Alendronate Not Tied to Serious Upper GI Events.

NEW YORK -- Reassuring news regarding the gastrointestinal toxicity of oral alendronate was provided by multiple studies presented at the annual meeting of the American College of Gastroenterology.

Two large Merck-sponsored studies demonstrated that alendronate (Fosamax) wasn't associated with an increased risk of clinically relevant gastroduodenal ulcers. Moreover, osteoporosis appears to carry an intrinsically elevated risk of hospitalization for ulcers, perforations, and bleeding. This relationship may, in large part, account for the misperception that the use of alendronate is associated with a high risk of serious ulcers and their complications, according to Dr. Marc Hochberg, head of the division of rheumatology at the University of Maryland, Baltimore.

He presented a secondary analysis of upper GI safety data from the Fracture Intervention Trial in which 6,459 postmenopausal women with low bone mineral density were randomized to daily alendronate or placebo and followed for 3.8 years.

The overall incidence of upper GI complaints, most of which consisted of dyspepsia and abdominal pain, wasn't significantly different in the alendronate and placebo groups: 47.5% with alendronate vs. 46.2% with placebo. Hospitalization for perforations, ulcers, and bleeds occurred in 0.5% of alendronate-treated patients and 0.6% on placebo.

Furthermore, alendronate use in the Fracture Intervention Trial wasn't associated with an increase in upper GI tract events, even among subsets of women known to be at increased risk for such events, specifically those who are older than age 75, those who use nonsteroidal anti-inflammatory agents, or those with a history of upper GI disease.

Dr. Hochberg also presented highlights from a new retrospective cohort study involving roughly 24,000 women ...