The American Diabetes Association (ADA) issued updates to its 2019 Standards of Medical Care in Diabetes on March 27 in light of recent evidence surrounding icosapent ethyl and dapagliflozin.
Specifically, the standards now recommend icosapent ethyl, manufactured by Amarin under the brand name Vascepa, be considered for patients with diabetes and atherosclerotic cardiovascular disease if they have elevated triglycerides (135-499 mg/dL) despite taking statins.
The medication is currently FDA approved to reduce triglyceride levels in adults with severe hypertriglyceridemia (above 500 mg/dL) but Amarin announced March 28 it has submitted a supplemental new drug application (sNDA) to expand that label. The FDA hasn’t communicated when it expects to finish reviewing that application, according to Amarin.
The ADA’s new recommendation for icosapent ethyl can be traced to the REDUCE-IT trial. That study, originally published in November, found the purified EPA product was linked to a 25 percent reduction in first major adverse cardiovascular events (MACE) when compared to placebo in a population of statin-treated patients with elevated triglycerides—a median of 216 mg/dL.
A recent analysis of REDUCE-IT presented at the American College of Cardiology’s scientific sessions in New Orleans concluded that when repeat events were also considered, the total MACE reduction was 30 percent.
“As we have commenced transmission of data to the FDA for the submission of our sNDA seeking an expansion of the Vascepa label based on the landmark REDUCE-IT results, we are pleased by ADA’s acknowledgement of the importance of the REDUCE-IT results in its 2019 update of the Standards of Care,” Craig B. Granowitz, MD, PhD, senior vice president and chief medical officer of Amarin, said in a press release.
“The medical community will also hopefully take note of recent research reporting the prevalence of, and increased costs associated with, diabetes mellitus and high triglyceride levels despite statin therapy.”
The ADA said it also revised three sections of its Standards of Care based on findings from the DECLARE-TIMI 58 Trial, which found dapagliflozin was associated with reductions in chronic kidney disease (CKD) progression as well as hospitalizations for heart failure. The updated document is available online in Diabetes Care.
“New research can lead to improved patient outcomes and quality of life, and the American Diabetes Association is proud to continue to provide the most current evidence-based guidelines for people living with diabetes,” William T. Cefalu, MD, the ADA’s Chief Scientific, Medical and Mission Officer, said in a release. “These Living Standards of Care updates via the online annotations to our yearly Standards of Care enable us to translate and communicate significant research findings that will empower health professionals to provide optimal care for millions of Americans living with diabetes.”
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.