Factors predicting relapse during maintenance treatment with famotidine in patients with healed reflux esophagitis. Dutch Esophagitis Study Group.

Little is known about possible predictive factors influencing the relapse rate in patients with healed reflux esophagitis during maintenance therapy with histamine2 (H2)-receptor antagonists. Therefore, the efficacy of famotidine 20 mg twice daily was evaluated in an open-label prospective study in 317 patients who had experienced healing of erosive reflux esophagitis after treatment with famotidine; 259 patients completed the study and were assessable according to study protocol. The cumulative endoscopic relapse rates at 4, 8, and 12 months were 20%, 30%, and 36%, respectively, according to the per-protocol analysis. The most predictive determinant of relapse was the duration of acute treatment required to achieve healing: Relapse occurred significantly less often in patients who experienced healing with 6 weeks of acute treatment than in those who experienced healing with 12 and 24 weeks of treatment. The second most important determinant was the initial endoscopic severity of the disease. Patients with initial grade I esophagitis had significantly fewer relapses. Relapse rate appeared to be unrelated to initial severity and duration of symptoms, smoking habits, or strength of acute treatment. The results showed that maintenance therapy with famotidine 20 mg twice daily is effective in a large proportion of patients with healed reflux esophagitis, with few adverse effects reported.