doi:10.1111/j.1440-1746.2006.04292.x
716 Journal of Gastroenterology and Hepatology 21 (2006) 716–721
© 2006 Journal of Gastroenterology and Hepatology Foundation and Blackwell Publishing Asia Pty Ltd
Blackwell Publishing AsiaMelbourne, AustraliaJGHJournal of Gastroenterology and Hepatology0815 93192006 Blackwell Publishing Asia Pty Ltd200621716721Original Article Pantoprazole in bleeding peptic ulcersSA Zargar
et al.
GASTROENTEROLOGY
Pantoprazole infusion as adjuvant therapy to endoscopic
treatment in patients with peptic ulcer bleeding: Prospective
randomized controlled trial
Showkat Ali Zargar, Gul Javid, Bashir Ahmad Khan, Ghulam Nabi Yattoo, Altaf Hussain Shah,
Ghulam Mohammad Gulzar, Jaswinder Singh Sodhi, Sheikh Abdul Mujeeb, Mushtaq Ahmad Khan,
Nisar Ahmad Shah and Hakim Mohamad Shafi
Department of Gastroenterology, Sher-i-Kashmir Institute of Medical Sciences, Srinagar, Kashmir, India
Abstract
Background and Aim: Following successful endoscopic therapy in patients with peptic
ulcer bleeding, rebleeding occurs in 20% of patients. Rebleeding remains the most impor-
tant determinant of poor prognosis. We investigated whether or not administration of
pantoprazole infusion would improve the outcome in ulcer bleeding following successful
endoscopic therapy.
Methods: In this double-blind, placebo-controlled, prospective trial, patients who had
gastric or duodenal ulcers with active bleeding or non-bleeding visible vessel received
combined endoscopy therapy with injection of epinephrine and heater probe application.
Patients who achieved hemostasis were randomly assigned to receive pantoprazole (80 mg
intravenous bolus followed by an infusion at a rate of 8 mg per hour) or placebo for 72 h.
The primary end-point was the rate of rebleeding.
Results: Rebleeding was lower in the pantoprazole group (8 of 102 patients, 7.8%) than in
the placebo group (20 of 101 patients, 19.8%; P = 0.01). Patients in the pantoprazole group
required significantly fewer transfusions (1 ± 2.5 vs 2 ± 3.3; P = 0.003) and days of hospi-
talization (5.6 ± 5.3 vs 7.7 ± 7.3; P = 0.0003). Rescue therapies were needed more fre-
quently in the placebo group (7.8% vs 19.8%; P = 0.01). Three (2.9%) patients in the
pantoprazole group and eight (7.9%) in the placebo group required surgery to control their
bleeding ( P = 0.12). Two patients in the pantoprazole group and four in the placebo group
died ( P = 0.45).
Conclusion: In patients with bleeding peptic ulcers, the use of high dose pantoprazole
infusion following successful endoscopic therapy is effective in reducing rebleeding,
transfusion requirements and hospital stay.
© 2006 Blackwell Publishing Asia Pty Ltd
Introduction
Despite remarkable progress in the treatment of chronic peptic
ulcer disease, acute gastroduodenal ulcer bleeding remains a
therapeutic challenge with significant morbidity and mortality.
Endoscopic therapy using injection or thermal methods signifi-
cantly reduces rebleeding, the need for surgery and mortality in
patients with peptic ulcer bleeding (PUB), and is now recom-
mended as the first hemostatic modality of choice for these
patients.
1
Although this therapy achieves successful hemostasis in
more than 90% of patients, unfortunately rebleeding occurs in 10–
30% of patients,
2–5
with an average of 21%.
6
Because rebleeding
has been recognized as the single most important adverse prognos-
tic factor contributing to morbidity and mortality,
7,8
it is likely that
further improvements in the outcome will be aimed at preventing
rebleeding.
Gastric acidity may play an important role in the pathogenesis
of rebleeding. Both acid and pepsin may produce adverse effects
on coagulation by interfering with the intrinsic and extrinsic
coagulation system, fibrinogen polymerization, and platelet
aggregation.
8,9
Numerous trials of H
2
receptor antagonists have not
consistently shown a significant benefit in such patients.
10,11
How-
ever, two recent reviews of the use of a high-dose of omeprazole in
patients with PUB concluded that it improves the outcome.
12,13
Key words
endoscopic hemostasis, pantoprazole, peptic
ulcer bleeding, peptic ulcer rebleeding, proton
pump inhibitors, randomized trials.
Accepted for publication 30 November 2004.
Correspondence
Dr Showkat Ali Zargar, Professor and Head,
Department of Gastroenterology, Sher-i-
Kashmir Institute of Medical Sciences., PO Box
27; Soura Srinagar, Kashmir, India.
Email: showkatzargar@yahoo.com