Drug Class Review on Calcium Channel Blockers
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Drug Class Review on Calcium Channel Blockers Final Report Update 2 Evidence Tables 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 EVIDENCE TABLES Evidence Table 1. Quality assessment of randomized trials............................................................. 3 Evidence Table 2. Hypertension active controlled trials ................................................................ 57 Evidence Table 3. Quality of life trials......................................................................................... 159 Evidence Table 4. Angina head to head trials............................................................................... 204 Evidence Table 5. Angina active controlled trials ........................................................................ 219 Evidence Table 6. Angina placebo controlled trials ..................................................................... 246 Evidence Table 7. Supraventricular arrhythmia head to head trials ............................................. 258 Evidence Table 8. Supraventricular arrhythmia active controlled trials....................................... 264 Evidence Table 9. Supraventricular arrhythmia placebo controlled trials.................................... 297 Evidence Table 10. Systolic dysfunction active controlled trials ................................................. 309 Evidence Table 11. Systolic dysfunction placebo controlled trials .............................................. 318 Evidence Table 12. Adverse events in hypertension active controlled trials............................... 342 Evidence Table 13. Adverse events in angina head to head trials ............................................... 352 Evidence Table 14. Adverse events in supraventricular arrhythmia trials.................................. 355 Evidence Table 15. Observational studies of cancer ................................................................... 357 Evidence Table 16. Observational studies of cardiovascular events ........................................... 381 Evidence Table 17. Observational studies of other adverse events ............................................. 387 Evidence Table 18. Quality assessment of observational studies ................................................ 399 Calcium Channel Blockers Update #2 2 of 404 Final Report Drug Effectiveness Review Project Evidence Table 1. Quality assessment of randomized trials Author, Eligibility Outcome Patient Year Allocation criteria assessors unaware of Country Random assignment concealed Groups similar at baseline specified blinded treatment Intention-to-treat (ITT) analysis Amlodipine comparisons TOMHS (Treatment of Mild Adequate; a block NR No; Neaton reported between- Yes Yes Yes In Neaton, 1993 stated that "all analyses Hypertension Study) randomization scheme was groups differences in: were by treatment allocation (ITT)", but Mascioli, 1990 used with stratification by 1) number of VPBs on 24-hour Treatment of Mild Hypertension Treatment of Mild clinical center and use of ambulatory ECG (p=0.01) Research Group, 1991 noted that there Hypertension Research antihypertensive drugs at 2) percentage with are differences in patient # between Group, 1991 initial screening echocardiographic LVH baseline and QOL data at 1 year Neaton, 1993 (p=0.04) Grimm, 1997 United States Omvik, 1993 NR NR Yes Yes Yes Yes No Norway VALUE Adequate, computer- NR Yes Yes Yes Yes Yes Julius 2004 generated. Weber 2004 Multinational (US and Europe) Lewis 2001 NR Adequate No; slightly lower proportion Yes Yes Yes Yes International of the patients in the placebo group were female (p=0.02) Nifedipine comparisons Metelitsa, 1996 NR NR Absolute data NR, but Yes Yes Yes No described homogeneity between groups Bulpitt, 2000 NR NR Not clear Yes Yes Yes No Austria, Italy, Germany, Described as "very similar"; Netherlands, Poland, Spain, data NR; may be available in Switzerland, and the UK separate paper Calcium Channel Blockers Update #2 3 of 404 Final Report Drug Effectiveness Review Project Evidence Table 1. Quality