Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole

F. Pace, V. Annese, A. Prada, A. Zambelli, S. Casalini, P. Nardini, G. Bianchi Porro, Z. Rossi, P. Fenderico, F. Molinari, A. Molinari, M. Poletti, A. Benedetti, L. Bolognini, P. Cercamondi, S. Piergallini, N. Pieroni, F. Ridolfi, A. Palazzi, A. AgnolucciP. Ceccatelli, F. Laurenzi, M. Grassini, G. Iaquinto, V. D'Onofrio, N. Giardullo, L. Pasquale, A. Sedici, R. Moschetta, G. Maurogiovanni, Biedo Costan, B. Germana, P. Lecis, F. Negrini, S. Signorelli, P. Landi, P. Malaguti, E. Roda, Vergori De, L. Gandolfi, F. Torresan, F. Chilovi, S. Benvenuti, T. Grasso, S. Adamo, A. Sabatino, A. Anderloni, P. M. Mannucci, P. A. Testoni, A. Andriulli, The Italian Rabeprazole Study Group

Research output: Contribution to journalArticle

Abstract

Background.: Previous studies have shown similar effects of rabeprazole and omeprazole, when used at the same dose in the treatment of reflux oesophagitis. However, such studies have been conducted as superiority studies but interpreted as equivalence ones. Aim.: To properly assess the comparative efficacy of rabeprazole and omeprazole in inducing complete endoscopic healing and symptom relief in patients with reflux oesophagitis. Methods.: Patients (n = 560) with Savary-Miller grade I-III reflux oesophagitis were randomised in a double-blind, double-dummy fashion to rabeprazole or omeprazole 20 mg once daily for 4-8 weeks. Then, patients endoscopically healed and symptomatically relieved were openly maintained with rabeprazole 10 mg or 2 × 10 mg once daily (in the event of clinical and/or endoscopic relapse) for a maximum of 48 weeks. Results.: After 4-8 weeks of treatment, healing (primary end-point) was observed in 228/233 (97.9%) patients in the rabeprazole group and in 231/237 (97.5%) in the omeprazole one (equivalence effect demonstrated by p <0.0001 at Blackwelder test and an upper confidence limit at 97.5% of 0.023). However, rabeprazole was faster in inducing heartburn relief than omeprazole (2.8 ± 0.2 versus 4.7 ± 0.5 days of therapy to reach the first day with satisfactory heartburn relief, p = 0.0045 at log-rank test). In the maintenance phase, 15.2% of patients had an endoscopic and/or clinical relapse. Conclusion.: Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.

Original languageEnglish
Pages (from-to)741-750
Number of pages10
JournalDigestive and Liver Disease
Volume37
Issue number10
DOIs
Publication statusPublished - Oct 1 2005

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Keywords

  • Curative/maintenance therapy
  • Gastro-oesophageal reflux disease
  • Heartburn
  • Rabeprazole

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Pace, F., Annese, V., Prada, A., Zambelli, A., Casalini, S., Nardini, P., Bianchi Porro, G., Rossi, Z., Fenderico, P., Molinari, F., Molinari, A., Poletti, M., Benedetti, A., Bolognini, L., Cercamondi, P., Piergallini, S., Pieroni, N., Ridolfi, F., Palazzi, A., ... The Italian Rabeprazole Study Group (2005). Rabeprazole is equivalent to omeprazole in the treatment of erosive gastro-oesophageal reflux disease. A randomised, double-blind, comparative study of rabeprazole and omeprazole 20 mg in acute treatment of reflux oesophagitis, followed by a maintenance open-label, low-dose therapy with rabeprazole. Digestive and Liver Disease, 37(10), 741-750. https://doi.org/10.1016/j.dld.2005.04.026