A disputed government study of common painkillers found that naproxen increased the risk of heart attack and other cardiovascular events compared with a fake pill, according to data published yesterday, nearly two years after the study was halted.
The study's results relate to whether naproxen, which is sold over the counter as Aleve by Bayer AG of Germany, is as safe as is commonly believed. The results didn't point to a clear conclusion. The class of drugs to which naproxen belongs is generally considered to carry some heightened cardiovascular risks. This study's results "provide some support" for that theory, the study's authors wrote, but added that "the measure of this risk remains a matter of speculation."
Bayer said in a statement the "overwhelming body of scientific evidence" supports naproxen's safety. The company also noted the study involved long-term use of naproxen to ward off Alzheimer's disease, which isn't consistent with Aleve's intended use as a short-term pain reliever.
The study found the cardiovascular risk of Pfizer Inc.'s Celebrex painkiller wasn't meaningfully higher than that associated with a fake pill, or placebo.
The detailed data published for the first time yesterday showed that about 2,500 seniors across the U.S. participated in the study. Those on naproxen experienced cardiovascular death, heart attack, stroke, congestive heart failure and transient ischemic attack at a rate 63% higher than those in the placebo group. Those on Celebrex had a 10% greater risk of such events than in the placebo group.
The results were published online by Public Library of Science, a San Francisco nonprofit group. The results were more detailed than findings cited in the government's announcement of the study's halt in December 2004.
The study's authors cautioned that the naproxen data weren't definitive due to the study's early termination. A leading cardiologist blasted the findings, accusing the National Institutes of Health of improperly terminating the study and making it impossible to interpret the results reliably.
The suggestion of a heart risk for naproxen runs counter to previous studies indicating it is among the safest on the heart of all nonsteroidal anti-inflammatory drugs, or NSAIDs, a class of drugs that include ibuprofen and diclofenac. The dispute surrounding the NIH study likely means the debate about the heart risks of NSAIDs will continue. The debate gained full force after Merck & Co. pulled its Vioxx painkiller from the market in 2004 over cardiovascular-safety concerns.
The NIH's National Institute on Aging started the Alzheimer's Disease Anti-Inflammatory Prevention Trial, or Adapt, in 2001 to test whether naproxen and Celebrex were effective in preventing Alzheimer's dementia or delaying cognitive decline in elderly people. Both drugs were compared with a placebo. Merck pulled Vioxx off the market after it was linked to elevated risks of cardiovascular events. As concern increased about the safety of drugs related to Vioxx, including Celebrex, a number of studies that included them were halted -- including the Adapt trial.
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