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 MULTICENTER, RANDOMIZED, DOUBLE-BLIND CLINICAL-TRIAL

Background/Aims. The efficacy of proton pump inhibitors is considered linked to morning, fasting administration. The aim of the present stud y was to assess efficacy and tolerability of the proton pump inhibitor s lansoprazole given at bedtime as compared to ranitidine, both in acu te and maintenance treatment of duodenal ulcer. Methods. This was a ra ndomised double blind study. The patients were divided into 4 treatmen t groups as follows (healing/maintenance): 1) lansoprazole 30 mg/lanso prazole 15 mg; 2) lansoprazole 30 mg/placebo; 3) ranitidine 300 mg/ran itidine 150 mg; 4) ranitidine 300 mg/placebo. Healing and relapse of u lcers 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 we re enrolled in 9 study centres. The cumulative healing rates (per-prot ocol 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-t reat analysis)) was lower in the lansoprazole/lansoprazole group (23.3 %), than those reported by the other groups of patients lansoprazole/p lacebo (39.3%); ranitidine/ranitidine (45.8%); ranitidine/placebo (50% ). The disease-free time from healing was significantly longer for lan soprazole treated patients (p < 0.05). All treatments were very well t olerated, only few minor adverse events being reported. Conclusions. L ansoprazole maintains its greater efficacy vs ranitidine even when adm inistered at bedtime, both for the healing and for the maintenance tre atment of duodenal ulcer. Lansoprazole (half dose formulation) may be useful for the treatment of patients requiring long-term acid suppress ion.