Shimabukuro 2011.
Methods | 4‐Week wash‐out dietary baseline stabilisation period 4‐Week before‐and‐after trial |
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Participants | 15 individuals with type 2 diabetes and hypercholesterolaemia aged 30 to 79 years; TC ≥ 220 mg/dL, TG 150 to 350 mg/dL Exclusion criteria: statin hypersensitivity, hepatic dysfunction, renal dysfunction, pregnancy, poorly controlled diabetes, recent stroke, CHD, congestive heart failure, FH, secondary hyperlipidaemia Atorvastatin baseline TC: 6.58 mmol/L (254 mg/dL) Atorvastatin baseline LDL‐C: 4.23 mmol/L (164 mg/dL) Atorvastatin baseline HDL‐C: 1.42 mmol/L (55 mg/dL) Atorvastatin baseline TG: 1.96 mmol/L (174 mg/dL) |
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Interventions | Atorvastatin 10 mg/d Pitavastatin 2 mg/d |
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Outcomes | Per cent change from baseline at 4 weeks of serum TC, LDL‐C, HDL‐C and TG | |
Notes | Atorvastatin group 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 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 | Data on all participants were reported |
Selective reporting (reporting bias) | Low risk | All lipid parameters were measured |
Other bias | Unclear risk | No source of funding was provided |