EFFECT OF NORMALIZATION OF ESOPHAGEAL ACID REFLUX TIME ON RECURRENCE OF EROSIVE ESOPHAGITIS - RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF 2 DOSES OF FAMOTIDINE

Two hundred sixty-seven patients with healed erosive or ulcerative eso phagitis were enrolled in a double-blind, randomized, maintenance tria l comparing famotidine 20 and 40 mg BID with placebo, Endoscopies were scheduled at baseline and after 3 and 6 months of treatment. Unschedu led endoscopy was done if symptoms of moderate or greater severity rec urred for 3 consecutive days, Relapse rates at 6 months were 26% for p atients treated with famotidine 20 mg BID (n = 110) and 24% for those treated with famotidine 40 mg BID (n = 108), compared with 41% for pat ients receiving placebo (n = 49). The difference in relapse rates in t he famotidine 20 mg BID group and 40 mg BID group was statistically si gnificant compared with the placebo group (P = 0.012 and P = 0.010 for the famotidine 20-mg BID and 40-mg BID groups, respectively), Patient s also provided a global assessment of their symptoms relative to base line. As measured by the distribution of global assessment responses, patients in the famotidine groups experienced significantly less sympt omatic 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 patient s treated with famotidine 20 mg or 40 mg BID are less likely than plac ebo-treated patients to experience a recurrence of endoscopically veri fied erosive esophagitis and less likely to report worsening symptoms.