Yu 2002.
Methods | 8‐week dietary and washout run‐in period 8‐week before‐and‐after study |
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Participants | 21 men and women with primary hypercholesterolaemia age 18‐75 years old LDL‐C > 160 mg/dL (4.14 mmol/L), TG < 350 mg/dL (3.95 mmol/L) Exclusion criteria: severe uncontrolled hypertension. diabetes mellitus, uncontrolled hypothyroidism, renal impairment (SCr > 2.0 mg/dL), known chronic liver disease or elevated serum transaminase levels (ALT/AST > 1.5 x ULN). MI, unstable angina, cerebral vascular accident, and TIA within 3 months before the trial; and CABG or PCTA within 6 months before the trial, concomitant treatment with corticosteroids, androgens, erythromycin, oral anticoagulants, or other lipid‐lowering agents was not permitted during the trial. Cerivastatin 0.3 mg/d baseline TC: 6.60 mmol/L (255.2 mg/dL) Cerivastatin 0.3 mg/d baseline LDL‐C: 4.63 mmol/L (179.1 mg/dL) Cerivastatin 0.3 mg/d baseline HDL‐C: 1.31 mmol/L (50.7 mg/dL) Cerivastatin 0.3 mg/d baseline TG: 1.43 mmol/L (126.5 mg/dL) |
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Interventions | Cerivastatin 0.3 mg/d evening dosing Lovastatin 20 mg/d evening dosing |
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Outcomes | Percentage change from baseline at 8 weeks of plasma TC, LDL‐C, HDL‐C and TG | |
Source of funding | Bayer Taiwan Co | |
Notes | Lovastatin 20 mg/d group was not analysed SDs were imputed by the method of Furukawa 2006 |
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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 | Trial supported by Bayer Taiwan Co. data may support bias for cerivastatin |
ALT: alanine transaminase; AST: aspartate transaminase; BMI: body mass index; BP: blood pressure; CABG: coronary artery bypass graft; CAD: coronary artery disease; CK: creatine kinase; CVD: cardiovascular disease; FH: familial hypercholesterolaemia; GI: gastrointestinal; HBA1c: haemoglobin A1c; HDL‐C: high‐density lipoprotein cholesterol; HMG CoA; 3‐hydroxy‐3‐methyl‐glutarylcoenzyme A; HRT: hormone‐replacement therapy; IUD: intrauterine device; LDL‐C: low‐density lipoprotein cholesterol; MI: myocardial infarction; NYHA: New York Heart Association; OCP: oral contraceptive pill; PCI: percutaneous coronary intervention; PTCA: percutaneous transluminal coronary angioplasty; PVD: peripheral vascular disease; RCT: randomised, double‐blind, placebo‐controlled trial; SCr: serum creatinine; SD: standard deviation; SGOT: serum glutamic oxaloacetic transaminase; SGPT: serum glutamic pyruvic transaminase; SLE: systemic lupus erythematosus; TC: total cholesterol; TG: triglyceride; TIA: transient ischaemic attack; TSH: thyroid‐stimulating hormone; ULN: upper limit of normal; WDAEs: withdrawals due to adverse effects; WHO: World Health Organization