Aim: To compare the efficacy and tolerability of pantoprazole 40 mg and omeprazole MUPS 40 mg in patients with moderate to severe gastroesophageal reflux disease (GERD).
Methods: In this randomized, double-blind, parallel-group, multicenter study conducted in Austria, Germany, Portugal, Switzerland and The Netherlands, patients with endoscopically confirmed moderate to severe GERD (Savary/Miller esophagitis grade II/III) were enrolled. They received a once-daily dose of either 40 mg pantoprazole or 40 mg omeprazole MUPS. Healing was determined by endoscopy after 4 weeks of treatment. If patients were not healed, treatment was extended for another 4 weeks. An additional endoscopy was performed in these cases after 8 weeks of treatment. Healing was determined by endoscopy after 4 and 8 weeks. In addition, treatment effect on symptoms was evaluated by the investigator using a questionnaire assessing heartburn, reflux regurgitation and pain on swallowing at each visit, as well as by a self-administered questionnaire comprising further 24 gastrointestinal symptoms. Analyses were performed for the intention-to-treat (ITT) and the per-protocol (PP) population. In addition, patients with high compliance (HC: 90% </=110%) were considered in a separate group. Adverse events and the influence of the Helicobacter pylori status were investigated.
Results: A total of 669 outpatients were enrolled in the study, with 337 patients receiving pantoprazole and 332 omeprazole MUPS. The PP population consisted of 552 patients, 282 treated with pantoprazole and 270 with omeprazole MUPS. The healing rates in both treatment groups were shown to be equivalent and were higher in patients who adhered closely to the administration protocol (HC). According to ITT (ITT(HC)) analyses, healing rates were 65.3% (77.4%) in the pantoprazole and 66.3% (74.7%) in the omeprazole group after 4 weeks. Furthermore, patients infected with H. pylori had slightly but not significantly higher healing rates than those with a negative test result. The safety profile of both treatments was comparable.
Conclusion: Pantoprazole 40 mg and omeprazole MUPS 40 mg were equivalent with respect to healing after 4 and 8 weeks of treatment in patients with reflux esophagitis grade II/III. Overall, HC patients had higher healing rates than the regular compliant patients. Both drugs were well tolerated and safe.
Copyright 2003 S. Karger AG, Basel