Bayer 1992.

Methods	No washout required because participants were not receiving any lipid‐lowering medications within 4 weeks of the trial; 6 months for probucol 1‐month, RCT
Participants	36 men and women with primary hypercholesterolaemia aged 18‐75 years LDL‐C ≥ 130 mg/dL (3.36 mmol/L) and TG ≤ 350 mg/dL (4.02 mmol/L) Exclusion criteria: homozygous FH, CVD or cerebrovascular disease, TIA, uncontrolled hypertension, diabetes mellitus, clinically significant eye disease, malignancy, psychosis, chronic liver disease, prior exposure to cerivastatin nor HMG CoA reductase inhibitor hypersensitivity, drug or alcohol abuse, child bearing potential, patients who had taken another investigational drug within 30 d of trial, concurrent use of corticosteroids, erythromycin, oral anticoagulants, hypoglycaemic agents, digoxin, androgens, immunosuppressants or cimetidine and significant laboratory abnormalities Placebo baseline TC: 6.90 mmol/L (267 mg/dL) Placebo baseline LDL‐C: 4.84 mmol/L (187 mg/dL) Placebo baseline HDL‐C: 1.22 mmol/L (47 mg/dL) Placebo baseline TG: 1.89 mmol/L (167 mg/dL) Cerivastatin 0.3 mg/d baseline TC: 6.90 mmol/L (267 mg/dL) Cerivastatin 0.3 mg/d baseline LDL‐C: 4.68 mmol/L (181 mg/dL) Cerivastatin 0.3 mg/d baseline HDL‐C: 1.29 mmol/L (50 mg/dL) Cerivastatin 0.3 mg/d baseline TG: 1.99 mmol/L (176 mg/dL)
Interventions	Placebo evening dosing Cerivastatin 0.3 mg/d evening dosing
Outcomes	Percentage change from baseline at 4 weeks of blood TC, LDL‐C, HDL‐C, TG, and WDAEs
Source of funding	Bayer
Notes	SDs were imputed by the method of Furukawa 2006
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of random sequence generation was not reported
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind: placebo and cerivastatin tablets were all identical in appearance
Blinding of outcome assessment (detection bias) LDL‐C	Low risk	Lipid parameters were measured in a remote laboratory
Blinding of outcome assessment (detection bias) WDAE	Unclear risk	Method of blinding for WDAEs was not reported
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	All participants were included in the efficacy analysis for the placebo group [(24‐23)/24]*100 = 4.2% participants were not included in the efficacy analysis for the cerivastatin 0.3 mg/d group
Incomplete outcome data (attrition bias) LDL cholesterol	Low risk	All participants were included in the efficacy analysis for the placebo group [(24‐23)/24]*100 = 4.2% participants were not included in the efficacy analysis for the cerivastatin 0.3 mg/d group
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	All participants were included in the efficacy analysis for the placebo group [(24‐23)/24]*100 = 4.2% participants were not included in the efficacy analysis for the cerivastatin 0.3 mg/d group
Incomplete outcome data (attrition bias) Triglycerides	Low risk	All participants were included in the efficacy analysis for the placebo group [(24‐23)/24]*100 = 4.2% participants were not included in the efficacy analysis for the cerivastatin 0.3 mg/d group
Selective reporting (reporting bias)	Low risk	LDL‐C outcome was reported
Other bias	High risk	Bayer funded the trial, data may support bias for cerivastatin