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Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study).
J Clin Lipidol. 2012 Nov-Dec; 6(6):565-72.JC

Abstract

BACKGROUND

Icosapent ethyl (IPE; formerly AMR101) is a high-purity prescription form of eicosapentaenoic acid ethyl ester. In the MARINE study we evaluated the efficacy and safety of IPE in patients with very high triglycerides (TG; ≥500 mg/dL) and previously demonstrated significant reductions in TG levels with no significant increases in low-density lipoprotein (LDL) cholesterol levels.

OBJECTIVES

In this follow-up, exploratory analysis, we report the effects of IPE on lipoprotein particle concentration and size.

METHODS

MARINE was a phase 3, multicenter, placebo-controlled, randomized, double-blind, 12-week study. Hypertriglyceridemic patients (N = 229) were randomized to three treatment groups: IPE 4 g/day, IPE 2 g/day, or placebo. Lipoprotein particle concentrations and sizes were measured by nuclear magnetic resonance spectroscopy.

RESULTS

Compared with placebo, IPE 4 g/day significantly reduced median concentrations of large very-low-density lipoprotein (VLDL; -27.9%; P = .0211), total LDL (-16.3%; P = .0006), small LDL (-25.6%; P < .0001), and total high-density lipoprotein (HDL; -7.4%; P = .0063) particles and reduced VLDL particle size (-8.6%; P = .0017). In this patient population with TG ≥500 mg/dL, IPE did not significantly change the overall sizes of LDL or HDL particles.

CONCLUSION

IPE 4 g/day significantly reduced large VLDL, total LDL, small LDL, and total HDL particle concentrations and VLDL particle size in patients with TG ≥500 mg/dL. Changes in VLDL particle concentration and size reflect the TG-lowering effects of eicosapentaenoic acid. The reduction in LDL particle concentration with IPE is novel among ω-3 therapies and is consistent with the previously reported reduction in apolipoprotein B and lack of LDL-C increase with IPE in patients with very high TG levels.

CLINICAL TRIAL REGISTRATION NUMBER

NCT01047683.

Authors+Show Affiliations

Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY 40213, USA. hbaysmd@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23312052

Citation

Bays, Harold E., et al. "Icosapent Ethyl, a Pure EPA Omega-3 Fatty Acid: Effects On Lipoprotein Particle Concentration and Size in Patients With Very High Triglyceride Levels (the MARINE Study)." Journal of Clinical Lipidology, vol. 6, no. 6, 2012, pp. 565-72.
Bays HE, Braeckman RA, Ballantyne CM, et al. Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study). J Clin Lipidol. 2012;6(6):565-72.
Bays, H. E., Braeckman, R. A., Ballantyne, C. M., Kastelein, J. J., Otvos, J. D., Stirtan, W. G., & Soni, P. N. (2012). Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study). Journal of Clinical Lipidology, 6(6), 565-72. https://doi.org/10.1016/j.jacl.2012.07.001
Bays HE, et al. Icosapent Ethyl, a Pure EPA Omega-3 Fatty Acid: Effects On Lipoprotein Particle Concentration and Size in Patients With Very High Triglyceride Levels (the MARINE Study). J Clin Lipidol. 2012 Nov-Dec;6(6):565-72. PubMed PMID: 23312052.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study). AU - Bays,Harold E, AU - Braeckman,Rene A, AU - Ballantyne,Christie M, AU - Kastelein,John J, AU - Otvos,James D, AU - Stirtan,William G, AU - Soni,Paresh N, Y1 - 2012/07/24/ PY - 2011/10/14/received PY - 2012/06/28/revised PY - 2012/07/15/accepted PY - 2013/1/15/entrez PY - 2013/1/15/pubmed PY - 2013/7/11/medline SP - 565 EP - 72 JF - Journal of clinical lipidology JO - J Clin Lipidol VL - 6 IS - 6 N2 - BACKGROUND: Icosapent ethyl (IPE; formerly AMR101) is a high-purity prescription form of eicosapentaenoic acid ethyl ester. In the MARINE study we evaluated the efficacy and safety of IPE in patients with very high triglycerides (TG; ≥500 mg/dL) and previously demonstrated significant reductions in TG levels with no significant increases in low-density lipoprotein (LDL) cholesterol levels. OBJECTIVES: In this follow-up, exploratory analysis, we report the effects of IPE on lipoprotein particle concentration and size. METHODS: MARINE was a phase 3, multicenter, placebo-controlled, randomized, double-blind, 12-week study. Hypertriglyceridemic patients (N = 229) were randomized to three treatment groups: IPE 4 g/day, IPE 2 g/day, or placebo. Lipoprotein particle concentrations and sizes were measured by nuclear magnetic resonance spectroscopy. RESULTS: Compared with placebo, IPE 4 g/day significantly reduced median concentrations of large very-low-density lipoprotein (VLDL; -27.9%; P = .0211), total LDL (-16.3%; P = .0006), small LDL (-25.6%; P < .0001), and total high-density lipoprotein (HDL; -7.4%; P = .0063) particles and reduced VLDL particle size (-8.6%; P = .0017). In this patient population with TG ≥500 mg/dL, IPE did not significantly change the overall sizes of LDL or HDL particles. CONCLUSION: IPE 4 g/day significantly reduced large VLDL, total LDL, small LDL, and total HDL particle concentrations and VLDL particle size in patients with TG ≥500 mg/dL. Changes in VLDL particle concentration and size reflect the TG-lowering effects of eicosapentaenoic acid. The reduction in LDL particle concentration with IPE is novel among ω-3 therapies and is consistent with the previously reported reduction in apolipoprotein B and lack of LDL-C increase with IPE in patients with very high TG levels. CLINICAL TRIAL REGISTRATION NUMBER: NCT01047683. SN - 1933-2874 UR - https://www.unboundmedicine.com/medline/citation/23312052/Icosapent_ethyl_a_pure_EPA_omega_3_fatty_acid:_effects_on_lipoprotein_particle_concentration_and_size_in_patients_with_very_high_triglyceride_levels__the_MARINE_study__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1933-2874(12)00273-5 DB - PRIME DP - Unbound Medicine ER -