EFFICACY AND TOLERABILITY OF PANTOPRAZOLE 40 MG VERSUS 80 MG IN PATIENTS WITH REFLUX ESOPHAGITIS

Background: Pantoprazole is a substituted benzimidazole which is a pot ent inhibitor of gastric acid secretion by its action upon H+, K+-ATPa se. Methods: Pantoprazole 40 mg and 80 mg were compared in a randomize d double-blind study in 192 out-patients with stage II or III (Savary- Miller classification) reflux oesophagitis. Patients received either p antoprazole 40 mg (n = 97) or pantoprazole 80 mg (n = 95), once daily before breakfast for 4 weeks. Treatment was extended for a further 4 w eeks if the oesophagitis had not healed. Results: After 4 weeks comple te healing of the reflux oesophagitis was seen in 78% of protocol-corr ect patients given pantoprazole 40 mg daily (n = 86), and in 72% in th e 80 mg (n = 87) group. The cumulative healing rates after 8 weeks wer e 95 and 94%, respectively (P > 0.05, Cochran-Mantel-Haenszel), and ti me until healing of oesophagitis comparable in both groups. Difference s between doses were also not significant in an intention-to-treat ana lysis. Both dosing schedules were well tolerated and the patients expe rienced remarkable symptom relief. No adverse event or changes in labo ratory values of clinical significance could definitely be ascribed to the trial medication. Conclusion: The 40 mg pantoprazole dosage is co mparable to 80 mg in reflux oesophagitis, both in efficacy and tolerab ility.