Alvi A. Rahman, from McGill University in Montreal, Quebec, and colleagues examined whether gabapentinoid use is associated with severe exacerbation in patients with COPD in a propensity score-matched, new-user cohort study. Within a base cohort of COPD patients, those initiating gabapentinoid therapy with an indication were matched with nonusers. The cohort included 356 gabapentinoid users with epilepsy, 9,411 with neuropathic pain, and 3,737 with other chronic pain who were matched to nonusers in a 1:1 ratio.

The researchers found that gabapentinoid use was associated with an increased risk for severe COPD exacerbations compared with nonuse overall (hazard ratio, 1.39) and across the indications of epilepsy, neuropathic pain, and other chronic pain (hazard ratios, 1.58, 1.35 and 1.49, respectively).

“These findings support the warnings from regulatory agencies and highlight the importance of considering this potential risk when prescribing gabapentin and pregabalin to patients with COPD,” the authors write.

The study was partially supported by a grant from Boehringer Ingelheim.

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Still, the agency noted officials cannot rule out that “a small risk may exist,” and it will continue to look into similar reports involving these glucagon-like peptide-1 receptor agonists.

The FDA review comes on the heels of a study funded by the National Institutes of Health that showed people taking semaglutide had a lower risk for suicidal thoughts than those taking other drugs to treat obesity and diabetes. In that study, researchers tracked more than 240,000 obese people and more than 1.5 million people with type 2 diabetes. They looked at the risk for suicidal ideation within six months of starting the medicines, as well as at later times.

At six months, the researchers found that among people taking the drug for weight loss, semaglutide was linked to a 73% lower risk for first-time suicidal ideation and a 56% lower risk for recurrent suicidal ideation. The drugs to which semaglutide was compared included bupropion, naltrexone, orlistat, topiramate and phentermine. For people with type 2 diabetes, the reductions were 64 and 49%, respectively. Here, the drugs to which semaglutide was compared included insulin, metformin, dipeptidyl peptidase 4 inhibitors, and sodium-glucose cotransporter 2 inhibitors.

Even though semaglutide was associated with a lower risk for suicidal ideation in the NIH study, the investigators wrote in a research briefing that the data “do not yet justify off-label treatment” for suicidal thoughts.

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Odeya Barayev, MD, from Ben Gurion University of the Negev in Be’er Sheva, Israel, and colleagues evaluated whether new statin use was associated with a lower risk for mortality or MACE among adults older than 65 years with CKD stages 3 to 4 and no history of ASCVD. The analysis included data from 14,828 U.S. veterans.

The researchers found that risk for all-cause mortality was lower among participants initiating statins versus noninitiators (hazard ratio, 0.91; 95% confidence interval, 0.85 to 0.97). There was a trend observed toward a lower risk for MACE (hazard ratio, 0.96; 95% confidence interval, 0.91 to 1.02). Results persisted in prespecified subgroup analyses.

“Among US veterans older than 65 years with CKD stages 3 to 4 and no prior ASCVD, statin initiation was associated with a lower risk of all-cause mortality compared with no statin initiation. Results should be confirmed in a randomized clinical trial,” the authors write. “However, until such trials are completed, these data argue against withholding or deprescribing statins for primary prevention in older patients with CKD stages 3 to 4.”

Several authors disclosed financial ties to Novartis; one author disclosed ties to Anthos Therapeutics.

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US residents can now buy directly from Canadian pharmacies out of their own pockets, but state Medicaid programs have not been allowed to purchase medications in bulk from Canada. On average, US drug prices are more than double those found in Canada, according to a Rand Corp. analysis. Brand-name drugs are even more expensive, with US prices nearly triple those of Canadian prices, the report adds.

Florida says it could save up to $150 million in the first year of the program by importing medicines that treat HIV, AIDS, diabetes, hepatitis C, mental health disorders and other conditions, the state claimed in a lawsuit filed against the FDA regarding its proposed importation program.

FDA Commissioner Robert Califf, MD, said in a statement issued Friday that his agency is “committed to working with states and Indian tribes” that want to develop similar importation programs. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” he noted.

