Isaacsohn 1998.

Methods	10‐week washout period 12‐week before‐and‐after study
Participants	200 men and women aged 18‐75 years with documented primary hypercholesterolaemia LDL‐C ≥ 157.5 mg/dL (4.07 mmol/L) or ≥ 130 mg/dL (3.36 mmol/L) with documented CAD of ≥ 2 cardiovascular risk factors plasma TG ≤ 400 mg/dL (4.52 mmol/L) have a food rating score ≤ 15 Exclusion criteria: clinically active CVD, hypertension with alterations in diuretic or beta blocker therapy within 2 months of entry, uncontrolled diabetes mellitus or other endocrine abnormalities and uncontrolled hypothyroidism, ophthalmic abnormalities, cancer other than basil cell or squamous cell carcinoma, psychosis, hepatic dysfunction, weight 140% ideal body weight, statin hypersensitivity, significant GI tract disorders, child bearing potential homozygous FH, renal dysfunction, current use of other medications that would interfere with the trial, treatment with other hypolipidaemic drugs within 10 weeks of entry, drug or alcohol abuse, night shift workers, therapy with another investigational product within 30 d, other medical conditions which might interfere with the trial Cerivastatin 0.2 mg/d baseline TC: 6.94 mmol/L (268 mg/dL) Cerivastatin 0.2 mg/d baseline LDL‐C: 4.74 mmol/L (183 mg/dL) Cerivastatin 0.2 mg/d baseline HDL‐C: 1.24 mmol/L (48 mg/dL) Cerivastatin 0.2 mg/d baseline TG: 2.03 mmol/L (180 mg/dL)
Interventions	Fluvastatin 20 mg/d for 0‐6 weeks evening dosing Fluvastatin 40 mg/d for 6‐12 weeks evening dosing Cerivastatin 0.2 mg/d for 0‐6 weeks evening dosing Cerivastatin 0.3 mg/d for 6‐12 weeks evening dosing
Outcomes	Percentage change from baseline at 6 weeks of plasma TC, LDL‐C, HDL‐C, and TG
Source of funding	Novartis
Notes	Fluvastatin 20 mg/d for 0‐6 weeks Fluvastatin 40 mg/d for 6‐12 weeks Cerivastatin 0.3 mg/d for 6‐12 weeks Fluvastatin groups were not included in the efficacy analysis
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	High risk	[(200‐174)/200]*100 = 13% participants were not included in the efficacy analysis
Incomplete outcome data (attrition bias) LDL cholesterol	High risk	[(200‐174)/200]*100 = 13% participants were not included in the efficacy analysis
Incomplete outcome data (attrition bias) HDL cholesterol	High risk	[(200‐174)/200]*100 = 13% participants were not included in the efficacy analysis
Incomplete outcome data (attrition bias) Triglycerides	High risk	[(200‐174)/200]*100 = 13% participants were not included in the efficacy analysis
Selective reporting (reporting bias)	Low risk	LDL‐C outcome was reported
Other bias	High risk	Novartis funded the trial, data may support bias against cerivastatin