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

Abstract 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 ⩽ 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.