{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T22:33:17Z","timestamp":1791671597358,"version":"4.3.4"},"reference-count":44,"publisher":"Oxford University Press (OUP)","issue":"24","license":[{"start":{"date-parts":[[2023,5,23]],"date-time":"2023-05-23T00:00:00Z","timestamp":1684800000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008732","name":"Uehara Memorial Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008732","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012029","name":"Japanese Heart Failure Society Tsuchiya Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100012029","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000274","name":"British Heart Foundation","doi-asserted-by":"publisher","award":["RE\/18\/6\/34217"],"award-info":[{"award-number":["RE\/18\/6\/34217"]}],"id":[{"id":"10.13039\/501100000274","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001639","name":"Vera Melrose Heart Failure Research Fund","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001639","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,6,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>Because an increased risk of amputation with canagliflozin was reported in the CANVAS trials, there has been a concern about the safety of sodium\u2013glucose cotransporter 2 inhibitors in patients with peripheral artery disease (PAD) who are at higher risk of amputation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and results<\/jats:title>\n                  <jats:p>A patient-level pooled analysis of the DAPA-HF and DELIVER trials, which evaluated the efficacy and safety of dapagliflozin in patients with heart failure (HF) with reduced, mildly reduced\/preserved ejection fraction, respectively, was conducted. In both trials, the primary outcome was the composite of worsening HF or cardiovascular death, and amputation was a prespecified safety outcome. Peripheral artery disease history was available for 11 005 of the total 11 007 patients. Peripheral artery disease was reported in 809 of the 11 005 patients (7.4%). Median follow-up was 22 months (interquartile range 17\u201330). The rate of the primary outcome (per 100 person-years) was higher in PAD patients than that in non-PAD patients: 15.1 [95% confidence interval (CI) 13.1\u201317.3) vs. 10.6 (10.2\u201311.1]; adjusted hazard ratio 1.23 (95% CI 1.06\u20131.43). The benefit of dapagliflozin on the primary outcome was consistent in patients with [hazard ratio 0.71 (95% CI 0.54\u20130.94)] and without PAD [0.80 (95% CI 0.73\u20130.88)] (Pinteraction = 0.39). Amputations, while more frequent in PAD patients, were not more common with dapagliflozin, compared with placebo, irrespective of PAD status (PAD, placebo 4.2% vs. dapagliflozin 3.7%; no PAD, placebo 0.4% vs. dapagliflozin 0.4%) (Pinteraction = 1.00). Infection rather than ischaemia was the main trigger for amputation, even in patients with PAD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The risk of worsening HF or cardiovascular death was higher in patients with PAD, as was the risk of amputation. The benefits of dapagliflozin were consistent in patients with and without PAD, and dapagliflozin did not increase the risk of amputation.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/eurheartj\/ehad276","type":"journal-article","created":{"date-parts":[[2023,5,23]],"date-time":"2023-05-23T18:17:58Z","timestamp":1684865878000},"page":"2170-2183","source":"Crossref","is-referenced-by-count":34,"title":["Heart failure, peripheral artery disease, and dapagliflozin: a patient-level meta-analysis of DAPA-HF and DELIVER"],"prefix":"10.1093","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7380-4144","authenticated-orcid":false,"given":"Jawad H","family":"Butt","sequence":"first","affiliation":[{"name":"British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA , UK"},{"name":"Department of Cardiology, Copenhagen University Hospital Rigshospitalet , Copenhagen , Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Kondo","sequence":"additional","affiliation":[{"name":"British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA , UK"},{"name":"Department of Cardiology, Nagoya University Graduate School of Medicine , Nagoya , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingming","family":"Yang","sequence":"additional","affiliation":[{"name":"British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pardeep S","family":"Jhund","sequence":"additional","affiliation":[{"name":"British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kieran F","family":"Docherty","sequence":"additional","affiliation":[{"name":"British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0885-1953","authenticated-orcid":false,"given":"Muthiah","family":"Vaduganathan","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Brigham and Women\u2019s Hospital, Harvard Medical School , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian