Use of Guideline-Recommended Risk Reduction Strategies Among Patients With Diabetes and Atherosclerotic Cardiovascular Disease
2019; Lippincott Williams & Wilkins; Volume: 140; Issue: 7 Linguagem: Inglês
10.1161/circulationaha.119.041730
ISSN1524-4539
AutoresSuzanne V. Arnold, James A. de Lemos, Robert S. Rosenson, Christie M. Ballantyne, Yuyin Liu, Katherine E. Mues, Shushama Alam, Mary Elliott‐Davey, Deepak L. Bhatt, Christopher P. Cannon, Mikhail Kosiborod,
Tópico(s)Diabetes, Cardiovascular Risks, and Lipoproteins
ResumoHomeCirculationVol. 140, No. 7Use of Guideline-Recommended Risk Reduction Strategies Among Patients With Diabetes and Atherosclerotic Cardiovascular Disease Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBUse of Guideline-Recommended Risk Reduction Strategies Among Patients With Diabetes and Atherosclerotic Cardiovascular DiseaseInsights From Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) Suzanne V. Arnold, MD, MHA, James A. de Lemos, MD, Robert S. Rosenson, MD, Christie M. Ballantyne, MD, Yuyin Liu, MS, Katherine E. Mues, PhD, MPH, Shushama Alam, PharmD, Mary Elliott-Davey, MSc, Deepak L. Bhatt, MD, MPH, Christopher P. Cannon, MD, Mikhail Kosiborod, MD and On behalf of the GOULD Investigators Suzanne V. ArnoldSuzanne V. Arnold Suzanne V. Arnold, MD, MHA, Saint Luke's Mid America Heart Institute, 4401 Wornall Rd, Kansas City, MO 64111. Email E-mail Address: [email protected] Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City (S.V.A., M.K.). , James A. de LemosJames A. de Lemos Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (J.A.D.). , Robert S. RosensonRobert S. Rosenson The Cardiometabolic Disorders Unit, Icahn School of Medicine at Mount Sinai, New York (R.S.R.). , Christie M. BallantyneChristie M. Ballantyne Department of Medicine, Baylor College of Medicine and Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX (C.M.B.). , Yuyin LiuYuyin Liu Baim Institute for Clinical Research, Boston, MA (Y.L., C.P.C.). , Katherine E. MuesKatherine E. Mues Amgen Inc, Thousand Oaks, CA (K.E.M., S.A., M.E-D.). , Shushama AlamShushama Alam Amgen Inc, Thousand Oaks, CA (K.E.M., S.A., M.E-D.). , Mary Elliott-DaveyMary Elliott-Davey Amgen Inc, Thousand Oaks, CA (K.E.M., S.A., M.E-D.). , Deepak L. BhattDeepak L. Bhatt Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.L.B., C.P.C.). , Christopher P. CannonChristopher P. Cannon Baim Institute for Clinical Research, Boston, MA (Y.L., C.P.C.). Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (D.L.B., C.P.C.). , Mikhail KosiborodMikhail Kosiborod Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City (S.V.A., M.K.). The George Institute for Global Health, Sydney, Australia (M.K.). and On behalf of the GOULD Investigators Originally published7 Jun 2019https://doi.org/10.1161/CIRCULATIONAHA.119.041730Circulation. 2019;140:618–620Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: June 8, 2019: Ahead of Print Patients with atherosclerotic cardiovascular disease (ASCVD) and concomitant diabetes mellitus are at particularly high risk for new and recurrent ischemic events and heart failure, and therefore derive greater absolute benefit from secondary prevention therapies than patients without concomitant diabetes mellitus.1 Previous analyses reported suboptimal use of evidence-based therapies in this vulnerable group,1,2 but did not include data on newer lipid and glucose-lowering therapies. Given the emergence of nonstatin low-density lipoprotein–lowering agents and glucose-lowering medications with cardiovascular benefits, the number of evidence-based therapies for secondary prevention has expanded. Thus, we examined contemporary use of medications to reduce cardiovascular risk in a large cohort of US patients with diabetes mellitus and ASCVD.GOULD (Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management) is an ongoing US-based registry designed to describe longitudinal cholesterol treatment patterns among patients with ASCVD. Eligible patients had (1) ASCVD (coronary artery, cerebrovascular, or peripheral artery disease) and (2) low-density lipoprotein ≥70 mg/dL or on a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor. Patient demographics, comorbidities, medications, and laboratory data were obtained at the enrollment visit. Only baseline data were used for this analysis. The prespecified criterion for guideline-recommended optimal medical therapy among patients with diabetes and ASCVD was high-intensity statin, antiplatelet agent (or anticoagulant, excluding triple therapy), ACE-I/ARB ([angiotensin-converting enzyme-inhibitors/angiotension II receptor blockers] excluding glomerular filtration rate [GFR] <30 mL/min per 1.73m2), and (for patients with type 2 diabetes; excluding GFR 20%. Only 6.9% received therapy that met the definition of optimal medical management for secondary prevention. Rates were slightly lower among patients treated by cardiologists versus noncardiologists (5.6% versus 8.0%; P=0.057).Download figureDownload PowerPointFigure. Use of cardiovascular and glucose-lowering medications among patients with diabetes mellitus and atherosclerotic cardiovascular disease. *Components of optimal medical therapy: high-intensity statin, antiplatelet agent or anticoagulant (excluding triple therapy), ACE inhibitor or ARB (excluding glomerular filtration rate <30 mL/[min·1.73 m2]), and SGLT2 inhibitor or GLP1 receptor agonist (for type 2 diabetes mellitus; excluding glomerular filtration rate <30 mL/[min·1.73 m2]). ACE indicates angiotensin converting enzyme; ARB, angiotensin II receptor blocker; CV, cardiovascular; DPP4, dipeptidyl peptidase-4; GLP1, glucagon-like peptide 1; PCSK9, proprotein convertase subtilisin/kexin type 9; and SGLT2, sodium-glucose cotransporter-2.In summary, in a large contemporary US cohort of patients with diabetes mellitus and ASCVD, few patients received comprehensive guideline–recommended medical therapies for cardiovascular risk reduction. Although most patients were on a statin, antiplatelet agent or anticoagulant, and ACE-I/ARB, we found suboptimal use of many effective secondary prevention strategies. For example, fewer than