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J Womens Health (Larchmt). 2018 Sep;27(9):1170-1176. doi: 10.1089/jwh.2017.6757. Epub 2018 Mar 27.

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

Author information

1
1 Utah Lipid Center , Salt Lake City, Utah.
2
2 Department of Medicine, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center , Houston, Texas.
3
3 Department of Endocrinology, Metabolism, and Nutrition, Duke University School of Medicine , Durham, North Carolina.
4
4 Medical Affairs, Amarin Pharma, Inc. , Bedminster, New Jersey.
5
5 Clinical Development, Amarin Pharma, Inc. , Bedminster, New Jersey.
6
6 Department of Medicine, Columbia University Medical Center , New York, New York.

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.

KEYWORDS:

cardiovascular diseases; diabetes mellitus; eicosapentaenoic acid; hypertriglyceridemia; women's health

PMID:
29583081
PMCID:
PMC6148718
DOI:
10.1089/jwh.2017.6757
[Indexed for MEDLINE]
Free PMC Article

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