Sarano 2003.
Methods | 8‐week dietary washout period 16‐week before and after trial |
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Participants | 56 men and women with coronary artery disease with type 2 diabetes mellitus controlled with oral medication LDL‐C = 4.1 mmol/L (159 mg/dL) Triglycerides > 2.3 mmol/L (204 mg/dL) 30 men and women with coronary artery disease and mixed hyperlipidaemia without diabetes mellitus all participants ranged in age from 40‐70 years 40 participants received fluvastatin Included patients were on a standard lipid‐lowering diet and those with type 2 diabetes a diet with reduced carbohydrate content Inclusion criteria: unstable angina, MI, coronary bypass surgery, balloon angioplasty within 6 months of study, type 1 diabetes mellitus, uncontrolled diabetes, renal dysfunction, hepatic dysfunction no exclusion criteria cholelithiasis and triglycerides > 4.5 mmol/L (399 mg/dL) Fluvastatin 40 mg/day baseline TC : 7.88 mmol/L (305 mg/dL) Fluvastatin 40 mg/day baseline LDL‐C : 5.45 mmol/L (211 mg/dL) Fluvastatin 40 mg/day baseline HDL‐C : 1.01 mmol/L (39 mg/dL) Fluvastatin 40 mg/day baseline triglycerides: 3.14 mmol/L (278 mg/dL) |
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Interventions | Fluvastatin 40 mg/day Fenofibrate 200 mg/day |
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Outcomes | per cent change from baseline at 4 weeks of serum TC, LDL‐C, HDL‐C, and triglycerides | |
Source of Funding | unknown | |
Notes | Fenofibrate 200 mg/day 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 |