Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: The EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial John J.P.

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Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: The EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial John J.P. Kastelein, MD, PhD, FESC, Kevin C. Maki, PhD, Andrey Susekov, MD, Marat Ezhov, MD, PhD, Borge G. Nordestgaard, MD, DMSc, Ben N. Machielse, MSc, Douglas Kling, BS, MBA, Michael H. Davidson, MD, FACC Journal of Clinical Lipidology Volume 8, Issue 1, Pages 94-106 (January 2014) DOI: 10.1016/j.jacl.2013.10.003 Copyright © 2014 National Lipid Association Terms and Conditions

Figure 1 Study design. For subjects previously on OM3 drugs/supplements who needed to washout, or subjects who required statin/CAI/statin-CAI dose adjustment or addition, V1 was 8 weeks before random assignment. For all other subjects, including those who were on a stable dose of statin, CAI, or statin-CAI at least 4 weeks before screening (V2) or who needed to washout of bile acid sequestrants, fibrates, niacin, or other lipid-altering supplements, V1 was 4 weeks before random assignment. CAI, cholesterol absorption inhibitor; OM3-FFA, omega-3 free fatty acids; OO, olive oil; V, visit. Journal of Clinical Lipidology 2014 8, 94-106DOI: (10.1016/j.jacl.2013.10.003) Copyright © 2014 National Lipid Association Terms and Conditions

Figure 2 Subject disposition and flow of subjects through the trial. ∗The majority (69%) of the screen failures were because of triglyceride levels out of the acceptable inclusion range (≥500 mg/dL and <2000 mg/dL). The next most prevalent reason for screen failure was other laboratory abnormality (24%), largely uncontrolled diabetes (glycosylated hemoglobin ≥9%). †Other withdrawal refers to subjects who had a clinically significant lipid abnormality that resulted in withdrawal, but that was not considered an adverse event because it was expected for dyslipidemic conditions. AE, adverse event; MITT, modified intent-to-treat; OM3-FFA, omega-3 free fatty acids; OO, olive oil; SAE, serious adverse event. Journal of Clinical Lipidology 2014 8, 94-106DOI: (10.1016/j.jacl.2013.10.003) Copyright © 2014 National Lipid Association Terms and Conditions