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.
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.


OBJECTIVE
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.


CONCLUSIONS
Rabeprazole is equivalent to omeprazole in healing reflux oesophagitis, but shows a faster activity on reflux symptoms in the early treatment phase.
Pace
F
F
Department of Gastroenterology, Luigi Sacco University Hospital, Via G.B. Grassi, 74, 20157 Milan, Italy. cn.fapac@tin.it
Annese
V
V
Prada
A
A
Zambelli
A
A
Casalini
S
S
Nardini
P
P
Bianchi Porro
G
G
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000863:Antacids / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000473:pathology; D006356:Heartburn / Q000188:drug therapy; D016481:Helicobacter Infections / Q000188:drug therapy / Q000473:pathology; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D017060:Patient Satisfaction; D064750:Rabeprazole; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000863:Antacids; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D064750:Rabeprazole; D009853:Omeprazole