PMID- 33368855 OWN - NLM STAT- MEDLINE DCOM- 20210709 LR - 20220531 IS - 1463-1326 (Electronic) IS - 1462-8902 (Print) IS - 1462-8902 (Linking) VI - 23 IP - 4 DP - 2021 Apr TI - The cost-effectiveness of dapagliflozin in treating high-risk patients with type 2 diabetes mellitus: An economic evaluation using data from the DECLARE-TIMI 58 trial. PG - 1020-1029 LID - 10.1111/dom.14308 [doi] AB - AIM: To undertake a cost-effectiveness analysis of dapagliflozin in treating high-risk patients with type 2 diabetes mellitus (T2DM), using both directly observed events in the DECLARE-TIMI 58 trial and surrogate risk factors to predict endpoints not captured within the trial. METHODS: An established T2DM model was adapted to integrate survival curves derived from the DECLARE-TIMI 58 trial, and extrapolated over a lifetime for all-cause mortality, hospitalization for heart failure, stroke, myocardial infarction, hospitalization for unstable angina, and end-stage kidney disease. The economic analysis considered the overall DECLARE trial population, as well as reported patient subgroups. Total and incremental costs, life-years and quality-adjusted life-years associated with dapagliflozin versus placebo were estimated from the perspective of the UK healthcare payer. RESULTS: In the UK setting, treatment with dapagliflozin compared to placebo was estimated to be dominant, with an expected increase in quality-adjusted life-years from 10.43 to 10.48 (+0.06) and a reduction in lifetime total costs from pound39 451 to pound36 899 (- pound2552). Across all patient subgroups, dapagliflozin was estimated to be dominant, with the greatest absolute benefit in the prior heart failure subgroup (incremental lifetime costs - pound4150 and quality-adjusted life-years +0.11). CONCLUSIONS: The results of this study demonstrate that dapagliflozin compared to placebo appears to be cost-effective, when considering evidence reported from the DECLARE-TIMI 58 trial, at established UK willingness-to-pay thresholds. The findings highlight the potential of dapagliflozin to have a meaningful impact in reducing the economic burden of T2DM and its associated complications across a broad T2DM population. CI - (c) 2020 Health Economics and Outcomes Research Ltd. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. FAU - McEwan, Phil AU - McEwan P AUID- ORCID: 0000-0001-7488-9058 AD - Health Economics and Outcomes Research Ltd, Cardiff, UK. FAU - Morgan, Angharad R AU - Morgan AR AD - Health Economics and Outcomes Research Ltd, Cardiff, UK. FAU - Boyce, Rebecca AU - Boyce R AD - Health Economics and Outcomes Research Ltd, Cardiff, UK. FAU - Bergenheim, Klas AU - Bergenheim K AD - BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. FAU - Gause-Nilsson, Ingrid A M AU - Gause-Nilsson IAM AD - BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. FAU - Bhatt, Deepak L AU - Bhatt DL AD - TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. FAU - Leiter, Lawrence A AU - Leiter LA AUID- ORCID: 0000-0002-1040-6229 AD - Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. FAU - Johansson, Peter A AU - Johansson PA AD - BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. FAU - Mosenzon, Ofri AU - Mosenzon O AUID- ORCID: 0000-0002-5702-7584 AD - Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. FAU - Cahn, Avivit AU - Cahn A AUID- ORCID: 0000-0002-7830-9994 AD - Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. FAU - Wilding, John P H AU - Wilding JPH AUID- ORCID: 0000-0003-2839-8404 AD - University of Liverpool, Liverpool, UK. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210125 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Benzhydryl Compounds) RN - 0 (Glucosides) RN - 1ULL0QJ8UC (dapagliflozin) SB - IM MH - Benzhydryl Compounds/therapeutic use MH - Cost-Benefit Analysis MH - *Diabetes Mellitus, Type 2/drug therapy/epidemiology MH - Glucosides/therapeutic use MH - Humans PMC - PMC8048502 OTO - NOTNLM OT - SGLT2 inhibitor OT - cost-effectiveness OT - dapagliflozin OT - type 2 diabetes COIS- P.M., A.R.M. and R.B. are employees of Health Economics and Outcomes Research Ltd. Health Economics and Outcomes Research Ltd received fees from AstraZeneca in relation to this study. K.B., I.G.-N. and P.A.J. are employees of AstraZeneca. L.A.L. has 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, Lexicon, Merck, Novo Nordisk, Sanofi, and Servier. A.C. reports grants and personal fees from AstraZeneca and Novo Nordisk and personal fees from Abbott, Eli Lilly, Sanofi, Boehringer Ingelheim, Merck Sharp & Dohme, Medial Early-Sign and GlucoMe. J.W. has received honoraria from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, Mundipharma, Napp, Novo Nordisk, Sanofi and Takeda, and research support from AstraZeneca and Novo Nordisk. DLB discloses the following relationships - Advisory Board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, MyoKardia, PhaseBio, PLx Pharma, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: 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), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: 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; 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 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 (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today'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: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, MyoKardia, Owkin, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Novo Nordisk, Takeda. EDAT- 2020/12/29 06:00 MHDA- 2021/07/10 06:00 PMCR- 2021/04/15 CRDT- 2020/12/28 12:36 PHST- 2020/12/16 00:00 [revised] PHST- 2020/10/02 00:00 [received] PHST- 2020/12/20 00:00 [accepted] PHST- 2020/12/29 06:00 [pubmed] PHST- 2021/07/10 06:00 [medline] PHST- 2020/12/28 12:36 [entrez] PHST- 2021/04/15 00:00 [pmc-release] AID - DOM14308 [pii] AID - 10.1111/dom.14308 [doi] PST - ppublish SO - Diabetes Obes Metab. 2021 Apr;23(4):1020-1029. doi: 10.1111/dom.14308. Epub 2021 Jan 25.