Dujovne 2000.
Methods | 6‐8‐week run‐in phase 8‐week before‐and‐after study |
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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) |
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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 |
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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 |