Efficacy and safety of 25 and 50 μg desmopressin orally disintegrating tablets in Japanese patients with nocturia due to nocturnal polyuria: Results from two phase 3 studies of a multicenter randomized double-blind placebo-controlled parallel-group development program

Osamu Yamaguchi, Kristian V Juul, Ali Falahati, Toru Yoshimura, Futoshi Imura, Mikiya Kitamura, Osamu Yamaguchi, Kristian V Juul, Ali Falahati, Toru Yoshimura, Futoshi Imura, Mikiya Kitamura

Abstract

This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP). Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted. The primary endpoint was change from baseline in mean number of nocturnal voids. In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period. In males, 50 and 25 μg desmopressin ODTs significantly reduced the number of nocturnal voids by -1.21 (P < .0001) and - 0.96 (P = .0143), respectively, and significantly prolonged the time to first awakening to void by 117.60 minutes (P < .0001) and 93.37 minute (P = .0009), respectively, with no safety concerns. In females, 25 μg desmopressin ODT significantly prolonged the time to first awakening to void by 116.11 minutes (P = .0257), with no safety concerns. The reduction in the number of nocturnal voids (-1.11) was not significantly different compared with placebo (P = .0975). Desmopressin ODTs (50 and 25 μg) were an effective and well-tolerated treatment for nocturia due to NP in Japanese males, and desmopressin ODT 50 μg is an appropriate dose in these patients. For patients who are likely to experience hyponatremia, such as elderly males, starting with 25 μg desmopressin ODT should be considered.

Keywords: desmopressin; nocturia; nocturnal polyuria.

© 2019 The Authors. LUTS: Lower Urinary Tract Symptoms published by John Wiley & Sons Australia, Ltd.

Figures

Figure 1
Figure 1
Change from baseline in the mean number of nocturnal voids throughout the 12‐week treatment period in males (full analysis set). Data are the mean ± 95%CI. ODT, orally dissolving tablet
Figure 2
Figure 2
Change from baseline in the mean number of nocturnal voids throughout the 12‐week treatment in females (full analysis set). Data are the mean ± 95%CI. ODT, orally dissolving tablet
Figure 3
Figure 3
Change from baseline in the mean time to first awakening to void throughout the 12‐week treatment in males (full analysis set). ODT, orally dissolving tablet
Figure 4
Figure 4
Change from baseline in the mean time to first awakening to void throughout the 12‐week treatment in females (full analysis set). ODT, orally dissolving tablet
Figure 5
Figure 5
Change from baseline in the mean number of nocturnal voids (NOC VD) stratified by baseline value for females in Japanese (in this present study) versus global studies.7 Data are the mean ± 95%CI. ODT, orally dissolving tablet. The numbers below each columns denotes the change from baseline in the mean number of nocturnal voids
Figure 6
Figure 6
Plot of minimum post‐dosing serum sodium concentrations in male subjects according to age. ODT, orally dissolving tablet
Figure 7
Figure 7
Plot of minimum post‐dosing serum sodium concentrations in female subjects according to age. ODT, orally dissolving tablet

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