Intravenous Esomeprazole for Prevention of Recurrent Peptic Ulcer Bleeding: A Randomized Trial. Export

@article{citeulike:4280694, abstract = {BACKGROUND: Use of proton-pump inhibitors in the management of peptic ulcer bleeding is controversial because of discrepant results reported in different ethnic groups. OBJECTIVE: To determine whether intravenous esomeprazole better prevents recurrent peptic ulcer bleeding than placebo in a multiethnic patient sample. 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: Patients 18 years or older with peptic ulcer bleeding from a single gastric or duodenal ulcer showing high-risk stigmata. 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; 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\% [95\% CI of difference, 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\% [95\% CI of difference, 1.1\% to 9.2\%]; 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: High-dose intravenous esomeprazole given after successful endoscopic therapy to patients with high-risk peptic ulcer bleeding reduced recurrent bleeding at 72 hours and had sustained clinical benefits for up to 30 days. Primary Funding: AstraZeneca Research and Development.}, author = {Sung, Joseph J Y J. and Barkun, Alan and Kuipers, Ernst J J. and M\"{o}ssner, Joachim and Jensen, Dennis M M. and Stuart, Robert and Lau, James Y Y. and Ahlbom, Henrik and Kilhamn, Jan and Lind, Tore and {}}, citeulike-article-id = {4280694}, citeulike-linkout-0 = {http://view.ncbi.nlm.nih.gov/pubmed/19221370}, citeulike-linkout-1 = {http://www.hubmed.org/display.cgi?uids=19221370}, day = {16}, issn = {1539-3704}, journal = {Annals of internal medicine}, keywords = {pud}, month = {February}, posted-at = {2009-04-07 00:45:41}, priority = {2}, title = {Intravenous Esomeprazole for Prevention of Recurrent Peptic Ulcer Bleeding: A Randomized Trial.}, url = {http://view.ncbi.nlm.nih.gov/pubmed/19221370}, year = {2009} }

TY - JOUR ID - citeulike:4280694 L3 - citeulike-article-id:4280694 N2 - BACKGROUND: Use of proton-pump inhibitors in the management of peptic ulcer bleeding is controversial because of discrepant results reported in different ethnic groups. OBJECTIVE: To determine whether intravenous esomeprazole better prevents recurrent peptic ulcer bleeding than placebo in a multiethnic patient sample. 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: Patients 18 years or older with peptic ulcer bleeding from a single gastric or duodenal ulcer showing high-risk stigmata. 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; 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% [95% CI of difference, 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% [95% CI of difference, 1.1% to 9.2%]; 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: High-dose intravenous esomeprazole given after successful endoscopic therapy to patients with high-risk peptic ulcer bleeding reduced recurrent bleeding at 72 hours and had sustained clinical benefits for up to 30 days. Primary Funding: AstraZeneca Research and Development. JF - Annals of internal medicine SN - 1539-3704 TI - Intravenous Esomeprazole for Prevention of Recurrent Peptic Ulcer Bleeding: A Randomized Trial. KW - pud AU - Sung, Joseph J Y AU - Barkun, Alan AU - Kuipers, Ernst J AU - Mössner, Joachim AU - Jensen, Dennis M AU - Stuart, Robert AU - Lau, James Y AU - Ahlbom, Henrik AU - Kilhamn, Jan AU - Lind, Tore PY - 2009/02/16/ UR - http://view.ncbi.nlm.nih.gov/pubmed/19221370 ER -