Osamah 1997.
Methods | no washout period required because no patient was receiving hypolipidaemic treatment 24‐week before and after trial |
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Participants | 30 men 40‐70 years old 6 mmol/L < plasma TC < 8 mmol/L (232 mg/dL < plasmaTC < 309 mg/dL) plasma TG < 3 mmol/L (266 mg/dL) with no chronic or metabolic diseases, no acute coronary event Fluvastatin 40 mg/day baseline TC : 7.675 mmol/L (297 mg/dL) Fluvastatin 40 mg/day baseline LDL‐C : 5.295 mmol/L (205 mg/dL) Fluvastatin 40 mg/day baseline triglycerides: 2.76 mmol/L (244 mg/dL) |
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Interventions | Fluvastatin 40 mg/day | |
Outcomes | per cent change from baseline at 4‐12 weeks of serum TC, LDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | 12‐24 week time period 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 | High risk | 16.7% 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 was not reported |