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. 2020 Jan 25;2020(1):CD012501. doi: 10.1002/14651858.CD012501.pub2

Dujovne 2000.

Methods 6‐8‐week run‐in phase
8‐week before‐and‐after study
Participants 479 men and women with type IIa or IIb hypercholesterolaemia age 18‐75 years old
TG < 350 mg/dL (3.95 mmol/L)
Exclusion criteria: history of MI, angina, stroke, recent TIA, recent coronary revascularisation, uncontrolled hypertension or hypothyroidism, type 2 diabetes, chronic liver disease, renal dysfunction, alcohol or drug abuse, CPK values are 3 x ULN
Cerivastatin 0.3 mg/d baseline TC: 6.7 mmol/L (259 mg/dL)
 Cerivastatin 0.3 mg/d baseline LDL‐C: 4.49 mmol/L (174 mg/dL)
 Cerivastatin 0.3 mg/d baseline HDL‐C: 1.3 mmol/L (50 mg/dL)
Cerivastatin 0.3 mg/d baseline TG: 1.99 mmol/L (176 mg/dL)
Cerivastatin 0.4 mg/d baseline TC: 6.75 mmol/L (261 mg/dL)
 Cerivastatin 0.4 mg/d baseline LDL‐C: 4.55 mmol/L (176 mg/dL)
 Cerivastatin 0.4 mg/d baseline HDL‐C: 1.3 mmol/L (50 mg/dL)
Cerivastatin 0.4 mg/d baseline TG: 1.98 mmol/L (175 mg/dL)
Interventions Cerivastatin 0.3 mg/d evening dosing
Cerivastatin 0.4 mg/d evening dosing
Pravastatin 20 mg/d evening dosing
Pravastatin 40 mg/d evening dosing
Outcomes Percentage change from baseline at 8 weeks of serum TC, LDL‐C, HDL‐C and TG
Source of funding Bayer
Notes Pravastatin 20 mg/d and pravastatin 40 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