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Title: Alendronate + NSAIDs Causes No Additional Upper Gastrointestinal Adverse Events for Osteoporosis Patients: Presented at DDW

"Alendronate + NSAIDs Causes No Additional Upper Gastrointestinal Adverse Events for Osteoporosis Patients: Presented at DDW"

By Ed Susman ORLANDO, FL -- May 22, 2003 -- The combination of bisphosphonates and non-steroidal anti-inflammatory drugs (NSAIDs) does not appear to increase the risk of upper gastrointestinal (GI) adverse events, even though these drug classes both are associated with such events. Richard Petruschke, PharmD, a senior medical researcher at Merck & Co., of West Point, Pennsylvania, and colleagues conducted a randomised, double-blind study in 48 centers in the US. He presented the findings of this study here on May 19th at Digestive Disease Week. Results show there were no adverse-event issues when alendronate or placebo was added to the regimens of patients being treated for osteoporosis who were also on an NSAID for arthritis. "We found that once weekly administration of 70 mg of alendronate was generally well tolerated and, when used concomitantly with NSAIDs, did not increase the rate of upper GI adverse events relative to placebo over a 3-month study period," stated. In his poster presentation, Dr. Petruschke noted, "Safety assessments of oral bisphosphonates have focused on upper GI adverse events because of the known potential for bisphosphonates to irritate the upper gastrointestinal mucosa. Similarly, NSAIDs may induce gastric-mucosa damage, and are frequently used by the same patient population." Dr. Petruschke and colleagues performed a subgroup analysis of the 450 individuals in the study and found that, of the 224 patients on alendronate, 11.2% had an upper GI adverse event. Similarly, of 226 patients on placebo, 13.4% experienced an upper GI adverse event. In the combination arms, among the 135 patients taking NSAIDs along with alendronate, 11.1% experienced an adverse event, while among the 122 patients taking placebo plus alendronate, 11.6% experienced an adverse event. None of the differences between the groups achieved statistical significance, Dr. Petruschke said. The DDW meeting was jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract. This study was funded by Merck & Co. [Study title: Upper Gastrointestinal Tolerability of Once-weekly Alendronate 70 mg with Concomitant NSAID Use. Abstract 106737]

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