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Advances in Preventive Medicine
Volume 2012 (2012), Article ID 103728, 11 pages
http://dx.doi.org/10.1155/2012/103728
Clinical Study

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

1Schulich Heart Centre, Sunnybrook Health Sciences Centre, D380-2075 Bayview, Avenue, Toronto, ON, Canada M4N 3M5
2JSS Medical Research Inc., 9400 Henri-Bourassa W., St-Laurent, PQ, Canada H4S 1N8
3McGill University, Montreal, PQ, Canada
4Division of Cardiology, Toronto East General Hospital, 751 Pape Avenue, Toronto, ON, Toronto East General Hospital, Canada M4K 3T1
53430 Finch Avenue East, Scarborough, ON, Canada M1W 2R5
6Merck Canada Inc., 16711 Trans-Canada Hwy., Kirkland, PQ, Canada H9H 3L1

Received 16 May 2012; Revised 26 October 2012; Accepted 30 October 2012

Academic Editor: Ramesh Vemulapalli

Copyright © 2012 Mina Madan et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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 (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%; ) 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% ( ) 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.