Effect of normalization of esophageal acid reflux time on recurrence of erosive esophagitis: randomized, placebo-controlled trial of two doses of famotidine

Two hundred sixty-seven patients with healed erosive or ulcerative esophagitis were enrolled in a double-blind, randomized, maintenance trial comparing famotidine 20 and 40 mg BID with placebo, Endoscopies were scheduled at baseline and after 3 and 6 months of treatment. Unscheduled endoscopy was done if symptoms of moderate or greater severity recurred for 3 consecutive days, Relapse rates at 6 months were 26% for patients treated with famotidine 20 mg BID (n = 110) and 24% for those treated with famotidine 40 mg BID (n = 108), compared with 41% for patients receiving placebo (n = 49). The difference in relapse rates in the famotidine 20 mg BID group and 40 mg BID group was statistically significant compared with the placebo group (P = 0.012 and P = 0.010 for the famotidine 20-mg BID and 40-mg BID groups, respectively), Patients also provided a global assessment of their symptoms relative to baseline. As measured by the distribution of global assessment responses, patients in the famotidine groups experienced significantly less symptomatic deterioration at 3 and 6 months (P less than or equal to 0.05) than did those in the placebo group, The results indicate that patients treated with famotidine 20 mg or 40 mg BID are less likely than placebo-treated patients to experience a recurrence of endoscopically verified erosive esophagitis and less likely to report worsening symptoms.