(HealthDay News) — For patients with later-stage autosomal dominant polycystic kidney disease (ADPKD), tolvaptan is associated with a slower decline in estimated glomerular filtration rate (eGFR) than placebo, according to a study published online Nov. 4 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Society of Nephrology, being held Oct. 31 to Nov. 5 in New Orleans.
Vincente E. Torres, M.D., Ph.D., from the Mayo Clinic in Rochester, Minnesota, and colleagues conducted a phase 3 trial involving 1,370 patients with ADPKD who were randomized to receive tolvaptan or placebo for 12 months in a 1-to-1 ratio. The change in the eGFR from baseline to follow-up was assessed as the primary end point.
The researchers found that the change from baseline in the eGFR was −2.34 and −3.61 ml/minute/1.73 m² in the tolvaptan and placebo groups, respectively (difference, 1.27 ml/min/m²; 95 percent confidence interval, 0.86 to 1.68; P < 0.001). Elevations in the alanine aminotransferase level (to more than three times the upper limit of normal range) occurred in 5.6 and 1.2 percent of patients in the tolvaptan and placebo groups, respectively. No elevations of more than twice the upper limit of normal range were seen in the bilirubin level.
“Tolvaptan resulted in a slower decline than placebo in the estimated GFR over a one-year period in patients with later-stage ADPKD,” the authors write.
The study was funded by Otsuka Pharmaceuticals and Otsuka Pharmaceutical Development and Commercialization.