For 2019, the ADA updated Section 10 of its Standards of Care based on the published results of the REDUCE-IT study, which found icosapent ethyl provided a statistically significant 30% risk reduction in total (first and subsequent) cardiovascular events compared to placebo in the statin-treated patient population. Among the patients studied in REDUCE-IT, 59% had diabetes.
See Type2Nation article on REDUCE-IT Study.
“While we know that the benefits of Vascepa are not limited to people with diabetes, we are very pleased by ADA’s recognition of the importance of the REDUCE-IT study and its unprecedented outcomes by including Vascepa in the ADA Standards of Care,” said Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. “The prevalence of cardiovascular disease in people with diabetes is staggering, and we are encouraged by the ADA’s focus on reducing cardiovascular risk.”
The Standards of Care update references the drug, icosapent ethyl, studied in REDUCE-IT, which Amarin markets under the brand name, Vascepa® (icosapent ethyl) capsules. Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Amarin has commenced transmission of data to the FDA to support the submission of a supplemental new drug application (sNDA) seeking an expansion of the Vascepa FDA label based on the landmark REDUCE-IT results. Accordingly, FDA has not reviewed and opined on an sNDA related to REDUCE-IT.
Based on the results of REDUCE-IT in both primary and secondary prevention populations, the Living Standards of Care now include the recommendation that icosapent ethyl:
The ADA added that this updated finding was:
“…based on the outcome of Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT), which determined the addition of icosapent ethyl to statin therapy for patients with high triglyceride levels reduced cardiovascular events.”
The ADA standards also reiterate that:
“It should be noted that data are lacking with other omega-3 fatty acids, and results of the REDUCE-IT trial should not be extrapolated to other products.”
Cardiovascular disease is the leading cause of morbidity and mortality for individuals with diabetes, and cardiovascular disease is the cause of one in three deaths in the U.S. The ADA added that:
“Recently published research indicated an urgent need to update the 2019 Standards of Care to ensure optimal treatment recommendations for people with cardiovascular disease and diabetes.”
The findings were made with a level “A” grade of scientific evidence, which under ADA standards, reflects that REDUCE-IT was considered to be a large well-designed clinical trial. Generally, according to ADA, A level recommendations have the best chance of improving outcomes when applied to the population to which they are appropriate.
Icosapent ethyl capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. It is not fish oil but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient from degradation.
Amarin Corporation plc. is a pharmaceutical company that is focused on developing therapeutics to improve cardiovascular health. For more information about Amarin, visit www.amarincorp.com.