Table 1.
Prospective randomized statin trials in both primary and secondary prevention. Reprinted with permission.
| STUDY | DRUG | DESIGN | OUTCOMES |
|---|---|---|---|
| Primary prevention studies | |||
| AFCAPS/TexCAPS | Lovastatin, 20–40 mg/d vs placebo | 6,605 men and women | 40% reduction in fatal and nonfatal MI; 37% reduction in first ACS; 33% reduction in coronary revascularizations; 32% reduction in unstable angina |
| ASCOT | Atorvastatin 10 mg/d vs placebo | 10,305 hypertensive men (n = 8,463) and women (n = 1,942) with treated high BP and no previous CAD | 36% reduction in total CHD/nonfatal MI; 27% reduction in fatal and nonfatal stroke; total coronary event reduced by 29%; fatal and nonfatal stroke reduced by 27% |
| CARDS | Atorvastatin 10 mg/d vs placebo | 2,838 patients with type 2 diabetes mellitus and 1 CHD risk factor | 37% reduction in major cardiovascular events; 27% reduction in total mortality; 13.4% reduction in acute CVD events; 36% reduction in acute coronary events; 48% reduction in stroke |
| Heart Protection Study | Simvastatin 40 mg/d vs placebo | 20,536 high-risk patients (previous CHD, other vascular disease, hypertension among men aged > 65 y, or diabetes) | 25% reduction in all-cause and coronary death rates and in strokes; need for revascularization reduced by 24%; fatal and nonfatal stroke reduced by 25%; nonfatal MI reduced by 38%; coronary mortality reduced by 18%; all-cause mortality reduced by 13%; cardiovascular event rate reduced by 24% |
| PROSPER | Pravastatin 40 mg/d vs placebo | 5,804 men (n = 2,804) and women (n = 3,000) aged 70–82 y | 15% reduction in combined end point (fatal/nonfatal MI or stroke); 19% reduction in total/nonfatal CHD; no effect on stroke (but 25% reduction in TIA) |
| WOSCOPS6 | Pravachol therapy 40 mg/d vs placebo | 6,595 men | CHD death in nonfatal MI reduced by 31%; CVD death reduced by 32%; total mortality reduced by 22% |
| JUPITER | Rosuvastatin 20 mg/d vs placebo | 17,802 men (> 50 y) and women (> 60 y) with no history of CAD or DM, entry LDL < 130 mg/dL, and CRP > 2.0 mg/L | 44% reduction in primary end point in major coronary events; 65% reduction in nonfatal MI; 48% reduction in nonfatal stroke; 46% reduction in need for revascularization; 20% reduction in all-cause mortality |
| 4S | Simvastatin 20 mg/d vs placebo | 4,444 patients with angina pectoris or history of MI | Coronary mortality reduced by 42%; myocardial revascularization reduced by 37%; all-cause mortality reduced by 30%; nonfatal major coronary event reduced by 34%; fatal and nonfatal stroke reduced by 30% |
| AVERT | Atorvastatin 80 mg/d vs angioplasty and usual care | 341 patients with stable CAD | 36% reduction in ischemic event; delayed time to first ischemic event reduced by 36% |
| CARE | Pravastatin 40 mg/d vs placebo | 3,583 men and 576 women with history of MI | Death from CHD or nonfatal MI reduced by 24%; death from CHD reduced by 20%; nonfatal MI reduced by 23%; fatal MI reduced by 37%; CABG or PTCA reduced by 27% |
| IDEAL | Atorvastatin 80 mg/d vs simvastatin 20–40 mg/day | 8,888 men and women with CHD | Major cardiac events reduced by 13%, nonfatal MI reduced by 17%, revascularization reduced by 23%, peripheral arterial disease reduced by 24% |
| LIPID | Pravachol 40 mg/d vs placebo | 9,014 patients | Coronary mortality reduced by 24%; stroke reduced by 19%; fatal CHD or nonfatal MI reduced by 24%; fatal or nonfatal MI reduced by 29% |
| LIPS | Fluvastatin 40 mg/d vs placebo | 1,667 men and women aged 18–80 y post-angioplasty for CAD | 22% lower rate in major coronary events (e.g., cardiac deaths, nonfatal MI, or reintervention procedure) |
| MIRACL | Atorvastatin 80 mg/d vs placebo | 3,086 patients with ACS | Reduction in composite end point by 16%; ischemia reduced by 26%; stroke reduced by 50% |
