Effect of Dapagliflozin on Hematocrit in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From DECLARE-TIMI 58

TY - JOUR

T1 - Effect of Dapagliflozin on Hematocrit in Patients With Type 2 Diabetes at High Cardiovascular Risk

T2 - Observations From DECLARE-TIMI 58

AU - Kolkailah, Ahmed A.

AU - Wiviott, Stephen D.

AU - Raz, Itamar

AU - Murphy, Sabina A.

AU - Mosenzon, Ofri

AU - Bhatt, Deepak L.

AU - Leiter, Lawrence A.

AU - Wilding, John P.H.

AU - Gause-Nilsson, Ingrid

AU - Sabatine, Marc S.

AU - McGuire, Darren K.

N1 - Funding Information: Research Institute, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, Icon Clinical, Janssen, Lexicon, Merck, Servier, St. Jude Medical, and Xoma. S.D.W.’s spouse, Dr. Caroline Fox, is an employee of Merck. S.D.W. is a member of the TIMI Study Group, which has received institutional research grant support through Brigham and Women’s Hospital from Abbott, Amgen, Aralez, AstraZeneca, Bayer HealthCare Pharmaceuticals, Inc., BRAHMS, Daiichi-Sankyo, Eisai, GlaxoSmithKline, Intarcia, Janssen, MedImmune, Merck, Novartis, Pfizer, Poxel, Quark Pharmaceuticals, Roche, Takeda, The Medicines Company, and Zora Biosciences. I.R. discloses the following relationships: advisory board for Astra-Zeneca, Eli Lilly and Company, Merck Sharp & Dohme, Novo Nordisk, Inc., and Sanofi; consultant for AstraZeneca, Insuline Medical, Medial EarlySign, Ltd., CamerEyes, Ltd., Exscopia, Orgenesis, Ltd., BOL Pharma, Glucome, Ltd., DarioHealth, Diabot, and Concenter BioPharma; speaker’s bureau for AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme, Novo Nordisk, Inc., and Sanofi; and stock/shareholder of Glucome, Ltd., Orgenesis, Ltd., DarioHealth, and CamerEyes, Ltd. O.M. discloses the following relationships: advisory board for Novo Nordisk, Eli Lilly, Sanofi, Merck Sharp & Dohme, Boehringer Ingelheim, Novartis, AstraZeneca, and BOL Pharma; research grant support, through Hadassah Hebrew University Hospital, from Novo Nordisk and AstraZeneca; speaker’s bureau for AstraZeneca, Novo Nordisk, Eli Lilly and Company, Sanofi, Merck Sharp & Dohme, Boehringer Ingelheim, and Janssen. S.A.M. discloses the following: research grant support, through Brigham and Women’s Hospital, from Abbott, Amgen, Anthos Therapeutics, AstraZe-neca, Bayer HealthCare Pharmaceuticals, Inc., Daiichi-Sankyo, Eisai, Intarcia, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Inc., Roche, Siemens Healthcare Diagnostics, Inc., The Medicines Company, and Zora Biosciences. D.L.B. discloses the following relationships: advisory board for Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Jans-sen, Level Ex, Medscape Cardiology, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, and Regado Biosciences; board of directors for Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; inaugural chair, American Heart Association Quality Oversight Committee; data monitoring committees for Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the Portico Resheathable Transcatheter Aortic Valve System US IDE Trial [PORTICO-IDE], funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis [ExCEED] trial, funded by Edwards), Contego Medical (Chair, Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System [PERFORMANCE 2]), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation [ENVISAGE] trial, funded by Daiichi Sankyo), Novartis, and Population Health Research Institute; honoraria from Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting [RE-DUAL PCI] clinical trial steering committee funded by Boehringer Ingelheim; Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome [AEGIS-II] executive committee funded by CSL Behring), Belvoir Publications (editor in chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Duke Clinical Research Institute (clinical trial steering committees, including for the A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease [PRONOUNCE] trial, funded by Ferring Pharmaceuticals), HMP Global (editor in chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor, associate editor), K2P (cochair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (Continuing Medical Education steering committees), MJH Life Sciences, Population Health Research Institute (for the Cardiovascular OutcoMes for People Using Anticoagulation StrategieS [COMPASS] operations committee, publications