Pinon 2002.
Methods | 4‐6 week washout period 6‐month before and after trial |
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Participants | 27 men and women with polygenic hypercholesterolaemia 20‐65 years old serum cholesterol >240 mg/dL; LDL‐C > 160 mg/dL; triglycerides < 200 mg/dL (serum cholesterol > 6.21mmol/L; LDL‐C > 4.14 mmol/L; triglycerides < 2.26 mmol/L) exclusion criteria: renal and hepatic dysfunction, cancer, inflammatory or infectious diseases,, previous ischaemic event, thyroid hormone alterations obesity, chronic alcoholism, diabetes mellitus, hypertension or pregnancy and surgery within 3 months of study |
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Interventions | Fluvastatin 40 mg/day | |
Outcomes | per cent change from baseline at 3 months of serum TC, LDL‐C, HDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | SDs were imputed by the method of Furukawa 2006 except for triglycerides which was determined from the P value | |
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 |