Sebestjen 2002.
Methods | 6‐week run‐in period 12‐week before‐and‐after study |
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Participants | 38 men with combined hyperlipidaemia 19 received cerivastatin 19 received fenofibrate TC > 6.0 mmol/L (232 mg/dL), LDL‐C > 4.0 mmol/L (155 mg/dL) and TG is between 2.2‐4.6 mmol/L (195‐407 mg/dL) Exclusion criteria: none reported Cerivastatin 0.2 mg/d baseline TC: 6.8 mmol/L (263 mg/dL) Cerivastatin 0.2 mg/d baseline LDL‐C: 4.2 mmol/L (162 mg/dL) Cerivastatin 0.2 mg/d baseline HDL‐C: 0.96 mmol/L (37 mg/dL) Cerivastatin 0.2 mg/d baseline TG: 3.5 mmol/L (310 mg/dL) |
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Interventions | Cerivastatin 0.2mg/d for 0‐6 weeks Cerivastatin 0.2‐0.4 mg/d for 6‐12 weeks Fenofibrate 250 mg/d for 0‐12 weeks |
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Outcomes | Percentage change from baseline at 8 weeks of blood TC, LDL‐C, HDL‐C and TG | |
Source of funding | Unknown | |
Notes | Cerivastatin 0.2‐0.4 mg/d for 6‐12 weeks Fenofibrate 250 mg/d for 0‐12 weeks groups were not analysed |
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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‐C | Low risk | Lipid parameters were measured in a remote laboratory |
Blinding of outcome assessment (detection bias) WDAE | High risk | No comparison possible |
Incomplete outcome data (attrition bias) Total cholesterol | Low risk | All participants were included in the efficacy analysis |
Incomplete outcome data (attrition bias) LDL cholesterol | Low risk | All participants were included in the efficacy analysis |
Incomplete outcome data (attrition bias) HDL cholesterol | Low risk | All participants were included in the efficacy analysis |
Incomplete outcome data (attrition bias) Triglycerides | 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 not reported |