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. 2018 Mar 6;2018(3):CD012282. doi: 10.1002/14651858.CD012282.pub2

Davidson 2003.

Methods 6‐week dietary run‐in washout period
6‐week before and after trial
Participants 838 men and women aged > 20 years with primary hypercholesterolaemia 337 received fluvastatin
triglycerides ≤ 4.5 mmol/L (399 mg/dL)
LDL‐C ≥ 3.4 mmol/L (131mg/dL) with evidence of CHD or other atherosclerotic disease
LDL‐C ≥ 4.1 mmol/L (159mg/dL) with ≥2 other CHD risk factors but no CHD or other atherosclerotic disease
LDL‐C ≥ 4.9 mmol/L (189mg/dL) without CHD or other atherosclerotic disease and < 2 other CHD risk factors
exclusion criteria: MI, coronary bypass surgery or angioplasty in the prior 3 months
current coronary insufficiency, clinically significant ventricular arrhythmias, potential childbearing, pregnancy
Fluvastatin 20 mg/day baseline TC : 7.1 mmol/L (275 mg/dL)
 Fluvastatin 20 mg/day baseline LDL‐C : 4.9 mmol/L (189 mg/dL)
 Fluvastatin 20 mg/day baseline HDL‐C : 1.2 mmol/L (46 mg/dL)
Fluvastatin 20 mg/day baseline triglycerides: 2.1 mmol/L (186 mg/dL)
Fluvastatin 40 mg/day baseline TC : 7.0 mmol/L (271 mg/dL)
 Fluvastatin 40 mg/day baseline LDL‐C : 4.8 mmol/L (186 mg/dL)
 Fluvastatin 40 mg/day baseline HDL‐C : 1.2 mmol/L (46 mg/dL)
Fluvastatin 40 mg/day baseline triglycerides: 2.2 mmol/L (195 mg/dL)
Interventions Lovastatin 10 mg/day for 6 weeks
Lovastatin 20 mg/day for 6 weeks
Lovastatin 40 mg/day for 6 weeks
Fluvastatin 20 mg/day for 6 weeks
Fluvastatin 40 mg/day for 6 weeks
Outcomes per cent change from baseline at 6 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides
Source of Funding unknown
Notes Lovastatin 10 mg/day for 6 weeks
Lovastatin 20 mg/day for 6 weeks
Lovastatin 40 mg/day for 6 weeks
groups were not analysed
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 All participants were 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