Lee 2012.
| Methods | 4‐Week dietary wash‐out period 8‐Week randomised open‐label study |
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| Participants | 78 men and women aged 20 to 79 years; LDL‐C > 130 mg/dL (3.36 mmol/L), TG 150 to 499 mg/dL (1.69‐5.63 mmol/L) 39 participants received atorvastatin, 39 received atorvastatin/ezetimibe Exclusion criteria: familial hypercholesterolaemia, pregnancy, breastfeeding, history of acute cerebrovascular accident, MI within 3 months of trial entry, serum creatinine > 2.0 mg/dL, transaminase level > 2 × ULN, thyroid dysfunction, serum creatine kinase > 2.5 × ULN, infection, inflammatory disease, cancer, adverse reactions to test drugs Atorvastatin 20 mg/d baseline TC: 6.44 mmol/L (249 mg/dL) Atorvastatin 20 mg/d baseline LDL‐C: 4.16 mmol/L (161 mg/dL) Atorvastatin 20 mg/d baseline HDL‐C: 1.23 mmol/L (48 mg/dL) Atorvastatin 20 mg/d baseline TG: 2.25 mmol/L (199 mg/dL) |
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| Interventions | Atorvastatin 20 mg/d Atorvastatin/ezetimibe 5 mg/5 mg/d |
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| Outcomes | Per cent change from baseline at 8 weeks of serum TC, LDL‐C, HDL‐C and TG | |
| Notes | Atorvastatin 20 mg/d; treatment arm was analysed SDs were imputed |
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| 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 | High risk | 11/39 (28.2%) participants were not included in the efficacy analysis |
| Selective reporting (reporting bias) | Low risk | All lipid parameters were included in the efficacy analysis |
| Other bias | Low risk | Industry did not fund the trial |