Maintenance Treatment with Cimetidine in Peptic Ulcer Disease for Up to 4 Years

Abstract

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.

Maintenance Treatment with H₂Receptor Antagonists for Duodenal Ulcer Disease: Toward a Rational Use

“…Several studies have investigated whether a period of maintenance treatment might be followed by a long-lasting resistance to relapse [12,21]. The results have usually been negative: maintenance treatment was protective only as long as treatment lasted [12,22,23], One large international study [20], however, has recently found a different result. After a relapse-free period of 2 years, patients treated with cimetidine were reallo cated to placebo.…”

“…receptor antagonists and placebo might therefore result more from differences in symptom relief and rehealing rates than from an actual difference in the number of recur rences, though this question is controversial [17], There is reason to think that the rela tively high proportion of asymptomatic recur rences may be a consequence of maintenance The probability of symptomatic ulcer relapse and the risk of asymptomatic reulceration are calculated using standard life table analysis. 1 From Bardhan et al [7], 2 From Walan et al [20], therapy, since the effect is dose related: higher maintenance doses yield a greater proportion of asymptomatic recurrences, without further decreasing the total recurrence rate [ 18].…”

“…The safety of long-term maintenance treatment has been examined in several trials of patients who took cimetidine 400 mg [ 11,20] or rani tidine 150 mg [31] at bedtime for 3-6 years, none of them finding new adverse effects with prolonged therapy. Long-term studies of the safety of famotidine and nizatidine have not yet been published, and certainly lifelong therapy with any drug will require close moni toring.…”

Prescribing Policy for Antiulcer Treatment in the Elderly

“…Most data come from indirect observations based on analysis of risk factors for recurrence in ulcer patients not selected by age (Bardhan et al 1988b;Bianchi Porro & Parente 1991;Lee et al 1991;Penston & W ormsley 1989;Sonnenberg et al 1981;Walan et al 1987), and which do not in-clude old age among the causes of ulcer recurrence. There are also some interesting but scanty results of studies carried out specifically in geriatric patients.…”

Indication and Surgical Therapy in Uncomplicated Peptic Ulcer Disease

“…The recurrence rate after discontinuing long-term therapy is given as 50-92% in the literature [5], Accord ing to Walan [43] the monthly incidence under contin uous cimetidine therapy was 2%. The results of surgical treatment indicate that vagotomy appears to offer the best protection against relapse: the monthly recurrence rate is between 0.1 and 0.23%, which is an order of mag nitude lower than the rates observed under treatment with H2-receptor antagonists.…”