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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.
Dig Liver Dis. 2005 Oct; 37(10):741-50.DL

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 2x10 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.

Authors+Show Affiliations

Department of Gastroenterology, Luigi Sacco University Hospital, Via G.B. Grassi, 74, 20157 Milan, Italy. cn.fapac@tin.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16024305

Citation

Pace, F, et al. "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 : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, vol. 37, no. 10, 2005, pp. 741-50.
Pace F, Annese V, Prada A, et al. 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. Dig Liver Dis. 2005;37(10):741-50.
Pace, F., Annese, V., Prada, A., Zambelli, A., Casalini, S., Nardini, P., & Bianchi Porro, G. (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 : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 37(10), 741-50.
Pace F, et al. 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. Dig Liver Dis. 2005;37(10):741-50. PubMed PMID: 16024305.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Pace,F, AU - Annese,V, AU - Prada,A, AU - Zambelli,A, AU - Casalini,S, AU - Nardini,P, AU - Bianchi Porro,G, AU - ,, PY - 2005/02/25/received PY - 2005/04/20/accepted PY - 2005/7/19/pubmed PY - 2006/6/7/medline PY - 2005/7/19/entrez SP - 741 EP - 50 JF - Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver JO - Dig Liver Dis VL - 37 IS - 10 N2 - 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 2x10 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. SN - 1590-8658 UR - https://www.unboundmedicine.com/medline/citation/16024305/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1590-8658(05)00232-X DB - PRIME DP - Unbound Medicine ER -