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James Keagy 2321

News roundup

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Is buprenorphine or methadone better for opioid use disorder in pregnancy?

Authors of a new study published in the New England Journal of Medicine compared outcomes in pregnant patients with opioid use disorder based on whether they received opioid agonist therapy with buprenorphine as opposed to methadone.

The dataset included more than 2.5 million pregnancies in the Medicaid population that resulted in live births from 2000 to 2018, and it found a similar risk for unfavorable outcomes in the mothers regardless of treatment agent received. However, the risk for adverse outcomes in the newborn babies—including neonatal abstinence syndrome, preterm birth, low birthweight, and small size for gestational age—was lower with buprenorphine than with methadone.

The study authors acknowledge that they do not yet know the biological mechanism underlying the differences between the treatment options, but they suspect that “differences in the pharmacologic mechanism of action” between the partial agonist buprenorphine and the full agonist methadone may come into play.

The National Institute on Drug Abuse sponsored the study.  ■

FDA grants fast track approval for OTC nasal spray

FDA has reportedly put an OTC version of naloxone nasal spray (Narcan—Emergent BioSolutions) on the fast track to approval.

Through the agency’s priority review process, the opioid overdose antidote tentatively could receive clearance early this spring. If so, Emergent BioSolutions would be the first of several makers to get a green light in response to regulators’ call for OTC formulations of overdose-reversal agents, which are needed to counter a surge in overdoses due to counterfeit fentanyl.

FDA informed prescription drug manufacturers in November 2022 that once enough data are available to support approval of a nonprescription naloxone product, any clinically comparable products sold only with a physician’s order would be viewed as mislabeled. Per the vision of FDA Commissioner Robert Califf, MD, naloxone should be as commonplace and accessible as defibrillators.  ■

Shingles may increase risk for stroke, heart attack

A new study published in the Journal of the American Heart Association found that shingles, also known as herpes zoster, is associated with an almost 30% higher long-term risk of major cardiovascular events such as stroke or heart attack.

Researchers from Brigham and Women’s Hospital in Boston conducted a large longitudinal study of more than 200,000 U.S. men and women who did not have a prior history of stroke or coronary heart disease.

The team collected information on shingles, stroke, and coronary heart disease using questionnaires collected every 2 years and confirmed the diagnoses with a medical record review.

Researchers followed the participants for up to 16 years and evaluated whether those who had developed shingles were at higher risk for stroke or coronary heart disease years after the shingles episode. They found that elevated risk may persist for 12 years or more after developing shingles. The researchers tracked incidences of stroke and coronary heart disease. They also evaluated a combined outcome of CVD, which included either stroke or coronary heart disease, whichever came first.

Additionally, they found that the risk may be greater among those with immunocompromising conditions or for those taking immunosuppressing treatments.

“Our findings suggest there are long-term implications of shingles and highlight the importance of public health efforts for prevention,” said lead author Sharon Curhan, MD, from Brigham and Women’s Hospital, in a news release. “Given the growing number of Americans at risk for this painful and often disabling disease and the availability of an effective vaccine, shingles vaccination could provide a valuable opportunity to reduce the burden of shingles and reduce the risk of subsequent cardiovascular complications.”

Due to timing, much of the study took place in the period before the shingles vaccines became widely available. Even after its introduction, the uptake of this vaccination has been generally low. Because of these limitations, researchers were not able to evaluate whether vaccination status may influence the association of shingles and long-term risk of a major cardiovascular event.

“We are currently collecting vaccination information among our participants and hope to conduct these studies in the future,” said Curhan.

As more people choose to receive the shingles vaccine, future studies could examine whether vaccination influences the relation of shingles to the risk of CVD.  ■

Study finds benzodiazepines for sleep increased overdose risk for young adults

New findings from a recent study in JAMA Network Open suggest that benzodiazepines—compared with alternative pharmacologic treatments for common sleep disorders—were associated with an increased risk of drug overdose among young people, especially those with a recent opioid prescription.


The cohort study included privately insured people ages 10 to 29 years identified from a U.S. commercial claims database. Of the 23,084 young people initiating benzodiazepine treatment and the 66,706 initiating a comparator treatment, the risk of drug overdose in the 6 months after treatment start was elevated for young people starting benzodiazepine treatment compared with alternative treatments (e.g., trazodone, hydroxyzine, zolpidem, zaleplon, and eszopiclone) for sleep disorders. This risk was further heightened for young people with a recent opioid prescription, according to the results.

Although benzodiazepines are commonly prescribed, even for young people, they are recommended less frequently for insomnia among children than among adults given the lack of efficacy and safety data for younger age groups. When benzodiazepines are prescribed for any age group, short-term treatment is recommended.

“Drug overdose is an important safety consideration when treating young people with benzodiazepines,” noted the study authors.   ■

Recovering COVID patients seem to have elevated risk for newly diagnosed diabetes

A new study in BMC Medicine found that people recovering from COVID-19 are at a higher risk of being newly diagnosed with diabetes.

The finding is based on a meta-analysis of 9 studies that included nearly 40 million participants, the largest study of its kind.

Researchers identified nearly 200,000 diabetes cases, estimating a post–COVID-19 incidence per 1,000 person-years of 15.53 and a relative risk of 1.62 compared with individuals who were not infected with COVID-19. The increased risk continued based on age, gender, type of diabetes, follow-up time, and COVID-19 severity, and it was significant even when the authors took undisclosed confounding into account.

Findings from the study also indicate a 20% higher risk for developing diabetes following COVID-19 compared with patients with other upper respiratory viruses, and an 82% increased risk compared with the general population.

Possible reasons for the higher risk include the effect of SARS-CoV-2 on pancreatic cells and the cytokine storm in people with excessive immune responses. The researchers said the findings underscore the need for health care providers to monitor patients’ glucose metabolism during the post-acute phase of COVID-19, in particular during the first 3 months following infection.   ■



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