Bayer 1998.

Methods	10‐week baseline washout period 6 months for probucol 24‐week RCT
Participants	908 men and women aged 18‐75 with documented primary hypercholesterolaemia Exclusion criteria: weight > 140% ideal body weight, homozygous FH, cancer except squamous or basal cell skin cancer or psychosis, women of childbearing potential, night shift workers, drug or alcohol abuse, MI, stroke, TIA, unstable angina, CABG and PTCA within 6 months of trial, uncontrolled hypertension within 3 months of trial, patients with hypertension who had a change in diuretic or beta blocker therapy within 3 months of trial, diabetes mellitus or other endocrine disorders, significant eye disease, active hepatic disease, GI disorders that could affect drug absorption, HMG CoA reductase inhibitor hypersensitivity, renal dysfunction, current use of corticosteroids, erythromycin, all macrolide antibiotics, rifampin, androgens, immunosuppressants, ketoconazole and itraconazole, treatment with cerivastatin within 6 months of trial and therapy with another investigational product within 30 d Placebo baseline TC: 7.10 mmol/L (275 mg/dL) Placebo baseline LDL‐C: 4.94 mmol/L (191 mg/dL) Placebo baseline HDL‐C: 1.25 mmol/L (48 mg/dL) Placebo baseline TG: 1.99 mmol/L (176 mg/dL) Cerivastatin 0.3 mg/d baseline TC: 7.15 mmol/L (276 mg/dL) Cerivastatin 0.3 mg/d baseline LDL‐C: 4.96 mmol/L (192 mg/dL) Cerivastatin 0.3 mg/d baseline HDL‐C: 1.26 mmol/L (49 mg/dL) Cerivastatin 0.3 mg/d baseline TG: 2.11 mmol/L (187 mg/dL) Cerivastatin 0.4 mg/d baseline TC: 7.05 mmol/L (273 mg/dL) Cerivastatin 0.4 mg/d baseline LDL‐C: 4.84 mmol/L (187 mg/dL) Cerivastatin 0.4 mg/d baseline HDL‐C: 1.27 mmol/L (49 mg/dL) Cerivastatin 0.4 mg/d baseline TG: 2.08 mmol/L (184 mg/dL)
Interventions	Placebo Cerivastatin 0.3 mg/d Cerivastatin 0.4 mg/d
Outcomes	Percentage change from baseline at 8 weeks of blood TC, LDL‐C, HDL‐C and TG
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 lipid parameter measurements unlikely influenced by lack of adequate blinding
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	High risk	No WDAE data for the 8‐week period
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias) LDL cholesterol	Low risk	All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	All participants were included in the efficacy analysis
Incomplete outcome data (attrition bias) Triglycerides	Low risk	All participants were included in the efficacy analysis
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