Davidson 2003.
Methods | 6‐week dietary run‐in washout period 6‐week before and after trial |
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Participants | 838 men and women aged > 20 years with primary hypercholesterolaemia 337 received fluvastatin triglycerides ≤ 4.5 mmol/L (399 mg/dL) LDL‐C ≥ 3.4 mmol/L (131mg/dL) with evidence of CHD or other atherosclerotic disease LDL‐C ≥ 4.1 mmol/L (159mg/dL) with ≥2 other CHD risk factors but no CHD or other atherosclerotic disease LDL‐C ≥ 4.9 mmol/L (189mg/dL) without CHD or other atherosclerotic disease and < 2 other CHD risk factors exclusion criteria: MI, coronary bypass surgery or angioplasty in the prior 3 months current coronary insufficiency, clinically significant ventricular arrhythmias, potential childbearing, pregnancy Fluvastatin 20 mg/day baseline TC : 7.1 mmol/L (275 mg/dL) Fluvastatin 20 mg/day baseline LDL‐C : 4.9 mmol/L (189 mg/dL) Fluvastatin 20 mg/day baseline HDL‐C : 1.2 mmol/L (46 mg/dL) Fluvastatin 20 mg/day baseline triglycerides: 2.1 mmol/L (186 mg/dL) Fluvastatin 40 mg/day baseline TC : 7.0 mmol/L (271 mg/dL) Fluvastatin 40 mg/day baseline LDL‐C : 4.8 mmol/L (186 mg/dL) Fluvastatin 40 mg/day baseline HDL‐C : 1.2 mmol/L (46 mg/dL) Fluvastatin 40 mg/day baseline triglycerides: 2.2 mmol/L (195 mg/dL) |
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Interventions | Lovastatin 10 mg/day for 6 weeks Lovastatin 20 mg/day for 6 weeks Lovastatin 40 mg/day for 6 weeks Fluvastatin 20 mg/day for 6 weeks Fluvastatin 40 mg/day for 6 weeks |
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Outcomes | per cent change from baseline at 6 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | Lovastatin 10 mg/day for 6 weeks Lovastatin 20 mg/day for 6 weeks Lovastatin 40 mg/day for 6 weeks groups were not analysed |
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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 |