Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies.
BACKGROUND
Current PPIs may not achieve desired outcomes in some GERD patients due to limited duration of acid inhibition.


OBJECTIVE
To evaluate a novel rabeprazole extended release (ER), which provides longer duration of drug exposure and acid suppression, in healing and symptomatic resolution of moderate-severe erosive oesophagitis.


METHODS
Patients with LA grade C or D oesophagitis were randomised to rabeprazole-ER 50 mg or esomeprazole 40 mg once daily in two identical 8-week double-blind trials (N = 2130). Two primary endpoints were tested sequentially: (1) healing by 8 weeks [hypothesis: rabeprazole-ER non-inferior to esomeprazole (non-inferiority margin = 8%)], (2) healing by 4 weeks [hypothesis: rabeprazole-ER superior to esomeprazole (P < 0.05)]. The secondary endpoint was sustained heartburn resolution at 4 weeks.


RESULTS
Rabeprazole-ER was non-inferior to esomeprazole in week-8 healing (80.0% vs. 75.0%; 77.5% vs. 78.4%). Week-4 healing (54.8% vs. 50.3%; 50.9% vs. 50.7%) and sustained heartburn resolution (48.3% vs. 48.2%; 53.2% vs. 52.5%) were not significantly different. Post hoc combined results for grade D revealed rabeprazole-ER vs. esomeprazole differences in week-8 healing = 10.4% (95% CI: -1.4%, 22.2%) and week-4 healing = 12.0% (P = 0.048).


CONCLUSIONS
Rabeprazole-ER is as effective as esomeprazole in healing moderate-severe oesophagitis and achieves similar rates of heartburn resolution. Subgroup analysis suggests the possibility of benefit in severe oesophagitis, but this requires further evaluation (ClinicalTrials.gov: NCT00658528 and NCT00658775).
University of Southern California, Los Angeles, 90033, USA. llaine@usc.edu
L
L
Laine
P O
PO
Katz
D A
DA
Johnson
I
I
Ibegbu
M J
MJ
Goldstein
C
C
Chou
G
G
Rossiter
Y
Y
Lu
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D064098:Esomeprazole / Q000008:administration & dosage*; D004941:Esophagitis / Q000188:drug therapy*; D005260:Female; D006356:Heartburn / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D064750:Rabeprazole; D012720:Severity of Illness Index; D013223:Statistics as Topic; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D064750:Rabeprazole; D064098:Esomeprazole