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Hypertriglyceridemia: HELP
Articles by Rebecca A. Juliano
Based on 10 articles published since 2010
(Why 10 articles?)
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Between 2010 and 2020, Rebecca A. Juliano wrote the following 10 articles about Hypertriglyceridemia.
 
+ Citations + Abstracts
1 Clinical Trial Effects of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) on Atherogenic Lipid/Lipoprotein, Apolipoprotein, and Inflammatory Parameters in Patients With Elevated High-Sensitivity C-Reactive Protein (from the ANCHOR Study). 2019

Miller, Michael / Ballantyne, Christie M / Bays, Harold E / Granowitz, Craig / Doyle, Ralph T / Juliano, Rebecca A / Philip, Sephy. ·Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland. Electronic address: mmiller@som.umaryland.edu. · Department of Medicine, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas. · Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky. · Amarin Pharma Inc, Bedminster, New Jersey. ·Am J Cardiol · Pubmed #31277790.

ABSTRACT: Icosapent ethyl is pure prescription eicosapentaenoic acid approved at 4 g/day as an adjunct to diet to reduce triglycerides (TG) in adults with TG ≥500 mg/dl. Elevated high-sensitivity C-reactive protein (hsCRP) is associated with increased cardiovascular risk. The 12-week ANCHOR study randomized 702 statin-treated patients at increased cardiovascular risk with TG 200 to 499 mg/dl despite low-density lipoprotein cholesterol (LDL-C) control (40 to 99 mg/dl). This post hoc analysis assessed 246 ANCHOR patients with baseline hsCRP ≥ 2.0 mg/L randomized to icosapent ethyl 4 g/day (n = 126; approved dose) or placebo (n = 120). Without increasing LDL-C, icosapent ethyl significantly reduced median TG (-20%; p < 0.0001), non-high-density lipoprotein cholesterol (-12.3%; p < 0.0001), total cholesterol (-11.1%; p < 0.0001), high-density lipoprotein cholesterol (-5.2%; p = 0.0042), very LDL-C (-21.0%; p < 0.0001), very low-density lipoprotein TG (-22.9%; p < 0.0001), remnant lipoprotein cholesterol (-23.0%; p = 0.0125), apolipoprotein B (-7.4%; p = 0.0021), apolipoprotein C-III (-16%; p < 0.0001), oxidized LDL (-13.7%; p = 0.0020), lipoprotein-associated phospholipase A

2 Clinical Trial Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. 2019

Bhatt, Deepak L / Steg, P Gabriel / Miller, Michael / Brinton, Eliot A / Jacobson, Terry A / Ketchum, Steven B / Doyle, Ralph T / Juliano, Rebecca A / Jiao, Lixia / Granowitz, Craig / Tardif, Jean-Claude / Ballantyne, Christie M / Anonymous2730968. ·From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B.) · FACT (French Alliance for Cardiovascular Trials), Département Hospitalo-Universitaire FIRE (Fibrose, Inflammation, and Remodeling), Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université Paris-Diderot, INSERM Unité 1148, Paris (P.G.S.) · National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London (P.G.S.) · the Department of Medicine, University of Maryland School of Medicine, Baltimore (M.M.) · the Utah Lipid Center, Salt Lake City (E.A.B.) · the Office of Health Promotion and Disease Prevention, Department of Medicine, Emory University School of Medicine, Atlanta (T.A.J.) · Amarin Pharma, Bedminster, NJ (S.B.K., R.T.D.J., R.A.J., L.J., C.G.) · Montreal Heart Institute, Université de Montréal, Montreal (J.-C.T.) · and the Department of Medicine, Baylor College of Medicine, and the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston (C.M.B.). ·N Engl J Med · Pubmed #30415628.

