SAN DIEGO—Nalbuphine, a semi-synthetic opioid drug, shows promise as a treatment for uremic pruritus in hemodialysis patients, according to data presented at Kidney Week.
In an 8-week double-blind study, Vandana S. Mathur, MD, of MathurConsulting, Woodside, Calif., and colleagues randomized 373 HD patients suffering from uremic pruritus to receive 60 mg or 120 mg of nalbuphine ER (128 and 120 patients, respectively) BID or placebo (125 patients). The study consisted of a 2-week titration period followed by a 6-week blinded period on a fixed dose of the drug or placebo and a wash-out period. The primary efficacy endpoint was the change from baseline to the evaluation period (weeks 7 and 8) in the 10-point numerical rating scale score (NRS) for itching (0 = no itch, 10 = worse possible itching).
The mean NRS in the nalbuphine 120 mg group decreased significantly from 6.94 to 3.51. The researchers observed a significant reduction in itch intensity compared with placebo as early as 1 week after titration to the fixed dosed. The mean NRS decreased in the nalbuphine 60 mg group, but this did not differ significantly compared with placebo.
The most common adverse events were nausea, vomiting, dizziness, and somnolence. The incidence rates of these events quickly approached that of placebo after the first week of titration, Dr. Mathur reported. Results showed that sleep quality improved significantly versus placebo, but other quality of life aspects such as mood and social functioning did not.
“The trial met its primary endpoint, demonstrating a significant reduction in itch intensity in the nalbuphine ER 120 mg BID group versus placebo in hemodialysis patients with moderate to severe uremic pruritus receiving background anti-pruritic medications, mostly antihistamines,” Dr. Mathur concluded.