A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes: The INFINITY Study. (5th December 2012)

• Record Type: Journal Article
• Authors: Madan, Mina; Vira, Tasnim; Rampakakis, Emmanouil; Gupta, Anup; Khithani, Anil; Balleza, Lyn; Vaillancourt, Julie; Boukas, Stella; Sampalis, John; de Carolis, Emidio
• Other Names: Vemulapalli Ramesh Academic Editor.
• Is Part Of: Advances in preventive medicine. Volume 2012(2012)
• Publication Date: 2012-12-05
• Subjects: Medicine, Preventive -- Periodicals; 613.05
• DOI: 10.1155/2012/103728
• Languages: English
• ISSNs: 2090-3480

Abstract

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.