| PROVE IT | Atorvastatin 80 mg/d vs pravastatin 40 mg/day | 4,162 patient with ACS | 16% reduction in composite end point; 14% reduction in CHD death, MI, or revascularization; revascularizations reduced by 14%; unstable angina reduced by 29% |
| REVERSAL | Atorvastatin 80 mg/d vs pravastatin 40 mg/day | 654 patients with CAD | Atheroma: atorvastatin 0.4%, pravastatin 2.7%, difference of −3.1%, P = .02 |
| TNT | Atorvastatin 10 mg/d vs 80 mg/day | 10,003 patients with CHD and LDL cholesterol 130–250 mg/dL | 22% reduction in composite end point; MI reduced by 22%; stroke reduced by 25% |
[i] Abbreviations: ACS: acute coronary syndrome; CABG: coronary artery bypass grafting; CAD: coronary artery disease; CHD: coronary heart disease; LDL: low-density lipoprotein; MI: myocardial infarction; PTCA: percutaneous transluminal coronary angioplasty. Trial acronyms: AFCAPS/TexCAPS: The Air Force/Texas Coronary Atherosclerosis Prevention Study: Implications for Preventive Cardiology in the General Adult US Population; ASCOT: Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm; CARDS: Collaborative Atorvastatin Diabetes Study; PROSPER: Pravastatin in elderly individuals at risk of vascular disease; WOSCOPS: West of Scotland Coronary Prevention Study; 4S: The Scandinavian Simvastatin Survival Study; AVERT: Atorvastatin versus Revascularization Treatment Investigators; CARE: Cholesterol and Recurrent Events Trial; IDEAL: Incremental Decrease in End Points Through Aggressive Lipid Lowering Study; JUPITER: The Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; LIPID: Long-Term Intervention with Pravastatin in Ischemic Disease; LIPS: Lescol Intervention Prevention Study; MIRACL: Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering Study; PROVE IT: Pravastatin or Atorvastatin Evaluation and Infection Therapy Study; REVERSAL: The REVERSing Atherosclerosis with Aggressive Lipid Lowering Study; TNT: Treating to New Targets Trial
Table 1.
Continued
| STUDY | DRUG | DESIGN | OUTCOMES |
|---|---|---|---|
| Primary prevention studies | |||
| AFCAPS/TexCAPS | Lovastatin, 20–40 mg/d vs placebo | 6,605 men and women | 40% reduction in fatal and nonfatal MI; 37% reduction in first ACS; 33% reduction in coronary revascularizations; 32% reduction in unstable angina |
| ASCOT | Atorvastatin 10 mg/d vs placebo | 10,305 hypertensive men (n = 8,463) and women (n = 1,942) with treated high BP and no previous CAD | 36% reduction in total CHD/nonfatal MI; 27% reduction in fatal and nonfatal stroke; total coronary event reduced by 29%; fatal and nonfatal stroke reduced by 27% |
| CARDS | Atorvastatin 10 mg/d vs placebo | 2,838 patients with type 2 diabetes mellitus and 1 CHD risk factor | 37% reduction in major cardiovascular events; 27% reduction in total mortality; 13.4% reduction in acute CVD events; 36% reduction in acute coronary events; 48% reduction in stroke |
| Heart Protection Study | Simvastatin 40 mg/d vs placebo | 20,536 high-risk patients (previous CHD, other vascular disease, hypertension among men aged > 65 y, or diabetes) | 25% reduction in all-cause and coronary death rates and in strokes; need for revascularization reduced by 24%; fatal and nonfatal stroke reduced by 25%; nonfatal MI reduced by 38%; coronary mortality reduced by 18%; all-cause mortality reduced by 13%; cardiovascular event rate reduced by 24% |
| PROSPER | Pravastatin 40 mg/d vs placebo | 5,804 men (n = 2,804) and women (n = 3,000) aged 70–82 y | 15% reduction in combined end point (fatal/nonfatal MI or stroke); 19% reduction in total/nonfatal CHD; no effect on stroke (but 25% reduction in TIA) |
| WOSCOPS6 | Pravachol therapy 40 mg/d vs placebo | 6,595 men | CHD death in nonfatal MI reduced by 31%; CVD death reduced by 32%; total mortality reduced by 22% |
