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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.