A DOUBLE-BLIND-STUDY OF PANTOPRAZOLE AND OMEPRAZOLE IN THE TREATMENT OF REFLUX ESOPHAGITIS - A MULTICENTER TRIAL

Background: Pantoprazole is a new substituted benzimidazole which is a potent inhibitor of gastric acid secretion by its action upon H+,K+-A TPase. Aim: To compare pantoprazole 40 mg with omeprazole 20 mg as onc e daily dosing in the treatment of reflux oesophagitis (grades II and III). Methods: This double-blind, randomized, multicentre study includ ed 286 patients. Patients were re-endoscoped after 4 weeks, and contin ued to receive a further 4 weeks of treatment if they were not healed at this time. Results: After 4 weeks of treatment, complete healing oc curred in 126/170 (74%) patients in the pantoprazole group and in 67/8 6 (78%) patients in the omeprazole group (per-protocol analysis). At 8 weeks, the corresponding healing rates were 153/170 (90%) and 81/86 ( 94%). The differences between the treatment groups were not significan t (P = 0.57 and 0.34). Improvement in the principal symptoms of reflux oesophagitis was also very similar between the treatment groups, with 59% and 69% at 2 weeks, and 83% and 86% at 4 weeks, respectively, bei ng free from any individual symptom. Both treatments were well tolerat ed. Conclusions: This study has shown pantoprazole and omeprazole to b e similarly effective and well tolerated in the treatment of mild to m oderate reflux oesophagitis.