Okada 2012.

Methods	Design: RCT Number of study centres: 13 centres in Japan Setting: not reported Patient recruitment: not reported Duration of study (Follow‐up): 52 weeks Clinical setting: coronary artery disease
Participants	Enrolment (N): 200 Randomised (N): intervention: 100; control:100 Withdrawn (N): intervention:22 ; control:28 Lost to follow‐up (N): not reported Completed the study (N): intervention: 78; control:72 Analysed (N): intervention: 78; control:72 Age (years) (mean ± SD): intervention: 65.7 ± 10.1; control: 65.9 ± 8.7 Sex (male, N, %): intervention: 57 (73.1%); control: 53 (73.6%) Smoking history (N, %): intervention: 26(33.3%); control: 25 (34.7%) BMI (kg/m², mean ± SD):): intervention: 25.1 ± 3.0; control: 25.3 ± 3.8 Diabetes (N, %): intervention: 41 (52.6%); control: 36 (50.0%) Hypertension (N, %): intervention: 57 (73.1%) ; control: 57 (79.2%) History of MI (N, %): intervention: 45 (57.7%) ; control: 42 (58.3%) Statin pretreatment (N, %): intervention: 100%; control:100% Inclusion criteria: Quote: "Patients with coronary artery disease whose LDL‐C levels were ≥70 mg/dL after treatment with atorvastatin 10 mg/day or rosuvastatin 2.5 mg/day". Exclusion criteria: adverse reactions to the study drugs; triglyceride level > 500m g/dL; ALT level more than twice the upper limit of normal; secondary dyslipidaemia; drug‐induced dyslipidaemia; ACS, a history of PCI, coronary artery bypass grafting, or stroke within 3 months. Women who were pregnant, at risk for becoming pregnant, or who were nursing infants were also excluded.
Interventions	Intervention: ezetimibe +atorvastatin 10 mg/day or rosuvastatin 2.5 mg/day Comparison: atorvastatin 20 mg/day or rosuvastatin 5 mg/day Details of any 'run‐in' period: not reported Concomitant medications: not reported Excluded medications: not reported
Outcomes	Primary: Lipid levels, campesterol, lathosterol, plasma protein convertase subtilisin/kexin type 9 (PCSK9) concentrations.
Notes	Funding: Financially supported by Merck Sharp & Dohme (MSD), Inc. and Bayer, Inc.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomly assigned, but no further details.
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	50/200 withdrew from the study
Selective reporting (reporting bias)	Unclear risk	No protocol published, or trials registry record found.
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists Financially supported by Merck Sharp & Dohme (MSD), Inc. and Bayer, Inc.