Intravenous esomeprazole for prevention of peptic ulcer re-bleeding: rationale/design of Peptic Ulcer Bleed study.
BACKGROUND
A limited number of trials have investigated the efficacy of proton pump inhibitors for peptic ulcer bleeding, and some study design issues have been identified.


OBJECTIVE
To present the design of a large trial evaluating the effects of intravenous esomeprazole on clinical outcomes in high-risk patients who have undergone endoscopic haemostasis for peptic ulcer bleeding.


METHODS
The Peptic Ulcer Bleed study is an international, randomized, double-blind, placebo-controlled trial comparing either esomeprazole 80 mg intravenous bolus infusion for 30 min followed by esomeprazole 8 mg/h intravenously for 71.5 h, or placebo infusion for 72 h, after successful endoscopic haemostasis in patients with peptic ulcer bleeding and associated high-risk stigmata. All patients will receive once daily oral esomeprazole 40 mg for 27 days after intravenous therapy. The primary end point is the rate of clinically significant re-bleeding during the first 72 h after endoscopy. Secondary end points include: rate of re-bleeding during the first 7 and 30 days after treatment; length of hospitalization; mortality; blood transfusion; endoscopic re-treatment and surgery.


RESULTS
Expected 2008.


CONCLUSIONS
The carefully designed protocol and quality control measures represent a pragmatic approach to contemporary challenges in peptic ulcer bleeding management and, it is hoped, qualify the Peptic Ulcer Bleed study as a new standard for future interventional studies.
Sung
J J Y
JJ
Institute of Digestive Diseases, Chinese University of Hong Kong, Shatin, Hong Kong, China. joesung@cuhk.edu.hk
Mössner
J
J
Barkun
A
A
Kuipers
E J
EJ
Lau
J
J
Jensen
D
D
Stuart
R
R
Junghard
O
O
Olsson
G
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010438:Peptic Ulcer Hemorrhage / Q000150:complications / Q000401:mortality / Q000517:prevention & control*; D012307:Risk Factors; D055502:Secondary Prevention; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D064098:Esomeprazole