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

83 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 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’ 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.

Original languageEnglish (US)
Pages (from-to)1102-1110
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number5
DOIs
StatePublished - May 2018

Keywords

  • CVOTs
  • SGLT2 inhibitors
  • cardiovascular outcomes
  • dapagliflozin
  • type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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