assessment of randomized trials Reporting of attrition, Differential loss to Author, Maintenance crossovers, follow-up or Year of comparable adherence, and overall high loss Similarity to target Country groups contamination to follow-up Score population Number recruited Exclusion criteria for recruitment Amlodipine comparisons TOMHS (Treatment of Mild Unclear Attrition, adherence, No Fair Good 11,914 screened Patients with evidence of cardiovascular disease or life- Hypertension Study) contamination clearly Average age: 55 years 902 randomized threatening illness or who were unable to make nutritional Mascioli, 1990 reported in Neaton, Gender: 62% male changes; inability to obtain a technically satisfactory baseline Treatment of Mild 1993 Race: 54.6% white echocardiogram Hypertension Research Group, 1991 Neaton, 1993 Grimm, 1997 United States Omvik, 1993 Unclear Attrition reported clearly No Fair Good 461 Patients with malignant or secondary HTN; known intolerance Norway Others NR Mean age: aml=54.1; to calcium antagonists or ACE inhibitors, or hepatic, ena=54.6 hematological or other diseases prohibiting the use of these SBP(mmHg): aml=162; drugs; women who were pregnant, breastfeeding, using oral ena=162 contraceptives or intending to become pregnant within the DBP(mmHg): aml=106; study period; angina pectoris, recent MI (within previous 6 ena=106 months) or cerebrovascular accident within the previous year; patients who were more than 30% overweight VALUE Yes Attrition, yes, others No: 0.5% Good High CV risk 15,313 Renal artery stenosis, pregnancy, acute MI, percutaneous Julius 2004 no. valsartan vs 0.6% transluminal coronary angioplasty or coronary artery bypass Weber 2004 amlodipine graft within the past 3 months, clinically relevant valvular Multinational (US and disease, cerebrovascular accident in the past 3 months, Europe) severe hepatic disease, severe chronic renal failure, congestive heart failure requiring ACE inhibitor therapy, patients on monotherapy with beta blockers for both coronary artery disease and hypertension. Lewis 2001 Yes Yes No Fair NR 1,715 NR International No No No No Nifedipine comparisons Metelitsa, 1996 Unclear Attrition reported clearly No Fair- Not clear 345 enrolled NR Others NR Poor Absolute data NR Bulpitt, 2000 Unclear Attrition clearly reported No Fair Good for elderly 771 enrolled NR Austria, Italy, Germany, Others NR population 747 randomized Netherlands, Poland, Spain, Mean age: bis=67.9; nif Switzerland, and the UK r=68.5 Calcium Channel Blockers Update #2 4 of 404 Final Report Drug Effectiveness Review Project Evidence Table 1. Quality assessment of randomized trials Author, Year Control group Length of Country standard of care follow-up Funding Amlodipine comparisons TOMHS (Treatment of Mild Yes At least 4 National Heart, Lung Hypertension Study) years and Blood Institute, Mascioli, 1990 Merck, Harp and Treatment of Mild Dohme Research Hypertension Research Laboratories and Group, 1991 Pfizer, Inc. Neaton, 1993 Grimm, 1997 United States Omvik, 1993 Yes 50 weeks NR Norway VALUE Yes Mean 4.2 Novartis Julius 2004 years Weber 2004 Multinational (US and Europe) Lewis 2001 Yes 932 days BMS International Nifedipine comparisons Metelitsa, 1996 Yes 8 months Bristol-Meyers Bulpitt, 2000 Yes 6 months Merck Austria, Italy, Germany, Netherlands, Poland, Spain, Switzerland, and the UK Calcium Channel Blockers Update #2 5 of 404 Final Report Drug Effectiveness Review Project Evidence Table 1. Quality assessment of randomized trials Author, Eligibility Outcome Patient Year Allocation criteria assessors unaware of Country Random assignment concealed Groups similar at baseline specified blinded treatment Intention-to-treat (ITT) analysis Fletcher, 1992 NR NR Yes Yes Yes Yes No Europe JMIC-B Yes Yes Yes Yes Yes Yes Yes Yui, 2004 Japan Poole-Wilson blocked and stratified by Yes Yes Yes Yes Yes Yes 2004 centre Multi-national Calcium Channel Blockers Update #2 6 of 404 Final Report Drug Effectiveness Review Project Evidence Table 1. Quality assessment of randomized trials Reporting of attrition, Differential loss to Author, Maintenance crossovers, follow-up or Year of comparable adherence, and