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ADA updates Standards of Care to reflect REDUCE-IT, DECLARE-TIMI 58 findings
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The American Diabetes Association on Wednesday issued revisions to its 2019 Standards of Medical Care in Diabetes to reflect findings from two recent large randomized controlled trials that included adults with type 2 diabetes and established cardiovascular disease.
The revised standards now recommend that icosapent ethyl (Vascepa, Amarin) be considered to reduce CV risk for patients with diabetes who have atherosclerotic CVD or other CV risk factors and who are prescribed a statin and have controlled LDL cholesterol but persistently elevated triglycerides. The recommendation is based on findings from the REDUCE-IT trial, which found that icosapent ethyl was superior to placebo for reducing risk for ischemic events in patients with elevated triglycerides at high CV risk despite statin therapy. The findings were presented at the American Heart Association (AHA) Scientific Sessions in November and reported by Healio.com.
Three sections of the standards have also been revised based on findings from DECLARE-TIMI 58, a randomized controlled trial of more than 17,000 patients with type 2 diabetes and atherosclerotic CVD. In that study, also presented at AHA in November, researchers found that the SGLT2 inhibitor dapagliflozin (Farxiga, AstraZeneca), when compared with placebo, was associated with reduced hospitalization for heart failure as well as a reduction in progression of chronic kidney disease.
In February, the FDA approved a label update for dapagliflozin, expanding its use for patients with type 2 diabetes and moderate renal impairment. As Endocrine Today previously reported, the expanded indication is intended for both dapagliflozin and dapagliflozin plus metformin extended-release (Xigduo XL, AstraZeneca) and lowers the estimated glomerular filtration rate threshold to 45 mL/min/1.73 m², indicating moderate CKD, from 60 mL/min/1.73 m².
Based on that label update, the Standards of Care updates reflect the lower eGFR.
“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, chief scientific, medical and mission officer for the ADA, said in the 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.”
The ADA now updates and revises the online version of the Standards of Care throughout the year, with annotations for new evidence or regulatory changes that merit immediate incorporation. The online version of the Standards of Care will include any research updates or policy changes that are approved throughout 2019. Updates to the Standards of Care are established and revised by the ADA’s Professional Practice Committee, a multidisciplinary team of 14 U.S. experts in the field of diabetes care, including physicians, diabetes educators, registered dietitians and others whose experience includes adult and pediatric endocrinology, epidemiology, public health, lipid research, hypertension, preconception planning and pregnancy care.
For the 2019 Standards of Care, two designated representatives from the American College of Cardiology (ACC) reviewed, provided feedback and endorsed the recommendations for CVD and risk management on behalf of the ACC.
The Living Standards of Care are available online at Diabetes Care. – by Regina Schaffer
For more information:
ADA Standards of Medical Care in Diabetes 2019. Available at: http://care.diabetesjournals.org/content/42/Supplement_1. Accessed March 27, 2019.
Disclosure: Cefalu is chief scientific, medical and mission officer for the ADA.
Perspective
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Osama Hamdy, MD, PhD, FACE
These changes are welcome and indicate how the ADA is keen to improve the life of our patients with diabetes based on high-quality randomized clinical trials.
Today, we have better tools to identify patients at higher CV risk, and we have many medications that are proven to reduce CV events, CV mortality and hospitalization for congestive heart failure. What is good about these recommendations is that they are very specific, which makes them practical.
For a long time, we have had only a few antihypertensive medications that slow the progression of chronic kidney disease. Adding dapagliflozin to that list, based on the powerful results of the DECLARE-TIMI 58 study, is giving our patients another option, especially considering that it is already an approved antidiabetes medication. The 30-day readmission rate for congestive heart failure is one of the major burdens on health care costs for patients with diabetes — 43% of diabetes costs are spent in hospitals — so the new recommendations are also welcome for that reason.
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