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 |
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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Enrolment (N): 84 Randomised (N): intervention: 40; control:44 Withdrawn (N): not reported Lost to follow‐up (N): not reported Completed the study (N): not reported Analysed (N): intervention: 40; control:44 Age (years) (mean ± SD):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. |
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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 |
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Outcomes |
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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 |