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 |
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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Enrolment (N): 148 Randomised (N): intervention: 74; control: 74 Withdrawn (N): intervention: 0; control: 0 Lost to follow‐up (N): not reported Completed the study (N): not reported Analysed (N): intervention: 74; control: 74 Age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. |
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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 |
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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" |