Efficacy of pantoprazole compared with omeprazole in prevention of relapse of reflux esophagitis: Double-blind, randomized multicenter trial

This multinational trial aimed to compare the efficacy of two doses of pantoprazole with the recommended dose of omeprazole for the prevention of recurrence of reflux esophagitis. Methods: Recruited were patients with esophagitis grade 2-4 (SavarylMiller) and symptoms of heartburn with or without regurgitation who at completion of a run-in phase during treatment with pantoprazole 40 mg once daily for 4-8 weeks (Gastroenterology 1999;116:GI011) had symptomatic relief and healed esophagitis (grade 0-1) demonstrated by endoscopy. A total of 639 patients from 60 centres in Austria, Belgium, Denmark, Finland, Greece, Norway, Sweden and Switzerland were allocated at random to double-blind maintenance treatment with pantoprazole 20 mg (n=211), pantoprazole 40 mg (n=218) or omeprazole 20 mg (n=21O) in the morning for up to 12 months. The patients had assessment of symptoms three-monthly and repeat endoscopy at 3 and 12 months, and in-between, if indicated by recurrence of symptoms. For the primary efficacy analysis (ITT population) patients with unknown endoscopic status at the time when they left the trial were considered as relapsed. Results: The treatment groups were well matched with regard to demographic and disease characteristics at baseline (such as gender; age; smoking habits; and severity and duration of reflux disease), and proportions of drop-outs and withdrawals in the groups were comparable. The endoscopic relapse rates were 23%, 17%, and 19% in the pantoprazole 20 mg, pantoprazole 40 mg, and omeprazole groups, respectively. The difference (and 95% confidence interval) between relapse rates in the pantoprazole 40 mg and omeprazole groups was -2% (-10% to 6%). Corresponding differences between pantoprazole 20 mg and omeprazole, and between pantoprazole 20 and 40 mg, were 4% (-4% to 12%), and 6% (-2% to 14%), respectively. Neither of the treatment differences was statistically significant. Absence of symptoms was highly predictive of maintenance of healing. All treatment regimens were well tolerated and no serious adverse events were attributed to treatment. Conclusion: Once daily 20-40 mg pantoprazole and 20 mg omeprazole were equally effective and safe for preventing recurrence of reflux esophagitis.