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Omega-3 carboxylic acids in patients with severe hypertriglyceridemia: EVOLVE II, a randomized, placebo-controlled trial Erik S.G. Stroes, MD, PhD, Andrey V. Susekov, MD, PhD, Tjerk W.A. de Bruin, MD, PhD, Mats Kvarnström, PhD, Hong Yang, MSc, Michael H. Davidson, MD Journal of Clinical Lipidology Volume 12, Issue 2, Pages (March 2018) DOI: /j.jacl Copyright © 2017 National Lipid Association Terms and Conditions
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Figure 1 Study design of EVOLVE II. aScreening visit for patients who required washout or stabilization of lipid-lowering therapy. This included patients who were previously receiving drugs or supplements containing OM3-CA, required adjustment to or addition of permitted statin, CAI, or statin–CAI combination, and had not been receiving a permitted stable dose of statin, CAI, or statin–CAI combination for at least 4 weeks before visit 1, and/or needed washout of bile acid sequestrants, fibrates, niacin, and/or other supplements known to alter lipid metabolism. bScreening visit for patients not requiring washout or stabilization of lipid-lowering therapy. cTo be eligible for randomization, patients needed to have a mean QTG of at least 500 mg/dL and <2500 mg/dL (or <2000 mg/dL in Canada). CAI, cholesterol-absorption inhibitor; EVOLVE II, EpanoVa fOr Lowering Very high triglyceridEs II; OM3-CA, omega-3 carboxylic acids; QTG, qualifying triglyceride measurement. Journal of Clinical Lipidology , DOI: ( /j.jacl ) Copyright © 2017 National Lipid Association Terms and Conditions
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Figure 2 Median (IQR) percentage changes from baseline to the Week 12 endpoint in serum TG concentrations in (A) the overall study population and (B) the subgroup of patients with qualifying TG concentrations >885 mg/dL. (A) N = 162 (OM3-CA 2 g daily [n = 81]; olive oil 2 g daily [n = 81]); (B) N = 105 (OM3-CA 2 g daily [n = 53]; olive oil 2 g daily [n = 52]) aWeek 12 endpoint with probabilities of missing imputation (see Methods section). CI, confidence interval; IQR, interquartile range; OM3-CA, omega-3 carboxylic acids; TG, triglyceride. Journal of Clinical Lipidology , DOI: ( /j.jacl ) Copyright © 2017 National Lipid Association Terms and Conditions
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Figure 3 Median (IQR) percentage changes from baseline to Week 12 in serum non-HDL-C, HDL-C, LDL-C, and VLDL-C concentrations in (A) the overall study population and (B) the subgroup of patients with qualifying TG concentrations >885 mg/dL. (A) N = 162 (OM3-CA 2 g daily [n = 81]; olive oil 2 g daily [n = 81]); (B) N = 105 (OM3-CA 2 g daily [n = 53]; olive oil 2 g daily [n = 52]). Please see Methods section for details of adjusted P values. P values were not adjusted for the exploratory variables (LDL-C and VLDL-C concentrations) or for the subgroup of patients with qualifying TG concentrations >885 mg/dL. CI, confidence interval; HDL-C, high-density lipoprotein cholesterol; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol; NA, not applicable; OM3-CA, omega-3 carboxylic acids; TG, triglyceride; VLDL-C, very-low-density lipoprotein cholesterol. Journal of Clinical Lipidology , DOI: ( /j.jacl ) Copyright © 2017 National Lipid Association Terms and Conditions
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