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

Wang 2017.

Methods Design: RCT
Number of study centres: single centre in China
Setting: inpatient and outpatient
Patient recruitment: June 2015 to June 2016
Duration of study (Follow‐up): 12 months
Clinical setting: type 2 diabetes mellitus complicated with coronary heart disease
Participants Enrolment (N): 100
Randomised (N): intervention: 51; control:49
Withdrawn (N): intervention:0 ; control:0
Lost to follow‐up (N): intervention: 0; control:0
Completed the study (N): intervention: 51; control:49
Analysed (N): intervention: 51; control:49
Age (years) (mean ± SD): intervention: 58 ± 10; control: 58 ± 9
Sex (male, N, %): intervention: 31 (60.8%); control: 30 (61.2%)
Smoking history (N, %): intervention:27 (52.9%) ; control:25 (51.0%)
BMI (>28kg/m², N, %): intervention: 36 (70.6%); control: 35 (71.4%)
Diabetes (N, %): intervention: 51 (100%); control:49 (100%)
Hypertension (N, %): intervention:34 (66.7%); control: 32 (65.3%)
History of CHD (N, %): intervention:51(100%) ; control:49 (100%)
Statin pretreatment (N, %): intervention:51 (100%) ; control:49 (100%)
Inclusion criteria: patients with CAS(carotid atherosclerosis) with type 2 diabetes mellitus and CHD.
Exclusion criteria: type 1 diabetes; malignant tumours; secondary hypertension; diabetic ketoacidosis; hyperglycaemic hyperosmolar status; heart failure; liver and kidney disease and other serious organic disease; suffering from infectious diseases within 2 weeks; trauma, surgery, mental stimulation within 6 months.
Interventions Intervention: ezetimibe 10 mg/day and atorvastatin 20 mg/day
Comparison: atorvastatin 20 mg/day
Details of any 'run‐in' period: not reported
Concomitant medications: Other drugs for hypertension and arterial sclerosis such as aspirin, β‐blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonist and hypoglycaemic drugs in both groups of patients were routinely applicated.
Excluded medications: not reported
Outcomes

  1. The levels of serum lipid, ALT , AST, CK, high‐sensitivity CRP (hs‐CRP), fasting blood glucose (FBG) and HbA1c.

  2. The intima‐media thickness (IMT) and plaque area of carotid artery.

  3. Side effects.
Notes Funding: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "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 Low risk All patients completed the study.
Selective reporting (reporting bias) Unclear risk No protocol published, or trials registry record found.
Other bias Low risk Quote: "The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript."