Ranitidine maintenance therapy in the prevention of duodenal ulceration; a comparison of 150 mg at night with 300 mg at night.

BACKGROUND

The purpose of this study was to investigate if the use of a higher night time dose of ranitidine (300 mg) could keep significantly more duodenal ulcer patients in remission than the usual maintenance dose (150 mg).

METHODS

Double-blind, multi-centre, parallel group study of patients with proven healed duodenal ulcer randomized to ranitidine 150 mg or 300 mg daily for 1 year. The primary study end-point was symptomatic, endoscopically proven ulcer relapse.

RESULTS

A total of 489 patients were recruited into the study. The endoscopically proven relapse rates were 6.1% of ranitidine 150 mg daily (n = 250) and 6.9% on 300 mg daily (n = 239). These differences were not statistically significant.

CONCLUSION

This study provides further evidence that maintenance therapy with ranitidine 150 mg daily is highly effective at preventing duodenal ulcer relapse. The use of the higher dose of 300 mg daily does not appear to keep significantly more patients in remission.