| Trial | control | p<0.05 | harm | NS |
|---|
| LIPS, 2002 | fluvastatin vs placebo | CV events (including revascularization) 0.80 [0.68; 0.96] | | all cause deaths 0.73 [0.48; 1.10] coronary deaths 0.53 [0.27; 1.04] coronary events 0.69 [0.47; 1.01] Rhabdomyolyses NaN [NaN; NaN] cardiac death 0.53 [0.27; 1.04] Infarctus non mortel et décès coronariens 0.69 [0.47; 1.01] non cardiovascular death 0.86 [0.48; 1.54] |
| ALERT, 2003 | fluvastatin vs placebo | | | all cause death 1.04 [0.84; 1.29] Cardiovascular death 0.67 [0.44; 1.01] cardiovascular death, CV events (nonfatal MI, or nonfatal stroke) 0.84 [0.66; 1.06] Noncardiovascular death 1.19 [0.86; 1.63] |
| LIPS (sub groups), 2002 | fluvastatin vs placebo | | | Death 0.73 [0.16; 3.25] fatal MI NaN [NaN; NaN] Revascularisation 0.88 [0.67; 1.15] Non fatal acute MI 1.30 [0.46; 3.72] Stroke (fatal & non fatal) NaN [NaN; NaN] Death from CHD 0.65 [0.11; 3.87] Major cardiovascular events 2.60 [0.70; 9.74] death, MI and stroke - 4 month 2.60 [0.70; 9.74] death, MI and stroke - 1 month 2.93 [0.31; 28.03] |
| FLORIDA, 2002 | fluvastatin vs placebo | | | Death 0.66 [0.26; 1.68] fatal MI 0.00 [0.00; NaN] Revascularisation 0.91 [0.60; 1.38] Non fatal acute MI 1.63 [0.64; 4.14] Stroke (fatal & non fatal) 0.00 [0.00; NaN] Death from CHD 0.52 [0.13; 2.05] Major cardiovascular events 0.95 [0.70; 1.28] Recurrent ischaemia 1.04 [0.57; 1.88] CABG 0.66 [0.32; 1.32] death, MI and stroke - 4 month 1.04 [0.44; 2.45] death, MI and stroke - 1 month 1.04 [0.30; 3.54] |
| LIPS (diabetic sub group), 2002 | fluvastatin vs placebo | Critère de jugement principal de l'étude 0.57 [0.37; 0.89] Evénement coronarien majeur 0.57 [0.37; 0.89] | | |
| ALERT (diabetic sub group), 2003 | fluvastatin vs placebo | | | |
| ALERT, 2003 | fluvastatin vs placebo | coronary events 0.67 [0.50; 0.90] | | all cause deaths 1.04 [0.84; 1.29] coronary deaths 0.67 [0.44; 1.01] CV events (including revascularization) 0.84 [0.66; 1.06] MI non fatal 0.70 [0.48; 1.01] stroke (fatal et non fatal) 1.18 [0.85; 1.63] cardiac death 0.67 [0.44; 1.01] non cardiovascular death 1.19 [0.86; 1.63] |
| LCAS, 1997 | fluvastatin vs placebo | | | all cause deaths 0.96 [0.20; 4.67] coronary events 0.62 [0.37; 1.04] Rhabdomyolyses NaN [NaN; NaN] cardiac death ∞ [NaN; ∞] non cardiovascular death 0.64 [0.11; 3.77] |
| Riegger et al., 1999 | fluvastatin vs placebo | | | all cause deaths 0.48 [0.09; 2.57] Rhabdomyolyses NaN [NaN; NaN] cardiac death 0.48 [0.09; 2.57] non cardiovascular death NaN [NaN; NaN] |
| BCAPS, 2001 | fluvastatin vs placebo | | | all cause deaths 1.01 [0.33; 3.10] cardiac death 0.50 [0.05; 5.53] non cardiovascular death 1.26 [0.34; 4.66] |
| FLARE, 1999 | fluvastatin vs placebo | | | all cause deaths 0.45 [0.12; 1.71] CV events (including revascularization) 0.97 [0.75; 1.24] MI non fatal 0.31 [0.09; 1.12] Rhabdomyolyses NaN [NaN; NaN] |
| FLARE (elderly subgroup), 1999 | fluvastatin vs placebo | | | All cause mortality 0.35 [0.07; 1.70] Coronary Heart Disease Mortality 0.70 [0.12; 4.12] Nonfatal Myocardial Infarction 0.58 [0.20; 1.70] |
| LIPS (elderly subgroup), 2002 | fluvastatin vs placebo | Revascularization 0.69 [0.51; 0.94] | | All cause mortality 0.66 [0.40; 1.11] Coronary Heart Disease Mortality 0.49 [0.21; 1.14] Nonfatal Myocardial Infarction 0.69 [0.33; 1.44] |
| HYRIM, 2005 | fluvastatin vs placebo | | | all cause deaths 0.81 [0.22; 2.97] cardiovascular events 0.74 [0.35; 1.58] |
| Trial | Treatments | Patients | Method |
|---|
| LIPS, 2002 | fluvastatin, 80 mg/d (n=844) vs. placebo (n=833)
| patients (aged 18-80 years) with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 3.5-7.0 mmol/L and with fasting triglyceride levels of less than 4.5 mmol/L
| double blind Parallel groups Sample size: 844/833 Primary endpoint: MACE (cardiac death, MI, reintervention) FU duration: 3.9 years
