COORDINATE-Diabetes: a 'Wake-Up Call' for Many Specialties

Miriam E. Tucker

July 03, 2023

SAN DIEGO ― Prescribing optimal medical therapy for people with both type 2 diabetes and cardiovascular disease can and should improve, speakers urged at the recent American Diabetes Association (ADA) 83rd Scientific Sessions.

A symposium there focused on the recent randomized, controlled COORDINATE-Diabetes trial, which investigated a multipronged educational intervention in 43 US cardiology clinics aimed at improving prescribing of guideline-recommended treatments for people with both type 2 diabetes and cardiovascular disease. Compared to clinics that were randomly assigned to offer usual care, the intervention significantly increased recommended prescribing of high-intensity statins, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), and sodium-glucose cotransporter 2 (SGLT2) inhibitors and/or glucagon-like peptide 1 receptor agonists (GLP-1 agonists).

COORDINATE-Diabetes was aimed at cardiologists, who typically see these patients more often than do endocrinologists. However, the results are relevant to all healthcare providers involved in the care of those with type 2 diabetes, speakers argued at the ADA symposium.

"This is a cardiology study. I think it's safe to say that not too many of you in the room are cardiologists. So why would you care about the results of the COORDINATE study?" said Ildiko Lingvay, MD, of the University of Texas Southwestern Medical Center, Dallas.

Linvay went on to outline reasons that the COORDINATE findings apply to endocrinologists and primary care clinicians, as well as cardiologists. For one, a study from her institution that was presented at a recent internal medicine meeting showed that among more than 10,000 patients with type 2 diabetes and cardiovascular disease, heart failure, and/or chronic kidney disease, the proportion of patients who were prescribed the appropriate guideline-indicated medications was 20.1% for those seen in primary care, 24.8% in endocrinology, 20.3% in cardiology, and 18.3% in nephrology.

"So, we [endocrinologists are] not that much better [than other specialties]" at prescribing, she noted.

Mikhail N. Kosiborod, MD, in independent commentary called the COORDINATE trial and other similar initiatives "the beginning of care transformation."

The COORDINATE-Diabetes results were originally presented in March at the joint scientific sessions of the American College of Cardiology and the World Heart Federation and were reported by Medscape. The study was simultaneously published in JAMA.

"They've Shown We Can Do Better"

Asked to comment, Robert H. Eckel, MD, told Medscape, "I look at COORDINATE as a wake-up call to the need for multispecialty approaches to people with type 2 diabetes and cardiovascular disease.... I think it's a step in the door."

Eckel, who has long advocated for a new "cardiometabolic" physician subspecialty, noted that COORDINATE-Diabetes "stopped short of training healthcare providers in the science and medicine of cardio-renal-metabolic disease."

Nonetheless, regarding the efforts toward a more coordinated system of care, Eckel said, "I support the concept, unequivocally." He is associated with the Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Center, University of Colorado, Denver.

But the cost-effectiveness of the intervention "requires time to assess," he added. "We don't know anything yet other than [that] managing drug administration to meet goals that relate to outcomes in people with diabetes can be accomplished. They've shown that we can do better."

Why Should You Care About a Cardiology Study?

In COORDINATE-Diabetes, 20 of the centers were randomly assigned to provide five interventions: assess local barriers, develop care pathways, coordinate care, educate clinicians, report data back to the clinics, and provide tools for the 459 participants. The other 23 clinics, with 590 participants, were randomly assigned to provide usual care per practice guidelines.

The primary outcome was the proportion of participants that prescribed all three groups of the recommended therapies at 6 to 12 months after enrollment; 37.9% presribed the intervention, and 14.5% provided usual care, a significant 23% difference (P < 0.001). The rate of prescriptions of each of the three individual drug groups was also significantly higher with the intervention. No differences were seen in cardiovascular risk factors or outcomes.

Lingvay pointed out that the interventions tested in COORDINATE ― such as fact sheets and medication passports for patients, system audits and feedback, and provider grand rounds ― can be extrapolated to any specialist setting.

She added that the long-held model of team-based care means that "everyone involved in the care of these patients is responsible for ensuring best practices are followed." Part of that, she said, is helping other specialists prescribe the same medications and communicate across the team.

For all specialists, she recommends using the resources available on the COORDINATE website.

"It's Not a Silver Bullet; Additional Solutions Are Needed"

In his commentary, Kosiborod, executive director of the Cardiometabolic Center Alliance, noted, "The treatments studied in COORDINATE represent the biggest advances in a generation when it comes to improving outcomes in this population.... We're living in a renaissance age with the number of tools we have available.... It's getting better every day."

