Missed Opportunities in the Trial on Proton-Pump Inhibitor Therapy in Bleeding Peptic Ulcers
Authors: Joseph J.Y. Sung
Journal: Annals of Internal Medicine (2009)

Letters20 October 2009Missed Opportunities in the Trial on Proton-Pump Inhibitor Therapy in Bleeding Peptic UlcersJoseph J.Y. Sung, MD, PhD, Alan Barkun, MD, and Ernst J. Kuipers, MDJoseph J.Y. Sung, MD, PhDFrom Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China; McGill University Health Centre, Montreal, Quebec H3G 1A4, Canada; and Erasmus MC University Medical Center, Rotterdam 3015 GD, The Netherlands.Search for more papers by this author, Alan Barkun, MDFrom Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China; McGill University Health Centre, Montreal, Quebec H3G 1A4, Canada; and Erasmus MC University Medical Center, Rotterdam 3015 GD, The Netherlands.Search for more papers by this author, and Ernst J. Kuipers, MDFrom Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China; McGill University Health Centre, Montreal, Quebec H3G 1A4, Canada; and Erasmus MC University Medical Center, Rotterdam 3015 GD, The Netherlands.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-151-8-200910200-00023 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:We thank all the correspondents for their considered comments. Ms. Yih and Dr. Tejani, Drs. Lin and Hsu, and Dr. Piscoya raised concerns about the use of placebo as a comparator in our study of patients with peptic ulcer bleeding. When this study was planned, the efficacy of intravenous PPI therapy for treatment of peptic ulcer bleeding was still in question, and no approved comparator treatment existed. After full discussion of the design with the U.S. Food and Drug Administration and the European Medicines Agency, it was agreed that the study should be placebo-controlled, which resulted in the ...References1. Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, et al. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007;356:1631-40. [PMID: 17442905] CrossrefMedlineGoogle Scholar2. Jensen DM, Pace SC, Soffer E, Comer GM; 315 Study Group. Continuous infusion of pantoprazole versus ranitidine for prevention of ulcer rebleeding: a U.S. multicenter randomized, double-blind study. Am J Gastroenterol. 2006;101:1991-9; quiz 2170. [PMID: 16968504] Google Scholar3. van Rensburg C, Barkun AN, Racz I, Fedorak R, Bornman PC, Beglinger C, et al. Clinical trial: intravenous pantoprazole vs. ranitidine for the prevention of peptic ulcer rebleeding: a multicentre, multinational, randomized trial. Aliment Pharmacol Ther. 2009;29:497-507. [PMID: 19053987] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Joseph J.Y. Sung, MD, PhD; Alan Barkun, MD; Ernst J. Kuipers, MDAffiliations: From Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, China; McGill University Health Centre, Montreal, Quebec H3G 1A4, Canada; and Erasmus MC University Medical Center, Rotterdam 3015 GD, The Netherlands.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoIntravenous Esomeprazole for Prevention of Recurrent Peptic Ulcer Bleeding Joseph J.Y. Sung , Alan Barkun , Ernst J. Kuipers , Joachim Mössner , Dennis M. Jensen , Robert Stuart , James Y. Lau , Henrik Ahlbom , Jan Kilhamn , and Tore Lind , for the Peptic Ulcer Bleed Study Group* Missed Opportunities in the Trial on Proton-Pump Inhibitor Therapy in Bleeding Peptic Ulcers Vivian Yih and Aaron Tejani Missed Opportunities in the Trial on Proton-Pump Inhibitor Therapy in Bleeding Peptic Ulcers Hwai-Jeng Lin and Yao-Chun Hsu Missed Opportunities in the Trial on Proton-Pump Inhibitor Therapy in Bleeding Peptic Ulcers Alejandro Piscoya Metrics 20 October 2009Volume 151, Issue 8Page: 590KeywordsConflicts of interestDeath ratesFood and Drug AdministrationHemorrhageInpatientsMortalityOral healthOutpatientsPeptic ulcersProton pump inhibitors ePublished: 20 October 2009 Issue Published: 20 October 2009 Copyright & PermissionsCopyright © 2009 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...