Kowalski 2006.
Methods | 4‐week dietary run‐in period 6‐week before and after trial |
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Participants | 35 men and women with mixed hyperlipidaemia age 35‐47 and BMI >25, low physical activity and family history of CHD 18 participants received fluvastatin TC > 300 mg/dL (7.76 mmol/L) LDL‐C 170 mg/dL (4.4 mmol/L) TG > 200 mg/dL (2.26 mmol/L) exclusion criteria: childbearing potential no baseline values |
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Interventions | Fluvastatin 40 mg/day Atorvastatin 10 mg/day |
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Outcomes | per cent change from baseline at 8‐12 weeks of serum TC, LDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | Atorvastatin group was not included in the efficacy analysis SDs were imputed by the method of Furukawa 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 | 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 |