Effect of Liraglutide on Cardiovascular Outcomes in Elderly Patients: A Post Hoc Analysis of a Randomized Controlled Trial

Abstract

Letters19 March 2019Effect of Liraglutide on Cardiovascular Outcomes in Elderly Patients: A Post Hoc Analysis of a Randomized Controlled TrialMatthew P. Gilbert, DO, MPH, Stephen C. Bain, MD, Edward Franek, MD, PhD, Esteban Jodar-Gimeno, MD, PhD, Michael A. Nauck, MD, Richard Pratley, MD, Rosângela Roginski Réa, MD, José Francisco Kerr Saraiva, MD, PhD, Søren Rasmussen, MSc, PhD, Karen Tornøe, MD, PhD, Bernt Johan von Scholten, MD, DMSc, and John B. Buse, MD PhD, and the LEADER Publication Committee on behalf of the LEADER Trial Investigators*Matthew P. Gilbert, DO, MPHLarner College of Medicine at The University of Vermont, South Burlington, Vermont (M.P.G.), Stephen C. Bain, MDInstitute of Life Science, Swansea University Medical School, Singleton Hospital, Swansea, United Kingdom (S.C.B.), Edward Franek, MD, PhDMossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland (E.F.), Esteban Jodar-Gimeno, MD, PhDQuirónsalud Madrid and Ruber Juan Bravo University Hospitals, Universidad Europea de Madrid, Madrid, Spain (E.J.), Michael A. Nauck, MDDiabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University of Bochum, Bochum, Germany (M.A.N.), Richard Pratley, MDFlorida Hospital Diabetes Institute, Florida Hospital Translational Research Institute for Metabolism and Diabetes, Orlando, Florida (R.P.), Rosângela Roginski Réa, MDHospital de Clínicas da Universidade Federal do Paraná, Curitiba, Brazil (R.R.R.), José Francisco Kerr Saraiva, MD, PhDPontifícia Universidade Católica de Campinas, Campinas, Brazil (J.F.K.), Søren Rasmussen, MSc, PhDNovo Nordisk A/S, Søborg, Denmark (S.R., K.T., B.J.V.), Karen Tornøe, MD, PhDNovo Nordisk A/S, Søborg, Denmark (S.R., K.T., B.J.V.), Bernt Johan von Scholten, MD, DMScNovo Nordisk A/S, Søborg, Denmark (S.R., K.T., B.J.V.), and John B. Buse, MD PhDDiabetes Center, University of North Carolina School of Medicine, Chapel Hill, North Carolina (J.B.B.), and the LEADER Publication Committee on behalf of the LEADER Trial Investigators*Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-1569 SectionsSupplemental MaterialAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: Comorbidities and complications associated with type 2 diabetes mellitus (T2DM) increase with age, making treatment of elderly persons with this condition challenging. Clinical data on the effect of antihyperglycemic treatment on cardiovascular (CV) events in elderly persons are limited (1). The U.S. Food and Drug Administration and European Medicines Agency recommend collecting comprehensive data on elderly patients with diabetes, particularly those aged 75 years or older, to inform appropriate treatment of this growing population (2, 3).Glucagon-like peptide-1 agonists are among the newer classes of antihyperglycemic agents recommended to treat T2DM because they have high glycemic efficacy and low ...References1. American Diabetes Association. 11. Older adults: standards of medical care in diabetes—2018. Diabetes Care. 2018;41:S119-25. [PMID: 29222382] doi:10.2337/dc18-S011 CrossrefMedlineGoogle Scholar2. U.S. Department of Health and Human Services; U.S. Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research. Guidance for industry. E7 studies in support of special populations: geriatrics—questions and answers. 2012. Accessed at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM189544.pdf on 18 September 2018. Google Scholar3. Committee for Human Medicinal Products. Adequacy of guidance on the elderly regarding medicinal products for human use. European Medicines Agency. 2006. Accessed at www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500049541.pdf on 18 September 2018. Google Scholar4. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38:140-9. [PMID: 25538310] doi:10.2337/dc14-2441 CrossrefMedlineGoogle Scholar5. Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, et al; LEADER Steering Committee. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-22. [PMID: 27295427] doi:10.1056/NEJMoa1603827 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Larner College of Medicine at The University of Vermont, South Burlington, Vermont (M.P.G.)Institute of Life Science, Swansea University Medical School, Singleton Hospital, Swansea, United Kingdom (S.C.B.)Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland (E.F.)Quirónsalud Madrid and Ruber Juan Bravo University Hospitals, Universidad Europea de Madrid, Madrid, Spain (E.J.)Diabetes Center Bochum-Hattingen, St. Josef-Hospital, Ruhr-University of Bochum, Bochum, Germany (M.A.N.)Florida Hospital Diabetes Institute, Florida Hospital Translational Research Institute for Metabolism and Diabetes, Orlando, Florida (R.P.)Hospital de Clínicas da Universidade Federal do Paraná, Curitiba, Brazil (R.R.R.)Pontifícia Universidade Católica de Campinas, Campinas, Brazil (J.F.K.)Novo Nordisk A/S, Søborg, Denmark (S.R., K.T., B.J.V.)Diabetes Center, University of North Carolina School of Medicine, Chapel Hill, North Carolina (J.B.B.)Presented in part at the American College of Cardiology 67th Annual Scientific Session and Expo, Orlando, Florida, 10–12 March 2018.Note: Dr. Gilbert had full access to the data and takes responsibility for their integrity and completeness and the accuracy of the analysis; is the guarantor for this article; and affirms that it is an honest, accurate, and transparent account of the study being reported. No important aspects of the study have been omitted, and any discrepancies from the study as originally planned have been explained.Acknowledgment: The authors thank the participants, investigators, and all those involved in the conduct of the trial and Aneela Majid, PhD, and Izabel James, MBBS, from Watermeadow Medical and funded by Novo Nordisk for medical writing and editorial support, respectively.Financial Support: By Novo Nordisk.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-1569.Reproducible Research Statement:Study protocol: See Supplement 1. Statistical code: SAS code (SAS Institute) is available from Dr. Gilbert (e-mail, matthew.[email protected]org). Data set: Subject-level analysis data sets are available from Dr. Gilbert (e-mail, matthew.[email protected]org).This article was published at Annals.org on 4 December 2018.* LEADER Publication Committee members who authored this work are: John B. Buse, Michael A. Nauck, Stephen C. Bain, and Richard Pratley. Members who contributed to this work but did not author it: Steven Marso, Bernard Zinman, Steven Nissen, Neil Poulter, Johannes Mann, and Florian M.M. Baeres. LEADER Trial Investigators who authored this work are: Matthew P. Gilbert, Stephen C. Bain, Edward Franek, Esteban Jodar-Gimeno, Richard Pratley, Rosângela Roginski Réa, José Francisco Kerr Saraiva, and John B. Buse. For investigators who contributed to this work but did not author it, see Supplement 2. 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