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 |
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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) |
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Interventions | Placebo Atorvastatin 20 mg/d Anacetrapib 10, 40, 150, 300 mg/d Atorvastatin 20 mg/d + anacetrapib 10, 40, 150, 300 mg/d |
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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 |
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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) | 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 |