title: A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes: The INFINITY Study.
abstract: 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 (STAT(2)). 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 STAT(2) 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.
authors.affiliation: Schulich Heart Centre, Sunnybrook Health Sciences Centre, D380-2075 Bayview, Avenue, Toronto, ON, Canada M4N 3M5.
authors.forename: Mina
authors.initials: M
authors.lastname: Madan
authors.forename: Tasnim
authors.initials: T
authors.lastname: Vira
authors.forename: Emmanouil
authors.initials: E
authors.lastname: Rampakakis
authors.forename: Anup
authors.initials: A
authors.lastname: Gupta
authors.forename: Anil
authors.initials: A
authors.lastname: Khithani
authors.forename: Lyn
authors.initials: L
authors.lastname: Balleza
authors.forename: Julie
authors.initials: J
authors.lastname: Vaillancourt
authors.forename: Stella
authors.initials: S
authors.lastname: Boukas
authors.forename: John
authors.initials: J
authors.lastname: Sampalis
authors.forename: Emidio
authors.initials: E
authors.lastname: de Carolis