Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial

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Presentation transcript:

Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial Patrick M. Moriarty, MD, Paul D. Thompson, MD, Christopher P. Cannon, MD, John R. Guyton, MD, Jean Bergeron, MD, Franklin J. Zieve, MD, PhD, Eric Bruckert, MD, Terry A. Jacobson, MD, Stephen L. Kopecky, MD, Marie T. Baccara-Dinet, MD, Yunling Du, PhD, Robert Pordy, MD, Daniel A. Gipe, MD Journal of Clinical Lipidology Volume 9, Issue 6, Pages 758-769 (November 2015) DOI: 10.1016/j.jacl.2015.08.006 Copyright © 2015 National Lipid Association Terms and Conditions

Figure 1 Flow chart. ITT, intent-to-treat. Journal of Clinical Lipidology 2015 9, 758-769DOI: (10.1016/j.jacl.2015.08.006) Copyright © 2015 National Lipid Association Terms and Conditions

Figure 2 LDL-C concentrations vs study time points (on-treatment analysis using raw data). Values at week 12 and week 24 data points indicate achieved LDL-C concentration and LS mean (SE) percent change from baseline. In a post-hoc ITT analysis, the mean (SD) change in LDL-C concentration in the atorvastatin arm was −31.9% (25.1%) at week 24. ITT, intent-to-treat; LDL-C, low-density lipoprotein cholesterol; LS, least squares; Pts, patients; SD, standard deviation; SE, standard error. Journal of Clinical Lipidology 2015 9, 758-769DOI: (10.1016/j.jacl.2015.08.006) Copyright © 2015 National Lipid Association Terms and Conditions

Figure 3 Distribution by 10-mg/dL increments of LDL-C concentration at baseline and week 24 in patients on alirocumab (left panel) or ezetimibe (right panel; modified ITT population using raw data). Comparison between week 24 and baseline is descriptive and exploratory, as 24-week data were not available for all patients. ITT, intent-to-treat; LDL-C, low-density lipoprotein cholesterol; SD, standard deviation; SE, standard error. Journal of Clinical Lipidology 2015 9, 758-769DOI: (10.1016/j.jacl.2015.08.006) Copyright © 2015 National Lipid Association Terms and Conditions

Figure 4 Kaplan–Meier estimates for time to first skeletal muscle–related AE (predefined as myalgia, muscle spasms, muscular weakness, musculoskeletal stiffness, or muscle fatigue). AE, adverse event; ALI, alirocumab; ATV, atorvastatin; CI, confidence interval; EZE, ezetimibe; HR, hazard ratio. Journal of Clinical Lipidology 2015 9, 758-769DOI: (10.1016/j.jacl.2015.08.006) Copyright © 2015 National Lipid Association Terms and Conditions