Isaacsohn 2003.

Methods	4‐week run‐in period 12‐week before and after trial
Participants	173 men and women at least 18 years of age primary hypercholesterolaemia TG ≤ 400 mg/dL (4.52 mmol/L) and LDL‐C levels ≥ pre established levels that were based on the presence or absence of atherosclerotic disease and other risk factors for CHD exclusion criteria: active liver disease or hepatic dysfunction, impaired renal function Fluvastatin 40 mg/day baseline TC : 7.01 mmol/L (271 mg/dL) Fluvastatin 40 mg/day baseline LDL‐C : 4.78 mmol/L (185 mg/dL) Fluvastatin 40 mg/day baseline HDL‐C : 1.27 mmol/L (49 mg/dL) Fluvastatin 40 mg/day baseline triglycerides: 2.15 mmol/L (190 mg/dL) Fluvastatin 80 mg/day baseline TC : 6.83 mmol/L (264 mg/dL) Fluvastatin 80 mg/day baseline LDL‐C : 4.68 mmol/L (181 mg/dL) Fluvastatin 80 mg/day baseline HDL‐C : 1.24 mmol/L (48 mg/dL) Fluvastatin 80 mg/day baseline triglycerides: 2.01 mmol/L (178 mg/dL)
Interventions	Fluvastatin 40 mg/day Fluvastatin 80 mg/day
Outcomes	per cent change from baseline at 4‐12 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides
Source of Funding	unknown
Notes	SDs were imputed by the method of Furikawa 2006
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Controlled before and after design
Allocation concealment (selection bias)	High risk	Controlled before and after design
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Lipid parameter measurements unlikely influenced by lack of blinding
Blinding of outcome assessment (detection bias) LDL‐cholesterol	Low risk	Lipid parameters were measured in a remote laboratory
Blinding of outcome assessment (detection bias) WDAEs	High risk	No comparison possible
Incomplete outcome data (attrition bias) All outcomes	Low risk	1.2% participants were not included in the efficacy analysis
Selective reporting (reporting bias)	Low risk	LDL‐C outcome was reported
Other bias	Unclear risk	Source of funding was not reported