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DG DISPATCH - ASBMR: More Gastric Erosions With Low Dose Alendronate Than Risedronate By Cameron Johnston Special to DG News TORONTO, ON -- September 26, 2000 - Post-menopausal women who use alendronate (Fosamax, Merck) to prevent osteoporosis have almost four times the risk of developing gastric ulcers as those who use risedronate (Actonel, Proctor & Gamble). These are the results of a study presented at the American Society of Bone and Mineral Research (ASBMR) meeting being held this week in Toronto, Canada, and published in the journal Gastroenterology. Investigators at McMaster University, in Hamilton, Canada, found that ulcers occur in 69 percent fewer patients treated with risedronate compared with alendronate. Over a two-week period, 255 women who used risedronate and 260 who used alendronate were given endoscopic examinations at baseline, day 8 and day 15. To perform this many endoscopes on patients in such a short period of time demands an extremely dedicated population for the study, but also consumes an enormous amount in terms of healthcare resources, so the study should, by any standards, be considered significant, according to the researchers. The women received 5 mg per day of risedronate and 10 mg per day of alendronate, which are the standard maximum daily doses approved in most countries and recommended by the makers of each drug. "It’s during the first two weeks of the study that we think most of the adverse effects occur," according to John Marshall, MD, assistant professor in the department of gastroenterology at McMaster University, who explained how such an important study can be accomplished in just two weeks. While other notable trials with the two drugs have involved thousands of subjects and have lasted upward of four and five years, these were randomly controlled trials, Dr. Marshall explained, and were designed to search for different end points. To date there have been no long head-to-head trials looking at each of these drugs with respect to safety, efficacy or tolerability, he said. “This was an endoscopic study -- planned to look only for endoscopic GI (gastrointestinal) results as an end point,” he added. In the study, the overall incidence of gastric ulcers was 13.2 percent in the alendronate group as compared with 4.1 percent in the risedronate group. After one week of treatment, the incidence of ulcers was 8.7 percent in the alendronate group and 3.9 percent in the risedronate cohort. By the end of the study, the ulcer rate was 8.7 percent among patients using alendronate and 3.5 percent in those using risedronate. These figures, however, apply only to gastric erosions. Ultimately, there were no significant differences between the two drugs in the incidence of esophageal and duodenal lesions. "An osteoporosis medication -- long-term or otherwise -- can only work if a patient can tolerate the medication," Dr. Marshall said. "It will be exciting to see how the results of the endoscopy studies translate into differences in event rates and tolerability in clinical practice." Related links: Fosamax, Actonel, Merck & Co., Proctor & Gamble. E-mail this page to a friend or colleague! To print, use this version