@article{55e4ac8e68eb416f9501688cf19eddaf,
title = "DECLARE-TIMI 58: Participants{\textquoteright} baseline characteristics",
abstract = "Aim: To describe the baseline characteristics of participants randomized in the Dapagliflozin Effect on CardiovascuLAR Events (DECLARE-TIMI 58) trial, the pivotal study conducted to assess cardiovascular (CV) outcomes with dapagliflozin. Methods: The DECLARE-TIMI 58 trial will analyse 17 160 patients with type 2 diabetes randomized to treatment with dapagliflozin (10 mg/d) or matching placebo. We analysed their baseline characteristics. Results: The participants{\textquoteright} mean ± SD age was 63.8 ± 6.8 years, 62.6% were male, and their mean ± SD diabetes duration was 11.8 ± 7.8 years, glycated haemoglobin 8.3% ± 1.2% (67 mmol/mol ± 9.7 mmol/mol) and body mass index 32.1 ± 6.0 kg/m2. Randomization included 6971 (40.6%) patients with atherosclerotic CV disease (CVD), and 10 189 (59.4%) patients with multiple risk factors (MRF) for CVD (defined as men age ≥ 55 years or women ≥60 years, with at least one of dyslipidaemia, hypertension or smoking). Patients with CVD compared with patients with MRF were younger (62.5 ± 8.1 vs 64.7 ± 5.6 years), more frequently male (72.1% vs 56.1%), less often used metformin (74.6% vs 81.2%), more often used insulin (44.2% vs 36.4%), and more frequently used statins, aspirin, clopidogrel and β-blockers (82.2%, 71.1%, 24.7% and 66.6% vs 63.7%, 39.1%, 1.5% and 32.3%, respectively). Conclusion: The DECLARE-TIMI 58 trial is expected to provide conclusive data on the effect of treatment with dapagliflozin in addition to standard of care, on CV outcomes in a broad patient population with type 2 diabetes and CVD or MRF for CVD.",
keywords = "CVOTs, SGLT2 inhibitors, cardiovascular outcomes, dapagliflozin, type 2 diabetes",
author = "Itamar Raz and Ofri Mosenzon and Bonaca, {Marc P.} and Avivit Cahn and Kato, {Eri T.} and Silverman, {Michael G.} and Bhatt, {Deepak L.} and Leiter, {Lawrence A.} and McGuire, {Darren K} and Wilding, {John P.H.} and Gause-Nilsson, {Ingrid A.M.} and Langkilde, {Anna M.} and Johansson, {Peter A.} and Sabatine, {Marc S.} and Wiviott, {Stephen D.}",
note = "Funding Information: I.R. discloses the following relationships: Advisory Board: AstraZeneca/ Bristol-Meyers Squibb, Eli Lilly and Company, Medscape LLC, Merck Sharp & Dohme Limited, Novo Nordisk, Inc., Sanofi, Orgenesis, SmartZyme Innovation Ltd, Labstyle Innovations Ltd; Consultant: Astra-Zeneca/Bristol-Meyers Squibb, Insuline Medical, Gili Medical, Kamada Ltd, FuturRx Ltd; Speaker{\textquoteright}s Bureau: AstraZeneca/Bristol-Meyers Squibb, Eli Lilly and Company, Johnson & Johnson, Merck Sharp & Dohme Limited, Novartis Pharma AG, Novo Nordisk, Inc., Sanofi, Teva; Stock/Shareholder: Insuline Medical, Labstyle Innovations SmartZyme Innovation Ltd, Orgenesis, Glucome Ltd. O.M. discloses the following relationships: Advisory Board: Novo Nordisk, Eli Lilly, Sanofi, Merck Sharp & Dohme, Boehringer Ingelheim, Jansen and Jansen, Novartis, Astra Zeneca; Grants paid to institution as study physician by AstraZe-neca and Bristol-Myers Squibb; Research grant support through Hadas-sah Hebrew University Hospital: Novo Nordisk; Speaker's Bureau: AstraZeneca and Bristol-Myers Squibb, Novo Nordisk, Eli Lilly, Sanofi, Novartis, Merck Sharp & Dohme, Boehringer Ingelheim. M.P.B. discloses the following relationships: consultant: Merck, AstraZeneca, Bayer and research support received from: Merck, AstraZeneca, MedImmune. A.-C. discloses the following relationships: consulting fees and payment for lectures from: AstraZeneca, Boehringer Ingelheim, Elli Lilly, MSD, Novartis, Novo Nordisk and Sanofi. E.T.K. discloses the following relationships: honoraria from AstraZeneca, Bristol-Myers Squibb, Daiichi-Sankyo, and Ono Pharmaceutical. M.G.S. has no relationships to disclose. D.L.B. discloses the following relationships: Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Cleveland Clinic, Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today{\textquoteright}s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, Pfizer, Roche, Sanofi Aventis, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald{\textquoteright}s Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott); Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, PLx Pharma, Takeda. L.A.L. discloses the following relationships: received research funding from, has provided CME on behalf of, and/or has acted as an advisor to: AstraZeneca, Boehringer Ingelheim, Eli Lilly, GSK, Janssen, Merck, Novo Nordisk, Sanofi, Servier. D.K.M. discloses the following relationships: honoraria for clinical trials leadership: Astra Zeneca, Sanofi Aventis, Janssen, Boehringer Ingelheim, Merck & Co, Novo Nordisk, Lexicon, Eisai, GlaxoSmithKline, Esperion; honoraria for consultancy: AstraZe-neca, Sanofi Aventis, Lilly US, Boehringer Ingelheim, Merck & Co, Pfizer, Novo Nordisk. J.W. discloses the following relationships: lecture fees from Astellas, AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Novo Nordisk, Merck, Orexigen, Sanofi; consultancy (Institutional) from Astra-Zeneca, Boehringer Ingelheim, Janssen, Lilly, and Orexigen; and grants to institution from Takeda, Novo Nordisk and AstraZeneca. I.G.N., A.M.-L. and P.A.J. are employees and shareholders of AstraZeneca. M.S.-S. discloses the following relationships: research support through hospital from Amgen; AstraZeneca; Daiichi-Sankyo; Eisai; GlaxoSmithK-line; Intarcia; Janssen Research and Development; Medicines Company; MedImmune; Merck; Novartis; Pfizer; Poxel; Takeda; and consulting fees from: Amgen; CVS Caremark; Esperion; Intarcia; Janssen Research and Development; MedImmune; Merck; Novartis. S.D.W. discloses the following relationships: grants and personal fees from AstraZeneca, grants and personal fees from Bristol Myers Squibb, grants and personal fees from Eisai, grants and personal fees from Merck, personal fees from Aegerion, personal fees from Angelmed, personal fees from Xoma, personal fees from ICON Clinical, personal fees from Boston Clinical Research Institute, grants and personal fees from Eli Lilly/Daiichi San-kyo, grants from Sanofi-Aventis, other from Merck Research Laboratory, personal fees from Boehringer Ingelheim, grants and personal fees from Amgen, personal fees from Allergan, grants and personal fees from Janssen, grants from Arena, personal fees from St Jude Medical, from Lexicon, outside the submitted work; Dr. Wiviott{\textquoteright}s wife is an employee of Merck. Funding Information: The trial was sponsored by AstraZeneca. Publisher Copyright: {\textcopyright} 2018 John Wiley & Sons Ltd",
year = "2018",
month = may,
doi = "10.1111/dom.13217",
language = "English (US)",
volume = "20",
pages = "1102--1110",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "5",
}