ABSTRACT: BACKGROUND: Patients with elevated triglyceride levels are at increased risk for ischemic events. Icosapent ethyl, a highly purified eicosapentaenoic acid ethyl ester, lowers triglyceride levels, but data are needed to determine its effects on ischemic events. METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled trial involving patients with established cardiovascular disease or with diabetes and other risk factors, who had been receiving statin therapy and who had a fasting triglyceride level of 135 to 499 mg per deciliter (1.52 to 5.63 mmol per liter) and a low-density lipoprotein cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter). The patients were randomly assigned to receive 2 g of icosapent ethyl twice daily (total daily dose, 4 g) or placebo. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. RESULTS: A total of 8179 patients were enrolled (70.7% for secondary prevention of cardiovascular events) and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.68 to 0.83; P<0.001); the corresponding rates of the key secondary end point were 11.2% and 14.8% (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001). The rates of additional ischemic end points, as assessed according to a prespecified hierarchical schema, were significantly lower in the icosapent ethyl group than in the placebo group, including the rate of cardiovascular death (4.3% vs. 5.2%; hazard ratio, 0.80; 95% CI, 0.66 to 0.98; P=0.03). A larger percentage of patients in the icosapent ethyl group than in the placebo group were hospitalized for atrial fibrillation or flutter (3.1% vs. 2.1%, P=0.004). Serious bleeding events occurred in 2.7% of the patients in the icosapent ethyl group and in 2.1% in the placebo group (P=0.06). CONCLUSIONS: Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo. (Funded by Amarin Pharma; REDUCE-IT ClinicalTrials.gov number, NCT01492361 .).

3 Clinical Trial Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on remnant-like particle cholesterol from the MARINE and ANCHOR studies. 2016

Ballantyne, Christie M / Bays, Harold E / Philip, Sephy / Doyle, Ralph T / Braeckman, Rene A / Stirtan, William G / Soni, Paresh N / Juliano, Rebecca A. ·Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, 6565 Fannin St. MSA 601, Houston, TX 77030, USA. Electronic address: cmb@bcm.tmc.edu. · Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA. · Amarin Pharma Inc., Bedminster, NJ, USA. ·Atherosclerosis · Pubmed #27596132.

ABSTRACT: BACKGROUND AND AIMS: Remnant-like particle cholesterol (RLP-C) is atherogenic and may increase atherosclerotic cardiovascular disease risk. Icosapent ethyl is a high-purity prescription eicosapentaenoic acid ethyl ester (approved as an adjunct to diet to reduce triglyceride [TG] levels in adult patients with TGs ≥500 mg/dL [≥5.65 mmol/L] at 4 g/day). In the MARINE and ANCHOR studies, icosapent ethyl reduced TG and other atherogenic lipid parameter levels without increasing low-density lipoprotein cholesterol (LDL-C) levels. This exploratory analysis evaluated the effects of icosapent ethyl on calculated and directly measured RLP-C. METHODS: MARINE (TGs ≥500 and ≤2000 mg/dL [≥5.65 mmol/L and ≤22.6 mmol/L]) and ANCHOR (TGs ≥200 and <500 mg/dL [≥2.26 and <5.65 mmol/L] despite statin-controlled LDL-C) were phase 3, 12-week, double-blind studies that randomized adult patients to icosapent ethyl 4 g/day, 2 g/day, or placebo. This analysis assessed median percent change from baseline to study end in directly measured (immunoseparation assay) RLP-C levels (MARINE, n = 218; ANCHOR, n = 252) and calculated RLP-C levels in the full populations. RESULTS: Icosapent ethyl 4 g/day significantly reduced directly measured RLP-C levels -29.8% (p = 0.004) in MARINE and -25.8% (p = 0.0001) in ANCHOR versus placebo, and also reduced directly measured RLP-C levels to a greater extent in subgroups with higher versus lower baseline TG levels, in patients receiving statins versus no statins (MARINE), and in patients receiving medium/higher-intensity versus lower-intensity statins (ANCHOR). Strong correlations were found between calculated and directly measured RLP-C for baseline, end-of-treatment, and percent change values in ANCHOR and MARINE (0.73-0.92; p < 0.0001 for all). CONCLUSIONS: Icosapent ethyl 4 g/day significantly reduced calculated and directly measured RLP-C levels versus placebo in patients with elevated TG levels from the MARINE and ANCHOR studies.

