WEDNESDAY, Sept. 2, 2015 (HealthDay News) -- For patients with diabetic nephropathy receiving an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, the addition of finerenone results in improvement in the urinary albumin-creatinine ratio (UACR), according to a study published in the Sept. 1 issue of the Journal of the American Medical Association.
George L. Bakris, M.D., from the University of Chicago, and colleagues conducted a randomized, double-blind, placebo-controlled trial at 148 sites in 23 countries. Participants with diabetes and high or very high albuminuria receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker were randomized to receive oral, once-daily finerenone (1.25 to 20 mg/day) or placebo for 90 days.
The researchers found that there was a dose-dependent reduction in UACR at day 90. In the finerenone 7.5, 10, 15, and 20 mg/day groups, the primary outcome (the placebo-corrected mean ratio of the UACR at day 90 relative to baseline) was reduced. In the placebo and finerenone 10 mg/day groups, the prespecified secondary outcome of hyperkalemia leading to discontinuation was not observed; incidences in the 7.5, 15, and 20 mg/day groups were 2.1, 3.2, and 1.7 percent, respectively. There were no between-group differences noted in the incidence of the prespecified secondary outcome of an estimated glomerular filtration rate decrease of 30 percent or more or in the incidence of adverse and serious adverse events.
"Further trials are needed to compare finerenone with other active medications," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Bayer HealthCare, which manufactures finerenone and funded the study.
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