Protocol Optimizing Meds for T2D and CVD Pushed Beyond Cardiology Alone

SAN DIEGO — Cardiovascular medications were better optimized for patients with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) following a multifaceted intervention involving clinician and patient education, the cluster-randomized COORDINATE-Diabetes trial found.

At cardiology clinics following the intervention protocol, prescriptions increased several-fold compared with usual care (37.9% vs 14.5%; adjusted OR 4.28, 95% CI 2.49-7.71) for patients not already on three evidence-based therapies: high-intensity statins, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), and SGLT2 inhibitors or GLP-1 receptor agonists (RAs).

Prescription of each individual therapy was also consistently higher in the intervention group compared with the usual care group:

• High-intensity statins: 70.7% vs 56.8% (adjusted OR 1.73, 95% CI 1.06-2.83)
• ACE inhibitor/ARB: 81.4% vs 68.4% (adjusted OR 1.82, 95% CI 1.14-2.91)
• SGLT2 inhibitor or GLP-1 RA: 60.4% vs 35.5% (adjusted OR 3.11, 95% CI 2.08-4.64)

Cardiologists Neha Pagidipati, MD, MPH, and Christopher Granger, MD, both of Duke Clinical Research Institute in Durham, North Carolina, detailed the trial’s findings at the American Diabetes Association (ADA) Scientific Sessions. The main report had been presented in March at the American College of Cardiology meeting and published simultaneously in JAMA at the time.

During the ADA session, COORDINATE-Diabetes co-investigator Ildiko Lingvay, MD, MPH, a diabetes specialist at the University of Texas Southwestern Medical Center in Dallas, stressed that the intervention can be extrapolated to any specialty and highlighted from an endocrinologist’s perspective that there’s still a long way to go for caring for this patient population.

In COORDINATE-Diabetes, 62% of people in the intervention group were still not receiving optimal therapy.

Although shown to improve health outcomes for patients with T2D and ASCVD, the medication types targeted in the trial are generally under-prescribed. Previous research showed that only approximately 2.7% of eligible patients are currently on all three forms of therapy, while 37.4% receive none.

“There is nothing more important now in all of medicine to improve the health of our patients than to more effectively implement what we know is effective,” said Granger, lamenting that treatments shown to better outcomes in high-quality randomized trials are only used appropriately 25% to 50% of the time in populations who stand to benefit.

Lingvay stressed multidisciplinary collaboration, as active communication between members of a patient’s care team — comprising cardiologists, endocrinologists, or others involved — and group support will lead to the best outcomes for the patient. “Everyone involved in the care of these patients is responsible for ensuring best-care practices are followed,” she said. “It’s your patient, it’s our patient. We need to do the right thing for our patients.”

Nevertheless, COORDINATE-Diabetes had been conducted solely at cardiology clinics because people with T2D and ASCVD are five to six times more likely to see a cardiologist than they are to see an endocrinologist, according to Pagidipati and collaborators. Participating clinics needed to have at least three cardiology providers and needed to be able to identify one or more local diabetes specialists as a potential collaborator for patients.

Testing in the study was a multifaceted approach tailored to each site and consisting of three main parts: assessment of each site and the unique barriers and issues it faces (e.g., access to care, inadequate support structures, and educational gaps), development of possible strategies to meet each site’s needs, then a final audit and feedback process to measure the success of the intervention.

The 43 participating cardiology clinic sites across the U.S. were split between 20 receiving the full intervention and 23 sites proceeding with usual care under professional guidelines.

In order to be included in the study, patients needed to have a T2D diagnosis, as well as a history of either coronary artery disease, peripheral arterial disease, or cerebrovascular disease. At each site, an average of 24 patients were enrolled as participants in the trial.

The cohort was over two-thirds men and Black participants made up approximately 16% of the patient population. More than 75% of individuals had a history of coronary heart disease.

A major limitation of COORDINATE-Diabetes is its uncertain representativeness of the U.S. or international population. Also of note were disruptions from the COVID-19 pandemic, which forced interventions to be administered remotely and perhaps not as intensely as originally intended.