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Background: Results from the COORDINATE-Diabetes trial (Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes - Diabetes) demonstrated that a multifaceted, clinic-based intervention increased prescription of evidence-based medical therapies to participants with type 2 diabetes and atherosclerotic cardiovascular disease. This secondary analysis assessed whether intervention success was consistent across sex, race, and ethnicity., Methods: COORDINATE-Diabetes, a cluster randomized trial, recruited participants from 43 US cardiology clinics (20 randomized to intervention and 23 randomized to usual care). The primary outcome was the proportion of participants prescribed all 3 groups of evidence-based therapy (high-intensity statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide 1 receptor agonist) at last trial assessment (6 to 12 months). In this prespecified analysis, mixed-effects logistic regression models were used to assess the outcome by self-reported sex, race, and ethnicity in the intervention and usual care groups, with adjustment for baseline characteristics, medications, comorbidities, and site location., Results: Among 1045 participants with type 2 diabetes and atherosclerotic cardiovascular disease, the median age was 70 years, 32% were female, 16% were Black, and 9% were Hispanic. At the last trial assessment, there was an absolute increase in the proportion of participants prescribed all 3 groups of evidence-based therapy in women (36% versus 15%), Black participants (41% versus 18%), and Hispanic participants (46% versus 18%) with the intervention compared with usual care, with consistent benefit across sex (male versus female; P interaction =0.44), race (Black versus White; P interaction =0.59), and ethnicity (Hispanic versus Non-Hispanic; P interaction = 0.78)., Conclusions: The COORDINATE-Diabetes intervention successfully improved delivery of evidence-based care, regardless of sex, race, or ethnicity. Widespread dissemination of this intervention could improve equitable health care quality, particularly among women and minority communities who are frequently underrepresented in clinical trials., Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03936660., Competing Interests: Dr Tannu has received funding from the National Institutes of Health (T32HL069749). Dr Pagidipati reported receiving personal fees from Boehringer Ingelheim, Lilly, AstraZeneca, Novartis, Novo Nordisk, Merck, and CRISPR Therapeutics and receiving grants from Amgen, Novartis, Novo Nordisk, and Eggland’s Best. Dr Nelson reported receiving personal fees from Boehringer Ingelheim, AstraZeneca, Amgen, Novartis, and Sanofi. Dr McGuire reported receiving personal fees from Duke Clinical Research Institute, AstraZeneca, Novo Nordisk, Esperion Therapeutics, Lilly, CSL Behring, Afimmune, Boehringer Ingelheim, Merck, Pfizer, Bayer, Lexicon Pharmaceuticals, Altimmune, Intercept Pharmaceuticals, and Applied Therapeutics. Dr Pop-Busui reported receiving personal fees from Boehringer Ingelheim, Roche, Procter & Gamble, and Lexicon Pharmaceuticals; receiving grants from JDRF (formerly the Juvenile Diabetes Research Foundation), Novo Nordisk, and Medtronic; and being on the board of directors and president of medicine and science for the American Diabetes Association. Dr Cavender reported receiving personal fees from Duke Clinical Research Institute, Novo Nordisk, Bayer, Medtronic, Boehringer Ingleheim, Zoll, Merck, Amgen, and Edwards Lifesciences and receiving grants from AstraZeneca, Novartis, Amgen, CSL Behring, and Boehringer-Ingelheim. Dr Aroda reported receiving personal fees from Duke Clinical Research Institute, Applied Therapeutics, Pfizer, Fractyl Health, Lilly, Novo Nordisk, and Sanofi and that her spouse is an employee of Janssen Pharmaceuticals and receives salary and employee benefits. Dr Richardson reported receiving grants from Blue Cross Blue Shield of Michigan and the Nielsen Foundation and receiving personal fees from the Annals of Family Medicine for serving as a diabetes editor. Dr Lingvay reported