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Effects of empagliflozin in patients with chronic kidney disease from Japan: exploratory analyses from EMPA-KIDNEY.
Nangaku, Masaomi; Herrington, William G; Goto, Shinya; Maruyama, Shoichi; Kashihara, Naoki; Ueki, Kohjiro; Wada, Jun; Watada, Hirotaka; Nakashima, Eitaro; Lee, Ryonfa; Massey, Dan; Mayne, Kaitlin J; Tomita, Aiko; Haynes, Richard; Hauske, Sibylle J; Kadowaki, Takashi.
Afiliación
  • Nangaku M; Division of Nephrology and Endocrinology, The University of Tokyo School of Medicine, Tokyo, 113-8655, Japan. mnangaku@m.u-tokyo.ac.jp.
  • Herrington WG; Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
  • Goto S; Tokai University School of Medicine, Isehara, Japan.
  • Maruyama S; Department of Nephrology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
  • Kashihara N; Kawasaki Medical School, Kurashiki, Japan.
  • Ueki K; Diabetes Research Center, Research Institute, National Center for Global Health and Medicine, Tokyo, Japan.
  • Wada J; Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
  • Watada H; Department of Metabolism &Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
  • Nakashima E; Department of Diabetes and Endocrinology, Chubu Rosai Hospital, Nagoya, Japan.
  • Lee R; Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
  • Massey D; Elderbrook Solutions GmbH On Behalf of Boehringer Ingelheim Pharma GmbH & Co.KG, Biberach, Germany.
  • Mayne KJ; Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
  • Tomita A; Tokai University School of Medicine, Isehara, Japan.
  • Haynes R; Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
  • Hauske SJ; Boehringer Ingelheim International GmbH, Ingelheim, Germany.
  • Kadowaki T; Vth Department of Medicine, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
Clin Exp Nephrol ; 28(6): 588-595, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38643286
ABSTRACT

BACKGROUND:

EMPA-KIDNEY assessed the effects of empagliflozin 10 mg once daily vs. placebo in 6609 patients with chronic kidney disease (CKD) at risk of progression, including 612 participants from Japan.

METHODS:

Eligibility required an estimated glomerular filtration rate (eGFR) of ≥ 20 < 45; or ≥ 45 < 90 ml/min/1.73m2 with a urinary albumin-to-creatinine ratio (uACR) of ≥ 200 mg/g. The primary outcome was a composite of kidney disease progression (end-stage kidney disease, a sustained eGFR decline to < 10 ml/min/1.73m2 or ≥ 40% from randomization, or renal death) or cardiovascular death. In post-hoc analyses, we explored the effects of empagliflozin in participants from Japan vs. non-Japan regions, including additional models assessing whether differences in treatment effects between these regions could result from differences in baseline characteristics.

RESULTS:

Japanese participants had higher levels of albuminuria and eGFR than those from non-Japan regions. During a median of 2.0 year follow-up, a primary outcome occurred in 432 patients (13.1%) in the empagliflozin group and in 558 patients (16.9%) in the placebo group (hazard ratio [HR], 0.72, 95% confidence interval [95%CI] 0.64-0.82; P < 0.0001). Among the participants from non-Japan regions, there were 399 vs. 494 primary outcomes (0.75, 0.66-0.86), and 33 vs. 64 (0.49, 0.32-0.75; heterogeneity p = 0.06) in Japan. Results were similar when models explicitly considered treatment interactions with diabetes status, categories of eGFR/uACR, and recruitment in Japan (heterogeneity p = 0.08). Safety outcomes were broadly comparable between the two groups, and by Japanese status.

CONCLUSIONS:

Empagliflozin safely reduced the risk of "kidney disease progression or cardiovascular death" in patients with CKD, with consistent effects in participants from Japan.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Compuestos de Bencidrilo / Progresión de la Enfermedad / Albuminuria / Insuficiencia Renal Crónica / Inhibidores del Cotransportador de Sodio-Glucosa 2 / Tasa de Filtración Glomerular / Glucósidos Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Clin Exp Nephrol Asunto de la revista: NEFROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Compuestos de Bencidrilo / Progresión de la Enfermedad / Albuminuria / Insuficiencia Renal Crónica / Inhibidores del Cotransportador de Sodio-Glucosa 2 / Tasa de Filtración Glomerular / Glucósidos Límite: Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Clin Exp Nephrol Asunto de la revista: NEFROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón