Pantoprazole versus ranitidine in the treatment of duodenal ulcer: A multicenter study in Brazil

OBJECTIVE: The aim of this study was to compare the effectiveness and toler ance of pantoprazole versus ranitidine in the treatment of duodenal ulcers in the Brazilian population. METHODS: A total of 222 patients with active duodenal ulcers (DU) were rand omly allocated to a double dummy blind treatment, either with ranitidine (R AN) 300 mg (111, aged from 20-68 yr old, 56 female) or with pantoprazole (P ANT) 40 mg (111 patients, 18-70 yr old, 45 female). After a 2-wk course of treatment, each patient was clinically and endoscopically assessed for ulce r healing. Failure to heal required a further 2-wk course of treatment and a new evaluation thereafter. RESULTS: In all, 77 of the 103 patients in the PANT group (74.8%) and 42 of the 94 patients in the RAN group (44.7%) who completed the study had ulcer healing after one 2-wk treatment course, and an additional 23 in the PANT group (22.3%) and 28 in the RAN group (29.8%) after the second 2-wk treatme nt course, totaling 100 (97.1%) and 70 (74.5%), respectively. Therapeutic g ain in favor of pantoprazole was significant both at the end of the first a nd the second 2-wk treatment course (p < 0.001). At 2 wk, symptoms remissio n was significantly higher in the PANT group (97.6%) than with the RAN grou p (77.5%) (p < 0.001). The Intention-to-treat analysis showed results stati stically similar to those observed in the per-protocol analysis. Minor adve rse events were reported by four patients in the PANT group and three in th e RAN group. No relevant laboratory abnormalities were seen. No patient wit hdrew from the study due to adverse events. CONCLUSIONS: Our results show that pantoprazole is more effective than rani tidine in the treatment of duodenal ulcer providing faster ulcer healing in most patients (97.1%), in 4 wk. Adverse events were rare and were similar in both groups, and had no influence on the therapeutic outcome.