In this manufacturer-funded trial, 404 patients starting ASA (dose range 75mg-325mg) underwent baseline and 12-week endoscopy, and were randomized to placebo or famotidine 20mg BID. At 12 weeks, the famotidine group had significantly fewer gastric ulcers (3% vs 15%), duodenal ulcers (1% vs 9%), and erosive esophagitis (4% vs 19%) compared to placebo. Famotidine is an effective strategy to prevent ASA-associated ulcers/esophagitis (abstract).
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Considering that patients were endoscopically screened at the end of the study, looking for the presence of esophageal, gastric and duodenal mucosa alterations, there is a considerable possibility that the investigators diagnosed clinically non-significant complications. This study looks very well designed but it shouldn’t be used yet to guide clinical decisions. Clinicians should wait for a study powered to detect clinically significant complications.
Daniel Capurro, MD.