However, Florida and other states still face hurdles before cheaper drugs can start shipping across the border. The Florida program will need to submit separate requests to the FDA for each prescription drug it wants to import, showing that it can maintain the integrity of the supply chain. The state must show that the drugs brought in from Canada are as effective as US-made medications, and that FDA-approved labels will be added to the medications before they are made available to patients.

The FDA approval is also expected to draw legal challenges from drugmakers, most likely by the lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA). The group has sued over previous efforts to import cheaper drugs from other countries. “We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan. Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” PhRMA president and CEO Stephen Ubl said in a statement Friday. “Politicians need to stop getting between Americans and their healthcare. PhRMA is considering all options for preventing this policy from harming patients.”

In addition, Canada has expressed reservations about its drug supply being co-opted by the United States. “Canada’s drug supply is too small to meet the demands of both American and Canadian consumers,” Maryse Durette, a spokeswoman for Health Canada, told The New York Times. “Bulk importation will not provide an effective solution to the problem of high drug prices in the US”

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Matthew S. Durstenfeld, MD, from the University of California in San Francisco, and colleagues conducted an observational cohort study involving 100,000 participants to examine whether nirmatrelvir treatment during acute SARS-CoV-2 infection reduces the risk for developing long COVID. A total of 4,684 individuals met the eligibility criteria: 21.1% were treated and 78.9% were untreated. Overall, 353 of 988 treated and 1,258 of 3,696 untreated participants responded to a survey regarding long COVID.

The researchers found that nirmatrelvir treatment was not associated with subsequent symptoms of long COVID at 5.4 ± 1.3 months after infection (odds ratio, 1.15; 95% confidence interval, 0.80 to 1.64; P = 0.45). Rebound symptoms or test positivity were not associated with symptoms of long COVID among the 666 treated individuals who answered the rebound questions (odds ratio, 1.34; 95% confidence interval, 0.74 to 2.41; P = 0.33).

“Our finding that Paxlovid treatment during acute infection is not associated with lower odds of long COVID surprised us, but it is consistent with two other rigorously conducted studies finding no difference in post-COVID conditions between four and six months after infection,” Durstenfeld said in a statement.

One author disclosed serving as a consultant for AstraZeneca and Gilead Sciences.

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Ying Huang, MD, PhD, from the Mayo Clinic in Rochester, MN, and colleagues compared all-cause mortality and thromboembolic events in patients undergoing sAVR receiving anticoagulation with warfarin (≥30 days of continuous prescription coverage after sAVR) versus patients with no systemic anticoagulation. The analysis included 10,589 adult patients having bioprosthetic sAVR with or without coronary artery bypass from 2007 through 2019 (2,930 pairs of propensity score-matched patients).

The researchers found that overall mortality was lower for the warfarin group than for the nonwarfarin group (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.47 to 1.00; P = 0.047). There was also a trend toward a decreased cumulative incidence of thromboembolic events (subdistribution HR [SHR], 0.62; 95% CI, 0.35 to 1.07; P = 0.09). For major bleeding events, cumulative incidence was higher for the warfarin group versus the nonwarfarin group (SHR, 1.94; 95% CI, 1.28 to 2.94; P = 0.002). In a subgroup analysis of patients undergoing isolated sAVR, results were similar.

“Our research finds that the small increased hazard of bleeding (4% versus 2.3%) may be an acceptable risk given the benefits in terms of mortality risk as well as reduced risk of thromboembolism,” coauthor Hartzell Schaff, MD, also from the Mayo Clinic, said in a statement.

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Anne C. Fernandez, PhD, from the University of Michigan in Ann Arbor, and colleagues used data from the January 2021 National Poll on Healthy Aging, which asked 2,023 US adults ages 50 to 80 years about past-year cannabis use, to identify demographic characteristics associated with cannabis use.

