[Superiority of pantoprazole over ranitidine in the treatment of duodenal ulcer. Mexican clinical experience. Mexican Study Group of Pantoprazole++ in Duodenal Ulcer].

BACKGROUND

Pantoprazole is a new Proton Pump Inhibitor that has demonstrated to be superior to ranitidine in the healing of the acid related diseases.

AIMS: To compare efficacy and tolerability of oral treatment with pantoprazole vs. ranitidine in outpatients with endoscopically confirmed florid duodenal ulcers in Mexican patients.

METHODS

Prospective, multicentric, balanced, randomized, double blind, parallel group comparison clinical trial. Each patient received 40 mg pantoprazole plus placebo or 300 mg ranitidine plus placebo once daily for 2 weeks; if patients had not healed endoscopically by then, treatment was continued for two more weeks, with a final endoscopy.

RESULTS

163 protocol-correct patients were analyzed: 82 for pantoprazole group and 81 for ranitidine group. Healing rates at week 2 were 72% for pantoprazole and 51% for ranitidine (p < 0.01) and correspondingly 95 and 86% at week 4. The percentage of patients suffering from pain declined faster in the pantoprazole group. Both products were well tolerated and safe.

CONCLUSIONS

Pantoprazole is well tolerated and significantly superior to ranitidine in florid duodenal ulcers healing.