Type 2 Diabetes Risk Management Guidelines Are Not Reflected in US Practices

Jennifer Green, MD

The American Diabetes Association (ADA) Standards of Medical Care, a living document on evidence-based treatment of diabetes and comorbid risks since 2018, received updates this year that reflect the increasingly comprehensive care provided by SGLT-2 inhibitors and GLP-1 agonists.

Just as importantly, Jennifer Green, MD, explained, they still require a greater adoption by all relevant prescribers in the US.

In a presentation at The Metabolic Institute of America’s (TMIOA) 2021 Heart in Diabetes sessions in New York, NY this weekend, Green, Professor of Medicine at Duke University Medical Center’s Division of Endocrinology, Metabolism and Nutrition, highlighted key 2020 additions to the ADA Standards of Medical Care document—headlined by the strengthened advocacy of SGLT2 inhibitor and GLP-1 agonist use in high-risk patients with type 2 diabetes (T2D), regardless of their glucose-lowering needs and metformin use.

Though metformin remains the recommended initial pharmacologic agent for T2D, early combination therapy with an evidenced agent should be considered for severely hyperglycemic patients.

Other high-risk categories were better defined for providers treating T2D who may be adding SGLT2 inhibitors or GLP-1 agonists: atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), or chronic kidney disease (CKD). Though previous guidance have recommended combination therapy for patients at such risk, few had stratified the risks in such a way. As Green said, “We tried to be a little more directive.”

The 2021 updates also provided guidance for initiating SGLT2 inhibitors in patients with T2D who don’t have HF but may nonetheless benefit from the drug class’ risk-reducing properties, with Green noting these patients “now have a home” in guideline categorization.

SGLT2 inhibitors or GLP-1 agonists are now recommended in:

• Patients with T2D who have established ASCVD or kidney disease, to reduce comprehensive cardiovascular disease risk and manage glucose levels.
• Patients with T2D who have established ASCVD, multiple risk factors for ASCVD or diabetic kidney disease, for reduced risk of major adverse cardiovascular events (MACE) or HF hospitalization.

As Green noted, patients with ASCVD and/or CKD may be progressed toward the recommended regimen differently, but the intent remains the same.

These new recommendations would implicate a significantly greater rate of US patients being eligible for multi-drug management of T2D and concurrent disease risks than is currently being actually treated. Green cited Duke colleagues’ assessment of the 2021 ADA guideline updates, as applied to a primary care electronic health record database. The findings identified approximately one-third of all observed primary care patients with T2D met criteria for SGLT2 inhibitor and GLP-1 agonist use based on the recommendations.

“That is an enormous percentage and an enormous number if applied to the entire country,” Green said.

However, real-world application paces significantly behind. A query of pharmacy and medical claims data from within Anthem identified 155,958 patients with T2D and established ASCVD. Duke investigators sought the proportion of such patients to treat their disease with any of the following regimen: high-intensity stain, ACE inhibitors or angiotensin receptor blockers, and SGLT2 inhibitors or GLP-1 agonists.

They found that 37.4% of patients were on none, 40.7% were on 1 therapy, 19.4% were on 2, and just 2.7% on all 3. Among patients prescribed SGLT2 inhibitors or GLP-1 agonists, a significant proportion were at lower risk of cardiovascular or renal outcomes than other eligible patients, Green noted.

Green stressed in her presentation that this data were US-based, insured patients who would have fewer barriers to high-cost regimens than others. She concluded her presentation with a call for “more overlap and shared responsibility” of stakeholders impacted by these guideline updates: primary care physicians, diabetologists, and cardiologists.

“Many people have clear indications for these newer drugs, but implementation remains inadequate, and there’s quite a lot of work to be done,” she said.

The Standards of Medical Care in Diabetes—2021 guideline and resources are available to view here.