Tolvaptan Slows Renal Function Decline in Later-Stage ADPKD
Patients with autosomal dominant polycystic kidney disease treated with tolvaptan experienced a 35% decrease in the annual rate of decline in eGFR.
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NEW ORLEANS—Tolvaptan slows the rate of kidney function decline in patients with later-stage autosomal dominant polycystic kidney disease (ADPKD), according to study findings presented at the American Society of Nephrology's Kidney Week 2017 meeting and published online concomitantly in the New England Journal of Medicine.
In the randomized, double-blind, placebo-controlled phase 3 REPRISE trial, patients with later-stage ADPKD who received tolvaptan for 12 months experienced a significant 35% reduction in the annual rate of estimated glomerular filtration rate (eGFR) decline compared with placebo recipients, lead investigator Vicente E. Torres, MD, PhD, of Mayo Clinic in Rochester, Minnesota, reported.
Previous studies had shown that the drug, which inhibits the vasopressin V2 receptor and is approved by the FDA for treating hyponatremia, slowed cyst growth and the rate of eGFR decline in patients with relatively early ADPKD (minimum eGFR of 60 mL/min/1.73 m2).
REPRISE enrolled 1370 ADPKD patients aged 18–55 years with an eGFR of 25–65 mL/min/1.73 m2 or aged 56–65 years with an eGFR of 25–44 mL/min/1.73 m2
Investigators randomly assigned patients to receive tolvaptan or placebo for 12 months. From pre-treatment baseline to post-treatment follow-up, the eGFR declined by 2.34 mL/min/1.73 m2 per year in the tolvaptan group and by 3.61 mL/min/1.73 m2 per year in placebo recipients, a significant 1.27 mL/min/1.73 m2 difference in the annual rate of decline. Assuming tolvaptan treatment would continue to slow the decrement in the eGFR by 1.27 mL/min/1.73 m2 per year, the time to CKD stage 5 would be extended from 6.2 to 9.0 years, according to Dr Torres and his colleagues.
With respect to safety, Dr Torres reported that transaminase elevations greater than 3 times the upper limit of normal occurred in 5.6% of tolvaptan-treated patients compared with 1.2% of placebo recipients. Transaminase levels in tolvaptan-treated patients returned to normal after withdrawal of the drug.
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Torres VE, Ouyang J, Czerwiec FS, et al. Tolvaptan slows eGFR decline in later-stage ADPKD. Study presented at the Kidney Week 2017 in New Orleans (Oct. 31 to Nov. 5). Late breaker abstract.