{"id":"3451eb1d9702","type":"article","url":"https://hartvaat.nl/2020/08/25/dapagliflozine-en-cardiale-renale-en-ledemaat-uitkomsten-bij-pav-declare-timi-58/","title":"Dapagliflozine en cardiale, renale en ledemaat-uitkomsten bij PAV: DECLARE-TIMI 58","title_en":"Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58.","category":"preventie","category_label":"Preventie","professions":["cardioloog","internist"],"tags":["dapagliflozine"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.119.044775","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.119.044775","authors":["Marc P Bonaca","Stephen D Wiviott","Thomas A Zelniker","Ofri Mosenzon","Deepak L Bhatt","Lawrence A Leiter","Darren K McGuire","Erica L Goodrich","Remo Holanda De Mendonca Furtado","John P H Wilding","Avivit Cahn","Ingrid A M Gause-Nilsson","Per Johanson","Martin Fredriksson","Peter A Johansson","Anna Maria Langkilde","Itamar Raz","Marc S Sabatine"],"significance":7,"published":"2020-08-25","source_date":"2020-08-25","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/preventie/preventie-bij-diabetes/"],"congress":"","summary_en":"This DECLARE-TIMI 58 subanalysis showed that dapagliflozin reduces cardiovascular events in patients with peripheral artery disease, extending the SGLT2 inhibitor benefit to this high-risk vascular population.","created":"2026-07-03T10:28:43Z","updated":"2026-07-03T13:27:53Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"DECLARE-TIMI 58 subanalyse bij patiënten met perifeer arterieel vaatlijden. Cardiovasculaire en ledemaat-uitkomsten met dapagliflozine.","abstract_original":"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<0.001). The relative risk reductions with dapagliflozin for CV death/HHF (HR, 0.86, PAD; HR, 0.82, no-PAD; P-interaction=0.79) and progression of kidney disease (HR, 0.78, PAD; HR, 0.76, no-PAD; P-interaction=0.84) were consistent regardless of PAD. There were 560 patients who had at least 1 limb ischemic event, 454 patients with at least 1 peripheral revascularization, and 236 patients with at least 1 amputation, with a total of 407 amputations reported. Overall, there were no significant differences in any limb outcome with dapagliflozin versus placebo including limb ischemic adverse events (HR, 1.07 [95% CI, 0.90-1.26]) and amputation (HR, 1.09 [95% CI, 0.84-1.40]), with no significant interactions by a history of PAD versus not (P-interactions=0.30 and 0.093, respectively). CONCLUSIONS: Patients with versus without PAD are at a higher risk of CV death of CV death, HHF, and kidney outcomes, and have a consistent benefits for CV death/HHF and progression of kidney disease with dapagliflozin. Patients with PAD had a higher risk of limb events, with no consistent pattern of incremental risk observed with dapagliflozin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01730534."}