L","family":"Claggett","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Brigham and Women\u2019s Hospital, Harvard Medical School , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian F","family":"Hernandez","sequence":"additional","affiliation":[{"name":"Duke University Medical Center , Durham, NC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1903-0018","authenticated-orcid":false,"given":"Carolyn S P","family":"Lam","sequence":"additional","affiliation":[{"name":"National Heart Centre Singapore , Singapore"},{"name":"Duke-National University of Singapore , Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio E","family":"Inzucchi","sequence":"additional","affiliation":[{"name":"Yale School of Medicine , New Haven, CT , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felipe A","family":"Martinez","sequence":"additional","affiliation":[{"name":"University of Cordoba , Cordoba , Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rudolf A","family":"de Boer","sequence":"additional","affiliation":[{"name":"Erasmus Medical Center , Rotterdam , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikhail N","family":"Kosiborod","sequence":"additional","affiliation":[{"name":"Saint Luke\u2019s Mid America Heart Institute , Kansas City, MO , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akshay S","family":"Desai","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Brigham and Women\u2019s Hospital, Harvard Medical School , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"K\u00f8ber","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Nagoya University Graduate School of Medicine , Nagoya , Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Ponikowski","sequence":"additional","affiliation":[{"name":"Department of Heart Disease, Wroclaw Medical University , Wroclaw , Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc S","family":"Sabatine","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women\u2019s Hospital , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjiv J","family":"Shah","sequence":"additional","affiliation":[{"name":"Northwestern University Feinberg School of Medicine , Chicago, IL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalia","family":"Zaozerska","sequence":"additional","affiliation":[{"name":"Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca , Gothenburg , Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrica","family":"Wilder\u00e4ng","sequence":"additional","affiliation":[{"name":"Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca , Gothenburg , Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1315-8176","authenticated-orcid":false,"given":"Olof","family":"Bengtsson","sequence":"additional","affiliation":[{"name":"Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca , Gothenburg , Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott D","family":"Solomon","sequence":"additional","affiliation":[{"name":"Cardiovascular Division, Brigham and Women\u2019s Hospital, Harvard Medical School , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6317-3975","authenticated-orcid":false,"given":"John J V","family":"McMurray","sequence":"additional","affiliation":[{"name":"British Heart Foundation Cardiovascular Research Centre, University of Glasgow , 126 University Place, Glasgow G12 8TA , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,5,23]]},"reference":[{"key":"2023062614534156600_ehad276-B1","doi-asserted-by":"crossref","first-page":"644","DOI":"10.1056\/NEJMoa1611925","article-title":"Canagliflozin and cardiovascular and renal events in type 2 diabetes","volume":"377","author":"Neal","year":"2017","journal-title":"N Engl J Med"},{"key":"2023062614534156600_ehad276-B2","doi-asserted-by":"crossref","first-page":"926","DOI":"10.1007\/s00125-019-4839-8","article-title":"Effects of canagliflozin on amputation risk in type 2 diabetes: the CANVAS program","volume":"62","author":"Matthews","year":"2019","journal-title":"Diabetologia"},{"key":"2023062614534156600_ehad276-B3","doi-asserted-by":"crossref","first-page":"1753","DOI":"10.1111\/dom.14091","article-title":"The effect of canagliflozin on amputation risk in the CANVAS program and the CREDENCE 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Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries Endorsed by: the European Stroke Organization (ESO)The task force for the diagnosis and treatment of peripheral arterial diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS)","volume":"39","author":"Aboyans","year":"2018","journal-title":"Eur Heart J"},{"key":"2023062614534156600_ehad276-B44","doi-asserted-by":"crossref","first-page":"734","DOI":"10.1161\/CIRCULATIONAHA.119.044775","article-title":"Dapagliflozin and cardiac, kidney, and limb outcomes in patients with and without peripheral artery disease in DECLARE-TIMI 58","volume":"142","author":"Bonaca","year":"2020","journal-title":"Circulation"}],"container-title":["European Heart 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