Kajinami 2003.
Methods | ≥ 8‐Week wash‐out period 24‐Week titration study |
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Participants | 35 Japanese men and women with heterozygous FH; TC > 230 mg/dL (5.94 mmol/L) Exclusion criteria: acute illness, bone disease, chronic endocrine or renal disease, bone metabolism affecting drugs Baseline TC: 9.21 mmol/L (356 mg/dL) Baseline LDL‐C: 7.19 mmol/L (278 mg/dL) Baseline HDL‐C: 1.27 mmol/L (49 mg/dL) Baseline TG: 1.63 mmol/L (144 mg/dL) |
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Interventions | Atorvastatin 10 mg/d for 0 to 4 weeks Atorvastatin 20 mg/d for 4 to 12 weeks Atorvastatin 40 mg/d for 12 to 24 weeks |
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Outcomes | Per cent change from baseline at 4 weeks of serum TC, LDL‐C, HDL‐C and TG | |
Notes | First atorvastatin dose 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 | The source of funding was not provided |