PHILADELPHIA—Desmopressin orally disintegrating tablets (ODT) 25/50 µg decrease nocturnal voids in nocturia patients with both nocturnal polyuria (NP) and mild daytime voiding dysfunction, according to study findings presented at the International Continence Society’s 2018 annual meeting.
The tablets demonstrate a similar safety and efficacy profile in nocturia patients with NP and mild day voiding dysfunction—overactive bladder (OAB) and/or benign prostatic obstruction (BPO)—as in patients with pure NP, investigators led by Jeffrey P. Weiss, MD, of SUNY Downstate College of Medicine in Brooklyn, New York, concluded.
Dr Weiss and his colleagues noted that a substantial proportion of patients with nocturia have other daytime lower urinary tract symptoms due to OAB or BPO.
His team analyzed data from 2 3-month, phase 3 double-blind randomized placebo-controlled trials of desmopressin ODT in men (50/75 µg) and women (25 µg) with 2 or more voids per night during 3-day screening. All patients had nocturnal polyuria (NP). Mild daytime LUTS associated with OAB/BPO were not specifically excluded, but concomitant medications for OAB/BPO, such as antimuscarinic agents, 5-alpha-reductase inhibitors, and alpha blockers, had to be stable for 3 months prior to screening, the authors noted.
The study population included 196 women with pure NP (no daytime symptoms) and 35 with NP and OAB, 152 men with pure NP and 75 with NP and OAB and/or BPO. In both women and men, desmopressin ODT demonstrated similar efficacy in patients with pure NP and those with NP and OAB/BPO with respect to reduction in nocturnal voids compared with placebo and percentage of patients achieving a 33% reduction in nocturnal voids.
Among women, desmopressin-treated patients with pure NP and NP plus OAB had a mean 0.30 and 0.24 decrease in the number of nocturnal voids, respectively, compared with placebo recipients. The proportion of women with pure NP who achieved a 33% reduction in nocturnal voids was 79% in the desmopressin group compared with 63% in the placebo arm. In the NP plus OAB group, the proportions were 72% vs 61%, respectively.
Among men, desmopressin-treated patients with pure NP and NP with OAB and/or BPO had a mean 0.34 and 0.32 decrease in the number of nocturnal voids, respectively, compared with placebo recipients. The proportion of men treated with desmopressin who had a 33% reduction in nocturnal voids was 72% and 54% in the pure NP and NP plus OAB and/or BPO groups, respectively. The proportions in the placebo arms were 55% and 40%, respectively.
According to the investigators, the study identified no new safety concerns.
Weiss JP, Malmberg A, Juul KV. Safety and efficacy of desmopressin orally disintegrating table 25/50 mg in patients with nocturia and mild daytime urinary symptoms. Data presented at the International Continence Society’s 2018 annual meeting in Philadelphia, August 28–31. Abstract 10.