Abstract

Background: In the DECLARE-TIMI 58 trial, involving patients with type 2 diabetes at high cardiovascular (CV) risk, dapagliflozin reduced the risk for heart failure hospitalization and adverse kidney outcomes, compared to placebo. Whether dapagliflozin lowers the risks for the broader outcome of adverse event (AE)-related hospital admissions is unknown. Methods: The DECLARE-TIMI 58 trial randomized 17,160 subjects with type 2 diabetes and a high risk for or established CV disease, to receive dapagliflozin or placebo (1:1). Dapagliflozin effect on AE-related hospital admissions was assessed overall and by baseline cardiovascular and kidney subgroups. Investigator reported system organ class classification was used to evaluate dapagliflozin's effects on admissions due to different etiologies. Results: Over a median follow up of 4.2 years, dapagliflozin reduced the risk of AE-related hospital admissions by 11% (32.4% vs. 35.4% of participants, HR 0.89 [95% CI 0.85, 0.94]; p<0.0001). The reduction in AE-related hospital admissions was consistent across baseline cardiovascular and kidney subgroups (p-interaction≥0.30) (Figure). Dapagliflozin reduced the risk for admissions due to cardiac disorders (HR 0.91 [95% CI 0.84,0.995] p=0.0387), renal or urinary disorders (0.61 [0.49, 0.77] p<0.0001), and other non-cardiac, non-renal etiologies (0.89 [0.84,0.95] p=0.0001). Conclusion: Dapagliflozin reduced the risk for AE-related hospital admissions, including non-cardiac and non-renal hospitalizations, in patients with type 2 diabetes. These findings have implications for patients' quality of life and overall type 2 diabetes-attributed healthcare burden.

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