Ose 1995.

Methods	6‐week placebo washout period 6‐week before and after trial
Participants	432 adults men and women patients total cholesterol ≥6.5 mmol/L (≥250 mg/dL) 213 received fluvastatin and 219 received simvastatin LDL cholesterol ≥ 4.9 mmol/L (≥190 mg/dL) for those without CHD and < 2 CHD risk factors; ≥ 4.1 mmol/L (≥160 mg/dL) for those without CHD but with ≥ 2 CHD risk factors; ≥3.4 mmol/L (≥ 130 mg/dL) for those with CHD exclusion criteria: patients > 70 years of age, secondary hypercholesterolaemia, unstable or Prinzmetal angina, MI or CABG within previous 2 months plasma triglyceride ≥4.0 mmol/L (≥ 350 mg/dL), childbearing potential, history of substance abuse, patients with poor mental function recent history of hepatitis, impaired hepatic function, uncontrolled diabetes mellitus, concurrent use of immunosuppressants or of investigational drug therapy prohibited within 30 days of study entry Fluvastatin 20 mg/day baseline TC : 8.3 mmol/L (321 mg/dL) Fluvastatin 20 mg/day baseline LDL‐C : 6.2 mmol/L (240 mg/dL) Fluvastatin 20 mg/day baseline HDL‐C : 1.3 mmol/L (50 mg/dL) Fluvastatin 40 mg/day baseline TC : 8.2 mmol/L (317 mg/dL) Fluvastatin 40 mg/day baseline LDL‐C : 8.0 mmol/L (309 mg/dL) Fluvastatin 40 mg/day baseline HDL‐C : 1.3 mmol/L (50 mg/dL)
Interventions	Fluvastatin 20 mg/day for 6 weeks Fluvastatin 40 mg/day for 6 weeks Simvastatin 5 mg/day for 6 weeks Simvastatin 10 mg/day for 6 weeks
Outcomes	per cent change from baseline at 6 weeks of plasma TC and LDL‐C
Source of Funding	Merck & Co. Inc
Notes	Simvastatin 5 mg/day for 6 weeks Simvastatin 10 mg/day for 6 weeks groups were not analysed HDL‐C data were not included in the efficacy analysis because the calculated value was different by more than 10% from the given value Triglyceride data were not included in the efficacy analysis because it was expressed as a median percent change from baseline
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	4.2% participants were not included in the efficacy analysis
Selective reporting (reporting bias)	Low risk	LDL‐C outcome was reported
Other bias	High risk	Merck & Co. Inc. funded the trial