Puccetti 2001.
Methods | 6‐week dietary period 6‐week before‐and‐after study |
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Participants | 25 men and women with primary hypercholesterolaemia mean age 48.2 received cerivastatin TC 6.93 mmol/L (268 mg/dL), HDL‐C 1.25 mmol/L (48.3 mg/dL) and TG 1.15 mmol/L (102 mg/dL) Exclusion criteria: history of cardiovascular events or current hypertension, diabetes, or liver, renal, thyroid, infectious, immunological or malignant diseases. None of the participants had a personal or family history of deep vein thrombosis or a tendency to bleed, an none of them were taking hypolipidaemic, antiplatelet, anticoagulant or profibrinolytic drugs Cerivastatin 0.2 mg/d baseline TC: 6.62 mmol/L (256 mg/dL) Cerivastatin 0.2 mg/d baseline LDL‐C: 4.89 mmol/L (189.1 mg/dL) Cerivastatin 0.2 mg/d baseline HDL‐C: 1.24 mmol/L (47.9 mg/dL) Cerivastatin 0.2 mg/d baseline TG: 1.05 mmol/L (93 mg/dL) |
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Interventions | Cerivastatin 0.2 mg/d Atorvastatin 10 mg/d Simvastatin 20 mg/d Pravastatin 20 mg/d Fluvastatin 20 mg/d |
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Outcomes | Percentage change from baseline at 6 weeks of plasma TC, LDL‐C, HDL‐C and TG | |
Source of funding | University of Siena | |
Notes | Atorvastatin 10 mg/d, simvastatin 20 mg/d, pravastatin 20 mg/d and fluvastatin 20 mg/d data were not analysed. 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‐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 | Low risk | Work funded by University of Siena |