The researchers found that 12.1% reported cannabis use in the past year. Among those who reported cannabis use, more than one-third (34.2%) reported using cannabis products four or more days per week. Cannabis use was found to be less likely among people who identified as Hispanic ethnicity or as “other” races versus non-Hispanic white participants, while cannabis use was found to be more likely among unmarried/unpartnered and unemployed respondents. Alcohol consumption was also associated with an increased likelihood of cannabis use.

“As the stress of the pandemic and the increased legalization of cannabis by states converged, our findings suggest cannabis use increased among older adults nationally,” Fernandez said in a statement. “Older adults represent a vulnerable age group for cannabis use due to interactions with medications, risky driving, cannabis-related mental health impacts and increased possibility of falls and memory issues.”

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Fumiki Yoshihara, from the National Cerebral and Cardiovascular Center in Osaka, Japan, and colleagues conducted a multicenter, randomized trial that enrolled patients at 18 medical facilities in Japan to examine the effects of dapagliflozin on UACR in patients with heart failure and T2D. Eligible participants were randomly assigned to a dapagliflozin or control group in a 1:1 ratio (146 and 148 patients, respectively).

At the end of the observation period, 107 patients (87.7%) were taking 5 mg dapagliflozin daily. The researchers observed no significant difference in the primary outcome of changes in UACR from baseline after a two-year observation between the dapagliflozin and control groups. Among the secondary end points, the dapagliflozin group had a larger mean decrease in left ventricular end-diastolic dimensions as one of the echocardiographic parameters. Compared with the control group, the dapagliflozin group had the composite end point less often, defined as cardiovascular death or hospitalization for cardiovascular events, hospitalization for heart failure events, hospitalization for all causes, and an additional change in prescriptions for heart failure in a two-year observation.

“The results obtained on the primary end point revealed no significant difference in renal dysfunction judged by UACR between the dapagliflozin and control groups, which is in contrast to previous findings from three randomized controlled trials,” the authors write.

Several authors disclosed ties to biopharmaceutical companies, including AstraZeneca and Ono Pharmaceuticals, which partially funded the study.

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When announcing the new drug application (NDA) filing on Tuesday, MAPS Public Benefit Corp. noted it has been studying the drug for this use for years. The FDA has 60 days to decide whether MDMA will be accepted for review and whether it will be fast-tracked through the approval process, the company said. The drug would be given in concert with talk therapy.

“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” MAPS CEO Amy Emerson said in a company news release. “If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health.”

Back in 2017, the FDA granted MDMA-assisted therapy a breakthrough therapy designation. The MDMA application included data on two studies, with 90 and 104 participants, respectively, that showed MDMA significantly reduced symptoms and impairment associated with PTSD when compared with a placebo. MAPS added that it has now completed a total of six late-stage clinical trials testing MDMA for PTSD.

If the FDA approves MDMA for this purpose, it would need to be rescheduled, MAPS noted, because it is a schedule I drug under the Controlled Substances Act, which the US Drug Enforcement Administration defines as having no accepted medical use.

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More than four out of five older adults (83%) think insurance companies should pay for drugs that help people with obesity manage their weight, according to poll results from more than 2,600 people ages 50 to 80 years.

A 2003 law currently prohibits Medicare from covering medications specifically for weight loss, although the federal insurance program can cover drugs that help people with type 2 diabetes manage their weight, researchers said in background notes.

In the poll, researchers found wide interest among older adults for using weight-loss drugs to drop extra pounds. About one in four poll respondents said they are overweight, and 63% of them are interested in taking a weight-loss medication. So are 45% of those who have diabetes, regardless of their weight. The drugs appear to make a good impression as well. Among those who had ever taken a weight-loss medication, 83% said they would do so again.

Poll results show that Ozempic/Wegovy has largely driven this new interest in weight-loss medications. The poll revealed that 61% of older adults had heard of the diabetes drug Ozempic, but only 18% had heard of the version approved specifically for weight loss, Wegovy. Other weight-loss drugs were much less familiar to poll respondents. Only 13% had heard of an older drug called phentermine, and just 3% had heard of Qsymia, Saxenda or Contrave.

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