half of patients were on a high-intensity statin, <10% were receiving ezetimibe despite low-density lipoprotein ≥70 mg/dL, <20% were prescribed glucose-lowering therapies with cardiovascular benefit, and a strikingly low proportion received a combination of all guideline-recommended risk reduction treatments.Our data confirm the slow uptake of SGLT2i and GLP-1 RAs in patients with type 2 diabetes mellitus and ASCVD, with only slightly higher use than was previously shown in a large US cohort from 2013 to 2016.4 Notably, use was markedly higher for sulfonylureas and dipeptidyl peptidase-4 inhibitors, agents with (at best) neutral cardiovascular impact. Although key cardiovascular outcomes trials were published in 2015 to 2017,3 changes to guidelines and medication indications lagged somewhat, which could explain some of the delay in uptake of these effective medications. Furthermore, despite trial evidence demonstrating efficacy of ezetimibe for event reduction in patients after acute coronary syndromes, particularly those with diabetes mellitus,5 ezetimibe was used less frequently than fibrates and fish oil—agents with weak evidence of benefit (except in the case of markedly elevated triglycerides; at least at the time of this study).Importantly, because we were unable to account for intolerance, contraindications, or other barriers to optimal medical therapy, these findings should not automatically be considered inappropriate care. For example, costs can be an important barrier to the use of SGLT2i, GLP-1 RAs, and PCSK9i. However, we also found that inexpensive medications such as aspirin, high-intensity statins, ezetimibe, and metformin were also suboptimally prescribed. In addition to multiple trials showing substantial reductions in ischemic events, heart failure, and cardiovascular mortality with the individual classes of agents that contributed to our composite definition of optimal secondary prevention, observational analyses have also estimated an ≈50% lower relative risk of mortality with combinations of these therapies in patients with ASCVD.1,2 Thus, our findings highlight a critical opportunity to improve care and outcomes in these high-risk patients.In conclusion, in a large contemporary multicenter cohort, we found suboptimal rates of use of secondary prevention therapies in high-risk patients with diabetes mellitus and ASCVD, particularly with high-intensity statins and glucose-lowering therapies with proven cardiovascular benefit. Given the high cardiovascular event rates in this patient population, improving use of these guideline-recommended therapies is an important potential opportunity to improve care and, in turn, reduce the risk of recurrent ASCVD events, heart failure hospitalizations, and cardiovascular mortality.Sources of FundingThe GOULD study is funded by Amgen. The coauthors from Amgen reviewed and edited the manuscript for intellectual content; however, the sponsors of the study had no role in the final review and approval of the manuscript for submission.DisclosuresDr de Lemos reports consulting income from Amgen, Regeneron, Janssen, Esperion, and Novo Nordisc. Dr Rosenson reports research grants from Akcea, Amgen, AstraZeneca, Medicines Company and Regeneron; consulting honorarium from Akcea, C5, CVS Caremark; honoraria from Amgen, Kowa and Pfizer; royalties from UpToDate, Inc; and stock ownership in MediMergent, LLC. Dr Ballantyne reports research grants (all paid to institution) from Abbott Diagnostic, Akcea, Amgen, Esperion, Novartis, Regeneron, Roche Diagnostic, Snaofi-Synthelabo, NIH, AHA, ADA; and consulting income from Abbott Diagnostics, Akcea, Amarin, Amgen, Arrowhead, Astra Zeneca, Boehringer Ingelhein, Denka Seiken, Esperion, Intercept, Janssen, Matina BioPharma Inc, Merck, Novartis, Regeneron, Roche Diagnostic, Sanofi-Synthelabo. Drs Mues, Alam, and Elliot-Davey are employed by Amgen. Dr Bhatt reports participation on the Advisory Boards of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, Regado Biosciences; the Board of Directors for the Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair of the American Heart Association Quality Oversight Committee; Data Monitoring Committees of the Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; honoraria of the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Medtelligence/ReachMD (CME steering committees), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national coleader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); and Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), and VA CART Research and Publications Committee (Chair). Dr Bhatt also reports research funding from Abbott, Amarin, Amgen (including for his role on the Steering Committee of GOULD), AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Idorsia, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; and reports receiving royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease). Dr Bhatt is also a site coinvestigator for Biotronik, Boston Scientific, St Jude Medical (now Abbott), Svelte; a trustee for the American College of Cardiology; and reports unfunded research for FlowCo, Fractyl, Merck, Novo Nordisk, PLx Pharma, Takeda. Dr Cannon reports research grants from Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Janssen, Merck; consulting fees from Aegerion, Alnylam, Amarin, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb, Corvidia, Eisai, Innovent, Janssen, Kowa, Merck, Pfizer, Regeneron, Sanofi. Dr Kosiborod reports research grants from AstraZeneca, Boehringer Ingelheim; other research support from AstraZeneca; and consulting honoraria from Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Amgen, GSK, Merck (Diabetes), Eisai, Intarcia, Novartis, and Glytec The other authors report no conflicts.FootnotesGuest Editor for this article was Michael D. Shapiro, MD.https://www.ahajournals.org/journal/circData sharing: The data that support the findings of this study and research materials, as well as experimental procedures and protocols, are available from the corresponding author upon reasonable request.Suzanne V. 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