Biblioteca Hospital 12 de Octubre

Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. (Registro nro. 16949)

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Campo de control de longitud fija nab a22 7a 4500
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Campo de control PC16949
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Campo de control 20220714113338.0
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Campo de control de longitud fija 220714b xxu||||| |||| 00| 0 eng d
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Centro transcriptor H12O
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Código de lengua del texto/banda sonora o título independiente eng
100 ## - PUNTO DE ACCESO PRINCIPAL - NOMBRE DE PERSONA
9 (RLIN) 539
Nombre de persona Ruilope Urioste, Luis Miguel
Término indicativo de función Nefrología
245 00 - MENCIÓN DE TÍTULO
Título Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial.
Tipo de material [artículo]
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Nombre del editor distribuidor etc. JAMA,
Fecha de publicación distribución etc. 2015
300 ## - DESCRIPCIÓN FÍSICA
Extensión 314(9):884-94.
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Nota general Formato Vancouver:
Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H et al; Mineralocorticoid Receptor Antagonist Tolerability Study–Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94.
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Nota de "Con" PMID: 26325557
504 ## - NOTA DE BIBLIOGRAFÍA; ETC.
Nota de bibliografía etc. Contiene 7 referencias
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Sumario etc. Importance: Steroidal mineralocorticoid receptor antagonists, when added to a renin-angiotensin system blocker, further reduce proteinuria in patients with chronic kidney disease but may be underused because of a high risk of adverse events.
Objective: To evaluate the safety and efficacy of different oral doses of the nonsteroidal mineralocorticoid receptor antagonist finerenone, given for 90 days to patients with diabetes and high or very high albuminuria who are receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker.
Design, setting, and participants: Randomized, double-blind, placebo-controlled, parallel-group study conducted at 148 sites in 23 countries. Patients were recruited from June 2013 to February 2014 and the study was completed in August 2014. Of 1501 screened patients, 823 were randomized and 821 received study drug.
Interventions: Participants were randomly assigned to receive oral, once-daily finerenone (1.25 mg/d, n = 96; 2.5 mg/d, n = 92; 5 mg/d, n = 100; 7.5 mg/d, n = 97; 10 mg/d, n = 98; 15 mg/d, n = 125; and 25 mg/d, n = 119) or matching placebo (n = 94) for 90 days.
Main outcomes and measures: The primary outcome was the ratio of the urinary albumin-creatinine ratio (UACR) at day 90 vs at baseline. Safety end points were changes from baseline in serum potassium and estimated glomerular filtration rate.

Results: The mean age of the participants was 64.2 years; 78% were male. At baseline, 36.7% of patients treated had very high albuminuria (UACR ≥300 mg/g) and 40.0% had an estimated glomerular filtration rate of 60 mL/min/1.73 m2 or lower. Finerenone demonstrated a dose-dependent reduction in UACR. The primary outcome, the placebo-corrected mean ratio of the UACR at day 90 relative to baseline, was reduced in the finerenone 7.5-, 10-, 15-, and 20-mg/d groups (for 7.5 mg/d, 0.79 [90% CI, 0.68-0.91; P = .004]; for 10 mg/d, 0.76 [90% CI, 0.65-0.88; P = .001]; for 15 mg/d, 0.67 [90% CI, 0.58-0.77; P<.001]; for 20 mg/d, 0.62 [90% CI, 0.54-0.72; P < .001]). The prespecified secondary outcome of hyperkalemia leading to discontinuation was not observed in the placebo and finerenone 10-mg/d groups; incidences in the finerenone 7.5-, 15-, and 20-mg/d groups were 2.1%, 3.2%, and 1.7%, respectively. There were no differences in the incidence of the prespecified secondary outcome of an estimated glomerular filtration rate decrease of 30% or more or in incidences of adverse events and serious adverse events between the placebo and finerenone groups.
Conclusions and relevance: Among patients with diabetic nephropathy, most receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, the addition of finerenone compared with placebo resulted in improvement in the urinary albumin-creatinine ratio. Further trials are needed to compare finerenone with other active medications.
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9 (RLIN) 625
Nombre de entidad o nombre de jurisdicción como elemento inicial Instituto de Investigación imas12
710 ## - PUNTO DE ACCESO ADICIONAL - NOMBRE DE ENTIDAD
9 (RLIN) 86
Nombre de entidad o nombre de jurisdicción como elemento inicial Servicio de Nefrología
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Identificador Uniforme del Recurso (URI) http://pc-h12o-es.m-hdoct.a17.csinet.es/pdf/pc/1/pc16949.pdf
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