COMPARISON OF OMEPRAZOLE WITH RANITIDINE FOR TREATMENT OF SYMPTOMS ASSOCIATED WITH GASTROESOPHAGEAL REFLUX DISEASE AND UNCOMPLICATED DUODENAL-ULCER

This randomized, single-blind, parallel group study was conducted to c ompare omeprazole with ranitidine for the treatment of symptoms associ ated with gastroesophageal reflux disease (GERD), uncomplicated duoden al ulcer (DU) or both. After baseline assessments, patients were rando mized to receive daily treatment with either 20 mg omeprazole or 300 m g ranitidine for four weeks. In total, 1481 patients (1001 omeprazole, 480 ranitidine) with a diagnosis of GERD (n=904) and/or DU (n=577), c onfirmed by endoscopy or barium meal and reporting moderate to severe symptoms, were included in the analyses. The seventy of overall daytim e symptoms reported by the omeprazole group at clinic visits was lower than that reported by the ranitidine group at week 2 for the entire p atient group (P=0.0002) and at both weeks 2 and 4 for the subgroup of patients with GERD (P=0.0001 and P=0.001, respectively). The severity of overall night-time symptoms reported by the omeprazole group was lo wer than that reported by the ranitidine group at week 4 for all patie nts as a whole (P=0.042) and at both weeks 2 and 4 for the subgroup of patients with GERD (P=0.035 and P=0.010, respectively). There were no significant differences in reports of adverse events. In the omeprazo le group, 19% of patients at week 2 and 15% of patients at week 4 repo rted adverse events, while the corresponding results from the ranitidi ne group were 21% and 11%. In conclusion, patients with GERD, DU or bo th treated with omeprazole 20 mg daily for four weeks showed statistic ally significant reduction in symptoms compared with patients treated with ranitidine 300 mg daily for the same period of time. The percenta ge of patients with any remaining daytime symptoms was 12% lower in th e omeprazole group compared with the ranitidine group at week 2, and 7 % lower at week 4. Five per cent fewer patients in the omeprazole grou p experienced night-time symptoms at either week 2 or week 4.