4 Clinical Trial Effects of icosapent ethyl on lipoprotein particle concentration and size in statin-treated patients with persistent high triglycerides (the ANCHOR Study). 2015

Ballantyne, Christie M / Braeckman, Rene A / Bays, Harold E / Kastelein, John J / Otvos, James D / Stirtan, William G / Doyle, Ralph T / Soni, Paresh N / Juliano, Rebecca A. ·Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA. Electronic address: cmb@bcm.tmc.edu. · Amarin Pharma Inc., Bedminster, NJ, USA. · Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA. · Academic Medical Center, Amsterdam, The Netherlands. · LipoScience, Raleigh, NC, USA. ·J Clin Lipidol · Pubmed #26073397.

ABSTRACT: BACKGROUND: Icosapent ethyl (IPE) is a high-purity prescription form of eicosapentaenoic acid ethyl ester approved at a dose of 4 g/day as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG ≥ 500 mg/dL). OBJECTIVE: In this prespecified exploratory analysis from the ANCHOR study of patients at high cardiovascular risk with TG ≥ 200 and <500 mg/dL despite statin control of low-density lipoprotein cholesterol, we assessed the effects of IPE on lipoprotein particle concentration and size and examined correlations of atherogenic particles with apolipoprotein B (ApoB). METHODS: Nuclear magnetic resonance spectroscopy was used to measure lipoprotein particle concentration and size. RESULTS: Compared with placebo (n = 211), IPE 4 g/day (n = 216) significantly reduced concentrations of: total (12.2%, P = .0002), large (46.4%, P < .0001), and medium (12.1%, P = .0068) very-low-density lipoprotein (VLDL) particles; total (7.7%, P = .0017) and small (13.5%, P < .0001) LDL particles; and total (7.4%, P < .0001) and large (31.0%, P < .0001) high-density lipoprotein particles. Atherogenic lipoprotein particles (total VLDL and total LDL) correlated with ApoB at baseline (R(2) = 0.57) and week 12 (R(2) = 0.65) as did total LDL particle concentration at baseline (R(2) = 0.53) and week 12 (R(2) = 0.59). Compared with placebo, IPE 4 g/day significantly reduced VLDL (7.7%, P < .0001) and high-density lipoprotein (1.2%, P = .0014) particle sizes with a modest but significant increase in LDL particle size (0.5%, P = .0031). CONCLUSIONS: Compared with placebo, treatment with IPE 4 g/day for 12 weeks reduced key atherogenic lipoprotein particle concentrations. At both baseline and end of study, atherogenic lipoprotein concentrations correlated with ApoB.

5 Article Icosapent ethyl reduces atherogenic markers in high-risk statin-treated patients with stage 3 chronic kidney disease and high triglycerides. 2019

Vijayaraghavan, Krishnaswami / Szerlip, Harold M / Ballantyne, Christie M / Bays, Harold E / Philip, Sephy / Doyle, Ralph T / Juliano, Rebecca A / Granowitz, Craig. ·a Institute of Congestive Heart Failure, Abrazo Arizona Heart Hospital , Phoenix , AZ , USA. · b Nephrology Division and Nephrology Fellowship Program, Baylor University Medical Center , Dallas , TX , USA. · c Department of Medicine, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center , Houston , TX , USA. · d Louisville Metabolic and Atherosclerosis Research Center , Louisville , KY , USA. · e Medical Affairs, Amarin Pharma Inc ., Bedminster , NJ , USA. · f Clinical Development, Amarin Pharma Inc ., Bedminster , NJ , USA. ·Postgrad Med · Pubmed #31306043.

ABSTRACT:

6 Article Icosapent Ethyl Effects on Fatty Acid Profiles in Statin-Treated Patients With High Triglycerides: The Randomized, Placebo-controlled ANCHOR Study. 2019

Ballantyne, Christie M / Manku, Mehar S / Bays, Harold E / Philip, Sephy / Granowitz, Craig / Doyle, Ralph T / Juliano, Rebecca A. ·Department of Medicine, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA. cmb@bcm.tmc.edu. · Amarin Pharma Inc, Bedminster, NJ, USA. · Clinical Research, Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA. · Medical Affairs, Amarin Pharma Inc, Bedminster, NJ, USA. · Research and Development, Amarin Pharma Inc, Bedminster, NJ, USA. ·Cardiol Ther · Pubmed #30788718.