Moreover, all the relevant professional society guidelines now recommend GLP-1 agonists and SGLT2 inhibitors. "And yet, when we look, less than 1 in 10 patients with type 2 diabetes and atherosclerotic cardiovascular disease are getting appropriate recommended care. One of the lessons of COORDINATE is that this needs to change if we're really going to improve our patients' lives."

The barriers aren't simply financial, Kosibrod said. He pointed to two studies that show that even reducing out-of-pocket costs resulted in only modest increases in adherence.

Educational gaps on the part of both clinicians and patients also factor in, as do misaligned incentives.

"Clinicians get paid for how many things they do, not necessarily how well they do them. Everyone wants to do the right thing, but ultimately, incentives do matter," he emphasized.

While the COORDINATE-Diabetes interventions addressed several of the barriers, two thirds of the participants still did not receive optimal therapy.

"It's not a silver bullet.... Additional solutions are needed," Kosiborod observed.

Transformation Occurs "When the Status Quo Is No Longer Acceptable"

Enter his institution, the Cardiometabolic Center Alliance, part of Saint Luke's Mid-America Heart Institute. The nonprofit system, which currently has 16 subscribing clinics around the country, offers patient-centered "team-based, coordinated, comprehensive care" for people with both type 2 diabetes and cardiovascular disease.

The model is led by preventive cardiology in collaboration with endocrinology and primary care. Support staff includes advance practice providers, nurse navigators, certified diabetes educators, dieticians, and pharmacists. Individualized treatment plans aim for "aggressive secondary risk reduction," Kosirobod noted.

Six-month data from the Cardiometabolic Center Alliance show an increase from 28.2% at baseline to 67.1% (P < .0001) in prescribing of a four-agent guideline-directed medical therapy "bundle," including the three from COORDINATE-Diabetes plus an antiplatelet or anticoagulant agent. Kosiborod presented these data during the ADA meeting in a poster.

Remaining questions involve sustainability, scalability, and system transformation, which require buy-in from multiple stakeholders, he noted.

He contends that it can be done. A prior example of "rapid and lasting care transformation" occurred in November 2006 with the launch of the "Door to Balloon (D2B) Alliance for Quality," which dramatically increased the proportion of patients who received primary angioplasty within 90 minutes at hospitals around the US. From January 2005 to September 2010, those proportions rose from 27.3% to 70.4%.

"Patients were coming into the emergency department with myocardial infarctions and waiting for hours before the interventional cardiologist came. The community said we needed a nationwide quality improvement initiative.... Almost every hospital in the country changed their systems of care. It was a huge national effort.... When we no longer consider the status quo acceptable, we can actually make something very special happen very quickly."

After the session, Kosiborod told Medscape that the Cardiometabolic Center Alliance is now gathering data to make the financial case for the approach.

"We're trying to develop a model that tells the admins which patients will save money, because, of course, if you can create a financial incentive, it only makes it go faster... We want to synchronize it in the best way possible."

Lingvay has receiving nonfinancial support and grants from Novo Nordisk, personal fees or nonfinancial support from Sanofi, Lilly, Boehringer Ingelheim, Merck/Pfizer, Mylan, AstraZeneca, Johnson & Johnson, Intercept, Target Pharma, Zealand, Shionogi, Carmot, Structure, Bayer, Mediflix, WebMD, GI Dynamics, Intarcia Therapeutics, Mannkind, Novartis, Structure Therapeutics, and Valeritas. Kosiborod is a consultant for Alnylam Pharmaceuticals, Inc, Amgen Inc, Applied Therapeutics Inc, AstraZeneca, Bayer Inc, Boehringer Ingelheim Inc, Cytokinetics Inc, Dexcom, Inc, Eli Lilly and Company, ESPERION Therapeutics, Inc, Janssen Pharmaceuticals, Inc, Lexicon Pharmaceuticals, Inc, Merck & Co, Inc, Novo Nordisk, Pharmacosmos A/S, Pfizer Inc, Sanofi, Vifor Pharma Management Ltd, and Youngene Therapeutics. He also receives research support from AstraZeneca and Boehringer Ingelheim Inc. Eckel serves on consulting/advisory boards for Amgen, Arrowhead, Better Co., Ionis, Kowa, Lexicon, Novo Nordisk, Precision BioSciences, The Healthy Aging Co, Tolmar, and Weight Watchers.

American Diabetes Association (ADA) 83rd Scientific Sessions: Poster presented June 25, 2023.

Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.

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