Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON)

被引:98
作者
Scheiman, James M. [1 ]
Devereaux, P. J. [2 ]
Herlitz, Johan [3 ]
Katelaris, Peter H. [4 ]
Lanas, Angel [5 ]
van Zanten, Sander Veldhuyzen [6 ]
Naucler, Emma [7 ]
Svedberg, Lars-Erik [7 ]
机构
[1] Univ Michigan, Med Ctr, Div Gastroenterol, Ann Arbor, MI 48109 USA
[2] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
[3] Sahlgrens Univ Hosp, Dept Mol & Clin Med, Gothenburg, Sweden
[4] Univ Sydney, Dept Gastroenterol, Concord Hosp, Sydney, NSW 2006, Australia
[5] Univ Hosp, Dept Med, I CS CIBERehd, Zaragoza, Spain
[6] Univ Alberta, Dept Med, Div Gastroenterol, Edmonton, AB, Canada
[7] AstraZeneca R&D, Molndal, Sweden
关键词
NONSTEROIDAL ANTIINFLAMMATORY DRUGS; EXPERT CONSENSUS DOCUMENT; CORONARY-ARTERY-DISEASE; SERVICES-TASK-FORCE; CARDIOVASCULAR-DISEASE; GASTROINTESTINAL SYMPTOMS; GASTRODUODENAL ULCERS; ANTIPLATELET AGENTS; ASPIRIN; EVENTS;
D O I
10.1136/hrt.2010.217547
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective To determine whether once-daily esomeprazole 40 mg or 20 mg compared with placebo reduces the incidence of peptic ulcers over 26 weeks of treatment in patients taking low-dose acetylsalicylic acid (ASA) and who are at risk for ulcer development. Design Multinational, randomised, blinded, parallel-group, placebo-controlled trial. Setting Cardiology, primary care and gastroenterology centres (n=240). Patients Helicobacter pylori-negative patients taking daily low-dose ASA (75-325 mg), who fulfilled one or more of the following criteria: age >= 18 years with history of uncomplicated peptic ulcer; age >= 60 years with either stable coronary artery disease, upper gastrointestinal symptoms and five or more gastric/duodenal erosions, or low-dose ASA treatment initiated within 1 month of randomisation; or age >= 65 years. All patients were ulcer-free at study entry. Interventions Once-daily, blinded treatment with esomeprazole 40 mg, 20 mg or placebo for 26 weeks. Main outcome measures The primary end point was the occurrence of endoscopy-confirmed peptic ulcer over 26 weeks. Results A total of 2426 patients (52% men; mean age 68 years) were randomised. After 26 weeks, esomeprazole 40 mg and 20 mg significantly reduced the cumulative proportion of patients developing peptic ulcers; 1.5% of esomeprazole 40 mg and 1.1% of esomeprazole 20 mg recipients, compared with 7.4% of placebo recipients, developed peptic ulcers (both p<0.0001 vs placebo). Esomeprazole was generally well tolerated. Conclusions Acid-suppressive treatment with once-daily esomeprazole 40 mg or 20 mg reduces the occurrence of peptic ulcers in patients at risk for ulcer development who are taking low-dose ASA.
引用
收藏
页码:797 / 802
页数:6
相关论文
共 33 条
[1]   ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines: A Focused Update of the ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use [J].
Abraham, Neena S. ;
Hlatky, Mark A. ;
Antman, Elliott M. ;
Bhatt, Deepak L. ;
Bjorkman, David J. ;
Clark, Craig B. ;
Furberg, Curt D. ;
Johnson, David A. ;
Kahi, Charles J. ;
Laine, Loren ;
Mahaffey, Kenneth W. ;
Quigley, Eamonn M. ;
Scheiman, James ;
Sperling, Laurence S. ;
Tomaselli, Gordon F. .
AMERICAN JOURNAL OF GASTROENTEROLOGY, 2010, 105 (12) :2533-2549
[2]   Prevalence, incidence, and prognostic value of anaemia in patients after an acute myocardial infarction: data from the OPTIMAAL trial [J].
Anker, Stefan D. ;
Voors, Adriaan A. ;
Okonko, Darlington ;
Clark, Andrew L. ;
James, Margaret K. ;
von Haehling, Stephan ;
Kjekshus, John ;
Ponikowski, Piotr ;
Dickstein, Kenneth .
EUROPEAN HEART JOURNAL, 2009, 30 (11) :1331-1339
[3]   Gastrointestinal causes of refractory iron deficiency anemia in patients without gastrointestinal symptoms [J].
Annibale, B ;
Capurso, G ;
Chistolini, A ;
D'Ambra, G ;
DiGiulio, E ;
Monarca, B ;
DelleFave, G .
AMERICAN JOURNAL OF MEDICINE, 2001, 111 (06) :439-445
[4]   NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND LIFE THREATENING COMPLICATIONS OF PEPTIC-ULCERATION [J].
ARMSTRONG, CP ;
BLOWER, AL .
GUT, 1987, 28 (05) :527-532
[5]   Clopidogrel with or without Omeprazole in Coronary Artery Disease. [J].
Bhatt, Deepak L. ;
Cryer, Byron L. ;
Contant, Charles F. ;
Cohen, Marc ;
Lanas, Angel ;
Schnitzer, Thomas J. ;
Shook, Thomas L. ;
Lapuerta, Pablo ;
Goldsmith, Mark A. ;
Laine, Loren ;
Scirica, Benjamin M. ;
Murphy, Sabina A. ;
Cannon, Christopher P. .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (20) :1909-1917
[6]   A systematic review and meta-analysis on the hazards of discontinuing or not adhering to aspirin among 50 279 patients at risk for coronary artery disease [J].
Biondi-Zoccai, Giuseppe G. L. ;
Lotrionte, Marzia ;
Agostoni, Pierfrancesco ;
Abbate, Antonio ;
Fusaro, Massimiliano ;
Burzotta, Francesco ;
Testa, Luca ;
Sheiban, Imad ;
Sangiorgi, Giuseppe .
EUROPEAN HEART JOURNAL, 2006, 27 (22) :2667-2674
[7]  
Calonge N, 2009, ANN INTERN MED, V150, P396
[8]   Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding [J].
Chan, FKL ;
Ching, JYL ;
Hung, LCT ;
Wong, VWS ;
Leung, VKS ;
Kung, NNS ;
Hui, AJ ;
Wu, JCY ;
Leung, WK ;
Lee, VWY ;
Lee, KKC ;
Lee, YT ;
Lau, JYW ;
To, KF ;
Chan, HLY ;
Chung, SCS ;
Sung, JJY .
NEW ENGLAND JOURNAL OF MEDICINE, 2005, 352 (03) :238-244
[9]  
Collins R, 2009, LANCET, V373, P1849, DOI 10.1016/S0140-6736(09)60503-1
[10]   A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE) [J].
Gent, M ;
Beaumont, D ;
Blanchard, J ;
Bousser, MG ;
Coffman, J ;
Easton, JD ;
Hampton, JR ;
Harker, LA ;
Janzon, L ;
Kusmierek, JJE ;
Panak, E ;
Roberts, RS ;
Shannon, JS ;
Sicurella, J ;
Tognoni, G ;
Topol, EJ ;
Verstraete, M ;
Warlow, C .
LANCET, 1996, 348 (9038) :1329-1339