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Alendronate May Multiply Risk Of Gastric Ulcer In Naproxen-Taking Patients
Doctor's
Guide By Andrew Bowser PHOENIX, AZ -- October 19, 1999 -- Alendronate (Fosamax) may work synergistically with nonsteroidal anti-inflammatory drugs (NSAIDs) to produce gastric ulcers, according to the results of a single-center trial of healthy volunteers suggests.
The results of the study were presented yesterday (Oct. 18) at the American College of Gastroenterology, in Phoenix, AZ. In the study, investigators randomized 26 volunteers age 30 and older to 10 day regimens of alendronate 10 mg/day, naproxen 500 mg twice daily and the combination in a cross-over fashion with one to four week washout periods between treatments. Endoscopists, who were blinded to the treatment, used video endoscopy before and after the treatment to evaluate the degree of mucosal damage to the esophagus, stomach and duodenal bulb, both before and after treatment. They found gastric ulcers in 10 patients following administration of the alendronate-naproxen combination, compared with only two of the volunteers who received alendronate alone and three who received naproxen alone. The difference in ulcer incidence between those who got the combination and those who got either one alone was significant (p = 0.05). In addition, alendronate plus naproxen was poorly tolerated, with 69 percent of the volunteers being treated reporting side effects, compared with 23 percent of those given naproxen and 54 percent of those given alendronate. While those findings are compelling, the study is small, and some large epidemiologic studies have not shown an increase in frequency of peptic ulcer disease complications with alendronate or alendronate plus NSAIDS. "These data will eventually have to be put into perspective but, until then, one should use the combination with caution," said Dr. David Y. Graham of Baylor College of Medicine in Houston, Texas, USA. "Possibly the use of a COX-2 inhibitor would be safer if one wished to use an NSAID with alendronate."
Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved
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