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Lipid Effects of Icosapent Ethyl in Women with Diabetes Mellitus and Persistent High Triglycerides on Statin Treatment: ANCHOR Trial Subanalysis.
- Source :
-
Journal of Women's Health (15409996) . Sep2018, Vol. 27 Issue 9, p1170-1176. 7p. 2 Charts, 1 Graph. - Publication Year :
- 2018
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *DRUG therapy for hyperlipidemia
*STATINS (Cardiovascular agents)
*HYPERLIPIDEMIA
*ERYTHROCYTES
*APOLIPOPROTEINS
*CARDIOVASCULAR diseases risk factors
*DIABETES
*DRUG tolerance
*DIET therapy for heart diseases
*INFLAMMATORY mediators
*LIPIDS
*LIPOPROTEINS
*LOW density lipoproteins
*MEDICAL prescriptions
*PATIENT safety
*STATISTICS
*TRIGLYCERIDES
*WHITE people
*DATA analysis
*EICOSAPENTAENOIC acid
*RANDOMIZED controlled trials
*PREVENTION
*THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 15409996
- Volume :
- 27
- Issue :
- 9
- Database :
- Academic Search Index
- Journal :
- Journal of Women's Health (15409996)
- Publication Type :
- Academic Journal
- Accession number :
- 131680086
- Full Text :
- https://doi.org/10.1089/jwh.2017.6757