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

Luo 2014.

Methods Design: RCT
Number of study centres: single centre
Setting: inpatient and outpatient
Patient recruitment: July 2010 and December 2011
Duration of study (Follow‐up): 12months
Clinical setting: hypercholesterolaemia
Participants Enrolment (N): 84
Randomised (N): intervention: 40; control:44
Withdrawn (N): not reported
Lost to follow‐up (N): not reported
Completed the study (N): not reported
Analysed (N): intervention: 40; control:44
Age (years) (mean ± SD): intervention: 67.2 ± 6.4; control: 66.3 ± 5.8
Sex (male, N, %): intervention: 22 (55%); control: 22 (50%)
Smoking history (N, %): not reported
BMI (kg/m², mean ± SD):): intervention: 24.4 ± 4.6; control: 24.7 ± 4.4
Diabetes (N, %): intervention: 12 ; control: 16
Hypertension (N, %): not reported
History of CHD (N, %): intervention: 36; control: 34
Statin pretreatment (N, %): not reported
Inclusion criteria: elderly hypercholesterolaemic patients who still had abnormal LDL‐C levels (≤ 2 .6 mM) after undergoing lipid‐lowering therapy for three months.
Exclusion criteria: patients with hypertension, blood diseases, hepatorenal dysfunction, severe infectious disease and heart failure were excluded.
Interventions Intervention: atorvastatin 20 mg/night in combination with ezetimibe10 mg/day
Comparison: atorvastatin 20 mg/night
Details of any 'run‐in' period: not reported
Concomitant medications: not reported
Excluded medications: not reported
Outcomes
  1. Blood lipid level and high‐sensitivity C‐reactive protein (hsCRP).

  2. Carotid intima‐media thickness, carotid plaque Crouse integral, Carotid diameter

  3. Cardiovascular events (myocardial infarction, cardiovascular death) and adverse reactions.

Notes Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomised" 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 Unclear risk Not reported
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