Sardo 2002.
Methods | 4‐Week to 6‐week run‐in period 12‐week single‐centre randomised placebo‐controlled study Randomised 1:1 ratio (atorvastatin:placebo) Evening doses | |
Participants | 40 men and women from Italy recruited from a medical centre, mean age 45 years with hypercholesterolaemia; TC > 7.0 mmol/L (271 mg/dL), LDL‐C > 4.1 mmol/L (159 mg/dL), TG < 2.0 mmol/L (177 mg/dL) Exclusion criteria: arterial HTN, BMI > 27, thyroid disease, renal and hepatic dysfunction, smoking, diabetes, infection, inflammatory or autoimmune disease, arterial and cardiovascular disease Placebo baseline TC: 7.61 mmol/L (294 mg/dL) Placebo baseline LDL‐C: 5.34 mmol/L (206 mg/dL) Placebo baseline HDL‐C: 1.38 mmol/L (53 mg/dL) Placebo baseline TG: 1.14 mmol/L (101 mg/dL) Atorvastatin baseline TC: 7.52 mmol/L (291 mg/dL) Atorvastatin baseline LDL‐C: 5.41 mmol/L (209 mg/dL) Atorvastatin baseline HDL‐C: 1.35 mmol/L (52 mg/dL) Atorvastatin baseline TG: 1.17 mmol/L (104 mg/dL) |
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Interventions | Placebo Atorvastatin 10 mg/d |
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Outcomes | Per cent change from baseline at 4 to 12 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 | Unclear risk | The source of funding was not provided |