ABSTRACT: INTRODUCTION: Fatty acid content in plasma and red blood cells (RBCs) may provide insight into potential physiologic benefits of omega-3 fatty acids. Icosapent ethyl is a pure prescription form of eicosapentaenoic acid (EPA) ethyl ester approved by the US Food and Drug Administration at a dose of 4 g/day as an adjunct to diet to reduce triglyceride levels in adults with severe (≥ 500 mg/dl) hypertriglyceridemia. METHODS: This was a prespecified exploratory subset analysis of the ANCHOR study, which randomized 702 statin-treated patients at increased cardiovascular risk with triglycerides 200-499 mg/dl and controlled low-density lipoprotein cholesterol (40-99 mg/dl). This analysis examined effects of icosapent ethyl 4 g/day versus placebo on fatty acid levels in plasma and RBCs using a gas chromatograph assay method with flame ionization detector. RESULTS: In plasma, treatment with icosapent ethyl 4 g/day resulted in significant increases versus placebo in the mean concentrations of EPA (+ 635%; P < 0.0001) and its metabolite, docosapentaenoic acid n-3 (+ 143%; P < 0.0001) with no significant change in docosahexaenoic acid. Treatment with icosapent ethyl 4 g/day versus placebo also resulted in significant decreases in the omega-6 fatty acids linoleic acid (- 25%) and arachidonic acid (AA; - 31%), as well as the AA/EPA ratio (- 91%). Icosapent ethyl 4 g/day also decreased the omega-9 fatty acid oleic acid (- 29%) and the saturated fatty acids palmitic acid (- 23%) and stearic acid (- 16%) (all P < 0.0001). Results were similar for RBCs. CONCLUSIONS: Icosapent ethyl 4 g/day significantly increased EPA and produced other potentially beneficial shifts in fatty acids in plasma and RBCs versus placebo. TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT01047501 FUNDING: Amarin Pharma Inc. Plain language summary available for this article.

7 Article Lipid Effects of Icosapent Ethyl in Women with Diabetes Mellitus and Persistent High Triglycerides on Statin Treatment: ANCHOR Trial Subanalysis. 2018

Brinton, Eliot A / Ballantyne, Christie M / Guyton, John R / Philip, Sephy / Doyle, Ralph T / Juliano, Rebecca A / Mosca, Lori. ·1 Utah Lipid Center , Salt Lake City, Utah. · 2 Department of Medicine, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center , Houston, Texas. · 3 Department of Endocrinology, Metabolism, and Nutrition, Duke University School of Medicine , Durham, North Carolina. · 4 Medical Affairs, Amarin Pharma, Inc. , Bedminster, New Jersey. · 5 Clinical Development, Amarin Pharma, Inc. , Bedminster, New Jersey. · 6 Department of Medicine, Columbia University Medical Center , New York, New York. ·J Womens Health (Larchmt) · Pubmed #29583081.

