| Trial | control | p<0.05 | harm | NS |
|---|
| CCAIT, 1994 | vs placebo | | | all cause deaths 1.01 [0.14; 7.06] coronary deaths 1.98 [0.18; 21.59] MI non fatal 0.84 [0.26; 2.69] non cardiovascular death 0.00 [0.00; NaN] |
| MARS, 1993 | vs placebo | | | all cause deaths ∞ [NaN; ∞] coronary deaths 0.00 [0.00; NaN] non cardiovascular death ∞ [NaN; ∞] |
| AFCAPS/TexCAPS, 1998 | vs placebo | coronary events 0.76 [0.62; 0.92] Demonstrated Infarctus non mortel et décès coronariens 0.76 [0.62; 0.92] | | Pancreatitis 0.70 [0.27; 1.84] all cause deaths 1.04 [0.76; 1.41] coronary deaths 0.73 [0.34; 1.59] cardiovascular death 0.68 [0.37; 1.26] Rhabdomyolyses 0.50 [0.05; 5.51] stroke (fatal et non fatal) 0.82 [0.41; 1.67] non cardiovascular death 1.21 [0.84; 1.74] incident diabetes 0.98 [0.70; 1.38] |
| Excel, 1991 | vs placebo | | | all cause deaths 2.78 [0.85; 9.05] coronary deaths 2.36 [0.72; 7.75] Rhabdomyolyses NaN [NaN; NaN] non cardiovascular death ∞ [NaN; ∞] |
| Weintraub, 1994 | vs placebo | | | non cardiovascular death NaN [NaN; NaN] |
| AFCAPS/TexCAPS (diabetic sub group), 1998 | vs placebo | | | |
| CRISP 20mg, 1994 | vs placebo | | | |
| ACAPS, 1994 | vs placebo | all cause deaths 0.12 [0.02; 0.99] | | coronary deaths 0.00 [0.00; NaN] cardiovascular death 0.00 [0.00; NaN] MI non fatal 1.00 [0.29; 3.42] Rhabdomyolyses NaN [NaN; NaN] stroke (fatal et non fatal) 0.00 [0.00; NaN] cardiac death 0.00 [0.00; NaN] non cardiovascular death 0.50 [0.05; 5.48] |
| Sahni, 1991 | vs placebo | | | all cause deaths 0.79 [0.22; 2.83] coronary deaths 0.49 [0.09; 2.62] non cardiovascular death 1.97 [0.18; 21.34] |
| CLAPT, 1999 | vs placebo | | | all cause deaths 0.00 [0.00; NaN] MI non fatal 0.00 [0.00; NaN] cardiac death 0.00 [0.00; NaN] non cardiovascular death NaN [NaN; NaN] |
| CRISP 40mg, 1994 | vs placebo | | | |
| AFCAPS (women subgroup) , 1998 | vs placebo | | | All cause mortality 1.57 [0.61; 4.01] CHD events 0.67 [0.34; 1.29] cancer 1.14 [0.70; 1.87] Cv events 0.67 [0.34; 1.29] |
| Trial | Treatments | Patients | Method |
|---|
| CCAIT, 1994 | lovastatin begun at 20 mg/d and titrated to 40 and 80 mg during the first 16 weeks to attain a fasting low-density lipoprotein (LDL) cholesterol < or = 130 mg/dL (n=165) vs. placebo (n=166)
| patients with diffuse but not necessarily severe coronary atherosclerosis documented on a recent arteriogram and with fasting serum cholesterol between 220 and 300 mg/dL
| double-blind Parallel groups Sample size: 165/166 Primary endpoint: minimum lumen diameter changes FU duration: 2 years
|
| MARS, 1993 | lovastatin 80 mg/day (n=123) vs. placebo (n=124)
| patients, 37 to 67 years old, with total cholesterol ranging from 4.92 to 7.64 mmol/L (190 to 295 mg/dL) and angiographically defined coronary artery disease
| double blind Parallel groups Sample size: 123/124 Primary endpoint: change in percent diameter stenosis FU duration: 2.0y
|
| AFCAPS/TexCAPS, 1998 | lovastatin 20-40 mg/d (n=3304) vs. placebo (n=3301)
| men and women without clinically evident atherosclerotic cardiovascular disease with average total cholesterol (TC) and LDL-C levels and below-average high-density lipoprotein cholesterol (HDL-C) levels
| double blind Parallel groups Sample size: 3304/3301 Primary endpoint: major coronary event FU duration: 5.2 years
|
| Excel, 1991 | lovastatin (20 mg once daily, 40 mg once daily, 20 mg twice daily, or 40 mg twice daily) (n=6582) vs. placebo (n=1663) | patients with moderate hypercholesterolemia | double blind Parallel groups Sample size: 6582/1663 Primary endpoint: not defined FU duration: 0.9 years |
| Weintraub, 1994 | lovastatin 40 mg orally twice daily (n=203) vs. placebo (n=201)
| patients undergoing PTCA
| double blind Parallel groups Sample size: 203/201 Primary endpoint: FU duration: 0.5 years
|
| AFCAPS/TexCAPS (diabetic sub group), 1998 | lovastatin (n=84) vs. placebo (n=71) | men and women without clinically evident atherosclerotic cardiovascular
disease with average total cholesterol (TC) and LDL-C levels and below-average high-density
lipoprotein cholesterol (HDL-C) levels | double blind Parallel groups Sample size: 84/71 Primary endpoint: FU duration: |
| CRISP 20mg, 1994 | lovastatin 20mg daily (n=-9) vs. placebo (n=-9) 3 arms placebo, lovastatin 20mg and 40mg | elderly (mean 71y) with low-density lipoprotein cholesterol levels greater than 4.1 and less than 5.7 mmol/L | double blind Parallel groups Sample size: -9/-9 Primary endpoint: changes in blood lipid levels FU duration: 1 years |
| ACAPS, 1994 | lovastatin 20mg daily (n=460) vs. placebo (n=459) factorial design of warfarin and lovastatin
| men and women, 40 to 79 years old, with early carotid atherosclerosis and moderately elevated LDL cholesterol.
| double blind Factorial plan Sample size: 460/459 Primary endpoint: change in mean maximum intimal-medial thickness FU duration: 2.8 years
|
| Sahni, 1991 | lovastatin 20-40mg/d (n=79) vs. conventional therapy alone (n=78) | patients undergoing successful PTCA
| open Parallel groups Sample size: 79/78 Primary endpoint: FU duration: 2 years
|
| CLAPT, 1999 | lovastatin begun at 20 mg daily and tritrated up to 80 mg daily (n=112) vs. usual care (n=114) | patients underwenting PTCA | open (blind assessement) Parallel groups Sample size: 112/114 Primary endpoint: mean segment diameter FU duration: 2.0 years |
| CRISP 40mg, 1994 | lovastatin 40 mg daily (n=-9) vs. placebo (n=-9)
| elderly (mean 71y) with low-density lipoprotein cholesterol levels greater than 4.1 and less than 5.7 mmol/L
| double blind Parallel groups Sample size: -9/-9 Primary endpoint: changes in blood lipid levels FU duration: 1 years
|
| AFCAPS (women subgroup) , 1998 | Lovastatin 20–40 mg daily (n=499) vs. placebo (n=498) | men and postmenopausal women without clinical evidence of cardiovascular disease (CVD) who had average low-density lipoprotein cholesterol and below average high-density lipoprotein cholesterol - subgroup of women | double blind Parallel groups Sample size: 499/498 Primary endpoint: FU duration: 5.2 y |
