Homma 2003.
Methods | 8‐week washout period 24‐week before and after trial |
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Participants | 30 men and women with non familial type 2 hyperlipoproteinaemia exclusion criteria: familial hypercholesterolaemia and familial combined hyperlipoproteinaemia TG > 350 mg/dL (3.95 mmol/L) and those treated with probucol, diabetes mellitus, CHD, or cerebrovascular disease Fluvastatin 20 mg/day baseline TC : 7.76 mmol/L (300 mg/dL) Fluvastatin 20 mg/day baseline LDL‐C : 5.25 mmol/L (203 mg/dL) Fluvastatin 20 mg/day baseline HDL‐C : 1.66 mmol/L (64 mg/dL) Fluvastatin 20 mg/day baseline triglycerides: 1.9 mmol/L (168 mg/dL) |
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Interventions | Fluvastatin 20 mg/day for 12 weeks Fluvastatin 40 mg/day 12‐24 weeks |
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Outcomes | per cent change from baseline at 12 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | Fluvastatin 40 mg/day 12‐24 weeks was not analysed SDs were imputed by the method of Furukawa 2006 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Controlled before and after design |
Allocation concealment (selection bias) | High risk | Controlled before and after design |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Lipid parameter measurements unlikely influenced by lack of blinding |
Blinding of outcome assessment (detection bias) LDL‐cholesterol | Low risk | Lipid parameters were measured in a remote laboratory |
Blinding of outcome assessment (detection bias) WDAEs | High risk | No comparison possible |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were included in the efficacy analysis |
Selective reporting (reporting bias) | Low risk | LDL‐C outcome was reported |
Other bias | Unclear risk | Source of funding was not reported |