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Drug Class Review on Newer Antiplatelet Agents

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Drug Class Review on Newer Antiplatelet Agents Drug Class Review on Newer Antiplatelet Agents Final Report November 2005 The Agency for Healthcare Research and Quality has not yet seen or approved this report The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Janet H. Dailey, PharmD Peter Glassman, MBBS, MSc Marika Suttorp, MS Cony Rolón, BA Produced by Southern California Evidence-based Practice Center RAND 1700 Main Street, PO Box 2138 Santa Monica, CA 90407 Paul Shekelle, co-Director Sally Morton, co-Director Copyright © 2005 by Oregon Health & Science University Portland, Oregon 97201. All rights reserved. Final Report Drug Effectiveness Review Project TABLE OF CONTENTS Introduction....................................................................................................................................4 Scope and Key Questions ..........................................................................................................7 Inclusion Criteria .......................................................................................................................7 Methods...........................................................................................................................................8 Literature Search........................................................................................................................8 Study Selection ..........................................................................................................................8 Data Abstraction ........................................................................................................................9 Extraction of Efficacy Data .......................................................................................................9 Extraction of Adverse Event Data ...........................................................................................10 Quality Assessment .................................................................................................................10 Meta-Analysis of Adverse Event Data ....................................................................................11 Results ...........................................................................................................................................11 Overview..................................................................................................................................11 Question 1. Effectiveness ........................................................................................................14 Question 1a. Outcomes: Acute Coronary Syndrome...............................................................14 Question 1b. Outcomes: Prior Ischemic Stroke or TIA...........................................................25 Question 1c. Outcomes: Symptomatic Peripheral Vascular Disease.......................................31 Question 2. Safety or Adverse Events .....................................................................................34 Meta-Analysis of Specific Adverse Events: Comparison with Aspirin...................................41 Question 3. Safety and Efficacy: Patient Subgroups ...............................................................45 In-Text Tables Table 1. FDA Approved Indications and Use of Selected Antiplatelet Agents in Acute Coronary Syndrome, Stroke/TIA and Peripheral Vascular Disease ........................................................................................................................6 Table 2. Eligible Outcomes........................................................................................................7 Table 3. Large Clinical Trials Included per Type of Study Population...................................13 Table 4. Outcomes from CURE...............................................................................................19 Table 5. PCI-CURE: Major Outcomes Events from PCI to 30 days and End of Follow-up..................................................................................................................23 Table 6. CREDO: Major Outcome Events at 1 Year...............................................................24 Table 7. MATCH Trial: Number of Patients (%) with Events................................................29 Table 8. CAPRIE Trial: Comparison of Outcome Event Cluster Rates..................................33 Table 9. CURE: Incidence of all Types of Bleeding per Months of Therapy .........................35 Table 10. CURE: Percentage of Major and Life-Threatening Bleeding per Aspirin Dose .............................................................................................................36 Table 11. Meta-analysis: Frequency of Bleeding Complications per Antiplatelet Class and Dose..........................................................................................................38 Table 12. Meta-analysis: Comparing the Incidence of Adverse Events with Thienopyridines with Aspirin in High Risk Patients ................................................40 Table 13. ESPS-2: Percentage of Patients with most Common Adverse Events ....................41 Table 14. Adverse Event Analysis at Patient Level: Antiplatelet Agents vs. Aspirin.......................................................................................................................42 Table 15. Adverse Event Analysis at Patient Level: Ticlopidine vs. Clopidogrel ..................43 Newer Antiplatelet Agents Page 2 of 238 Final Report Drug Effectiveness Review Project Table 16. Adverse Event analysis at Patient Level: Ticlopidine Plus Aspirin vs. Clopidogrel Plus Aspirin...........................................................................................44 Table 17. Results of CAPRIE: Treatment Effect on Outcome by Subgroup...........................47 Table 18. ESPS-2 Trial: Outcome Data for First Stroke (fatal or non-fatal) in Patients with IHD, PVD, NIDDM and IDDM..........................................................48 Table 19. Summary of the Evidence by Key Question............................................................50 References.....................................................................................................................................54 Figure Figure 1. Results of Literature Search .....................................................................................60 Appendices Appendix A. Description and Grade of Recommendations for Level of Evidence.................61 Appendix B. Search Strategies ................................................................................................62 Appendix C. Quality Assessment methods for drug class reviews for the Drug Effectiveness Review Project ...................................................................................66 Appendix D. Bibliography of Excluded Articles.....................................................................70 Appendix E. Drug Interactions with Newer Antiplatelet Agents ............................................77 Appendix F. Definitions of the FDA Pregnancy Categories ...................................................77 Evidence Tables Table A1. Randomized Controlled Trials................................................................................78 Table A2. Quality Assessment for Controlled Trials.............................................................148 Table A3. Adverse Event Quality Assessment......................................................................183 Table A4. Systematic Reviews ..............................................................................................211 Newer Antiplatelet Agents Page 3 of 238 Final Report Drug Effectiveness Review Project INTRODUCTION I. Scope of the problem Atherosclerosis often starts in late adolescence or early adulthood, although clinical manifestations typically occur years later. Statistics from 2002 indicate that approximately 70.1 million Americans have at least one type of cardiovascular disease (CVD) including ischemic coronary heart disease, stroke, and/or peripheral arterial disease (PAD). An estimated 2,600 Americans die of CVD each day, an average of 1 death every 34 seconds. Over 700,000 people will experience a new or recurrent stroke each year, meaning that on average, every 45 seconds someone in the United States has a cerebrovascular accident.1 Ischemic coronary heart disease varies in its presentation and includes stable angina, unstable angina, non-ST segment elevated myocardial infarction (NSTEMI) or even a ST- segment elevated MI (STEMI). All of these presentations except stable angina are often referred to as acute coronary syndrome (ACS). Atherosclerotic cerebrovascular disease also varies in presentation from asymptomatic arterial stenosis, i.e., carotid stenosis, to transient ischemic attacks to thromboembolic stroke. Peripheral arterial disease frequently manifests as intermittent claudication of the lower extremity, though other presentations include arterial aneurysms, typically of the aorta, and renovascular disease. Although there are various approaches to secondary prevention of vascular disease, a principal
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