DECLARE-TIMI 58: Participants' baseline characteristics

Itamar Raz, Ofri Mosenzon, Marc P. Bonaca, Avivit Cahn, Eri T. Kato, Michael G. Silverman, Deepak L. Bhatt, Lawrence A. Leiter, Darren K McGuire, John P.H. Wilding, Ingrid A.M. Gause-Nilsson, Anna M. Langkilde, Peter A. Johansson, Marc S. Sabatine, Stephen D. Wiviott

Research output: Contribution to journalArticlepeer-review

77 Scopus citations

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 17160 patients with type 2 diabetes randomized to treatment with dapagliflozin (10mg/d) or matching placebo. We analysed their baseline characteristics. Results: The participants' mean±SD age was 63.8±6.8years, 62.6% were male, and their mean±SD diabetes duration was 11.8±7.8years, glycated haemoglobin 8.3%±1.2% (67 mmol/mol ± 9.7 mmol/mol) and body mass index 32.1±6.0kg/m2. Randomization included 6971 (40.6%) patients with atherosclerotic CV disease (CVD), and 10189 (59.4%) patients with multiple risk factors (MRF) for CVD (defined as men age ≥55years or women ≥60years, 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±5.6years), 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.

Original languageEnglish (US)
JournalDiabetes, Obesity and Metabolism
DOIs
StateAccepted/In press - Jan 1 2017

Keywords

  • Cardiovascular outcomes
  • CVOTs
  • Dapagliflozin
  • SGLT2 inhibitors
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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