WEDNESDAY, June 26, 2002 (HealthDayNews) -- A medical trial involving a relative handful of patients could have major implications for the multitude of Americans who are taking low doses of aspirin to prevent heart disease and other conditions.
The trial, done by doctors at the University of Hong Kong, showed that giving a drug called a proton pump inhibitor can prevent stomach ulcers in people taking low-dose aspirin. The report appears in tomorrow's New England Journal of Medicine.
While that study included only high-risk patients -- those who had already had ulcers -- the results should draw attention from any doctor who has patients taking low-dose aspirin, says Dr. Harold Frucht, an associate professor of clinical medicine at the Columbia College of Physicians and Surgeons in New York City. As director of the institution's cancer prevention program, he has people taking low-dose aspirin to reduce the risk of colon cancer.
Anyone who takes aspirin for a prolonged period runs the risk of an ulcer, Frucht says, and the Hong Kong study offers the first practical method for reducing that risk.
"Our study demonstrated that for subjects who develop ulcers while taking low-dose aspirin, they can resume the aspirin -- which they need -- safely with much reduced risk of ulcer recurrence if they take a proton pump inhibitor together," says Dr. Kam Chuen Lai, leader of the Hong Kong group.
However, Frucht sees a much broader meaning.
"This paper will be huge," Frucht says. "There are a lot of people, especially elderly people, on low-dose aspirin. Most gastroenterologists right now probably will not put a person on proton pump inhibitor maintenance therapy to prevent an ulcer. When this paper comes out, it might change a lot of people's minds."
There are two possible caveats, Frucht says. One is scientific, since there was a small number of patients in the study. The other is economic, thanks to the high cost of proton pump drugs. Both are solvable, he says.
The Hong Kong study included only 123 patients, all of whom had ulcers while on low-dose aspirin therapy. The ulcers were cured by standard therapy, antibiotics to attack Heliobacter pylori, bacteria known to cause ulcers, but the patients remained at high risk of a recurrence.
The Hong Kong doctors devised two different treatments for the patients. All continued to take aspirin, while 62 of them also took lansoprazole, a proton pump inhibitor marketed as Prevacid, which reduces production of acid in the stomach. The other 61 patients took a placebo.
The doctors monitored both groups carefully. After a follow-up averaging one year, nine of the 61 patients in the placebo group had ulcer recurrences, compared to just one of the 62 patients in the lansoprazole group. The doctors then ended the trial, saying the beneficial effects of lansoprazole were so clear that it would be unethical to continue.
The small numbers are forgivable, Frucht says, because "these were patients most at risk, with the highest likelihood of developing ulcers. If you want to show statistical significance quickly, this is the group you would choose."
The economic drawback is the cost of proton pump inhibitor drugs, he says, but that could soon be solved.
"There are five on the market, and all are pretty much similar in action," Frucht says. "It is difficult to argue that one would be better than another. One of them will come off patent shortly, and should be available as a generic." That drug is omeprazole, whose brand name is Prilosec.
"We expect similar results for other proton pump inhibitors," Lai says.
A study including a large number of people at lower risk of ulcers would be desirable to prove the point, Frucht says, but "statistically, they [the Hong Kong researchers] now have done the job."
What To Do
You can learn more about this drug from the National Library of Medicine.
Try the American Heart Association to learn about aspirin as a heart disease preventive, and the National Institute of Diabetes and Digestive and Kidney Diseases for the lowdown on ulcers.
