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1.  A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes: The INFINITY Study 
Background. There is a paucity of data regarding the effectiveness and safety of lipid-lowering treatments among South-Asian patients. Methods. Sixty-four South-Asian Canadians with coronary artery disease or diabetes and persistent hypercholesterolemia on statin therapy, were randomized to ezetimibe 10 mg/day co-administered with statin therapy (EZE + Statin) or doubling their current statin dose (STAT2). Primary outcome was the proportion of patients achieving target LDL-C (<2.0 mmol/L) after 6 weeks. Secondary outcomes included the change in lipid profile and the incidence of treatment-emergent adverse events through 12 weeks. Exploratory markers for vascular inflammation were assessed at baseline and 12 weeks. Results. At 6 weeks, the primary outcome was significantly higher among the EZE + Statin patients (68% versus 36%; P = 0.031) with an OR (95% CI) of 3.97 (1.19, 13.18) upon accounting for baseline LDL-C and adjusting for age. At 12 weeks, 76% of EZE + Statin patients achieved target LDL-C compared to 48% (P = 0.047) of the STAT2 patients (adjusted OR (95% CI) = 3.31 (1.01,10.89)). No significant between-group differences in exploratory markers were observed with the exception of CRP. Conclusions. Patients receiving ezetimibe and statin were more likely to achieve target LDL-C after 6 and 12 weeks compared to patients doubling their statin dose. Ezetimibe/statin combination therapy was well tolerated among this cohort of South-Asian Canadians, without safety concerns.
PMCID: PMC3529456  PMID: 23304534
2.  Effectiveness of Ezetimibe in Reducing the Estimated Risk for Fatal Cardiovascular Events in Hypercholesterolaemic Patients with Inadequate Lipid Control While on Statin Monotherapy as Measured by the SCORE Model 
Objectives. The aim of this prospective cohort, multicentre study was to assess the effect of coadministrating ezetimibe 10 mg/day with an ongoing statin on the estimated risk for Cardiovascular (CVD) mortality in patients with persistently elevated LDL-C after statin monotherapy. Methods. The Systematic Coronary Risk Evaluation (SCORE) function was used to estimate the 10-year risk for cardiovascular mortality at baseline and 6 weeks. Primary outcome measures were absolute and percent changes in estimated Coronary Heart Disease (CHD) Mortality Risk, and general CVD Mortality Risk (Total CVD Mortality Risk). Results. 825 patients were included in the analysis. Mean (SD) age was 62 (10.5) years and 62.3% were males. The mean (SD) estimated Total CVD Mortality Risk decreased from 0.068 (0.059) at baseline to 0.053 (0.046) at 6 weeks (RR = 0.77; 95% CI:0.689–0.867), while the estimated CHD Mortality Risk decreased from 0.047 (0.040) at baseline to 0.034 (0.029) at 6 weeks (RR = 0.72; 95% CI:0.624–0.826). Conclusions. Co-administration of ezetimibe with a statin is effective in significantly reducing the estimated risk for cardiovascular mortality as measured by the SCORE model.
PMCID: PMC3169312  PMID: 21991439

Results 1-2 (2)