The American Diabetes Association (ADA) has updated the Standards of Medical Care in Diabetes for 2019 based on recently published research.
One update reflects data from the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT) cardiovascular outcomes study (N=8179). Icosapent ethyl capsules (Vascepa; Amarin) are currently approved as adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (≥500mg/dL). The REDUCE-IT trial evaluated the effect of icosapent ethyl as add-on therapy to statins in patients with high cardiovascular risk who, despite stable statin therapy, had elevated triglycerides.
Section 10 of the Standards of Care now states that for both primary and secondary prevention populations, icosapent ethyl should “…be considered for patients with diabetes and atherosclerotic cardiovascular disease (ASCVD) or other cardiac risk factors on a statin with controlled low-density cholesterol (LDL-C), but with elevated triglycerides (135-499) to reduce cardiovascular risk (Level A recommendation).” This update reflects results from REDUCE-IT where the addition of icosapent ethyl to statin therapy in patients with high triglycerides lowered cardiovascular events; a statistically significant 30% risk reduction in total cardiovascular events was seen vs placebo in statin-treated patients.
As data are inadequate with other omega-3 fatty acid products, the Standards state that data from REDUCE-IT trial “should not be extrapolated to other products.”
Sections 9, 10, and 11 were also revised based on data from the Dapagliflozin Effect on Cardiovascular Events-Thrombosis in Myocardial Infarction 58 (DECLARE-TIMI 58) Trial where dapagliflozin demonstrated a reduction of hospitalization for heart failure and a reduction in progression of chronic kidney disease. Dapaliglflozin (Farxiga; AstraZeneca) is currently approved as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The Standards of Care provide evidence-based recommendations for the diagnosis and treatment of children and adults with type 1, type 2, or gestational diabetes; strategies to improve the prevention of delay of type 2 diabetes; and therapeutic approaches that reduce complications and positively affect health outcomes.
For more information visit care.diabetesjournals.org.