BOSTON - Plavix, a heart drug recommended by medical groups as an easy-on-the-stomach substitute for aspirin, instead showed a much higher risk of recurrent ulcers in a small but provocative study.
The study could upend the treatment guidelines for tens of thousands of Americans who must take anticlotting drugs for their hearts but are prone to gastrointestinal problems.
"These are very surprising findings, because the conventional wisdom is that Plavix is a GI-safe medicine - or I should say "has been' a GI-safe medicine," said Dr. Byron Cryer of the University of Texas Southwestern Medical School and Veterans Affairs hospital in Dallas.
He said he has stopped prescribing Plavix to his own patients who have a high risk of ulcers, but believes the drug is still safe for others. He said the U.S. guidelines for Plavix should be re-evaluated.
He wrote an editorial to accompany the study, published in today's New England Journal of Medicine.
The findings, reached by Hong Kong researchers, come as a surprise because Plavix was gentle on the stomach in previous testing. However, the patients in earlier research had a normal ulcer risk overall. This study looked at patients who had already had an ulcer.
An estimated 50-million Americans take aspirin, the inexpensive old standby, to ward off heart attacks and strokes. But aspirin can cause bleeding, ulcers or other stomach problems in perhaps a third of users.
Plavix is recommended as an alternative by the American Heart Association and American College of Cardiology. It was the 12th best-selling prescription drug in the United States in 2003, at $2.2-billion.