Orr 2009.
Methods | Participants were not taking any medications; no wash‐out was required 12‐Week double‐blind randomised placebo‐controlled trial |
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Participants | 26 obese men and women aged 40 to 65 years; BP < 160/100 mmHg, TC < 300 mg/dL, TG < 450 mg/dL Exclusion criteria: elevated transaminase levels, BMI ≥ 25 kg/m2, brachial arterial BP ≤ 159/99 mmHg Placebo baseline TC: 5.87 mmol/L (227 mg/dL) Placebo baseline LDL‐C: 4.19 mmol/L (162 mg/dL) Placebo baseline HDL‐C: 1.11 mmol/L (43 mg/dL) Placebo baseline TG: 1.41 mmol/L (125 mg/dL) Atorvastatin 80 mg/d baseline TC: 5.46 mmol/L (211 mg/dL) Atorvastatin 80 mg/d baseline LDL‐C: 3.85 mmol/L (149 mg/dL) Atorvastatin 80 mg/d baseline HDL‐C: 1.14 mmol/L (44 mg/dL) Atorvastatin 80 mg/d baseline TG: 1.39 mmol/L (123 mg/dL) |
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Interventions | Placebo Atorvastatin 80 mg/d |
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Outcomes | Per cent change from baseline at 12 weeks of serum TC, LDL‐C, HDL‐C, TG There were no adverse events reported during the study |
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Notes | SDs were imputed | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information about sequence generation was insufficient to permit judgement of 'yes' or 'no' |
Allocation concealment (selection bias) | Unclear risk | Information about allocation concealment was insufficient to permit judgement of 'yes' or 'no' |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data on all participants were reported |
Selective reporting (reporting bias) | Low risk | All lipid parameters were measured; WDAEs were reported |
Other bias | High risk | Pfizer funded the trial |