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Clopidogrel Versus Other Antiplatelet Agents in the Secondary Prevention Canadian Agency for Agence canadienne Drugs and Technologies des médicaments et des in Health technologies de la santé technology report Clopidogrel versus Other Antiplatelet Agents in HTA the Secondary Prevention of Vascular Events in Issue 123 Adults with Cerebrovascular Disease: Clinical December 2009* and Cost-Effectiveness Analyses *An amendment was made in August 2010 Supporting Informed Decisions Until April 2006, the Canadian Agency for Drugs and Technologies in Health (CADTH) was known as the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Publications can be requested from: CADTH 600-865 Carling Avenue Ottawa ON Canada K1S 5S8 Tel.: 613-226-2553 Fax: 613-226-5392 Email: [email protected] or downloaded from CADTH’s website: http://www.cadth.ca Cite as: Banerjee S, Brown A, Hutton B, McGahan L, Asakawa K, Clark M, Severn M, Cox JL, Sharma M. Clopidogrel versus Other Antiplatelet Agents in the Secondary Prevention of Vascular Events in Adults with Cerebrovascular Disease: Clinical and Cost-Effectiveness Analyses. [Technology report number 123]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2009. Production of this report is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Prince Edward Island, Saskatchewan, and theYukon. The Canadian Agency for Drugs and Technologies in Health takes sole responsibility for the final form and content of this report. The views expressed herein do not necessarily represent the views of Health Canada or any provincial or territorial government. Reproduction of this document for non-commercial purposes is permitted provided appropriate credit is given to CADTH. CADTH is funded by Canadian federal, provincial, and territorial governments. Legal Deposit – 2009 National Library of Canada ISBN: 978-1-926680-34-7 (print) ISBN: 978-1-926680-35-4 (online) H0481 – December 2009 PUBLICATIONS MAIL AGREEMENT NO. 40026386 RETURN UNDELIVERABLE CANADIAN ADDRESSES TO CANADIAN AGENCY FOR DRUGS AND TECHNOLOGIES IN HEALTH 600-865 CARLING AVENUE OTTAWA ON K1S 5S8 Canadian Agency for Drugs and Technologies in Health Clopidogrel versus Other Antiplatelet Agents in the Secondary Prevention of Vascular Events in Adults with Cerebrovascular Disease: Clinical and Cost-Effectiveness Analyses Srabani Banerjee, MSc, PhD1 Allan Brown, BSc, MBA, MA1 Brian Hutton, MSc, PhD (candidate)1 Lynda McGahan, MSc1 Keiko Asakawa, MA, MBA, PhD1 Michelle Clark, BSc1 Melissa Severn, MISt1 Jafna L. Cox, MD, FRCPC, FACC2 Mukul Sharma, MD, MSc, FRCPC3 December 2009 1 Canadian Agency for Drugs and Technologies in Health, Ottawa, Ontario 2 Heart and Stroke Foundation Endowed Chair in Cardiovascular Outcomes; Director of Research, Division of Cardiology; Professor of Medicine and Community Health and Epidemiology, Dalhousie University; Staff Cardiologist, Capital Health, Halifax, Nova Scotia 3 Deputy Director, Canadian Stroke Network; Director, Regional Stroke Program; Assistant Professor of Medicine, University of Ottawa; Ottawa Health Research Institute, Ottawa, Ontario Reviewers These individuals kindly provided comments on this report. External Reviewers Paul Armstrong, MD John Eikelboom, MBBS Distinguished University Professor, Associate Professor Medicine (Cardiology) McMaster University University of Alberta Hamilton, ON Edmonton, AB Susan Griffin, MSc Health Economics George A. Wells, MSc PhD Research Fellow Director, Cardiovascular Research Methods University of York Centre York, UK University of Ottawa Heart Institute Ottawa, ON Carlo Marra, BSc(Pharm.) PharmD PhD Associate Professor University of British Columbia Vancouver, BC CADTH Peer Review Group Reviewers James Brophy, MEng MD FRCP(C) FACC PhD Rick Audas, BBA MBA MA(Econ) PhD Professor of Medicine & Epidemiology Assistant Professor, Medicine McGill University Memorial University Montreal, QC St. John’s, NL Industry: The following manufacturers were provided with an opportunity to comment on an earlier version of this report: Bayer Inc., Boehringer Ingelheim (Canada) Ltd., Hoffmann-La Roche Ltd., and Sanofi-aventis. All comments that were received were considered when preparing the final report. This report is a review of existing public literature, studies, materials and other information and documentation (collectively the “source documentation”) which are available to CADTH. The accuracy of the contents of the source documentation on which this report is based is not warranted, assured, or represented in any way by CADTH and CADTH does not assume responsibility for the quality, propriety, inaccuracies or reasonableness of any statements, information or conclusions contained in the source documentation. CADTH takes sole