IMPROVED DUODENAL-ULCER HEALING WITH PANTOPRAZOLE COMPARED WITH RANITIDINE - A MULTICENTER STUDY

Objective: To compare the efficacy and tolerability of pantoprazole 40 mg (once daily in the morning) with ranitidine 300 mg (once daily at bedtime) in duodenal ulcer healing. Design: Prospective multicentre, randomized, double-blind, parallel-group comparison. Patients: The study included 199 outpatients aged from 18 to 75 years, with endoscopically confirmed active duodenal ulcer disease. Methods: Endoscopy and standard laboratory assessments, including serum gastrin levels, were carried out at the beginning of the study, after 2 and, where applicable, after 4 weeks. Results: Of the patients, 182 (98 on pantoprazole, 84 on ranitidine), median age 39 years, completed the study. Complete ulcer healing in protocol-correct patients after 2 weeks was significantly higher (P<0.001) in patients given pantoprazole (61%) compared with those given ranitidine (35%). After 4 weeks, the cumulative healing rates were 97 and 81%, respectively (P<0.001, Cochran-Mantel/Haenszel method). Ulcer healing occurred significantly faster with pantoprazole than with ranitidine (P<0.001, Uleman's U-test). Conclusions: Pantoprazole is significantly more effective than ranitidine for healing of duodenal ulcer both at 2 and 4 weeks. There was no significant difference between the two groups with respect to complete pain relief after 2 weeks of treatment. Both pantoprazole and ranitidine were well tolerated with no serious adverse events.