Maintenance treatment with cimetidine in peptic ulcer disease for up to 4 years.

A multinational maintenance trial was conducted in 1842 peptic ulcer patients to investigate the efficacy and safety of continuous cimetidine maintenance therapy for up to 4 years. Patients with healed ulcers entered maintenance treatment with a 400-mg bedtime dose of cimetidine. Symptomatic ulcer relapse occurred in 17.2% of patients during the 1st year of treatment, in 9.6% during the 2nd year, and in 8.8% during the 3rd year. In addition to life-table analysis, the monthly prevalence of active ulceration over the 3-year period was examined. The average monthly prevalence rates were 2.1%, 1.8%, and 1.5% for the three successive yearly periods of continued cimetidine treatment. The adverse reactions observed in this study were not different from those previously reported with cimetidine. Moreover, there was a progressive decrease in the incidence of adverse events over the 4 years, thus establishing the long-term safety of continuous cimetidine treatment. It is concluded from this study that cimetidine maintenance treatment not only continues to be effective and safe beyond 1 year but also may reduce the risk of relapse over time.