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

Bloomfield 2009.

Methods Visit 1 to Visit 2 period was 6 weeks if the participant needed to wash out from fibrate therapy, or 4 weeks for other lipid‐lowering therapy. Participants not requiring a wash‐out had 2 weeks between Visit 1 and Visit 2. 2‐Week to 6‐week placebo run‐in between Visits 2 and 3. Participants were randomly assigned at Visit 3
8‐Week multi‐centre randomised double‐blind placebo‐controlled parallel‐group dose‐ranging study
Participants 589 men and women aged 18 to 75 years; LDL‐C 110 to 190 mg/dL (2.84‐4.91 mmol/L), TG > 150 mg/dL (1.69 mmol/L)
59 received placebo, 59 received atorvastatin, 236 received anacetrapib, 235 received anacetrapib + atorvastatin
Exclusion criteria: CHD history, symptomatic artery disease, uncontrolled cardiac arrhythmias, HTN (> 160/90 mmHg), uncontrolled diabetes, women of childbearing potential or who were pregnant or lactating, use of drugs that affect serum lipids
Placebo baseline TC: 5.78 mmol/L (224 mg/dL)
Placebo baseline LDL‐C: 3.60 mmol/L (139 mg/dL)
Placebo baseline HDL‐C: 1.33 mmol/L (51 mg/dL)
Atorvastatin baseline TC: 5.85 mmol/L (226 mg/dL)
 Atorvastatin baseline LDL‐C: 3.64 mmol/L (141 mg/dL)
 Atorvastatin baseline HDL‐C: 1.31 mmol/L (51 mg/dL)
Interventions Placebo
Atorvastatin 20 mg/d
Anacetrapib 10, 40, 150, 300 mg/d
Atorvastatin 20 mg/d + anacetrapib 10, 40, 150, 300 mg/d
Outcomes Per cent change from baseline at 4 weeks of serum TC, LDL‐C and HDL‐C
Notes Placebo and atorvastatin monotherapy groups were analysed  
WDAEs were reported       
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) Low risk "Randomized via an interactive voice response system equally to one of 10 groups"
Blinding (performance bias and detection bias) 
 All outcomes Low risk "Double‐blind"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Placebo 1/59 was not included in the efficacy analysis
Atorvastatin 20 mg/d 1/59 was not included in the efficacy analysis
1.7% of participants were not included in the efficacy analysis
Selective reporting (reporting bias) High risk TG data were not reported because they were expressed as median values
Other bias High risk Merck funded the study; data may support bias against atorvastatin