Clinical trial: intravenous pantoprazole vs. ranitidine for the prevention of peptic ulcer rebleeding: a multicentre, multinational, randomized trial.
BACKGROUND
Controlled pantoprazole data in peptic ulcer bleeding are few.


OBJECTIVE
To compare intravenous (IV) pantoprazole with IV ranitidine for bleeding ulcers.


METHODS
After endoscopic haemostasis, 1256 patients were randomized to pantoprazole 80 mg+8 mg/h or ranitidine 50 mg+13 mg/h, both for 72 h. Patients underwent second-look endoscopy on day 3 or earlier, if clinically indicated. The primary endpoint was an overall outcome ordinal score: no rebleeding, rebleeding without/with subsequent haemostasis, surgery and mortality. The latter three events were also assessed separately and together.


RESULTS
There were no between-group differences in overall outcome scores (pantoprazole vs. ranitidine: S0: 91.2 vs. 89.3%, S1: 1.5 vs. 2.5%, S2: 5.4 vs. 5.7%, S3: 1.7 vs. 2.1%, S4: 0.19 vs. 0.38%, P = 0.083), 72-h clinically detected rebleeding (2.9% [95% CI 1.7, 4.6] vs. 3.2% [95% CI 2.0, 4.9]), surgery (1.9% [95% CI 1.0, 3.4] vs. 2.1% [95% CI 1.1, 3.5]) or day-3 mortality (0.2% [95% CI 0, 0.09] vs. 0.3% [95% CI 0, 1.1]). Pantoprazole significantly decreased cumulative frequencies of events comprising the ordinal score in spurting lesions (13.9% [95% CI 6.6, 24.7] vs. 33.9% [95% CI 22.1, 47.4]; P = 0.01) and gastric ulcers (6.7% [95% CI 4, 10.4] vs. 14.3% [95% CI 10.3, 19.2], P = 0.006).


CONCLUSIONS
Outcomes amongst pantoprazole and ranitidine-treated patients were similar; pantoprazole provided benefits in patients with arterial spurting and gastric ulcers.
van Rensburg
C
C
Tygerberg Academic Hospital, University of Stellenbosch, Cape Town, South Africa. c.j.vr@telkomsa.net
Barkun
A N
AN
Racz
I
I
Fedorak
R
R
Bornman
P C
PC
Beglinger
C
C
Balanzó
J
J
Devière
J
J
Kupcinskas
L
L
Luehmann
R
R
Doerfler
H
H
Schäfer-Preuss
S
S
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D000077402:Pantoprazole; D010438:Peptic Ulcer Hemorrhage / Q000188:drug therapy* / Q000517:prevention & control; D011899:Ranitidine / Q000008:administration & dosage*; D055502:Secondary Prevention; D013223:Statistics as Topic; D055815:Young Adult
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D011899:Ranitidine; D000077402:Pantoprazole