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Table 1 Features of randomized statin secondary prevention trials designed to detect differences in clinically important end-points

From: A randomized trial to assess the impact of opinion leader endorsed evidence summaries on the use of secondary prevention strategies in patients with coronary artery disease: the ESP-CAD trial protocol [NCT00175240]

Trial Treatment (mg/day) andFollow-up Duration Key Eligibility Criteria Number of Patients Mean Age (yrs) % Change in LDL-c Relative Risk Reduction, Mortality and MI (95% CI)
4S [2] Simvastatin 20 mg for 5.4 yrs (median) 35–70 yrs, prior angina or AMI, fasting total cholesterol 5.5–8.0 mmol/L 4444 58.6 -35% 30% (15% to 42%) and 27% (20% to 34%)
LIPID [3] Pravastatin 40 mg for 6.1 yrs (mean) 31–75 yrs, prior AMI or unstable angina, fasting total cholesterol 4 – 7 mmol/L 9014 62 -25% 22% (13% to 31%) and 29% (18% to 38%)
CARE [4] Pravastatin 40 mg for 5.0 yrs (median) 21–75 yrs, prior AMI, fasting LDL cholesterol 3.0–4.5 mmol/L 4159 59 -28% 9% (-12% to 26%) and 25% (8% to 39%)
MRC/BHF Heart Protection Study[5] Simvastatin 40 mg for 5.0 yrs (mean) 40–80 yrs, increased risk of CV death (due to known atherosclerotic disease, or diabetes, or hypertension with other CV risks) 20 536 NR -29% 13% (6% to 19%) and 27% (21% to 33%)
MIRACL [6] Atorvastatin 80 mg for 16 weeks (mean) 18 – 77 yrs, ACS, screening cholesterol <7.0 mmol 3086 65 -52% 6% (-31% to 33%) and 10% (-16% to 31)
LIPS [7] Fluvastatin 80 mg for 3.9 yrs (median) 18 – 80 yrs, after percutaneous intervention, screening cholesterol 3.5–7.0 mmol 1677 60 -27% 31% (17% to -14%) and 19% (62% to -24%)
PROSPER[8] Pravastatin 40 mg for 3.2 yrs (mean) 70–82 yrs, with vascular disease or at high risk, screening cholesterol 4.0–9.0 mmol/L 5804 75 -34% 3% (17% to -14%) and 14% (-3% to +28%)1
ASCOT [9] Atorvastatin 10 mg for 3.3 yrs (median) 40–79 yrs, hypertension plus >3 other cardiovascular risk factors, screening cholesterol ≤ 6.5 mmol/L 10 305 63 -35% 13% (29% to -6%) and 36% (17% to 50%)
PROVE IT-TIMI 22 [10] Atorvastatin 80 mg vs. Pravastatin 40 mg for 2.0 yrs (mean) > 18 yrs, ACS, screening cholesterol ≤ 6.21 mmol/L or 5.18 mmol/L if on lipid lowering therapy 4162 58.3 Atorva: -42% Prava: -10% 28% (-2% to +50%) and 13% (-8% to 32%)1
TNT [11] Atorvastatin 80 mg vs. Atorvastatin 10 mg for 4.9 yrs (median) 35–75 yrs, stable CAD, LDL-c < 3.4 mmol/L 10 001 61 Atorva 80 mg: -21% Atorva 20 mg: no change -1% (-19% to +15%) and 22% (7% to 34%)1
IDEAL [12] Atorvastatin 80 mg vs. Simvastatin 20 mg for 4.8 yrs (median) 18–80 years, prior AMI 8888 62 Atorva : -34% Simva : -17% 2% (-13% to 15%) and 17% (2% to 29%)1
ALLHAT-LLT [15] Pravastatin 40 mg for 4.8 yrs (mean) Hypertension, older than 55 years, at least one other cardiac risk factor and LDL-c 3.1–4.9 mmol/L without known CAD or 2.6–3.3 with known CAD 10 355 66 -17% 1% (-11% to +11%) and 9% (-4% to +21%)
  1. 1. Based on hazard ratio; LDL-c= LDL cholesterol; CAD = coronary artery disease; AMI = acute myocardial infarction; ACS = acute coronary syndrome; CV = cardiovascular; Atorva = atorvastatin; Prava = Pravastatin; Simva = simvastatin.