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Drug Class Review on HMG-Coa Reductase Inhibitors (Statins)

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Drug Class Review on HMG-Coa Reductase Inhibitors (Statins) Drug Class Review on HMG-CoA Reductase Inhibitors (Statins) Final Report June 2004 Mark Helfand, MD, MPH Susan Carson, MPH Cathy Kelley, PharmD Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Final Report Drug Effectiveness Review Project TABLE OF CONTENTS Introduction......................................................................................………...................3 Scope and Key Questions ........................................................................................4 Methods............................................................................................................................5 Results ..............................................................................................................................7 Question 1. LDL-lowering.......................................................................................7 a. Percent reductions .................................................................................7 b. Percent meeting NCEP goals..............................................................13 Question 2. Ability to increase HDL-c ..................................................................14 Question 3. Effect on risk of cardiovascular events ..............................................15 Question 4. Subgroups...........................................................................................26 Question 5. Risks in special populations ...............................................................28 Summary........................................................................................................................34 References......................................................................................................................37 Tables Table 1. Percent reduction in LDL-c with statins ...............................................9 Table 2. Trials of rosuvastatin vs. atorvastatin ..................................................11 Table 3. Equivalent doses of statins...................................................................12 Table 4. Achieving Target LDL-cholesterol goals ............................................13 Table 5. Outpatient trials with CHD endpoints………………………………..16 Table 6. Inpatient trials of acute MI or unstable angina……………………….21 Table 7. Studies of atherosclerotic progression that reported CHD outcomes ..23 Table 8. Post-revascularization trials.................................................................24 Table 9. Miscellaneous trials reporting clinical outcomes.................................25 Table 10. Potent Inhibitors of CYP 3A4..............................................................28 Table 11. Drugs Known to Inhibit Metabolism Via CYP 2C9............................29 Table 12. Summary of evidence ..........................................................................34 Figures Figure 1. .................................................................................................................51 Evidence Tables Evidence Table 1. Trials comparing LDL-c lowering ability of two or more statins.............................................................................................52 Evidence Table 2. Trials with primary CHD outcomes ………………………….90 Evidence Table 3. Internal validity of included trials…………………………....111 Evidence Table 4. External validity of included trials…………………………...143 Evidence Table 5. Atherosclerotic progression trials…………………………….163 Evidence Table 6. Post-revascularization and miscellaneous trials ……………..171 Appendices Appendix A. Search strategy…………………………………………………......179 Appendix B. Methods for drug class reviews…………………………………....180 Appendix C. Excluded Trials………………………………………………….....184 This report has not been reviewed or approved by the Agency for Healthcare Research and Quality Recommended citation for this report: Helfand M, Carson S, Kelley C. Drug Class Review on Statins. Final Report. http://www.ohsu.edu/drugeffectiveness/reports/documents/Statins Final Report u2.pdf 2004 Statins Page 2 of 187 Update #2 Final Report Drug Effectiveness Review Project INTRODUCTION Coronary heart disease (CHD) continues to be the leading cause of mortality and a significant cause of morbidity among North Americans. In 1999, CHD claimed 529,659 lives, translating into about one out of every five deaths in the United States.1 High levels of cholesterol, or hypercholesterolemia, are an important risk factor for CHD. The 3-hydroxy-3- methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors, also known as statins, are the most effective class of drugs for lowering serum low-density lipoprotein cholesterol (LDL-c) concentrations. They are first-line agents for patients who require drug therapy to reduce serum LDL-c concentrations. The statins work by blocking an enzyme, HMG-CoA reductase that is the rate-limiting step in the manufacture of cholesterol. Statins reduce LDL-cholesterol, total cholesterol, and triglycerides and slightly increase high-density lipoprotein (HDL-c). Statins may also have anti- inflammatory effects. A recent good-quality systematic review found that all statins are equally effective at lowering C-reactive protein levels, but do not affect fibrinogen or several other markers of inflammation.2 No study has evaluated whether the effect of statins on any marker is related to their effect on cardiovascular outcomes. The third report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) was released in September 2002.3 The report stresses that the intensity of treatment is directly related to the degree of cardiovascular risk. Target LDL-c levels depend on the patient’s risk of heart disease, medical history, and initial LDL-c level. For most patients who are prescribed a statin, the target will be 130 mg/dL or 100 mg/dL. In ATP-III, patients who have Type II diabetes without CHD; peripheral or carotid vascular disease; and patients who have multiple risk factors and a 10-year risk of CHD > 20% are said to have “CHD equivalents,” meaning that the criteria for using drug therapy and the LDL target (<100 mg/dL) is the same as for patients who have a history of CHD. Six statins are available in the US and Canada: atorvastatin (Lipitor) fluvastatin (Lescol, Lescol XL) lovastatin (Mevacor, Altocor) pravastatin (Pravachol) rosuvastatin (ZD4522) (Crestor) simvastatin (Zocor) Fluvastatin (Lescol XL) and lovastatin (Altocor) are available in extended-release as well as immediate-release forms. Lovastatin and pravastatin are natural statins found in fungi; simvastatin is a semisynthetic statin based on lovastatin, and atorvastatin, fluvastatin, and rosuvastatin are fully synthetic. Usual starting doses are rosuvastatin 10 mg, atorvastatin 10 mg, and 20 mg of the other statins. Taking a statin at bedtime or with the evening meal improves its ability to lower LDL. The maximum daily dose for rosuvastatin is 40 mg. For all other statins, the maximum FDA- approved daily dose is 80 mg. For lovastatin and pravastatin, the maximum dose usually is prescribed as 40 mg twice a day. Statins Page 3 of 187 Update #2 Final Report Drug Effectiveness Review Project Scope and Key Questions The purpose of this review is to compare the efficacy and adverse effects of different statins. The Oregon Evidence-based Practice Center wrote preliminary key questions, identifying the populations, interventions, and outcomes of interest, and based on these, the eligibility criteria for studies. These were reviewed and revised by representatives of organizations participating in the Drug Effectiveness Review Project. The participating organizations of DERP are responsible for ensuring that the scope of the review reflects the populations, drugs, and outcome measures of interest to clinicians, patients. The participating organizations approved the following key questions to guide this review: 1. How do statins compare in their ability to reduce LDL-c? a. Are there doses for each statin that produce similar percent reduction in LDL-c between statins? b. Is there a difference in the ability of a statin to achieve National Cholesterol Education Program (NCEP) goals? 2. How do statins compare in their ability to raise HDL-c? 3. How do statins compare in their ability to reduce the risk of nonfatal myocardial infarction, angina, CHD mortality, all-cause mortality, stroke, or need for revascularization (coronary artery bypass graft, angioplasty, or stenting)? 4. Are there differences in efficacy or safety of statins in different demographic groups (age, sex, race)? 5. Are there differences in the safety of statins when used in special populations or with other medications (drug-drug interactions)? In addressing this question, we focused on the following populations and adverse effects: a. Patients with diabetes b. Patients with HIV c. Organ transplant recipients d. Patients at high risk for myotoxicity e. Patients at high risk for hepatotoxicity f. Patients using fibrates (gemfibrozil, fenofibrate) or niacin The choice of key questions reflects the view that the following criteria may be used to select a statin: (1) the ability to lower LDL-c, (2) the ability to raise HDL-c, (3) the amount of information on cardiovascular outcomes available for each statin, (4) adverse effects, and (5) effects in demographic subgroups and in patients with concurrent medical conditions and drug therapies. Statins Page 4 of 187 Update #2 Final Report Drug Effectiveness Review
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