Efficacy and Safety of Dapagliflozin in Patients With Chronic Kidney Disease Across the Spectrum of Frailty.
J Gerontol A Biol Sci Med Sci
; 79(2)2024 Feb 01.
Article
en En
| MEDLINE
| ID: mdl-37527836
ABSTRACT
BACKGROUND:
A sizeable proportion of patients with chronic kidney disease (CKD) are reported to be frail. Here we examined the safety and efficacy of dapagliflozin in patients with CKD by frailty level.METHODS:
Adults with CKD, with/without type 2 diabetes, with an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2, and urinary albumin-to-creatinine ratio 200-5 000 mg/g were randomized to dapagliflozin (10 mg/day) or placebo. The primary endpoint was a composite of sustained ≥50% eGFR decline, end-stage kidney disease (ESKD), or death from kidney or cardiovascular (CV) causes.RESULTS:
Frailty index (FI), assessed by Rockwood cumulative deficit approach, was calculable in 4 303/4 304 (99.9%) patients 1 162 (27.0%) in not-to-mildly frail (FI ≤0.210), 1 642 (38.2%) in moderately frail (FI 0.211-0.310), and 1 499 (34.8%) in severely frail categories (FI >0.311). Dapagliflozin reduced the risk of the primary composite endpoint across all FI categories (hazard ratios [95% confidence interval {CI}] 0.50 [0.33-0.76], 0.62 [0.45-0.85], and 0.64 [0.49--0.83], respectively; p-interactionâ =â 0.67). Results were similar for secondary outcomes including kidney composite outcome (sustained ≥50% eGFR decline, ESKD or death from kidney cause; p-interactionâ =â 0.44), CV endpoint (heart failure hospitalization or CV death; p-interactionâ =â 0.63), and all-cause mortality (p-interaction pâ =â .42). Results were consistent when using FI as a continuous variable. Occurrence of serious adverse events was numerically lower in patients receiving dapagliflozin versus placebo in all FI categories (16.9% vs 20.1%, 26.3% vs 30.7%, and 42.9% vs 47.8%, in not-to-mildly, moderately, and severely frail categories, respectively).CONCLUSIONS:
The relative benefit of dapagliflozin for all outcomes was consistent across all frailty categories, with no difference in associated safety.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Compuestos de Bencidrilo
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Diabetes Mellitus Tipo 2
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Nefropatías Diabéticas
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Insuficiencia Renal Crónica
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Fragilidad
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Glucósidos
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Fallo Renal Crónico
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
En
Revista:
J Gerontol A Biol Sci Med Sci
Asunto de la revista:
GERIATRIA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Países Bajos