receiving grants from Novo Nordisk, Boehringer Ingelheim, Sanofi, Structure Therapeutics, Merck, Pfizer, and Mylan and receiving personal fees from Novo Nordisk, Boehringer Ingelheim, Lilly, Sanofi, Zealand Pharma, Target RWE, Shionogi & Co, Pfizer, Johnson & Johnson, Carmot Therapeutics, Altimmune, Merck, Valeritas, Intercept Pharmaceuticals, and Bayer. Dr Al-Khalidi reported receiving personal fees from Medpace Holdings Inc and CSL Behring. T. Gaynor reported being an employee of Boehringer Ingelheim Pharmaceuticals, Inc. Dr Pak reported being an employee of Eli Lilly and Co. Dr Lopes reported receiving personal fees from Bayer, Boehringer Ingleheim, Bristol Myers Squibb, Daiichi Sankyo, GSK (formerly GlaxoSmithKline), Medtronic, Merck, Pfizer, Portola Pharmaceuticals, and Sanofi and receiving grants from Bristol Myers Squibb, GSK, Medtronic, Pfizer, and Sanofi. Dr Green reported receiving personal fees from Boehringer Ingelheim, Lilly, Bayer, Novo Nordisk, Pfizer, AstraZeneca, Sanofi, Hawthorne Effect, Omada Health, Vertex Pharmaceuticals, Valo Therapeutics, and Anji Pharmaceuticals and receiving grants from Merck, Roche, Sanofi, and Lexicon Pharmaceuticals. Dr Granger reported receiving personal fees from AbbVie, Abiomed, Alnylam Pharmaceuticals, Anthos Therapeutics, Bayer, Boston Scientific, Bristol Myers Squibb, Cardionomic, CeleCor Therapeutics, Cadrenal Therapeutics, Janssen Pharmaceuticals, Medscape, Medtronic, Merck, Novo Nordisk, Novartis, PLx Pharma, Pfizer, Philips, Reata Pharmaceuticals, and NephroSynergy; receiving grants from Bristol Myers Squibb, Janssen Pharmaceuticals, Novartis, Pfizer, and Philips; and having equity in Tenac.io. The other authors reported no conflicts. This research was made possible in part by a collaborative grant with Boehringer Ingelheim Pharmaceuticals, Inc and Lilly USA, LLC, which provided financial support for the study. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors and were fully responsible for all aspects of the trial and publication development.

Importance: Evidence-based therapies to reduce atherosclerotic cardiovascular disease risk in adults with type 2 diabetes are underused in clinical practice., Objective: To assess the effect of a coordinated, multifaceted intervention of assessment, education, and feedback vs usual care on the proportion of adults with type 2 diabetes and atherosclerotic cardiovascular disease prescribed all 3 groups of recommended, evidence-based therapies (high-intensity statins, angiotensin-converting enzyme inhibitors [ACEIs] or angiotensin receptor blockers [ARBs], and sodium-glucose cotransporter 2 [SGLT2] inhibitors and/or glucagon-like peptide 1 receptor agonists [GLP-1RAs])., Design, Setting, and Participants: Cluster randomized clinical trial with 43 US cardiology clinics recruiting participants from July 2019 through May 2022 and follow-up through December 2022. The participants were adults with type 2 diabetes and atherosclerotic cardiovascular disease not already taking all 3 groups of evidence-based therapies., Interventions: Assessing local barriers, developing care pathways, coordinating care, educating clinicians, reporting data back to the clinics, and providing tools for participants (n = 459) vs usual care per practice guidelines (n = 590)., Main Outcomes and Measures: The primary outcome was the proportion of participants prescribed all 3 groups of recommended therapies at 6 to 12 months after enrollment. The secondary outcomes included changes in atherosclerotic cardiovascular disease risk factors and a composite outcome of all-cause death or hospitalization for myocardial infarction, stroke, decompensated heart failure, or urgent revascularization (the trial was not powered to show these differences)., Results: Of 1049 participants enrolled (459 at 20 intervention clinics and 590 at 23 usual care clinics), the median age was 70 years and there were 338 women (32.2%), 173 Black participants (16.5%), and 90 Hispanic participants (8.6%). At the last follow-up visit (12 months for 97.3% of participants), those in the intervention group were more likely to be