VISION 2013.
Methods | No participant received lipid‐altering agents; no wash‐out period was required 12‐Week randomised trial |
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Participants | 42 men and women with hyperlipidaemia aged 45 to 75 years 21 participants received pitavastatin; 21 received atorvastatin Exclusion criteria: age < 20 years, premenopausal females, diabetes, CVD, liver and renal dysfunction, endocrine disease, administration of agents that could affect lipid metabolism and oxidation Atorvastatin baseline TC: 6.96 mmol/L (269 mg/dL) Atorvastatin baseline LDL‐C: 4.73 mmol/L (183 mg/dL) Atorvastatin baseline HDL‐C: 1.42 mmol/L (55 mg/dL) Atorvastatin baseline TG: 1.49 mmol/L (132 mg/dL) |
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Interventions | Pitavastatin 2 mg/d Atorvastatin 10 mg/d |
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Outcomes | Per cent change from baseline at 12 weeks of serum TC, LDL‐C, HDL‐C and TG | |
Notes | Pitavastatin group was not included in the efficacy analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Atorvastatin 10 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 10 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 10 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 included in the efficacy analysis |
Other bias | Low risk | Industry did not fund the trial |