|
| ALERT, 2003 | fluvastatin (n=1050) vs. placebo (n=1052) | renal transplant recipients with
total cholesterol 4·0–9·0 mmol/L. | double blind Parallel groups Sample size: 1050/1052 Primary endpoint: major adverse cardiac event FU duration: 5.1 years |
| LIPS (sub groups), 2002 | Fluvastatin, 80 mg (n=417) vs. Placebo (n=407) | patients with unstable angina and successful first percutaneous coronary intervention initially this study included patients with unstable or stable coronary heart disease (844 vs 833) | double blind Parallel groups Sample size: 417/407 Primary endpoint: MACE FU duration: 1, 4, and 6 months sub group of patients with unstable angina |
| FLORIDA, 2002 | Fluvastatin, 80 mg (early initiation) (n=265) vs. Placebo (n=275) | patients with an AMI and total cholesterol of <6.5 mmol.l | double blind Parallel groups Sample size: 265/275 Primary endpoint: FU duration: 1, 4, and 6 months |
| LIPS (diabetic sub group), 2002 | fluvastatin (n=120) vs. placebo (n=82) | patients (aged 18-80 years) with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dL | double blind Parallel groups Sample size: 120/82 Primary endpoint: MACE FU duration: 3.9y |
| ALERT (diabetic sub group), 2003 | fluvastatin (n=197) vs. placebo (n=199) | renal transplant recipients with
total cholesterol 4·0–9·0 mmol/L | double blind Parallel groups Sample size: 197/199 Primary endpoint: FU duration: |
| ALERT, 2003 | fluvastatin 40 mg daily (n=1050) vs. placebo (n=1052) | renal transplant recipients with total cholesterol 4.0-9.0 mmol/L | double-blind Parallel groups Sample size: 1050/1052 Primary endpoint: major adverse cardiac event FU duration: 5.1 years |
| LCAS, 1997 | fluvastatin 20 mg twice daily (n=164) vs. placebo (n=157) | men and women aged 35 to 75 years with angiographic CHD and mean low-density lipoprotein (LDL) cholesterol of 115 to 190 mg/dl despite diet | double-blind Parallel groups Sample size: 164/157 Primary endpoint: minimum lumen diameter FU duration: 2.5 years |
| Riegger et al., 1999 | fluvastatin 40 mg (o.a.d. or b.i.d.) (n=187) vs. placebo (n=178) | hyperlipidaemic patients with symptomatic, clinically-diagnosed (exercise-ECG) coronary heart disease | double blind Parallel groups Sample size: 187/178 Primary endpoint: FU duration: 1.0 years |
| BCAPS, 2001 | fluvastatin 40 mg once daily (n=395) vs. placebo (n=398) factorial design of fluvastatin versus placebo and metoprolol CR/XL vs placebo | subjects who had carotid plaque but no symptoms of carotid artery disease | double-blind Factorial plan Sample size: 395/398 Primary endpoint: not unique (IMT) FU duration: 3.0 years |
| FLARE, 1999 | fluvastatin 40 mg twice daily (n=409) vs. placebo (n=425) | successful coronary balloon angioplasty | double blind Parallel groups Sample size: 409/425 Primary endpoint: angiographic restenosis FU duration: 40 weeks |
| FLARE (elderly subgroup), 1999 | Fluvastatin 80mg (n=179) vs. (n=187) | CAD requiring PCI, subgroup of age 65-80 y | double blind parallel groups Sample size: 179/187 Primary endpoint: FU duration: 0.8y |
| LIPS (elderly subgroup), 2002 | Fluvastatin 80mg (n=324) vs. (n=299) | CAD requiring PCI, subgroup of age 65-80 y | double blind parallel groups Sample size: 324/299 Primary endpoint: FU duration: 3.9y |
| HYRIM, 2005 | fluvastatin 40 mg daily (n=283) vs. placebo (n=285) factorialdesign with 2nd randomization between intensive lifestyle intervention (physical activity and diet) or usual care (treatment of hypertension and other disorders by own private physician). | drug-treated hypertensive men aged 40-74 years with total cholesterol 4.5-8.0 mmol/L, triglycerides <4.5 mmol/L, body mass index 25-35 kg/m2, and a sedentary lifestyle | double blind Factorial plan Sample size: 283/285 Primary endpoint: Carotid IMT FU duration: 4 year |
