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. 2015 Mar 11;2015(3):CD008226. doi: 10.1002/14651858.CD008226.pub3

Blagden 2007.

Methods 4‐Week baseline period
6‐Week randomised open‐label parallel‐group multi‐centre study
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)
Interventions Atorvastatin 10 mg/d
Ezetimibe 10 mg/d + atorvastatin 10 mg/d
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                  
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