THU340 Efficacy And Safety Of Low-dose Spironolactone On Chronic Kidney Disease In Adults With Type 2 Diabetes: A Multicenter, Randomized Clinical Trial

Disclosure: A. Oiwa: None. D. Hiwatashi: None. T. Takeda: None. T. Miyamoto: None. I. Kawata: None. M. Koinuma: None. S. Kubota: None. S. Takayama: None. M. Yamazaki: None. M. Komatsu: None. Objective: To evaluate the albuminuria-lowering effect and safety regarding hyperkalemia of adding low-dose spironolactone (12.5 mg/day) to the renin-angiotensin system (RAS) blockers in adults with chronic kidney disease and type 2 diabetes. Research Design and Methods: This was a multicenter, open-label, randomized controlled trial. We enrolled 130 Japanese individuals aged ≥20 years with type 2 diabetes and albuminuria (≥30 mg/gCre), estimated glomerular filtration ≥30 mL/min/1.73 m(2), and serum potassium level <5.0 mEq/L. They were randomly assigned to the spironolactone-administered and control groups. The main outcomes were changes in urine albumin-to-creatinine ratio (UACR), serum potassium levels and renal function from baseline to the 24-week interventional period. Results: The spironolactone-administered group showed a significant reduction in UACR by a mean of 103.47 ± 340.80 mg/gCre from baseline compared with the control group that showed increased UACR by a mean of 63.93 ± 310.14 mg/gCre (p = 0.0007, Wilcoxon rank-sum test and T-test). As for serum potassium levels, although there was a statistically significant increase (p = 0.0026), none of the participants had a potassium level ≥5.5 mEq/L at 24 weeks. Further, there was a tendency that the higher the initial potassium level, the smaller the increase in serum potassium level (estimate −0.37, analysis of covariance). Conclusions: This study first demonstrated that low-dose spironolactone administration reliably reduced albuminuria and was safe against hyperkalemia. The administration of spironolactone, which is the oldest known and most cost-effective of all the other mineralocorticoid receptor antagonists, should be re-evaluated with consideration of lower doses. Presentation: Thursday, June 15, 2023