Newly Released Data Stirs Naproxen Debate

By Steven Reinberg
HealthDay Reporter
Friday, November 17, 2006; 12:00 AM

FRIDAY, Nov. 17 (HealthDay News) -- Just-released data from a trial that was stopped early in 2004 for safety reasons is re-igniting debate on the safety of two popular painkillers.

The trial suggested the over-the-counter painkiller Aleve boosted heart risks, while another controversial prescription painkiller known as Celebrex did not.

Now, the data from that trial has finally been made available. But that has not silenced one critic, who says this early data is unreliable and questions the reasons the trial was stopped prematurely.

"The trial was improperly stopped by what appears to be political considerations. When you do that, you generate data which we know is unreliable," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic Foundation.

Nissen is author of an accompanying commentary in the Nov. 17 online edition ofPLoS Clinical Trials, which has published the data from the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT).

Specifically, Nissen charges that ADAPT was cut short not on the advice of its safety-review board but by nervous officials at the U.S. National Institutes of Health, which had funded the trial. Those officials were worried about the media furor over the safety of now-withdrawn painkiller Vioxx, Nissen claims.

The medications in question all fall into the class of nonsteroidal anti-inflammatory drugs (NSAIDs), which include aspirin, naproxen, ibuprofen and cox-2 inhibitor medications such as Celebrex and the now-withdrawn Bextra and Vioxx.

Beginning in late 2004, major studies began to show that heart risks to users rose with long-term use of cox-2s. This led to the eventual withdrawal from the market of Vioxx and Bextra, and the U.S. Food and Drug Administration slapping a "black box" cardiovascular warning on the remaining cox-2, Celebrex.

In December of 2004, officials at the NIH announced the premature termination of the ADAPT trial, which had been set up to look at the possible usefulness of NSAIDs in preventing Alzheimer's disease.

Early results from that trial came as a surprise to many, because they suggested that long-term use of Celebrex didnotsignificantly boost heart risks, while the use of an over-the-counter rival, naproxen (Aleve), did.

"We ended up stopping the trial early, when another trial brought up some safety concerns about these drugs," said study author Barbara Martin, an assistant professor of epidemiology at Johns Hopkins Bloomberg School of Public Health.

"We found a small but not statistically significant risk with celecoxib, and a larger and statistically significant increased risk with naproxen," Martin said.

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