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New Pain Pills: Not Easier to Stomach?

Stomach-Protecting Pills May Be Best Way to Avoid Painkillers' Side Effect
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WebMD Health News

Dec. 1, 2005 - The new generation of pain drugs is supposed to be easier on the stomach. But new data suggest that older pain drugs plus stomach-protecting drugs work better.

Newer pain drugs are called Cox-2 inhibitors. The family includes Vioxx, Bextra, and Celebrex. The drugs became widely popular because they were supposed to be safer than older pain drugs -- traditional non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen. Ironically, Vioxx and Bextra were pulled from the market due to rare but potentially deadly heart side effects.

Yet clinical trials have shown that the Cox-2 inhibitors caused less stomach bleeding than the traditional NSAIDs. Now a new study -- which focused mainly on Vioxx -- shows that patients taking Cox-2 inhibitors had no fewer stomach bleeds or ulcers than those taking traditional NSAIDs.

The study appears in the Dec. 3 issue of BMJ.

Stomach-Protecting Drugs

The news isn't all bad, however. The researchers found that patients taking any kind of NSAID were able to avoid stomach bleeding and ulcers simply by combining them with stomach-protecting drugs.

Julia Hippisley-Cox, MD, and colleagues gathered information on 9,407 U.K. patients who suffered stomach bleeding or ulcers. They matched these patients to nearly 89,000 patients who didn't have stomach problems.

Patients were about one-and-a-half to two times more likely to have stomach problems if they were taking naproxen, aspirin, Vioxx, or ibuprofen. They did not find any stomach problems with Celebrex. But the study researchers downplay this finding because so few of the patients -- all treated between July 2000 and August 2004 -- took Celebrex.

Role of Cox-2 Drugs

But Cox-2 expert A. Mark Fendrick, MD, suggests that the patients who were given Cox-2 drugs had a higher risk of stomach problems to start with. Fendrick is professor of internal medicine and of health management and policy at the University of Michigan.

Patients with previous stomach problems are often given Cox-2 inhibitors instead of traditional NSAIDs. This could have skewed the findings, says Fendrick. "You could argue that the Cox-2 drugs were slightly better," he tells WebMD.

And a recent study found that doctors tend to prescribe Cox-2 drugs to patients who have a higher risk of stomach bleeds, says Harvard rheumatologist Lee Stuart Simon, MD. Simon recently finished a four-year stint as director of the branch of the FDA that monitors both the Cox-2 drugs and traditional NSAIDs.

"The question is, if a patient has pain and has a gastrointestinal risk -- beginning with age over 60, and then past history of ulcer, other drugs that cause bleeding risk, or being very frail and sick -- taking an NSAID adds up to a significant risk," Simon tells WebMD. "So if I saw a patient like that I would choose a [Cox-2 inhibitor] over a traditional NSAID."

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