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FDA advisory panel: Naproxen’s CV risk no less than other NSAIDs

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A panel of two FDA advisory committees voted 16-9 today against a conclusion that naproxen has a lower risk for cardiovascular thrombotic events compared with other nonsteroidal anti-inflammatory drugs.

“The committee is divided,” Tuhina Neogi, MD, PhD, associate professor of medicine and epidemiology, Boston University School of Medicine, and panel chairperson and member of the Arthritis Advisory Committee, said before the vote. “There are a number of individuals who feel that there is a preponderance of data that show a pattern that naproxen may have lower risk than other nonselective and selective [nonsteroidal anti-inflammatory drugs (NSAIDs)], and yet there are others who feel that the preponderance of evidence is largely based on observational data which have a number of bias issues that limit interpretability in terms of its validity.”

The FDA, which is not bound to advisory panel recommendations, will make a final decision at a later date.

The panel, which also included the Drug Safety and Risk Management Advisory Committee, had heard testimony from FDA speakers and industry representatives, as well as public input, on the cardiovascular (CV) safety of naproxen compared with other NSAIDs during the 2-day meeting.

The panel also voted 14-11 today in favor of a labeling question to reconsider advice regarding the latency of CV thrombotic risk. While current NSAID class labeling implies that CV thrombotic risk is not substantial with short treatment course, some studies have suggested there is no, or minimal latency period before the onset of CV thrombotic risk.

“Despite the split vote, everyone is saying the same thing, that no one should be interpreting that that there is a risk-free period,” Neogi summarized after the vote. “The purpose of the wording is to minimize whatever risk there is, such that you take it at the shortest period of time at the lowest dose.”

Earlier Tuesday, the panel heard from Garret FitzGerald, MD, Robert L. McNeil Jr. professor in Translational Medicine and Therapeutics, University of Pennsylvania, who spoke on the mechanistic basis for a CV hazard from NSAIDs.

Industry representatives, including Pfizer, Iroko Pharmaceuticals, Novartis Pharmaceuticals, Bayer HealthCare and McNeil Consumer Healthcare, presented study results assessing NSAIDs and CV safety Monday.

 

Steven E. Nissen

Steven E. Nissen, MD, MACC, chairman, cardiovascular medicine, Cleveland Clinic, presented data from the Prospective Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen (PRECISION), an ongoing study of 22,621 patients with osteoarthritis or rheumatoid arthritis randomly assigned treatment.

“The evidence suggests that celecoxib, naproxen and ibuprofen remain in equipoise,” according to research presented by Pfizer. “PRECISION will provide important information on three commonly used prescription NSAIDs.”

After Tuesday’s votes, panel members discussed any possible changes that should be made to the PRECISION trial and agreed it should continue.

CV risk is less likely in patients using naproxen compared with other NSAIDs, according to some speakers on Monday. Andrew D. Mosholder, MD, MPH, medical officer, Office of Pharmacovigilance and Epidemiology, Center for Drug Evaluation Research, FDA, said, while thrombotic CV risks by compound were confounded by dose, “lesser risks [are] generally seen with naproxen.”

Colin Baigent, BM, BCh, professor of epidemiology, University of Oxford, reported on a meta-analysis of randomized trials showing the cardiovascular and gastrointestinal effects of NSAIDs. He summarized that high-dose naproxen had lower major vascular event risk than other traditional NSAIDs, but “in patients on aspirin [eg, those at high vascular risk],” naproxen may interact with aspirin’s antiplatelet effect.”

“Naproxen has the most favorable risk profile” in a study of NSAIDs and CV risk, Gunnar H. Gislason, MD, PhD, FESC, FACC, cardiology professor, Copenhagen University Hospital Gentofte, reported in a presentation of results from nationwide cohort studies. – Bruce Thiel