Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58

BACKGROUND:Patients with peripheral artery disease (PAD) are at heightened risk of cardiovascular complications. The sodium-glucose cotransporter 2 inhibitor dapagliflozin reduces the risk for hospitalization for heart failure (HHF) and kidney events in patients with type 2 diabetes mellitus. An inc...

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Published in:Circulation (New York, N.Y.) N.Y.), 2020-08, Vol.142 (8), p.734-747
Main Authors: Bonaca, Marc P., Wiviott, Stephen D., Zelniker, Thomas A., Mosenzon, Ofri, Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Goodrich, Erica L., De Mendonca Furtado, Remo Holanda, Wilding, John P.H., Cahn, Avivit, Gause-Nilsson, Ingrid A.M., Johanson, Per, Fredriksson, Martin, Johansson, Peter A., Langkilde, Anna Maria, Raz, Itamar, Sabatine, Marc S.
Format: Article
Language:English
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Summary:BACKGROUND:Patients with peripheral artery disease (PAD) are at heightened risk of cardiovascular complications. The sodium-glucose cotransporter 2 inhibitor dapagliflozin reduces the risk for hospitalization for heart failure (HHF) and kidney events in patients with type 2 diabetes mellitus. An increased risk of amputation has been observed with canagliflozin in 1 previous trial. We examined cardiovascular and kidney efficacy and the risk of limb-related events in patients with and without PAD in an exploratory analysis. METHODS:A total of 17 160 patients with type 2 diabetes mellitus, including 1025 (6%) with PAD, were randomized. Key efficacy outcomes were MACE (cardiovascular [CV] death, myocardial infarction, stroke), CV death/HHF, and progression of kidney disease. Amputations, peripheral revascularization, and limb ischemic adverse events were site-reported and categorized by a blinded reviewer. RESULTS:Patients in the placebo arm with PAD versus those without tended to have higher adjusted risk of CV death, myocardial infarction, or stroke (adjusted hazard ratio [HR], 1.23 [95% CI, 0.97–1.56], P=0.094) and significantly higher adjusted risk of CV death/HHF (adjusted HR, 1.60 [95% CI, 1.21–2.12], P=0.0010) and progression of kidney disease (adjusted HR, 1.51 [95% CI, 1.13 – 2.03], P=0.0058), and limb adverse events (adjusted HR, 8.37, P
ISSN:0009-7322
1524-4539
DOI:10.1161/CIRCULATIONAHA.119.044775