Lorena 1997.
Methods | 1‐month dietary run‐in period 2‐month before and after trial |
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Participants | 20 men and women with type IIa and IIb hypercholesterolaemia age 40‐50 years exclusion criteria:diabetes mellitus, impaired hepatic and renal function, secondary hypercholesterolaemia, drug or alcohol abuse concomitant treatment with anticoagulants and antiplatelet drugs macrovascular complications history Fluvastatin 40 mg/day baseline TC : 7.2 mmol/L (278 mg/dL) Fluvastatin 40 mg/day baseline LDL‐C : 5.1 mmol/L (197 mg/dL) Fluvastatin 40 mg/day baseline HDL‐C : 1.3 mmol/L (50 mg/dL) Fluvastatin 40 mg/day baseline triglycerides: 2.3 mmol/L (204 mg/dL) |
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Interventions | Fluvastatin 40 mg/day for 8 weeks | |
Outcomes | per cent change from baseline at 8 weeks of plasma 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 | 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 |