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Heart failure, peripheral artery disease, and dapagliflozin: a patient-level meta-analysis of DAPA-HF and DELIVER.
Butt, Jawad H; Kondo, Toru; Yang, Mingming; Jhund, Pardeep S; Docherty, Kieran F; Vaduganathan, Muthiah; Claggett, Brian L; Hernandez, Adrian F; Lam, Carolyn S P; Inzucchi, Silvio E; Martinez, Felipe A; de Boer, Rudolf A; Kosiborod, Mikhail N; Desai, Akshay S; Køber, Lars; Ponikowski, Piotr; Sabatine, Marc S; Shah, Sanjiv J; Zaozerska, Natalia; Wilderäng, Ulrica; Bengtsson, Olof; Solomon, Scott D; McMurray, John J V.
Afiliação
  • Butt JH; British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.
  • Kondo T; Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
  • Yang M; British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.
  • Jhund PS; Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
  • Docherty KF; British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.
  • Vaduganathan M; British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.
  • Claggett BL; British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.
  • Hernandez AF; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Lam CSP; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Inzucchi SE; Duke University Medical Center, Durham, NC, USA.
  • Martinez FA; National Heart Centre Singapore, Singapore.
  • de Boer RA; Duke-National University of Singapore, Singapore.
  • Kosiborod MN; Yale School of Medicine, New Haven, CT, USA.
  • Desai AS; University of Cordoba, Cordoba, Argentina.
  • Køber L; Erasmus Medical Center, Rotterdam, The Netherlands.
  • Ponikowski P; Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
  • Sabatine MS; Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Shah SJ; Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
  • Zaozerska N; Department of Heart Disease, Wroclaw Medical University, Wroclaw, Poland.
  • Wilderäng U; TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA.
  • Bengtsson O; Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
  • Solomon SD; Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
  • McMurray JJV; Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Eur Heart J ; 44(24): 2170-2183, 2023 06 25.
Article em En | MEDLINE | ID: mdl-37220172
AIMS: Because an increased risk of amputation with canagliflozin was reported in the CANVAS trials, there has been a concern about the safety of sodium-glucose cotransporter 2 inhibitors in patients with peripheral artery disease (PAD) who are at higher risk of amputation. METHODS AND RESULTS: 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 17-30). 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) 13.1-17.3) vs. 10.6 (10.2-11.1]; adjusted hazard ratio 1.23 (95% CI 1.06-1.43). The benefit of dapagliflozin on the primary outcome was consistent in patients with [hazard ratio 0.71 (95% CI 0.54-0.94)] and without PAD [0.80 (95% CI 0.73-0.88)] (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. CONCLUSION: 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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Diabetes Mellitus Tipo 2 / Doença Arterial Periférica / Inibidores do Transportador 2 de Sódio-Glicose / Insuficiência Cardíaca Tipo de estudo: Clinical_trials / Systematic_reviews Limite: Humans Idioma: En Revista: Eur Heart J Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Diabetes Mellitus Tipo 2 / Doença Arterial Periférica / Inibidores do Transportador 2 de Sódio-Glicose / Insuficiência Cardíaca Tipo de estudo: Clinical_trials / Systematic_reviews Limite: Humans Idioma: En Revista: Eur Heart J Ano de publicação: 2023 Tipo de documento: Article