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Effects of Dapagliflozin in Patients with Membranous Nephropathy.
Chertow, Glenn M; Heerspink, Hiddo Lambers; Mark, Patrick B; Dwyer, Jamie P; Nowicki, Michal; Wheeler, David C; Correa-Rotter, Ricardo; Rossing, Peter; Toto, Robert D; Langkilde, Anna Maria; Jongs, Niels.
Afiliación
  • Chertow GM; Departments of Medicine, Epidemiology and Population Health, and Health Policy, Stanford University School of Medicine, Stanford, CA, USA.
  • Heerspink HL; Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
  • Mark PB; The George Institute for Global Health, UNSW Sydney, Sydney, NSW, Australia.
  • Dwyer JP; School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK.
  • Nowicki M; Renal and Transplant Unit, Queen Elizabeth University Hospital, Glasgow, UK.
  • Wheeler DC; Division of Nephrology and Hypertension, University of Utah, Salt Lake City, UT, USA.
  • Correa-Rotter R; Department of Nephrology, Hypertension and Kidney Transplantation, Central University Hospital, Medical University of Lodz, Lodz, Poland.
  • Rossing P; Department of Renal Medicine, University College London, London, UK.
  • Toto RD; The National Medical Science and Nutrition Institute Salvador Zubiran, Mexico City, Mexico.
  • Langkilde AM; Steno Diabetes Center Copenhagen, Herlev, Denmark.
  • Jongs N; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Glomerular Dis ; 4(1): 137-145, 2024.
Article en En | MEDLINE | ID: mdl-39144475
ABSTRACT

Introduction:

Despite the provision of renin-angiotensin-aldosterone-system inhibitors and immunosuppressive therapies, membranous nephropathy often progresses to end-stage kidney disease (ESKD). The objective of this prespecified analysis was to assess the safety and efficacy of dapagliflozin in patients with membranous nephropathy enrolled in the DAPA-CKD trial.

Methods:

Patients with an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 and urinary albumin-to-creatinine ratio (UACR) 200-5,000 mg/g were randomized to dapagliflozin 10 mg once daily or placebo, along with standard-of-care and followed for median 2.4 years. The primary endpoint was a composite of ≥50% sustained decline in eGFR, ESKD, or kidney or cardiovascular death. Exploratory efficacy endpoints included eGFR slope and UACR.

Results:

Among DAPA-CKD participants with membranous nephropathy, 19 were randomized to dapagliflozin and 24 to placebo. The mean (SD) age was 59.9 ± 12.1 years, the mean eGFR was 45.7 ± 12.1 mL/min/1.73 m2, and the median UACR was 1,694.5 (25%, 75% range 891-2,582.5) mg/g. Two of 19 (11%) patients randomized to dapagliflozin and five of 24 (21%) randomized to placebo experienced the primary composite endpoint. Total and chronic mean eGFR slopes for dapagliflozin and placebo were -3.87 and -4.29 and -2.66 and -4.22 mL/min/1.73 m2/year, respectively; corresponding between-group mean differences were 0.42 and 1.57 mL/min/1.73 m2/year. Dapagliflozin reduced geometric mean (SEM) UACR relative to placebo (-29.3% ± 1.2% vs. -3.6% ± 1.1%; between-group mean difference [95% CI] -26.7 [-50.4, 8.3]). Four (21%) patients randomized to dapagliflozin and seven (29%) randomized to placebo experienced a serious adverse event.

Conclusion:

In membranous nephropathy, the effects of dapagliflozin on kidney disease progression and albuminuria were generally favorable; there was insufficient power to justify formal inference testing.
Palabras clave

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Glomerular Dis Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Glomerular Dis Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos
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