Blagden 2007.
Methods | 4‐Week baseline period 6‐Week randomised open‐label parallel‐group multi‐centre study |
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Participants | 148 men and women with untreated primary hypercholesterolaemia and CHD aged 18 to 75 years; LDL‐C 3.3 to 5.2 mmol/L (130‐209 mg/dL), TG < 4.2 mmol/L (368 mg/dL) 76 participants received atorvastatin, 72 received ezetimibe + atorvastatin Exclusion criteria: congestive heart failure, MI, acute coronary insufficiency, coronary bypass surgery or angioplasty, unstable or severe peripheral artery disease within the past 3 months, unstable angina, poorly controlled type 1 and 2 diabetes, uncontrolled HTN, conditions that affect serum lipids or lipoproteins, renal dysfunction; blood, gastrointestinal or neurological disorders; AST, ALT, CK > 1.5 × ULN; cancer, statin hypersensitivity, individuals taking lipid‐lowering treatment, pregnancy Atorvastatin baseline TC: 5.89 mmol/L (228 mg/dL) Atorvastatin baseline LDL‐C: 4.09 mmol/L (158 mg/dL) Atorvastatin baseline HDL‐C: 1.37 mmol/L (53 mg/dL) |
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Interventions | Atorvastatin 10 mg/d Ezetimibe 10 mg/d + atorvastatin 10 mg/d |
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Outcomes | Per cent change from baseline at 4 weeks of serum TC, LDL‐C, HDL‐C and TG | |
Notes | Atorvastatin group was analysed SDs were imputed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Atorvastatin 10 mg/d; intervention was analysed, and as no placebo group was included for comparison, assessment of random sequence generation is not applicable |
Allocation concealment (selection bias) | Unclear risk | Atorvastatin 10 mg/d; intervention was analysed, and as no placebo group was included for comparison, assessment of allocation concealment is not applicable |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Atorvastatin 10 mg/d; intervention was analysed, and as no placebo group was included for comparison, blinding status is not applicable |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1/76 were not included in the efficacy analysis because of adverse events 1.3% of participants were excluded from the efficacy analysis |
Selective reporting (reporting bias) | Low risk | All lipid parameters were measured |
Other bias | High risk | Schering‐Plough funded the study; data may support bias against atorvastatin |