Kim 2013.
Methods | 4‐Week wash‐out period 8‐Week before‐and‐after study |
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Participants | Eligible patients were men and women aged 20 to 79 years with documented primary hypercholesterolaemia; LDL‐C > 100 mg/dL Exclusion criteria: therapy with other investigational drugs within 30 days of randomisation, statin hypersensitivity, uncontrolled hypertension, poorly controlled diabetes mellitus, unstable angina, new‐onset MI, creatinine > 2.5 mg/dL, ALT > 2 × ULN, AST > 2 × ULN, CK 2 × ULN, history of malignancy or psychosis, chronic liver disease, drug or alcohol abuse, women who could become pregnant, HRT Atorvastatin 20 mg/d baseline TC: 5.875 mmol/L (227 mg/dL) Atorvastatin 20 mg/d baseline LDL‐C: 4.03 mmol/L (156 mg/dL) Atorvastatin 20 mg/d baseline HDL‐C: 1.24 mmol/L (48 mg/dL) Atorvastatin 20 mg/d baseline TG: 1.74 mmol/L (154 mg/dL) |
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Interventions | Atorvastatin 20 mg/d | |
Outcomes | Per cent change from baseline at 8 weeks of serum TC, LDL‐C, HDL‐C and TG | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Atorvastatin 20 mg/d; intervention was analysed, and as no placebo group was included for comparison, assessment of random sequence generation is not applicable |
Allocation concealment (selection bias) | Unclear risk | Atorvastatin 20 mg/d; intervention was analysed, and as no placebo group was included for comparison, assessment of allocation concealment is not applicable |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Atorvastatin 20 mg/d; intervention was analysed, and as no placebo group was included for comparison, blinding status is not applicable |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were included in the efficacy analysis |
Selective reporting (reporting bias) | Low risk | All lipid parameters were measured |
Other bias | Unclear risk | Dong‐A Pharmaceutical Company Co, Ltd, sponsored the study |