ABSTRACT: BACKGROUND: High triglycerides (TG) and diabetes mellitus type 2 (DM2) are stronger predictors of cardiovascular disease (CVD) in women than in men, but few randomized, controlled clinical trials have investigated lipid-lowering interventions in women and none have reported results specifically in women with high TG and DM2. Icosapent ethyl (Vascepa) is pure prescription eicosapentaenoic acid (EPA) ethyl ester approved at 4 g/day as an adjunct to diet to reduce TG ≥500 mg/dL. METHODS: The 12-week ANCHOR trial randomized 702 statin-treated patients (73% with DM; 39% women) at increased CVD risk with TG 200-499 mg/dL despite controlled low-density lipoprotein cholesterol (LDL-C; 40-99 mg/dL) to receive icosapent ethyl 2 g/day, 4 g/day, or placebo. This post hoc analysis included 146 women with DM2 (97% white, mean age 62 years) randomized to icosapent ethyl 4 g/day (n = 74) or placebo (n = 72). RESULTS: Icosapent ethyl significantly reduced TG (-21.5%; p < 0.0001) without increasing LDL-C and lowered other potentially atherogenic lipid/lipoprotein, apolipoprotein, and inflammatory parameters versus placebo. Icosapent ethyl increased EPA levels in plasma (+639%; p < 0.0001; n = 49) and red blood cells (+599%; p < 0.0001; n = 47) versus placebo. Safety and tolerability of icosapent ethyl were generally similar to placebo. CONCLUSION: In women with DM2 at high CVD risk with persistently high TG on statins, icosapent ethyl 4 g/day reduced potentially atherogenic parameters with safety and tolerability comparable to placebo. Potential CVD benefits of icosapent ethyl are being tested in ∼8000 men and women at high CVD risk with high TG on statins in the ongoing Reduction of Cardiovascular Events with Icosapent Ethyl - Intervention Trial (REDUCE-IT) cardiovascular (CV) outcome trial.

8 Article Usefulness of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women to Lower Triglyceride Levels (Results from the MARINE and ANCHOR Trials). 2017

Mosca, Lori / Ballantyne, Christie M / Bays, Harold E / Guyton, John R / Philip, Sephy / Doyle, Ralph T / Juliano, Rebecca A. ·Columbia University Medical Center, New York, New York. Electronic address: ljm10@columbia.edu. · Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas. · Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky. · Duke University School of Medicine, Durham, North Carolina. · Amarin Pharma Inc., Bedminster, New Jersey. ·Am J Cardiol · Pubmed #27939227.

ABSTRACT: There are limited data on the efficacy and safety of triglyceride (TG)-lowering agents in women. We conducted subgroup analyses of the effects of icosapent ethyl (a high-purity prescription form of the ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid) on TG levels (primary efficacy variable) and other atherogenic and inflammatory parameters in a total of 215 women with a broad range of TG levels (200-2000 mg/dl) enrolled in two 12-week placebo-controlled trials: MARINE (n = 18; placebo, n = 18) and ANCHOR (n = 91; placebo, n = 88). Icosapent ethyl 4 g/day significantly reduced TG levels from baseline to week 12 versus placebo in both MARINE (-22.7%; p = 0.0327) and ANCHOR (-21.5%; p <0.0001) without increasing low-density lipoprotein cholesterol levels. Significant improvements were also observed in non-high-density lipoprotein cholesterol levels in MARINE (-15.7%; p = 0.0082) and ANCHOR (-14.2%; p <0.0001) and total cholesterol levels in MARINE (-14.9%; p = 0.0023) and ANCHOR (-12.1%; p <0.0001), along with significant increases of >500% in eicosapentaenoic acid levels in plasma and red blood cells (all p <0.001). Icosapent ethyl was well tolerated, with adverse-event profiles comparable with findings in the overall studies. In conclusion, icosapent ethyl 4 g/day significantly reduced TG levels and other atherogenic parameters in women without increasing low-density lipoprotein cholesterol levels compared with placebo; the clinical implications of these findings are being evaluated in the REDUCtion of Cardiovascular Events With Eicosapentaenoic Acid [EPA]-Intervention Trial (REDUCE-IT) cardiovascular outcomes study.

9 Article Icosapent ethyl: Eicosapentaenoic acid concentration and triglyceride-lowering effects across clinical studies. 2016

Bays, Harold E / Ballantyne, Christie M / Doyle, Ralph T / Juliano, Rebecca A / Philip, Sephy. ·Louisville Metabolic and Atherosclerosis Research Center, 3288 Illinois Avenue, Louisville, KY 40213, USA. Electronic address: hbaysmd@aol.com. · Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, 6565 Fannin, M.S. A-601, Houston, TX 77030, USA. Electronic address: cmb@bcm.tmc.edu. · Amarin Pharma Inc., 1430 Route 206, Suite 200, Bedminster, NJ 07921, USA. Electronic address: ralph.doyle@amarincorp.com. · Amarin Pharma Inc., 1430 Route 206, Suite 200, Bedminster, NJ 07921, USA. Electronic address: rebecca.juliano@amarincorp.com. · Amarin Pharma Inc., 1430 Route 206, Suite 200, Bedminster, NJ 07921, USA. Electronic address: sephy.philip@amarincorp.com. ·Prostaglandins Other Lipid Mediat · Pubmed #27418543.

