A study on the prevention of duodenal ulcer recurrence with pirenzepine

A double-blind, controlled study with either 50 mg of pirenzepine or a placebo once a day was performed in 128 patients to determine the effect of pirenzepine against relapses of duodenal ulcer, the healing of the subjects' former ulcers having been confirmed endoscopically. The study lasted 12 months at longest; endoscopy was performed at 3,6,9 and 12 month intervals during the study, as well as when subjective symptoms developed. Cumulative non-relapse rates were obtained every 3 months according to the life expectancy table; at 3 and 6 months, they were 85.7% and 73.0% for the pirenzepine group and 67.9% and 49.0% for the placebo group, thus indicating significantly lower relapse rates in favour of the pirenzepine group (p less than 0.05). There was no significant difference between the two groups with regard to the 12-month cumulative non-relapse rate. Comparison of background factors in relapsed and non-relapsed cases suggested that relapses were more frequent among pirenzepine-treated patients who had required a shorter course of treatment or had received H2 antagonists in the treatment of their previous ulcer. Relapses of duodenal ulcer were closely correlated with relapses of subjective symptoms, but there was no significant difference between the pirenzepine group and the placebo group with regard to the frequency of subjective symptoms at the time of ulcer recurrence. Pirenzepine, like H2 antagonists, proved to prevent ulcer relapses temporarily. The relapse rate with the compound appeared to be higher in cases where the former ulcer had been treated with H2 antagonists.