In December 2018, the American Diabetes Association (ADA) published its yearly version of Standards of Medical Care in Diabetes. The publication provides comprehensive coverage of clinical guidelines and treatment recommendations with a target audience that includes physicians, researchers, patients, and payers.
The 2019 update was significant in that it was the first time that Section 10, which covers cardiovascular disease and risk management, was endorsed by the American College of Cardiology (ACC). Over time, hyperglycemia can damage the arteries, cause atherosclerosis, and lead to heart failure, myocardial infarction or stroke. As such, the changes made to Section 10 of the updated version are an important step forward in addressing cardiovascular (CV) risk, which is a largely unresolved issue in patients living with diabetes.
The Section 10 update has had multiple additions and revisions. This included additional information pertaining to diabetics with heart failure as well as recommendation updates for blood pressure and the use of aspirin in primary prevention. Information regarding the use of the ACC’s atherosclerotic cardiovascular disease (ASCVD) risk calculator for the assessment of 10-year ASCVD risk was also added. Recommendations for drugs that provide CV benefit in patients with ASCVD, with or without heart failure, were also added. Additionally, it includes updates regarding the use of glucagon-like peptide 1 (GLP-1) receptor agonists and sodium–glucose cotransporter 2 (SGLT-2) inhibitors, both of which are anti-diabetic drug classes that have been proven to confer CV benefits.
It is well known that diabetes increases the risk of CV comorbidities. GlobalData’s epidemiologists observed that around a third of diabetes patients in the US and Europe have CV disease. In 2008, the FDA recommended that upcoming treatments for type 2 diabetes (T2D) should provide evidence that the therapy will not increase the risk of CV events. In October, an FDA advisory panel narrowly voted to keep the mandate requiring T2D drug manufacturers to perform randomized CV safety outcomes trials. The newly published 2019 Standards of Medical Care in Diabetes corroborates the initiatives being made on the regulatory front in order to reduce mortality and improve the quality of life of diabetic patients with or at risk of CV disease.