Bulletin Today
APhA staff
Oral gepotidacin could be treatment for uncomplicated urogenital gonorrhea
Findings from a study published May 3, 2025, in The Lancet demonstrate that oral gepotidacin is a noninferior and safe alternative to ceftriaxone plus azithromycin for uncomplicated urogenital gonorrhea.
Given gepotidacin’s proven viability in the treatment of uncomplicated UTIs, researchers investigated whether the antibacterial would be equally safe and effective for uncomplicated urogenital gonorrhea.
For the trial—EAGLE-1—patients aged 12 years and older were randomized 1:1 to the study drug or to I.M. ceftriaxone plus oral azithromycin. The primary endpoint was reported for 202 oral gepotidacin recipients and 204 combination therapy patients who made up the microbiological intent-to-treat population. This sample included participants who received at least one dose of treatment and had confirmed ceftriaxone-susceptible Neisseria gonorrhoeae detected in the culture of their urogenital specimen collected at the beginning of the study.
The primary outcome of microbiological success, or culture-confirmed bacterial eradication of N. gonorrhoeae from the urogenital body site by days 4 to 8, was achieved by 92.6% of the gepotidacin patients and 91.2% of the standard care group. There were more cases of adverse events—mostly gastrointestinal and also mostly mild or moderate in nature—in the gepotidacin treatment arm. ■
ACIP recommends expanded RSV vaccine use and new meningococcal and chikungunya vaccines
CDC’s ACIP voted in April 2025 in favor of qualifying more adults for vaccination against RSV. They want to expand the criteria to include individuals aged 50 to 59 years who are high risk.
Currently the RSV vaccine is recommended for adults aged 75 years and older or those aged 60 to 74 years with risk factors for acute illness.
Lung transplantation, chronic kidney disease, heart failure, and severe obesity are among the health conditions that would qualify patients in the new 50-to-59-year age range to get an RSV vaccine and have it covered by insurance, if CDC accepts the recommendation.
ACIP also recommended that CDC accept a new meningococcal vaccine from GSK and a chikungunya vaccine from Bavarian Nordic. The committee additionally agreed to modify a previous recommendation for Valneva’s vaccine against chikungunya, a mosquito-borne infection. ■
Study finds disparities in GLP-1 prescriptions for obesity
Low-income populations are more vulnerable to obesity, but researchers say systemic barriers prevent many eligible patients from getting GLP-1 receptor agonists, which are broadly associated with improved health outcomes.
In a research letter published on April 29, 2025, in JAMA, the authors examined nationwide EHRs within the Epic Cosmos Dataset, focusing on obese adults prescribed semaglutide or tirzepatide exclusively for weight loss—not diabetes—between July 2020 and October 2024. The analysis identified over 39 million eligible patients, yet just 2.3% received prescriptions. Those who did were younger and tended to have higher BMI. Prescription recipients also were more likely to be female than male; non-Hispanic white than Hispanic, non-Hispanic Asian, or non-Hispanic Black; and urban dwellers versus rural residents.
The authors attributed the low rate of uptake and the disparity in use along racial/ethnic lines to factors including tight qualifying criteria, limited insurance coverage, and financial burden.
“These findings highlight the need to monitor evolving prescribing patterns and explore strategies that ensure equitable access to these therapies as the evidence, policy, and reimbursement landscape evolves,” the authors wrote. ■
Study supports changes in inhaled steroid dispensing to children after Flovent withdrawal
Authors of a study published April 26, 2025, in JAMA, warn that the elimination of the cap on rebates to Medicaid may inadvertently lead to treatment disruptions, as illustrated in the case of fluticasone propionate (Flovent—GlaxoSmithKline).
For years, there was a ceiling in place for drugmaker payouts tied to prescription drug cost increases exceeding the rate of inflation, but the American Rescue Plan Act of 2021 rolled back that protection.
To escape higher rebates for Flovent, which had already undergone big price jumps, GSK took the brand-name asthma inhaler, popular with pediatric patients, off the market.
Although it still offered an authorized generic, many children reportedly were left without treatment, as their health insurance did not cover it or did so only at a high cost-sharing level.
Study investigators say their analysis of data from the fourth quarters of 2021, 2022, and 2023 support the anecdotal evidence. The likelihood of inhaled steroid therapy discontinuation was about 6 percentage points greater among 1.4 million children who used Flovent in the index quarters than among the 969,268 minors who used only the authorized generic of Flovent or other inhaled steroids during that period.
The finding was especially true for children younger than 5 years and those on Medicaid—two populations at high risk for asthma morbidity.
The study authors said measures must be taken to prevent treatment disruptions in the event that other brand-name drugs are withdrawn from the market to avoid rebates. ■
Does BP reduction have a role in dementia for those with uncontrolled hypertension?
Research findings published April 21, 2025, in Nature Medicine, suggest that intensive BP control reduced the risk of all-cause dementia in patients with hypertension.
The study involved nearly 34,000 patients aged 40 years and older with uncontrolled hypertension in rural China.
Researchers randomized 163 villages to a nonphysician community health care provider-led intervention while another 163 villages received usual care. The trained nonphysician community health care providers in the intervention group initiated and titrated antihypertensive medications following a simple stepped-care protocol to reach a goal of bringing patients’ BP below 130/80 mm Hg, with supervision from primary care physicians.
After 4 years, there was a 22.0 mm Hg net reduction in systolic BP in the intervention group, while the reduction for diastolic BP was 9.3 mm Hg compared with the usual care group.
All-cause dementia—the primary outcome—was significantly lower in the intervention group compared with the usual care group. Serious adverse events were also less common in the intervention group, the researchers said. ■
Varenicline plus counseling could help youth quit vaping
Young people who take varenicline plus engage in behavioral counseling are more likely to quit vaping compared with those who received a placebo, according to a research letter published April 23, 2025, in JAMA.
The randomized clinical trial included 261 individuals aged 16 to 25 years who self-reported nicotine vaping 5 or more days per week in the past 90 days and had interest in quitting or reducing vaping in the coming month.
Participants were randomized to receive 12 weeks of varenicline, weekly behavioral counseling, and referral to text messaging vaping cessation support; placebo, counseling, and referral to text messaging support; or the text support service alone.
Continuous abstinence rates in the last month of treatment were 51% and 14% in the varenicline and placebo groups, respectively, and they were 28% and 7%, respectively, at 6-month follow-up.
There were no significant differences in continuous abstinence rates between the placebo and text support only groups. Overall, varenicline was well tolerated by recipients.
While two varenicline recipients and one placebo recipient discontinued the medications due to adverse effects, there were no drug-related serious adverse events. There were also no significant differences in treatment-emergent adverse events between the groups. ■