WASHINGTON—Treatment with spironolactone, an aldosterone antagonist, does not delay development of diabetic nephropathy in patients with type 2 diabetes, according to data presented at the American Society of Nephrology’s Kidney Week 2019 meeting.
In the PRIORITY (“Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria”) trial, 209 (12%) of 1775 patients (mean age 63 years) had a high risk of developing kidney disease based on their CKD273 urinary proteomics risk score. Investigators randomly assigned these high-risk patients to receive spironolactone (25 mg daily) or placebo in addition to standard care. At baseline, mean blood pressure was 135/79 mm Hg, estimated glomerular filtration rate was 81 mL/min/1.73m2, and urinary albumin-to-creatinine ratio (UACR) was 7 mg/g. In all, 88% of patients were taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.
The study’s primary end point was development of persistent microalbuminuria (UACR exceeding 30 mg/g with a 30% or more increase from baseline). Over a follow-up period as long as 4.3 years, microalbuminuria developed in 26% of spironolactone users vs 33% of placebo recipients, which corresponded to a nonsignificant 19% decreased risk associated with spironolactone, the investigators reported.
“The PRIORITY trial demonstrated for the first time in a prospective study that CKD273 predicts development of early kidney disease in diabetes, but the high risk could not be mitigated by spironolactone,” investigator Nete Tofte, MD, PhD, of Steno Diabetes Center in Denmark, told Renal & Urology News.
The proteomics classifier CKD273 by Mosaiques Diagnostics is based on the identification of 273 urine markers that are significantly altered between individuals with chronic kidney diseases and healthy controls. Study participants with a high-risk proteomic pattern in the urine showed a 4-fold increase in development of microalbumuria or early-stage kidney disease.
Lindhardt M, Tofte N, Frimodt-Moller M, et al. Spironolactone for the prevention of microalbuminuria in high-risk type 2 diabetes: Results from the multicenter randomized double-blind controlled trial PRIORITY. Presented at the American Society of Nephrology’s Kidney Week 2019 meeting held November 5-10 in Washington DC. Abstract FR-PO247.