| JUPITER | Rosuvastatin 20 mg/d vs placebo | 17,802 men (> 50 y) and women (> 60 y) with no history of CAD or DM, entry LDL < 130 mg/dL, and CRP > 2.0 mg/L | 44% reduction in primary end point in major coronary events; 65% reduction in nonfatal MI; 48% reduction in nonfatal stroke; 46% reduction in need for revascularization; 20% reduction in all-cause mortality |
| 4S | Simvastatin 20 mg/d vs placebo | 4,444 patients with angina pectoris or history of MI | Coronary mortality reduced by 42%; myocardial revascularization reduced by 37%; all-cause mortality reduced by 30%; nonfatal major coronary event reduced by 34%; fatal and nonfatal stroke reduced by 30% |
| AVERT | Atorvastatin 80 mg/d vs angioplasty and usual care | 341 patients with stable CAD | 36% reduction in ischemic event; delayed time to first ischemic event reduced by 36% |
| CARE | Pravastatin 40 mg/d vs placebo | 3,583 men and 576 women with history of MI | Death from CHD or nonfatal MI reduced by 24%; death from CHD reduced by 20%; nonfatal MI reduced by 23%; fatal MI reduced by 37%; CABG or PTCA reduced by 27% |
| IDEAL | Atorvastatin 80 mg/d vs simvastatin 20–40 mg/day | 8,888 men and women with CHD | Major cardiac events reduced by 13%, nonfatal MI reduced by 17%, revascularization reduced by 23%, peripheral arterial disease reduced by 24% |
| LIPID | Pravachol 40 mg/d vs placebo | 9,014 patients | Coronary mortality reduced by 24%; stroke reduced by 19%; fatal CHD or nonfatal MI reduced by 24%; fatal or nonfatal MI reduced by 29% |
| LIPS | Fluvastatin 40 mg/d vs placebo | 1,667 men and women aged 18–80 y post-angioplasty for CAD | 22% lower rate in major coronary events (e.g., cardiac deaths, nonfatal MI, or reintervention procedure) |
| MIRACL | Atorvastatin 80 mg/d vs placebo | 3,086 patients with ACS | Reduction in composite end point by 16%; ischemia reduced by 26%; stroke reduced by 50% |
| PROVE IT | Atorvastatin 80 mg/d vs pravastatin 40 mg/day | 4,162 patient with ACS | 16% reduction in composite end point; 14% reduction in CHD death, MI, or revascularization; revascularizations reduced by 14%; unstable angina reduced by 29% |
| REVERSAL | Atorvastatin 80 mg/d vs pravastatin 40 mg/day | 654 patients with CAD | Atheroma: atorvastatin 0.4%, pravastatin 2.7%, difference of −3.1%, P = .02 |
| TNT | Atorvastatin 10 mg/d vs 80 mg/day | 10,003 patients with CHD and LDL cholesterol 130–250 mg/dL | 22% reduction in composite end point; MI reduced by 22%; stroke reduced by 25% |
[i] Abbreviations: ACS: acute coronary syndrome; CABG: coronary artery bypass grafting; CAD: coronary artery disease; CHD: coronary heart disease; LDL: low-density lipoprotein; MI: myocardial infarction; PTCA: percutaneous transluminal coronary angioplasty. Trial acronyms: AFCAPS/TexCAPS: The Air Force/Texas Coronary Atherosclerosis Prevention Study: Implications for Preventive Cardiology in the General Adult US Population; ASCOT: Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm; CARDS: Collaborative Atorvastatin Diabetes Study; PROSPER: Pravastatin in elderly individuals at risk of vascular disease; WOSCOPS: West of Scotland Coronary Prevention Study; 4S: The Scandinavian Simvastatin Survival Study; AVERT: Atorvastatin versus Revascularization Treatment Investigators; CARE: Cholesterol and Recurrent Events Trial; IDEAL: Incremental Decrease in End Points Through Aggressive Lipid Lowering Study; JUPITER: The Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; LIPID: Long-Term Intervention with Pravastatin in Ischemic Disease; LIPS: Lescol Intervention Prevention Study; MIRACL: Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering Study; PROVE IT: Pravastatin or Atorvastatin Evaluation and Infection Therapy Study; REVERSAL: The REVERSing Atherosclerosis with Aggressive Lipid Lowering Study; TNT: Treating to New Targets Trial