A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes : The INFINITY Study

الملخص EN

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.