Drug Class Review on Calcium Channel Blockers
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Drug Class Review on Calcium Channel Blockers Final Report Update 2 March 2005 Original Report Date: September 2003 Update 1 Report Date: June 2004 A literature scan of this topic is done periodically 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. Marian S. McDonagh, PharmD Karen B. Eden, PhD Kim Peterson, MS Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Copyright © 2005 by Oregon Health & Science University Portland, Oregon 97201. All rights reserved. Note: A scan of the medical literature relating to the topic is done periodically (see http://www.ohsu.edu/ohsuedu/research/policycenter/DERP/about/methods.cfm for scanning process description). Upon review of the last scan, the Drug Effectiveness Review Project governance group elected not to proceed with another full update of this report. Some portions of the report may not be up to date. Prior versions of this report can be accessed at the DERP website. Final Report Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION........................................................................................................................... 4 Scope and Key Questions........................................................................................ 5 METHODS ...................................................................................................................................... 5 Literature Search................................................................................................................. 5 Study Selection ................................................................................................................... 5 Data Abstraction ................................................................................................................. 6 Validity Assessment............................................................................................................7 Data Synthesis..................................................................................................................... 7 RESULTS ........................................................................................................................................ 7 Overview .......................................................................................................................................... 7 Key Question 1: Effectiveness........................................................................................................ 8 Essential Hypertension........................................................................................................8 Angina....................................................................................................................... ……18 Supraventricular Arrhythmias........................................................................................... 23 Systolic Dysfunction......................................................................................................... 25 Key Question 2: Safety and Adverse Events .............................................................................. 28 Essential Hypertension...................................................................................................... 29 Angina....................................................................................................................... ……31 Supraventricular Arrhythmias........................................................................................... 31 Systolic Dysfunction......................................................................................................... 32 Evidence from Observational Studies............................................................................... 34 Key Question 3: Subgroups.......................................................................................................... 39 Essential Hypertension...................................................................................................... 39 Angina....................................................................................................................... ……41 Supraventricular Arrhythmias........................................................................................... 41 Systolic Dysfunction......................................................................................................... 41 SUMMARY ................................................................................................................................... 42 REFERENCES.............................................................................................................................. 44 IN-TEXT TABLES Table 1. All-cause mortality in patients with hypertension ........................................................... 11 Table 2. Cardiovascular disease mortality in patients with hypertension ...................................... 12 Table 3. Myocardial infarction in patients with hypertension ....................................................... 13 Table 4. Stroke in patients with hypertension ................................................................................ 14 Table 5. Heart failure in patients with hypertension ...................................................................... 15 Table 6. End stage renal disease in patients with hypertension ..................................................... 15 Table 7. Quality of life in patients with hypertension .................................................................... 16 Table 8. Active control trials of chronic stable angina ................................................................... 21 Table 9. Placebo-controlled trials of systolic dysfunction.............................................................. 28 Table 10. Observational studies of mortality .................................................................................. 37 Table 11. Strength of the evidence by key question ....................................................................... 42 FIGURES Figure 1. Results of literature search .............................................................................................. 56 Figure 2. All-cause mortality in hypertensives (CCB vs diuretic and/or beta-blocker).................. 57 Figure 3. All-cause mortality in hypertensives (CCB vs ACE inhibitor) ....................................... 58 Figure 4. Mean change in weekly angina attacks ........................................................................... 59 Calcium Channel Blockers Update #2 Page 2 of 194 Final Report Drug Effectiveness Review Project Figure 5. Mean change in weekly nitroglycerin doses ................................................................... 60 Figure 6. Mean change in time to angina onset .............................................................................. 61 Figure 7. Final ventricular rate plot ................................................................................................ 62 Figure 8. Flushing in hypertensives ................................................................................................ 63 Figure 9. Dizziness in hypertensives............................................................................................... 64 Figure 10. Headache in hypertensives ............................................................................................ 65 Figure 11. Edema in hypertensives................................................................................................. 66 Figure 12. Withdrawals due to adverse events in hypertension active-controlled trials of CCBs vs diuretics or beta-blockers............................................................................... 67 Figure 13. Withdrawals due to adverse events in hypertension active-controlled trials of CCBs vs ACE inhibitors............................................................................................... 68 Figure 14. Overall AE incidence in head-to-head trials of patients with angina ............................ 69 Figure 15. Withdrawal due to AE in head-to-head trials of patients with angina........................... 70 Figure 16. Edema incidence in head-to-head angina trials ............................................................. 71 Figure 17. Edema incidence in systolic dysfunction trials.............................................................. 72 Figure 18. Withdrawal rates in systolic dysfunction trials.............................................................. 73 APPENDICES Appendix A. Search strategy .......................................................................................................... 74 Appendix B. Quality assessment methods for drug class reviews.................................................. 77 Appendix C. Reports of trials excluded.......................................................................................... 81 Appendix D. Articles available as abstracts only.......................................................................... 187 Appendix E. Studies of quality of life with duration