Bedtime administration of lansoprazole does not modify its greater efficacy vs ranitidine in the acute and long-term treatment of duodenal ulcer. Results from a multicentre, randomised, double blind clinical trial.

BACKGROUND/AIMS: The efficacy of proton pump inhibitors is considered linked to morning, fasting administration. The aim of the present study was to assess efficacy and tolerability of the proton pump inhibitors lansoprazole given at bedtime as compared to ranitidine, both in acute and maintenance treatment of duodenal ulcer.

METHODS

This was a randomised double blind study. The patients were divided into 4 treatment groups as follows (healing/maintenance): 1) lansoprazole 30 mg/lansoprazole 15 mg; 2) lansoprazole 30 mg/placebo; 3) ranitidine 300 mg/ranitidine 150 mg; 4) ranitidine 300 mg/placebo. Healing and relapse of ulcers were assessed by endoscopy at 2, 4 and 8 weeks and then at 3, 6, 9 and 12 months during follow-up.

RESULTS

A total of 132 patients were enrolled in 9 study centres. The cumulative healing rates (per-protocol analysis) at 2, 4 and 8 weeks were 57.4%, 83.9% and 89.2% in the lansoprazole group and 30%, 70.2% and 78.7% in the ranitidine group (p = 0.01 at 2 weeks). The 12-month cumulative relapse rate (intent-to-treat analysis) was lower in the lansoprazole/lansoprazole group (23.3%), than those reported by the other groups of patients lansoprazole/placebo (39.3%); ranitidine/ranitidine (45.8%); ranitidine/placebo (50%). The disease-free time from healing was significantly longer for lansoprazole treated patients (p < 0.05). All treatments were very well tolerated, only few minor adverse events being reported.

CONCLUSIONS

Lansoprazole maintains its greater efficacy vs ranitidine even when administered at bedtime, both for the healing and for the maintenance treatment of duodenal ulcer. Lansoprazole (half dose formulation) may be useful for the treatment of patients requiring long-term acid suppression.