DECLARE-TIMI 58: Participants' baseline characteristics


Raz, Itamar, Mosenzon, Ofri, Bonaca, Marc P, Cahn, Avivit, Kato, Eri T, Silverman, Michael G, Bhatt, Deepak L, Leiter, Lawrence A, McGuire, Darren K, Wilding, John PH ORCID: 0000-0003-2839-8404 et al (show 5 more authors) (2018) DECLARE-TIMI 58: Participants' baseline characteristics. DIABETES OBESITY & METABOLISM, 20 (5). pp. 1102-1110.

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Abstract

<h4>Aim</h4>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.<h4>Methods</h4>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.<h4>Results</h4>The participants' 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/m<sup>2</sup> . 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).<h4>Conclusion</h4>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.

Item Type: Article
Uncontrolled Keywords: cardiovascular outcomes, CVOTs, dapagliflozin, SGLT2 inhibitors, type 2 diabetes
Depositing User: Symplectic Admin
Date Deposited: 23 Feb 2018 16:14
Last Modified: 19 Jan 2023 06:39
DOI: 10.1111/dom.13217
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3018337
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