Milani 1995.
Methods | 4‐week single‐blind placebo run‐in period 4‐week before and after trial |
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Participants | 20 men and women with type IIa primary hypercholesterolaemia age 53 years LDL‐C ≥ 160 mg/dL (4.14 mmol/L) Triglycerides ≤ 250 mg/dL (2.82 mmol/L) exclusion criteria: secondary forms of dyslipidaemia, obesity, abnormal liver or renal function, patients with neoplasms, acute MI, coronary bypass surgery Fluvastatin 40 mg/day baseline TC : 7.6 mmol/L (294 mg/dL) Fluvastatin 40 mg/day baseline LDL‐C : 5.5 mmol/L (213 mg/dL) Fluvastatin 40 mg/day baseline HDL‐C : 1.1 mmol/L (42.5 mg/dL) Fluvastatin 40 mg/day baseline triglycerides: 2.1 mmol/L (186 mg/dL) |
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Interventions | 40 mg/day fluvastatin for 4 weeks 40 mg/day pravastatin for 4 weeks |
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Outcomes | per cent change from baseline at 4 weeks of plasma TC, LDL‐C, HDL‐C and triglycerides | |
Source of Funding | unknown | |
Notes | 40 mg/day pravastatin for 4 weeks group was not analysed SDs were imputed by the method of Furikawa 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 | Not a blinded trial WDAEs were not reported compared to placebo |
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 |