Ma 2000.

Methods	10‐week washout run‐in period 8‐week before‐and‐after study
Participants	174 men and women with combined (type IIb) dyslipidaemia age 18‐80 years old received cerivastatin LDL‐C ≥ 130 mg/dL (3.4 mmol/L) or ≥ 100 mg/dL (2.6 mmol/L) if the patient had ≥ 2 of the following CAD risk factors: male > 45 years old; female > 55 years old, or postmenopausal and not on HRT; family history of premature CAD in a 1st degree relative; smoking ≥ 1 cigarettes/d; hypertension (systolic BP > 140 mmHg, diastolic BP > 90 mmHg, or antihypertensive therapy); TG ≥ 200 mg/dL (2.8 mmol/L) to ≤ 800 mg/dL (9 mmol/L) Exclusion criteria: women of childbearing potential who were not using adequate contraception, who were breast feeding, or who had a positive pregnancy test; unstable weight (variation of > 3 kg during the last 4 weeks of the run‐in); type 1 diabetes; type 2 diabetes (WHO classification) unless this was controlled by diet and/or oral treatment and/or fixed‐dose insulin (HbA1c ≥ 8.5% for 90 d before enrolment and fasting glucose < 10 mmol/L at randomisation); severe hypertension (diastolic BP ≥ 110 mmHg and/or systolic BP ≥ 180 mmHg on ≥ 3 consecutive occasions); MI, cerebrovascular accident, PTCA or CABG within the 3 months prior to the enrolment visit; congestive heart failure (NYHA class III or IV); significant arrhythmia or conduction disturbances; hypothyroidism (TSH > 7.5 mU/L or TSH > 5 mU/L and ≤ 7.5 mU/L plus total T4 < 7 ug/dL); any malignant tumour requiring treatment in the past 5 years (except squamous or basal cell skin cancer); known significant renal impairment (SCr ≥ 2.0 mg/dL) or known nephrotic syndrome; known liver disease and/or elevated serum transaminase (AST, ALT) > 1.5 x ULN and/or hepatosplenomegaly; known muscular or neuromuscular disease and/or serum CK > 3 x ULN if not otherwise explainable (e.g. Crohn's disease) which could result in impaired absorption of the trial drug; drug or alcohol abuse; concomitant treatment with immunosuppressants, rifampin, macrolide antibiotics, H2 blockers, azoles, corticosteroids or androgens; concomitant therapy for hyperlipidaemia; treatment with any other investigational drug (including either atorvastatin or cerivastatin) within 30 d prior to enrolment. Cerivastatin 0.4 mg/d baseline TC: 7.01 mmol/L (270.9 mg/dL) Cerivastatin 0.4 mg/d baseline LDL‐C: 4.35 mmol/L (168.4 mg/dL) Cerivastatin 0.4 mg/d baseline HDL‐C: 0.96 mmol/L (37.2 mg/dL) Cerivastatin 0.8 mg/d baseline TC: 6.65 mmol/L (257.0 mg/dL) Cerivastatin 0.8 mg/d baseline LDL‐C: 4.02 mmol/L (155.6 mg/dL) Cerivastatin 0.8 mg/d baseline HDL‐C: 1.04 mmol/L (40.3 mg/dL)
Interventions	Cerivastatin 0.4 mg/d evening dosing Cerivastatin 0.8 mg/d evening dosing Atorvastatin 10 mg/d evening dosing Atorvastatin 20 mg/d evening dosing
Outcomes	Percentage change from baseline at 8 weeks of blood TC, LDL‐C and HDL‐C
Source of funding	Bayer
Notes	Atorvastatin 10 mg/d and atorvastatin 20 mg/d groups were not analysed
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‐C	Low risk	Lipid parameters were measured in a remote laboratory
Blinding of outcome assessment (detection bias) WDAE	High risk	No comparison possible
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