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- Title
Effects of empagliflozin in patients with chronic kidney disease from Japan: exploratory analyses from EMPA–KIDNEY.
- Authors
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
- 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.
- Subjects
JAPAN; CHRONIC kidney failure; CHRONICALLY ill; EMPAGLIFLOZIN; GLOMERULAR filtration rate; KIDNEY diseases
- Publication
Clinical & Experimental Nephrology, 2024, Vol 28, Issue 6, p588
- ISSN
1342-1751
- Publication type
Academic Journal
- DOI
10.1007/s10157-024-02489-4