Esaxerenone (CS-3150) in Patients with Type 2 Diabetes and Microalbuminuria (ESAX-DN): Phase 3 Randomized Controlled Clinical Trial.
Aged
Albuminuria
/ diagnosis
Biomarkers
/ urine
Creatinine
/ urine
Diabetes Mellitus, Type 2
/ complications
Female
Humans
Japan
Kidney
/ drug effects
Male
Middle Aged
Mineralocorticoid Receptor Antagonists
/ adverse effects
Pyrroles
/ adverse effects
Remission Induction
Risk Factors
Sulfones
/ adverse effects
Time Factors
Treatment Outcome
diabetes mellitus
esaxerenone
microalbuminuria
Journal
Clinical journal of the American Society of Nephrology : CJASN
ISSN: 1555-905X
Titre abrégé: Clin J Am Soc Nephrol
Pays: United States
ID NLM: 101271570
Informations de publication
Date de publication:
07 12 2020
07 12 2020
Historique:
received:
07
05
2020
accepted:
21
10
2020
pubmed:
27
11
2020
medline:
15
12
2021
entrez:
26
11
2020
Statut:
ppublish
Résumé
Diabetic kidney disease is an important complication of type 2 diabetes. In a phase 2b study, adding esaxerenone to renin-angiotensin system inhibitors dose dependently reduced the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and microalbuminuria. This 52-week phase 3 study further investigated the effects of esaxerenone on the urinary albumin-to-creatinine ratio in this patient group. In this multicenter, randomized, double-blind study, patients with type 2 diabetes and a urinary albumin-to-creatinine ratio of 45 to <300 mg/g creatinine treated with renin-angiotensin system inhibitors were randomized to esaxerenone or placebo for 52 weeks ( Overall, 49 (22%) and nine (4%) patients in the esaxerenone and placebo groups, respectively, achieved urinary albumin-to-creatinine ratio remission (absolute difference 18%; 95% confidence interval, 12% to 25%; Adding esaxerenone to existing renin-angiotensin system inhibitor therapy in patients with type 2 diabetes and microalbuminuria increased the likelihood of albuminuria returning to normal levels, and reduced progression of albuminuria to higher levels.
Sections du résumé
BACKGROUND AND OBJECTIVES
Diabetic kidney disease is an important complication of type 2 diabetes. In a phase 2b study, adding esaxerenone to renin-angiotensin system inhibitors dose dependently reduced the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and microalbuminuria. This 52-week phase 3 study further investigated the effects of esaxerenone on the urinary albumin-to-creatinine ratio in this patient group.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS
In this multicenter, randomized, double-blind study, patients with type 2 diabetes and a urinary albumin-to-creatinine ratio of 45 to <300 mg/g creatinine treated with renin-angiotensin system inhibitors were randomized to esaxerenone or placebo for 52 weeks (
RESULTS
Overall, 49 (22%) and nine (4%) patients in the esaxerenone and placebo groups, respectively, achieved urinary albumin-to-creatinine ratio remission (absolute difference 18%; 95% confidence interval, 12% to 25%;
CONCLUSIONS
Adding esaxerenone to existing renin-angiotensin system inhibitor therapy in patients with type 2 diabetes and microalbuminuria increased the likelihood of albuminuria returning to normal levels, and reduced progression of albuminuria to higher levels.
Identifiants
pubmed: 33239409
pii: 01277230-202012000-00008
doi: 10.2215/CJN.06870520
pmc: PMC7769030
doi:
Substances chimiques
Biomarkers
0
Mineralocorticoid Receptor Antagonists
0
Pyrroles
0
Sulfones
0
Creatinine
AYI8EX34EU
esaxerenone
N62TGJ04A1
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1715-1727Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 by the American Society of Nephrology.
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