The American Diabetes Association update has recommendations that affect liraglutide, canagliflozin, and empagliflozin.
Recommendations from the American Diabetes Association (ADA) now give physicians guidance on diabetes drugs that reduce the risk of heart attacks and strokes, in light of the wave of clinical trials since 2015 that have shown some glucose-lowering therapies can offer cardiovascular benefits for high-risk patients.
Changes to the Standards of Diabetes Care for 2018 reflect recent FDA action on key diabetes technology, advise doctors to personalize treatment for older adults, and urge pregnant women with diabetes take low-dose aspirin after the first trimester to prevent preeclampsia.
The 2018 Standards may be just as notable for what they don’t change: the ADA held firm with its recommendation that most people with diabetes should be treated to a blood pressure goal of <140/90 mm Hg. Last month, the American College of Cardiology (ACC) and American Heart Association (AHA) revised their guidelines, and stage 1 hypertension now starts 130/80 mm Hg, down from 140/90 mm Hg.
The ADA noted it had just updated its recommendations on hypertension treatment in late August, and added a new algorithm for treating hypertension to the 2018 Standards.
In a statement, the ADA said it would update the Standards online throughout the year to keep pace with new evidence. “Since 1989, the American Diabetes Association has provided annual updates to the Standards of Care, and the Standards are accepted as the global standard for diabetes care. As new technology, research and treatments continue to improve and emerge, we are pleased that we will have the capacity to provide real-time updates to the Standards of Care throughout the year,” said ADA’s Chief Scientific, Medical and Mission Officer William T. Cefalu, MD, in the statement.
Key changes to the standards include:
Therapy for CV treatment
Changes for treating adults with type 2 diabetes (T2D) reflect results from cardiovascular outcomes trials since 2015. Four approved therapies have demonstrated cardiovascular (CV) benefits in clinical trials: 2 glucagon-like peptide-1 (GLP-1) receptor agonists from Novo Nordisk, liraglutide (Victoza) and the just-approved semaglutide (Ozempic) and the sodium glucose co-transporter-2 (SGLT2) inhibitors canagliflozin (Invokana, Janssen) and empagliflozin (Jardiance, Eli Lilly/Boehringer-Ingelheim). FDA has granted CV indications for liraglutide and empagliflozin, and canagliflozin has filed for an indication.
The updated standards say that patients with T2D and established atherosclerotic cardiovascular disease (ASCVD) should start lifestyle management and metformin, and then “incorporate an agent proven to reduce major adverse cardiovascular events and cardiovascular mortality (currently empagliflozin and liraglutide), after considering drug-specific and patient factors.”
The standards further state that for this group of patients, “canagliflozin may be considered to reduce major adverse cardiovascular events, based on drug-specific and patient factors.”
Use of CGM
The ADA added language about “flash” continuous glucose management technology that was approved in late September (Abbott’s Freestyle Libre), as well a new FDA indication for the Dexcom G5 CGM that allows dosing without a blood glucose test. CGM is recommended for adults with type 1 diabetes is now recommended to adults age 18 and over not meeting glycemic targets; the previous recommendation was age 25 and older.
Blood pressure monitoring and treatment
The ADA Standards state that clinical show “unequivocally” that treating BP to <140/90 mmHg reduces cardiovascular events as well as microvascular complications. However, the recommendation notes that a lower goal, of <130/80 or <120/80 mmHg “may be beneficial for selected patients with diabetes such as those with a high risk of cardiovascular disease. Such intensive blood pressure control has been evaluated in large randomized clinical trials and meta-analyses of clinical trials.”
The Standards say the ACCORD BP results offer the strongest evidence that the <140/90 mmHg goal is fine for most patients with diabetes. As for other trials, including SPRINT—which largely drove the most recent ACC/AHA guidelines—the “relevance of their results to people with diabetes is less clear.”
The ADA agreed with ACC/AHA that patients with hypertension should take their blood pressure at home to identify “white coat” syndrome, and to boost medication adherence. A new recommendation calls for considering a mineralcorticoid receptor agonist therapy in patients with resistant hypertension.
Language was updated to distinguish between patiepatients with ASCVD and primary prevention patients. The Standards discuss the use of statins for patients with diabetes as well as clinical trials involving non-statin agents: ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, and cholesteryl ester transfer protein (CETP) inhibitors. Recommendations incorporated results from the FOURIER (for the PCSK9 inhibitor evolocumab) and REVEAL trials (for the CETP inhibitor anacetrapib.)
Screening children and teens
The ADA calls for testing those younger than 18 for prediabetes and T2D if they are overweight or obese, using body mass index (BMI) above the 85th percentile for their age and gender, as initial screening criteria. Family history, a mother’s history of gestational diabetes, being a member of certain minority groups, or having other conditions associated with insulin resistance (listed in the Standards) would be other screening criteria.
The section on treating older adults emphasizes the need to tailor treatment goals to individual needs, particularly the need to avoid hypoglycemia. In 3 new recommendations, the ADA focuses on prescribing medication that (1) presents the lowest hypoglycemia risk, (2) avoids overtreatment of diabetes, and (3) keeps regimens simple. This aids the patient's adherence and holds down costs, the recommendations note.