Abstract | BACKGROUND: OBJECTIVE: DESIGN: Randomized trial conducted between October 2005 and December 2007; patients, providers, and researchers were blinded to group assignment. SETTING: 91 hospital emergency departments in 16 countries. PATIENTS: INTERVENTION: Intravenous esomeprazole bolus, 80 mg, followed by 8-mg/h infusion, over 72 hours or matching placebo, each given after successful endoscopic hemostasis. Intervention was allocated by computer-generated randomization. After infusion, both groups received oral esomeprazole, 40 mg/d, for 27 days. MEASUREMENTS: The primary end point was rate of clinically significant recurrent bleeding within 72 hours. Recurrent bleeding within 7 and 30 days, death, surgery, endoscopic re-treatment, blood transfusions, hospitalization, and safety were also assessed. RESULTS: Of 767 patients randomly assigned, 764 provided data for an intention-to-treat analysis (375 esomeprazole recipients and 389 placebo recipients). Fewer patients receiving intravenous esomeprazole (22 of 375) had recurrent bleeding within 72 hours than those receiving placebo (40 of 389) (5.9% vs. 10.3%; difference, 4.4 percentage points [95% CI, 0.6% to 8.3%]; P = 0.026). The difference in bleeding recurrence remained significant at 7 days and 30 days (P = 0.010). Esomeprazole also reduced endoscopic re-treatment (6.4% vs. 11.6%; difference, 5.2 percentage points [95% CI of difference, 1.1 percentage points to 9.2 percentage points]; P = 0.012), surgery (2.7% vs. 5.4%), and all-cause mortality rates (0.8% vs. 2.1%) more than placebo, although differences for the latter 2 comparisons were not significant. About 10% and 40% of patients in both groups reported serious and nonserious adverse events, respectively. LIMITATION: Endoscopic therapy was not completely standardized; some patients received epinephrine injection, thermal coagulation, or hemoclips alone, whereas others received combination therapy, but there were similar proportions with single therapy in each group. CONCLUSION: PRIMARY FUNDING SOURCE: AstraZeneca Research and Development.
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Authors | Joseph J Y Sung, Alan Barkun, Ernst J Kuipers, Joachim Mössner, Dennis M Jensen, Robert Stuart, James Y Lau, Henrik Ahlbom, Jan Kilhamn, Tore Lind, Peptic Ulcer Bleed Study Group |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 150
Issue 7
Pg. 455-64
(Apr 07 2009)
ISSN: 1539-3704 [Electronic] United States |
PMID | 19221370
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Proton Pump Inhibitors
- Esomeprazole
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Combined Modality Therapy
- Esomeprazole
(administration & dosage, adverse effects)
- Female
- Follow-Up Studies
- Hemostasis, Endoscopic
(methods)
- Humans
- Infusions, Intravenous
- Injections, Intravenous
- Male
- Middle Aged
- Peptic Ulcer Hemorrhage
(prevention & control, therapy)
- Proton Pump Inhibitors
(administration & dosage, adverse effects)
- Retreatment
- Secondary Prevention
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