Baggio 1994b.
Methods | 4‐week single‐blind placebo washout period 6‐week before and after trial |
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Participants | 39 men and women with type IIA primary hypercholesterolaemia mean age 67 years LDL‐cholesterol ≥ 160 mg/dL ( ≥ 4.14 mmol/L) triglycerides ≤ 250 mg/dL (≤ 2.82 mmol/L) exclusion criteria: secondary dyslipidaemia, diabetes mellitus controlled with drugs, obesity BMI ≥29 abnormal liver and renal function, cancer, MI and coronary bypass surgery Fluvastatin 40 mg/day baseline TC : 8.17 mmol/L (316 mg/dL) Fluvastatin 40 mg/day baseline LDL‐C : 5.92 mmol/L (229 mg/dL) Fluvastatin 40 mg/day baseline HDL‐C : 1.5 mmol/L (58 mg/dL Fluvastatin 40 mg/day baseline triglycerides: 1.64 mmol/L (145 mg/dL) |
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Interventions | Fluvastatin 40 mg/day | |
Outcomes | per cent change from baseline at 3‐6 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | SDs were imputed by the method of Furukawa 2006 | |
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 | High risk | 15.4% participants were not included in the efficacy analysis |
Selective reporting (reporting bias) | Low risk | LDL‐C outcome was reported |
Other bias | Unclear risk | Source of funding not reported |