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Icosapent ethyl (eicosapentaenoic acid ethyl ester): effects on apolipoprotein C-III in patients from the MARINE and ANCHOR studies

Session Poster session 2

Speaker Christie Ballantyne

Event : ESC Congress 2015

  • Topic : preventive cardiology
  • Sub-topic : Lipids
  • Session type : Poster Session

Authors : C M Ballantyne (Houston,US), HE Bays (Louisville,US), RA Braeckman (Doylestown,US), S Philip (Bedminster,US), WG Stirtan (Bedminster,US), RT Doyle (Bedminster,US), PN Soni (Mystic,US), R Juliano (Bedminster,US)

Authors:
C.M. Ballantyne1 , H.E. Bays2 , R.A. Braeckman3 , S. Philip4 , W.G. Stirtan4 , R.T. Doyle4 , P.N. Soni5 , R. Juliano4 , 1Baylor College of Medicine - Houston - United States of America , 2Louisville Metabolic and Atherosclerosis Research Center - Louisville - United States of America , 3Consultant - Doylestown - United States of America , 4Amarin Pharma Inc. - Bedminster - United States of America , 5Consultant - Mystic - United States of America ,

Citation:
European Heart Journal ( 2015 ) 36 ( Abstract Supplement ), 287

Background and introduction: Apolipoprotein C-III (ApoC-III) is a small protein that resides on various lipoproteins, inhibits lipoprotein/hepatic lipases, impairs hepatic uptake of triglyceride (TG)-rich lipoproteins (such as lipoprotein remnants), and generally promotes hypertriglyceridemia. Its increased activity may also contribute to insulin resistance and atherosclerosis. Prior reports of the omega-3 fatty acid eicosapentaenoic acid (EPA) alone or in combination with the omega-3 fatty acid docosahexaenoic acid have suggested inconsistent effects on ApoC-III levels. Icosapent ethyl (IPE) is a high-purity prescription form of EPA ethyl ester approved to reduce TG levels in adult patients with severe hypertriglyceridemia (TG ≥500 mg/dL).

Purpose: To evaluate the effects of IPE on ApoC-III levels in patients from the MARINE and ANCHOR studies.

Methods: MARINE and ANCHOR were 12-week, phase 3, double-blind studies that randomized adult patients to IPE 4 g/day, 2 g/day, or placebo. MARINE randomized 229 patients (TG ≥500 and ≤2000 mg/dL); ANCHOR randomized 702 patients at high risk for cardiovascular disease (TG ≥200 and <500 mg/dL) despite low-density lipoprotein cholesterol (LDL-C) control on statin therapy. This analysis assessed median percent change from baseline to study end in ApoC-III levels compared with placebo.

Results: Total ApoC-III levels were assessed in 148 (MARINE) and 612 (ANCHOR) patients. Compared with placebo, IPE statistically significantly reduced ApoC-III levels at 4 g/day (Table) and 2 g/day (14.3%, p=0.0154, MARINE; 8.5%, p=0.0008, ANCHOR).

Conclusions: Compared with placebo, IPE significantly reduced ApoC-III levels in adult patients in the MARINE and ANCHOR studies, in which IPE also significantly lowered TG and apolipoprotein B without increasing LDL-C.

ApoC-III levels in patients from the MARINE and ANCHOR studies (IPE 4 g/day and placebo groups only)
ApoC-IIIMedian baseline value, mg/dL (IQR)Median final value, mg/dL (IQR)Median change from baseline, % (IQR)Median change from baseline vs placebo, % (p value)
MARINE IPE 4 g/day n=5325.6 (11.6)19.7 (10.5)−10.1 (27.1)−25.1 (<0.0001)
MARINE Placebo n=4626.8 (17.3)32.7 (14.6)12.3 (41.5)
ANCHOR IPE 4 g/day n=20815.2 (4.76)13.7 (4.80)−9.4 (25.9)−19.2 (<0.0001)
ANCHOR Placebo n=20114.8 (4.48)16.2 (5.57)10.9 (30.0)
ApoC-III, apolipoprotein C-III; IPE, icosapent ethyl; IQR, interquartile range.

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