CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

February 11th, 2014

FDA Advisers: Meta-Analysis Does Not Prove That Naproxen Carries Lower CV Risk

Data from a meta-analysis suggesting that naproxen carries lower cardiovascular risk than other nonsteroidal anti-inflammatory drug are not reliable, FDA advisers concluded on Tuesday. Consequently, they voted that naproxen should not get a new label based on those data, Reuters reports.

The meta-analysis, published in the Lancet in 2013, found that coxibs or diclofenac conferred increased risk for major vascular events, and ibuprofen showed increased risk for coronary events, relative to placebo. Meanwhile, no such risk increases were seen with naproxen.

The FDA advisers recommended that naproxen’s prescribing information stay as is until data from the PRECISION trial are available. That large, randomized trial is comparing naproxen with celecoxib or ibuprofen in patients with osteoarthritis or rheumatoid arthritis.

Originally published in Physician’s First Watch

Categories: Uncategorized


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One Response to “FDA Advisers: Meta-Analysis Does Not Prove That Naproxen Carries Lower CV Risk”

  1. Vasiliy Vlassov, MD says:
    February 14, 2014 at 1:33 am

    Interesting, that Reuters cited: “”Meta-analyses are good for raising questions but not settling them,” said panelist Dr. Sanjay Kaul, a cardiologist and professor at UCLA School of Medicine.” Impressive saying, but totally wrong.
    Raising questions as well as settling them is the human being’s privilege. The systematic reviews, employing meta-analysis or not, is the best tool to feed the human brain with trials’ data.