Economides 2004.
Methods | Wash‐out was not required because participants were excluded if they received lipid‐lowering drugs within 3 months of the study 3‐Month randomised double‐blind placebo‐controlled trial |
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Participants | 77 men and women from USA with diabetes or at risk of diabetes aged 51 years (21‐80); BMI 29.65 Exclusion criteria: cardiac arrhythmia, congestive heart failure, uncontrolled HTN, recent stroke, chronic renal disease, severe dyslipidaemia or other serious chronic disease requiring active treatment, participants taking glucocorticoids, antineoplastic agents, psychoactive drugs and bronchodilators, type 2 diabetes and at risk of type 2 diabetes groups combined Placebo: Baseline TC: 5.48 mmol/L (212 mg/dL) Baseline LDL‐C: 3.28 mmol/L (127 mg/dL) Baseline HDL‐C: 1.61 mmol/L (62 mg/dL) Baseline TG: 1.25 mmol/L (111 mg/dL) Atorvastatin: Baseline TC: 5.16 mmol/L (200 mg/dL) Baseline LDL‐C: 3.10 mmol/L (120 mg/dL) Baseline HDL‐C: 1.51 mmol/L (58 mg/dL) Baseline TG: 1.29 mmol/L (114 mg/dL) |
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Interventions | Placebo Atorvastatin 20 mg/d |
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Outcomes | Per cent change from baseline at 12 weeks of serum TC, LDL‐C, HDL‐C and TG | |
Notes | No WDAEs were reported SDs were imputed |
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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 sequence generation was provided to permit judgement of 'yes' or 'no' |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Double‐blind fashion" |
Incomplete outcome data (attrition bias) All outcomes | High risk | 10/77 participants were not analysed 19% of participants were excluded from the efficacy analysis Risk of bias is quite high |
Selective reporting (reporting bias) | High risk | All lipid parameters were measured; WDAEs were not reported |
Other bias | High risk | Pfizer partially funded the study; data may support bias for the drug |