Table 9Outpatient and community-based placebo-controlled trials of statins with coronary heart disease endpoints

Trial (Quality)Risk status/Average annual event rate in placebo groupBaseline LDL (mg/dL)Study duration (years)% LDL reductionReduction in coronary events (relative risk reduction)aNumber needed to treat to prevent a coronary eventb
Trials of atorvastatin
ASCOT171, 172
Atorvastatin 10 mg (Fair-Good)
HTN plus CHD risk factors/0.9%1333.335%36%94
CARDS125
Atorvastatin 10 mg (Good)
Type 2 diabetes, no history of CVD 2.3%1173.936%37%31
4D134 (Fair)Type 2 diabetes, receiving dialysis 39%1264.042%18% (including PTCA and CABG)18
ASPEN142Type 2 diabetes, low LDL levels1134.2529%10.4% vs. 10.8%Results not significant
Xu145Diabetes, coronary artery disease1251.7524%37% (including revascularization)7
Trials of fluvastatin
ALERT173
Fluvastatin 40 mg (Good)
Patients with renal transplant 1.0%1605.132%Primary endpoint not significant (P=0.139), but 35% reduction in cardiac deaths or non-fatal MIResults not significant
Riegger129
Fluvastatin 40 mg (Fair)
Symptomatic CAD/2.8%198126.9%38%Results not significant
Trials of lovastatin
AFCAPS126
Lovastatin 20 mg-40 mg (Good)
Average risk, no history of CAD/1.1%1505.225%37%49
Trials of pravastatin
ALLHAT-LLC121
Pravastatin 40 mg (Fair-Good)
Hypertensive moderately high LDL-C and at least 1 additional
CHD risk factor/1.7%
1454.824%9%Results not significant
CARE122
Pravastatin 40 mg (Good)
History of CAD/2.6%139528%24%41
LIPID130;
Pravastatin 40 mg (Good)
History of CAD/2.6%1506.125%24%164
PREVEND IT124
Pravastatin 40 mg (Fair)
Average risk, persistent microalbuminuria 0.8%1743.825%13%Results not significant
PROSPER133
Pravastatin 40 mg (Good)
70–82 years old, history of CHD or risk factors/5.2%1473.227%15%24
WOSCOPS132
Pravastatin 40 mg (Good)
High risk, no history of CAD/1.5%1924.916%31%44
MEGA14440–70 yrs, bodyweight <40 kg, hypercholesterolemia, no CHD history1585.318% vs. 3%30%119
Trials of simvastatin
4S128
Simvastatin 20 mg (Good)
History of CAD/5.2%1875.435%34%11
Heart Protection Study123, 174
Simvastatin 40 mg (Good)
History of CVD, diabetes, or noncoronary vascular disease/2.1%1315.530%27%32
Trials of rosuvastatin
JUPITER81
Rosuvastatin 20 mg (Good)
LDL <130 mg/dL, high-sensitivity C-reactive protein levels > 2 mg/L, no history of CVD or diabetes1081.950%HR, 0.56 (95% CI, 0.46 to 0.69);
P<0.00001
25

Abbreviations: CABG, Coronary artery bypass graft, CAD, coronary artery disease; CHD, coronary heart disease; CVD, cardiovascular disease; HTN, hypertension; HR, hazard ratio; LDL-C, low-density lipoprotein cholesterol; PTCA, percutaneous transluminal coronary angioplasty.

a

Bolding indicates statistically significant results.

b

Not adjusted for length of trial or for baseline risk.

From: Adults

Cover of Drug Class Review: HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin
Drug Class Review: HMG-CoA Reductase Inhibitors (Statins) and Fixed-dose Combination Products Containing a Statin: Final Report Update 5 [Internet].
Smith MEB, Lee NJ, Haney E, et al.
Portland (OR): Oregon Health & Science University; 2009 Nov.
Copyright © 2009, Oregon Health & Science University, Portland, Oregon.

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