Gumprecht 2011.
Methods | 6‐Week to 8‐week wash‐out dietary stabilisation period 4‐Week before‐and‐after study |
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Participants | Eligible individuals aged 18 to 73 years; type 2 diabetes and combined dyslipidaemia, LDL‐C ≥ 100 and ≤ 220 mg/dL (≥ 2.6 and ≤ 5.7 mmol/L), TG ≥ 150 mg/dL (≥ 1.7 mmol/L) Exclusion criteria: homozygous FH, secondary dyslipidaemia, significant cardiovascular and cerebrovascular disease, neoplastic disease within 10 years, SBP/DBP > 160/90 mmHg, muscular or neuromuscular disease, supplement use that affects lipid metabolism Atorvastatin baseline LDL‐C: 3.77 mmol/L (146 mg/dL) |
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Interventions | Atorvastatin 20 mg/d Pitavastatin 4 mg/d |
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Outcomes | Per cent change from baseline at 4 weeks of serum LDL‐C | |
Notes | Atorvastatin group was analysed SD was 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 | Low risk | Data on all participants were reported |
Selective reporting (reporting bias) | High risk | Only LDL‐C was measured |
Other bias | Unclear risk | The study was funded by Kowa Research Europe Ltd |