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. 2018 Nov 19;2018(11):CD012502. doi: 10.1002/14651858.CD012502.pub2

Luo 2016.

Methods Design: randomised, prospective, double‐blind, and placebo‐controlled design
Number of study centres: single‐centre in China.
Setting: outpatient
Patient recruitment: June 2012 to September 2013
Duration of study (Follow‐up): 12 months
Clinical setting: coronary heart disease
Participants Enrolment (N): 148
Randomised (N): intervention: 74; control: 74
Withdrawn (N): intervention: 0; control: 0
Lost to follow‐up (N): not reported
Completed the study (N): not reported
Analysed (N): intervention: 74; control: 74
Age (years) (mean ± SD): intervention: 60.76 ± 11.56; control: 61.55 ± 9.72
Sex (male, N, %): intervention: 40 ( 54%); control: 44 ( 59%)
Smoking history (N, %): intervention: 30 (40.5%); control: 26 (35.1%)
BMI (kg/m², mean ± SD):): intervention: 25.23 ± 4.67; control: 24.68 ± 5.42
Diabetes (N, %): intervention: 34 (45.9%); control: 30 (40.5%)
Hypertension (N, %): intervention: 38 (51.4%); control: 36 (48.6%)
History of CHD (N, %): intervention: 74 ( 100%); control: 74 ( 100%)
Statin pretreatment (N, %): not reported (patients received lipid‐lowering therapy for 3 months before enrolment)
Inclusion criteria: patients with CHD, which was confirmed by coronary angiography
Exclusion criteria: Patients with blood diseases, hepatonephric dysfunction, severe infectious diseases, and heart failure were excluded from the study.
Interventions Intervention: atorvastatin 20 mg/day + ezetimibe10 mg/day
Comparison: atorvastatin 20 mg/day
Details of any 'run‐in' period: none
Concomitant medications: aspirin, β‐blockers, angiotensin‐converting enzyme inhibitors, angiotensin II receptor antagonists, and hypoglycaemic drugs
Excluded medications: not reported
Outcomes Blood lipid levels, carotid artery plaque, adverse events, rates of major adverse coronary events, including cardiac death, hospitalisation for unstable angina, nonfatal MI, coronary revascularisation, and stroke.
Notes Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were divided into the control and combination groups by the random number table method
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Report Quote: "double‐blind study, and placebo‐controlled", but according to the sentence "The control group received oral atorvastatin (Lipitor 20 mg, Pfizer, USA) every night, while the combination group received ezetimibe (Ezetrol 10 mg, Schering‐Plough, USA) in the morning and atorvastatin in the evening", we are not sure whether the control group was using matching placebo, and the blinding to the participants and personnel is unclear.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Missing outcome data balanced in numbers across intervention groups (< 1%)
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
Quote: "All of the authors declare that they have no conflicts of interest regarding this paper"