responsibility for the final form and content of this report. The statements and conclusions in this report are those of CADTH and not of its Panel members or reviewers i Clopidogrel versus Other Antiplatelet Agents in the Secondary Prevention of Vascular Events in Adults with Cerebrovascular Disease: Clinical and Cost-Effectiveness Analyses Authorship Srabani Banerjee, overall research lead for the project, selected articles, extracted data, performed standard meta-analyses, wrote sections of the clinical review, and contributed to revisions. Allan Brown, lead for the economic section, selected articles, extracted data for the economic review, performed the primary economic analyses, wrote the economic sections, and contributed to revisions. Brian Hutton extracted data, performed mixed treatment comparisons (MTC) meta-analyses, wrote sections of the clinical review, examined the set up of the economic model, and contributed to revisions. Keiko Asakawa selected articles and checked data for the economic review section, performed the population and budget impact analyses, wrote the budget impact and population impact sections, and contributed to revisions. Lynda McGahan selected articles, extracted data, wrote the Guidelines section, and contributed to revisions. Michelle Clark selected articles, extracted data, prepared tables, and contributed to revisions. Melissa Severn performed some of the literature searches, wrote the literature search methods section and the associated appendices, checked references, and contributed to revisions. Jafna Cox provided clinical expertise and guidance, wrote the Ethical and Psychosocial sections, and contributed to revisions. Mukul Sharma provided clinical expertise and guidance, and contributed to revisions. Acknowledgments The authors thank Elise Cogo for developing and executing the literature search, Eva Tsakonas for data extraction and quality assessment for the Guidelines section, Stella Chen for screening some of the alerts, Erin Russell for acting as second reviewer for the quality assessment of economic studies, Chris Cameron for examining the set-up of the economic model, and Doug Coyle for his guidance and advice on the economic model. The authors also thank all CADTH staff who provided assistance at various stages of the project. Clopidogrel versus Other Antiplatelet Agents in the Secondary Prevention of Vascular Events ii in Adults with Cerebrovascular Disease: Clinical and Cost-Effectiveness Analyses Conflicts of Interest Dr. John Eikelboom has been a speaker and consultant, and Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, and Sanofi-aventis have provided research support. Dr. Jafna Cox received funding from Bristol-Myers Squibb and Sanofi-aventis for research support; he has received honoraria for talks from Sanofi-aventis and Bristol-Myers Squibb (among others); and he has participated in the development of accredited CME activities that were sponsored by companies and an advisor board. Dr. Mukul Sharma has received support for speaking and travel, and honoraria as an advisory board member from Brisol-Myers Squibb, Sanofi-aventis, and Boehringer Ingelheim (Canada) Ltd. iii Clopidogrel versus Other Antiplatelet Agents in the Secondary Prevention of Vascular Events in Adults with Cerebrovascular Disease: Clinical and Cost-Effectiveness Analyses EXECUTIVE SUMMARY The Issue Approximately 5.7% of Canadians have cardiovascular disease (CVD).1 In 2005, 31% of all deaths in Canada were due to CVD.2 In 1998, the estimated total cost of CVD in Canada was $18.5 billion, of which $1.8 billion was spent on drugs.1 Clopidogrel, which is used for the prevention of atherothrombotic events, is an expensive drug relative to other treatment options, and the number of reimbursement requests for clopidogrel submitted to Canadian publicly funded drug plans is increasing. Objectives The aim of this report is to compare clopidogrel with other antiplatelet agents for the secondary prevention of vascular events in adults with cerebrovascular events [ischemic stroke or transient ischemic attack (TIA)]. This objective will be accomplished by addressing four research questions. 1. What is the comparative clinical effectiveness of clopidogrel (alone or in combination with acetylsalicylic acid [ASA]) versus other antiplatelet regimens (ASA, ticlopidine, dipyridamole, combination of fixed-dose ASA, and extended-release dipyridamole [ERDP]) for the secondary prevention of vascular events ( [myocardial infarction MI], stroke, or vascular death) in adult patients with cerebrovascular events (stroke, TIA)? a) What is the difference in the clinical effectiveness of dual therapy with clopidogrel and ASA based on the ASA dose? b) How is intolerance
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