Sposito 2003.
Methods | No lipid‐lowering therapy in the 6 months preceding the study 3‐Month dietary stabilisation period 6‐Week randomised placebo‐controlled trial |
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Participants | 45 men and women aged 30 to 76 years; LDL‐C > 100 mg/dL (2.59 mmol/L), TG < 400 mg/dL (4.52 mmol/L) Exclusion criteria: premenopausal women, diabetes mellitus, alcohol abuse; liver, renal and thyroid disease; cancer Placebo baseline TC: 6.34 mmol/L (245 mg/dL) Placebo baseline LDL‐C: 4.34 mmol/L (168 mg/dL) Placebo baseline HDL‐C: 0.98 mmol/L (38 mg/dL) Placebo baseline TG: 2.28 mmol/L (202 mg/dL) Atorvastatin 10 mg/d baseline TC: 6.49 mmol/L (251 mg/dL) Atorvastatin 10 mg/d baseline LDL‐C: 4.37 mmol/L (169 mg/dL) Atorvastatin 10 mg/d baseline HDL‐C: 0.98 mmol/L (38 mg/dL) Atorvastatin 10 mg/d baseline TG: 2.37 mmol/L (210 mg/dL) Atorvastatin 40 mg/d baseline TC: 6.00 mmol/L (232 mg/dL) Atorvastatin 40 mg/d baseline LDL‐C: 4.40 mmol/L (170 mg/dL) Atorvastatin 40 mg/d baseline HDL‐C: 0.91 mmol/L (35 mg/dL) Atorvastatin 40 mg/d baseline TG: 2.18 mmol/L (193 mg/dL) |
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Interventions | Placebo Atorvastatin 10 mg/d Atorvastatin 40 mg/d |
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Outcomes | Per cent change from baseline at 6 weeks of serum TC, LDL‐C, HDL‐C and TG | |
Notes | SDs were imputed WDAEs were not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information about sequence generation was provided to permit judgement of 'yes' or 'no' |
Allocation concealment (selection bias) | Unclear risk | No information about allocation concealment was provided to permit judgement of 'yes' or 'no' |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No information about blinding was provided to permit judgement of 'yes' or 'no' |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data on all participants were reported |
Selective reporting (reporting bias) | High risk | All lipid parameters were measured; WDAEs were not reported |
Other bias | Low risk | The study appears to be free of other sources of bias |