Leonhardt 1997.

Methods	4‐week dietary washout period 8‐week randomised, double‐blind placebo‐controlled trial
Participants	20 men and women age 50‐60 years with hypercholesterolaemia TC > 5.2 mmol/L (201 mg/dL) LDL‐C > 4.1 mmol/L ( 159 mg/dL) TG < 3.5 mmol/L (310 mg/dL) exclusion criteria:therapy with lipid‐lowering supplements, steroid hormones except oral contraceptives, immunosuppressants, aluminium antacids erythromycin, ketoconazole or analogs, p‐aminoacetic acid Placebo baseline TC : 8.89 mmol/L (343 mg/dL) Placebo baseline LDL‐C : 6.91 mmol/L (267 mg/dL) Placebo baseline HDL‐C : 1.15 mmol/L (44 mg/dL) Placebo baseline triglycerides: 1.82 mmol/L (161 mg/dL) Fluvastatin 40 mg twice daily baseline TC : 8.13 mmol/L (314 mg/dL) Fluvastatin 40 mg twice daily baseline LDL‐C : 5.94 mmol/L (230 mg/dL) Fluvastatin 40 mg twice daily baseline HDL‐C : 1.26 mmol/L (49 mg/dL) Fluvastatin 40 mg twice daily baseline triglycerides: 1.91 mmol/L (169 mg/dL)
Interventions	Placebo for 8 weeks Fluvastatin 40 mg twice daily for 8 weeks
Outcomes	per cent change from baseline at 8 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides
Source of Funding	unknown
Notes	no WDAEs were reported SDs were imputed by the method of Furukawa 2006
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Method of random sequence generation was not reported
Allocation concealment (selection bias)	High risk	No allocation concealment was reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind placebo and fluvastatin capsule appearances were not reported as appearing identical Lipid parameter measurements unlikely influenced by lack of proper 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 WDAEs were reported
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