prescribed all 3 therapies (173/457 [37.9%]) vs the usual care group (85/588 [14.5%]), which is a difference of 23.4% (adjusted odds ratio [OR], 4.38 [95% CI, 2.49 to 7.71]; P < .001) and were more likely to be prescribed each of the 3 therapies (change from baseline in high-intensity statins from 66.5% to 70.7% for intervention vs from 58.2% to 56.8% for usual care [adjusted OR, 1.73; 95% CI, 1.06-2.83]; ACEIs or ARBs: from 75.1% to 81.4% for intervention vs from 69.6% to 68.4% for usual care [adjusted OR, 1.82; 95% CI, 1.14-2.91]; SGLT2 inhibitors and/or GLP-1RAs: from 12.3% to 60.4% for intervention vs from 14.5% to 35.5% for usual care [adjusted OR, 3.11; 95% CI, 2.08-4.64]). The intervention was not associated with changes in atherosclerotic cardiovascular disease risk factors. The composite secondary outcome occurred in 23 of 457 participants (5%) in the intervention group vs 40 of 588 participants (6.8%) in the usual care group (adjusted hazard ratio, 0.79 [95% CI, 0.46 to 1.33])., Conclusions and Relevance: A coordinated, multifaceted intervention increased prescription of 3 groups of evidence-based therapies in adults with type 2 diabetes and atherosclerotic cardiovascular disease., Trial Registration: ClinicalTrials.gov Identifier: NCT03936660.

Several medications that are proven to reduce cardiovascular events exist for individuals with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease, however they are substantially underused in clinical practice. Clinician, patient, and system-level barriers all contribute to these gaps in care; yet, there is a paucity of high quality, rigorous studies evaluating the role of interventions to increase utilization. The COORDINATE-Diabetes trial randomized 42 cardiology clinics across the United States to either a multifaceted, site-specific intervention focused on evidence-based care for patients with T2DM or standard of care. The multifaceted intervention comprised the development of an interdisciplinary care pathway for each clinic, audit-and-feedback tools and educational outreach, in addition to patient-facing tools. The primary outcome is the proportion of individuals with T2DM prescribed three key classes of evidence-based medications (high-intensity statin, angiotensin converting enzyme inhibitor or angiotensin receptor blocker, and either a sodium/glucose cotransporter-2 inhibitor (SGLT-2i) inhibitor or glucagon-like peptide 1 receptor agonist (GLP-1RA) and will be assessed at least 6 months after participant enrollment. COORDINATE-Diabetes aims to identify strategies that improve the implementation and adoption of evidence-based therapies., Competing Interests: Conflict of interest None reported, (Copyright © 2022 Elsevier Inc. All rights reserved.)

Multiple sodium glucose cotransporter-2 inhibitors (SGLT-2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) have been shown to impart significant cardiovascular and kidney benefits, but are underused in clinical practice. Both SGLT-2i and GLP-1RA were first studied as glucose-lowering drugs, which may have impeded uptake by cardiologists in the wake of proven cardiovascular efficacy. Their significant effect on cardiovascular and kidney outcomes, which are largely independent of glucose-lowering effects, must drive a broader use of these drugs. Cardiologists are 3 times more likely than endocrinologists to see patients with both type 2 diabetes and cardiovascular disease, thus they are ideally positioned to share responsibility for SGLT-2i and GLP-1RA treatment with primary care providers. In order to increase adoption, SGLT-2i and GLP-1RA must be reframed as primarily cardiovascular and kidney disease risk-reducing agents with a side effect of glucose-lowering. Coordinated and multifaceted interventions engaging clinicians, patients, payers, professional societies, and health systems must be implemented to incentivize the adoption of these medications as part of routine cardiovascular and kidney care. Greater use of SGLT-2i and GLP-1RA will improve outcomes for patients with type 2 diabetes at high risk for cardiovascular and kidney disease.