ABSTRACT: Icosapent ethyl is a high-purity prescription form of eicosapentaenoic acid (EPA) ethyl ester approved at a dose of 4g/day as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. This post-hoc exploratory analysis examined the relationship of icosapent ethyl dose with EPA concentrations in plasma and red blood cells (RBCs) across 3 clinical studies-a phase 1 pharmacokinetic study in healthy adult volunteers and 2 pivotal phase 3 studies (MARINE and ANCHOR) in adult patients with hypertriglyceridemia-and examined the relationship between EPA levels and TG-lowering effects in MARINE and ANCHOR. In all 3 studies, icosapent ethyl produced dose-dependent increases in the concentrations of EPA in plasma and RBCs. In both MARINE and ANCHOR, these dose-dependent EPA increases correlated with the degree of TG level lowering (all P<0.01). In patients with high TG levels (≥200mg/dL) and treated with icosapent ethyl 4g/day, the end-of-treatment plasma and RBC EPA concentrations were >170μg/mL and>70μg/mL, respectively. These studies support icosapent ethyl as producing predictable dose-dependent pharmacokinetics/pharmacodynamics, with TG level lowering dependent upon icosapent ethyl dose and EPA concentrations in plasma and RBCs.

10 Article Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on plasma apolipoprotein C-III levels in patients from the MARINE and ANCHOR studies. 2016

Ballantyne, Christie M / Bays, Harold E / Braeckman, Rene A / Philip, Sephy / Stirtan, William G / Doyle, Ralph T / Soni, Paresh N / Juliano, Rebecca A. ·Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA. Electronic address: cmb@bcm.tmc.edu. · Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA. · Doylestown, PA, USA. · Amarin Pharma Inc., Bedminster, NJ, USA. · East Lyme, CT, USA. · Mystic, CT, USA. ·J Clin Lipidol · Pubmed #27206952.

ABSTRACT: BACKGROUND: Apolipoprotein C-III (ApoC-III) regulates lipoprotein and triglyceride (TG) metabolism and may have a causal role in cardiovascular disease. In the Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With an Open-Label Extension (MARINE) and ANCHOR studies, icosapent ethyl, a high-purity prescription eicosapentaenoic acid ethyl ester, reduced TG, and other atherogenic lipid parameters without increasing low-density lipoprotein cholesterol (LDL-C) compared with placebo. OBJECTIVE: To evaluate the effects of icosapent ethyl on plasma ApoC-III levels in patients from 2 phase 3 studies. METHODS: MARINE and ANCHOR were 12-week double-blind studies of icosapent ethyl in adult patients. Patients in MARINE had very high TG levels (≥500 and ≤2000 mg/dL) and patients in ANCHOR had high TG levels (≥200 and <500 mg/dL) despite statin control of LDL-C. This post hoc analysis of MARINE and ANCHOR assessed the median percent change from baseline in plasma ApoC-III levels vs placebo and includes subgroup analyses by statin use/efficacy and median ApoC-III levels. RESULTS: We assessed ApoC-III levels in 148 and 612 patients in the MARINE and ANCHOR studies, respectively. In MARINE, the approved prescription dose of icosapent ethyl (4 g/day) significantly reduced ApoC-III levels by 25.1% (P < .0001) vs placebo. In ANCHOR, icosapent ethyl 4 g/day significantly reduced ApoC-III levels by 19.2% (P < .0001) vs placebo; subanalysis by statin efficacy revealed significant reductions vs placebo in the higher-efficacy and medium-efficacy groups (24.6% and 17.2%, respectively; both P < .0001). CONCLUSION: Icosapent ethyl 4 g/day significantly reduced plasma ApoC-III levels in patients with elevated TGs from the MARINE and ANCHOR studies.