Filippova 1997.
Methods | 8‐week lipid lowering diet washout period 12‐week before and after trial |
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Participants | 20 patients with CAD Total cholesterol ≥ 5.2 mmol/L (201 mg/dL) one patient died 6 weeks before the start of the fluvastatin dosing no exclusion criteria reported 19 patients were included in the efficacy analysis Fluvastatin 20 mg/day baseline TC : 7.62 mmol/L (295 mg/dL) Fluvastatin 20 mg/day baseline LDL‐C : 5.17 mmol/L (200 mg/dL) Fluvastatin 20 mg/day baseline HDL‐C : 1.07 mmol/L (41 mg/dL) Fluvastatin 20 mg/day baseline triglycerides: 2.84 mmol/L (252 mg/dL) |
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Interventions | Fluvastatin 20 mg/day for 6 weeks Fluvastatin 40 mg/day for 6‐12 weeks |
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Outcomes | per cent change from baseline at 6 weeks of blood LDL‐C, HDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | Fluvastatin 40 mg/day for 6‐12 weeks group was not included in the efficacy analysis Total cholesterol data were not included in the efficacy analysis because the calculated value was different by more than 10% from the given value 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 | 5% 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 |