Introduction: Cardiovascular (CV) outcomes trial (CVOT) results have led to changes in indications for some glucose-lowering agents, with recommendations based on the presence of comorbidities., Objective: This study aimed to understand internal medicine (IM) and family medicine (FM) physicians' knowledge of CVOTs and beliefs about type 2 diabetes mellitus (T2DM) medications, excluding insulin, for CV disease risk reduction., Methods: WebMD, LLC, fielded a 23-item online survey from September 18 to 20, 2018, to 47,534 Medscape members (US IM and FM physicians) who were invited to participate via e-mail (quota = 500)., Results: Of the 702 physicians who responded, 503 were eligible and completed the survey. Overall, 39% of respondents were not familiar with the 2018 American Diabetes Association treatment recommendations for those with T2DM and atherosclerotic CV disease. Respondents reported they were most familiar with TECOS (42%), LEADER (39%), EMPA-REG OUTCOME (33%), and CANVAS (30%). Many respondents did not know which CVOT showed superiority for major adverse CV events (26%) or CV mortality (31%). When provided with a list of seven treatment priorities, 33% of respondents ranked using T2DM medications with CV benefits as least important., Conclusions: Findings from this 2018 survey suggest that there are knowledge gaps among IM and FM physicians regarding the results from CVOTs, with implications for the treatment of patients with T2DM and CV disease.

Aim: We examined eligibility and preventable cardiovascular disease events in US adults with diabetes mellitus from the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME)., Methods: We identified adults with diabetes mellitus eligible for EMPA-REG OUTCOME based on trial eligibility criteria available from the National Health and Nutrition Examination Surveys, 2007-2016. We estimated composite cardiovascular disease endpoints, as well as all-cause deaths, death from cardiovascular disease and hospitalizations for heart failure from trial treatment and placebo event rates, the difference indicating the preventable events., Results: Among 29,629 US adults aged ⩾18 years (representing 231.9 million), 4672 (27.3 million) had diabetes mellitus, with 342 (1.86 million) meeting eligibility criteria of EMPA-REG OUTCOME. We estimated from trial primary endpoint event rates of 10.5% and 12.1% in the empagliflozin and placebo groups, respectively, that based on the 'treatment' of our 1.86 million estimated EMPA-REG OUTCOME eligible subjects, 12,066 (95% confidence interval: 10,352-13,780) cardiovascular disease events could be prevented annually. Estimated annual preventable deaths from any cause, cardiovascular causes and hospitalizations from heart failure were 17,078 (95% confidence interval: 14,652-19,504), 14,479 (95% confidence interval: 12,422-16,536) and 9467 (95% confidence interval: 8122-10,812), respectively., Conclusion: Empagliflozin, if provided to EMPA-REG OUTCOME eligible US adults, may prevent many cardiovascular disease events, cardiovascular and total deaths, as well as heart failure hospitalizations.

Introduction: It is unclear whether patients and their loved ones appreciate that cardiovascular disease (CVD) is the major cause of morbidity and mortality in type 2 diabetes mellitus (T2DM). The purpose of this survey was to evaluate the degree of awareness regarding the link between T2DM and CVD., Methods: An online survey was conducted among US adults (general population) and adults with self-reported T2DM., Results: Of 13,027 participants recruited, 1505 completed the survey (12% response rate): 501 with T2DM and 1004 from the general population, of whom 364 knew someone with T2DM (e.g., partner, friend, relative, colleague: "SweetHearts"). Of those with T2DM, 52% were unaware that patients with T2DM are at increased risk of CVD and related macrovascular events. People with T2DM were more likely to be aware of the increased risk of microvascular disease (blindness [57%], nephropathy [57%], neuropathy [64%]) than macrovascular disease (myocardial infarction [41%], stroke [43%]). Despite CVD being the leading cause of death in T2DM, 67% of those with T2DM and 69% of SweetHearts were unaware of this, similar figures to those of the general population (74%). People with T2DM indicated they would take preventive measures if they were aware of their increased CVD risk: 88% would modify their diet and 81% would talk to their healthcare provider. Respondents with T2DM (73%) indicated that a desire to live longer/spend more time with family would motivate them to decrease their CVD risk., Conclusions: Findings indicate that education regarding the association between T2DM and CVD in patients and their loved ones is warranted. Plain language summary available for this article. Please see Fig. 1 and the following link: https://doi.org/10.6084/m9.figshare.7546817 ., Funding: The "For Your SweetHeart™" survey was supported by the Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance, and was developed in partnership with KRC Research.