the decrease in opioid prescribing with duration limits was “small but probably meaningful.” 

Restricting initial prescriptions to seven or fewer days is “reasonable because patients with new onset of pain should be re-evaluated in a week if the pain continues,” they write. 

However, Dr. Grady and Dr. Katz “worry” that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as has occurred in six states, “may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief.”

In their view, the data from this study suggest that limiting initial prescriptions to seven or fewer days is “helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

The study had no specific funding. Dr. Brenner, Dr. Grady, and Dr. Katz have disclosed no relevant financial relationships.

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