committee, steering committee, and U.S. national co-leader, funded by Bayer), Slack Publications (chief medical editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (secretary/treasurer), and WebMD (Continuing Medical Education steering committees); and other for Clinical Cardiology (deputy editor), National Cardiovascular Data Registry-Acute Coronary Treatment and Intervention Outcomes Network [NCDR-ACTION] Registry Steering Committee (chair), Veterans Health Administration Clinical Assessment, Reporting and Tracking System for Cath Labs [VA CART] Research and Publications Committee (chair); research funding from Abbott, Afimmune, Amarin, Amgen, AstraZe-neca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Gar-min, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Lexicon, Eli Lilly, Medtronic, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Regen-eron, Roche, Sanofi, Synaptic, The Medicines Company, and 89Bio; royalties from Elsevier (editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); site co-investigator for Abbott, Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Philips, and Svelte; trustee for American College of Cardiology; and unfunded research for FlowCo, Merck, and Takeda. L.A.L. has received research funding from, has provided continuing medical education on behalf of, and/or has acted as an advisor to AstraZeneca, Bayer, Boehringer Ingel-heim, Eli Lilly, Janssen, Lexicon, Merck, Novo Nordisk, Pfizer, Sanofi, and Servier. J.P.H.W. has received honoraria/lecture fees from AstraZe-neca, Boehringer Ingelheim, Lilly, Napp, Mundi-pharma, Sanofi, and Takeda. He has undertaken consultancy contracted via the University of Liverpool for AstraZeneca, Boehringer Ingel-heim, Janssen Pharmaceuticals, Lilly, Napp, Novo Nordisk, Mundipharma, Rhythm Pharmaceuticals, Sanofi, and Saniona and is a named grant holder (at University of Liverpool) for research grants for clinical trials from AstraZe-neca and Novo Nordisk. I.G.-N. discloses being an employee at BioPharmaceuticals R&D, Astra-Zeneca, Gothenburg, Sweden. M.S.S. declares research grant support, through Brigham and Women’s Hospital, from Amgen, Anthos Therapeutics, AstraZeneca, Bayer, Daiichi-Sankyo, Eisai, Intarcia, IONIS, The Medicines Company, MedImmune, Merck, Novartis, Pfizer, and Quark Pharmaceuticals and consulting for Althera, Amgen, Anthos Therapeutics, AstraZeneca, Bristol-Myers Squibb, CVS Caremark, DalCor, Dr. Reddy’s Laboratories, Fibrogen, IFM Therapeutics, Intarcia, MedImmune, Merck, and Novo Nordisk. Additionally, he is a member of the TIMI Study Group, which has also received institutional research grant support, through Brigham and Women’s Hospital, from Abbott, Regeneron, Roche, and Zora Biosciences. D.K.M. discloses personal fees from Boehringer Ingelheim, Janssen Research and Development LLC, Sanofi US, Merck & Co., Merck Sharp & Dohme, Eli Lilly USA, NovoNordisk, Glaxo-SmithKline, AstraZeneca, Lexicon Pharmaceuticals, Eisai, Pfizer, Metavant, Applied Therapeutics, Afimmune, CSL Behring, Bayer, and Esperion. No other potential conflicts of interest relevant to this article were reported. Author Contributions. A.A.K. wrote the manuscript and researched data. S.D.W., I.R., S.A.M., O.M., D.L.B., L.A.L., J.P.H.W., I.G.-N., and M.S.S. reviewed/edited the manuscript. D.K.M. wrote the manuscript and researched data. D.K.M. is the guarantor of this manuscript and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Funding Information: Funding. A.A.K. was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number T32HL12547. The content is solely the responsibility of the authors and does not necessarily represent the official view of the National Institutes of Health. Duality of Interest. S.D.W. discloses grants from Amgen, Arena, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, Janssen, Merck, and Sanofi and reports consulting fees from Arena, AstraZeneca, Aegerion, Allergan, Angelmed, Boehringer Ingelheim, Boston Clinical

PY - 2022/2

Y1 - 2022/2

UR - http://www.scopus.com/inward/record.url?scp=85123199784&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85123199784&partnerID=8YFLogxK

U2 - 10.2337/dc21-1668

DO - 10.2337/dc21-1668

M3 - Letter

C2 - 35020832

AN - SCOPUS:85123199784

SN - 0149-5992

VL - 45

SP - e27-e29

JO - Diabetes care

JF - Diabetes care

IS - 2

ER -