Ranitidine in the maintenance therapy of gastro-duodenal ulcer disease: Polish open multicentre study

Abstract

Our first stage 3-week trial (6) and second stage up to 6 weeks (7) showed that ranitidine provides the highest healing rate of 97% for duodenal and 95% for gastric ulcer. The study has been now prolonged for one year to assess the efficacy of maintenance therapy. Out of 258 patients who completed the second stage 232 voluntarily entered the open stage 3 in which they were given a single dose R 150 mg nocte, and were endoscopied after 4, 8 and 12 months. There were 153 duodenal and 79 gastric ulcers. 191 patients completed the study; no undesired effects were found and there was no medical reason to withdraw the drug from the long term use. Recurrent ulcer was found in 33.3% out of 126 duodenal ulcer cases, and in 29.2% out of 65 gastric ulcer patients who completed stage three. Sixteen percent of recurrent gastric ulcers and 26% of duodenal ulcers were asymptomatic. Recurrence rate was about twice as high in smokers as in non-smokers. These findings were compared with our long-term endoscopic survey of the natural history of peptic ulcer disease (8) in which yearly recurrence rate of duodenal ulcer was 68.4% and of gastric ulcers 73.5%, 14% of them being painless. This indicates that R is fairly well tolerated in long term use and may be useful to curb the ulcer recurrence rate.