Bayer 1995.

Methods	10‐week run‐in washout period 6‐week RCT
Participants	55 men and women with heterozygous FH aged 21‐75 years LDL‐C > 5.0 mmol/L (193 mg/dL), TG ≤ 4.02 mmol/L (356 mg/dL), hypertensive patients on a stable dose of beta‐blockers or diuretics and patients on thyroid replacement therapy TSH was ≤ 7.5mu/L with T4 within normal range, postmenopausal women on HRT Exclusion criteria: homozygous FH, MI, stroke, PTCA or coronary bypass surgery within the previous 6 months, congestive heart failure grade 3 or 4, significant cardiac arrhythmias, uncontrolled diabetes mellitus, endocrine disease, significant renal disease, respiratory disease, hepatic dysfunction, significant eye disease, neuromuscular disease, infections that may interfere with the trial, cancer within 5 years, women of child bearing potential, drug or alcohol abuse, night shift workers, mental disorders, HIV positive, pancreatitis, use of immunosuppressants, corticosteroids, androgens, erythromycin, niacin, psyllium, fish oil and excess bran and therapy with any other investigational drug within 30 d prior to the screening visit Placebo baseline TC: 9.00 mmol/L (348 mg/dL) Placebo baseline LDL‐C: 7.24 mmol/L (280 mg/dL) Placebo baseline HDL‐C: 1.19 mmol/L (46 mg/dL) Placebo baseline TG: 1.24 mmol/L (110 mg/dL) Cerivastatin 0.2 mg/d baseline TC: 9.08 mmol/L (351 mg/dL) Cerivastatin 0.2 mg/d baseline LDL‐C: 7.27 mmol/L (281 mg/dL) Cerivastatin 0.2 mg/d baseline HDL‐C: 1.16 mmol/L (45 mg/dL) Cerivastatin 0.2 mg/d baseline TG: 1.39 mmol/L (123 mg/dL) Cerivastatin 0.3 mg/d baseline TC: 9.59 mmol/L (371 mg/dL) Cerivastatin 0.3 mg/d baseline LDL‐C: 7.63 mmol/L (295 mg/dL) Cerivastatin 0.3 mg/d baseline HDL‐C: 1.19 mmol/L (46 mg/dL) Cerivastatin 0.3 mg/d baseline TG: 1.68 mmol/L (149 mg/dL)
Interventions	Placebo evening dosing Cerivastatin 0.2 mg/d evening dosing Cerivastatin 0.3 mg/d evening dosing
Outcomes	Percentage change from baseline at 6 weeks of plasma 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 fashion lipid parameter measurements unlikely influenced by lack of sufficient 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	Low risk	No participants withdrew due to adverse events
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