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Amarin Corporation plc (NASDAQ: AMRN) announced that brand-new data related to Vascepa (icosapent ethyl) will certainly be presented at the upcoming American Diabetes Association (ADA) 76th Scientific Sessions in brand-new Orleans (June 10-14) and published as an abstract in the Diabetes® Abstract Book.
The poster presentation is a post-hoc analysis of Type 2 diabetes patients from Amarin’s ANCHOR trial who, despite statin therapy, have actually persistent higher triglyceride levels. The 12-week ANCHOR trial studied the effects of Vascepa in adult patients at higher risk for cardio ailment along with persistent higher triglyceride levels (≥200 mg/dL and <500 mg/dL) after constant statin therapy.
Presentation post is as follows:
- Poster Presentation #173-P, Category 12-E Clinical Therapeutics/brand-new Technology-Oral Agents: Effects ofIcosapent Ethyl on Lipoprotein Particle Concentration and Dimension in Statin-Treated Patients along with Persistent higher Triglycerides: ANCHOR Patients along with Diabetes Mellitus — (Authors: Eliot A. Brinton, MD, FAHA, FNLA, Christie M. Ballantyne, MD, Harold E. Bays, MD, et al.)
- The poster will certainly be on display from Saturday, June 11 starting at 10 a.m. CDT to Monday, June 13 at 2 p.m. CDT, along with the author presentation scheduled for Sunday, June 12, in between 12:00 – 2:00 p.m. CDT.
Additional data that was accepted by the ADA Scientific Sessions Preparation Committee and will certainly be published in the Diabetes® Abstract Schedule is titled: “Eicosapentaenoic Acid, yet not various other TG-lowering Agents, Reversed Hyperglycemia-Induced Rat Endothelial Cell Dysfunction and Enhanced the Incentives of Atorvastatin Energetic Metabolite Ex Vivo” (Authors: R. Preston Mason, PhD, Robert F. Jacob, PhD, Hazem Dawoud, MS, Haidar Alhumaid, MS, et al.). This was an ex vivo experiment looking at the effects of eicosapentaenoic acid ± atorvastatin Energetic metabolite (ATM) relative to niacin or fenofibrate in glomerular endothelial cells from rats exposed to higher glucose.
About VASCEPA® (icosapent ethyl) capsules
VASCEPA® (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram of the omega-3 acid typically referred to as EPA in ethyl-ester form. Vascepa is not fish oil, yet is derived from fish through a stringent and complex FDA-regulated manufacturing procedure created to efficiently get rid of impurities and isolate and protect the solitary molecule Energetic ingredient. Vascepa is known in scientific literature as AMR101.
FDA-approved Indication and Usage
- VASCEPA (icosapent ethyl) is indicated as an adjunct to diet regimen to lessen triglyceride (TG) levels in adult patients along with major (≥500 mg/dL) hypertriglyceridemia.
- The effect of VASCEPA on the risk for pancreatitis and cardio mortality and morbidity in patients along with major hypertriglyceridemia has actually not been determined.
Important Safety post for VASCEPA
- VASCEPA is contraindicated in patients along with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any type of of its components.
- Use along with caution in patients along with known hypersensitivity to fish and/or shellfish.
- The the majority of common reported side reaction (incidence >2% and better compared to placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported side reaction >3% and better compared to placebo.
- Patients receiving treatment along with VASCEPA and various other drugs affecting coagulation (e.g., anti-platelet agents) need to be monitored periodically.
- In patients along with hepatic impairment, monitor ALT and AST levels periodically throughout therapy.
- Patients need to be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
- Adverse events and product complaints could be reported by calling
1-855-VASCEPA or the FDA at 1-800-FDA-1088.
FULL VASCEPA PRESCRIBING post can easily BE Discovered AT WWW.VASCEPA.COM.
Vascepa has actually been approved for Usage by the United States Meals and Drug Administration (FDA) as an adjunct to diet regimen to lessen triglyceride levels in adult patients along with major (≥ 500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of progression for potential Usage in various other indications that have actually not been approved by the FDA. Nil in this press launch need to be construed as promoting the Usage of Vascepa in any type of indication that has actually not been approved by the FDA.
