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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.
Low Urin Tract Symptoms. 2020 Jan; 12(1):8-19.LU

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.

Authors+Show Affiliations

Division of Lower Urinary Tract Symptom Research, Nihon University School of Engineering, Koriyama, Japan.Ferring International Pharmascience Center, Copenhagen, Denmark.Biometrics, R&D, Ferring Pharmaceuticals Co. Ltd, Tokyo, Japan.Project Development, R&D, Ferring Pharmaceuticals Co. Ltd, Tokyo, Japan.Project Development, R&D, Ferring Pharmaceuticals Co. Ltd, Tokyo, Japan.Project Development, R&D, Ferring Pharmaceuticals Co. Ltd, Tokyo, Japan.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

31397969

Citation

Yamaguchi, Osamu, et al. "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." Lower Urinary Tract Symptoms, vol. 12, no. 1, 2020, pp. 8-19.
Yamaguchi O, Juul KV, Falahati A, et al. 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. Low Urin Tract Symptoms. 2020;12(1):8-19.
Yamaguchi, O., Juul, K. V., Falahati, A., Yoshimura, T., Imura, F., & Kitamura, M. (2020). 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. Lower Urinary Tract Symptoms, 12(1), 8-19. https://doi.org/10.1111/luts.12276
Yamaguchi O, et al. 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. Low Urin Tract Symptoms. 2020;12(1):8-19. PubMed PMID: 31397969.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Yamaguchi,Osamu, AU - Juul,Kristian V, AU - Falahati,Ali, AU - Yoshimura,Toru, AU - Imura,Futoshi, AU - Kitamura,Mikiya, Y1 - 2019/08/09/ PY - 2019/04/10/received PY - 2019/05/26/revised PY - 2019/06/20/accepted PY - 2019/8/10/pubmed PY - 2020/12/15/medline PY - 2019/8/10/entrez KW - desmopressin KW - nocturia KW - nocturnal polyuria SP - 8 EP - 19 JF - Lower urinary tract symptoms JO - Low Urin Tract Symptoms VL - 12 IS - 1 N2 - 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. SN - 1757-5672 UR - https://www.unboundmedicine.com/medline/citation/31397969/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_ L2 - https://doi.org/10.1111/luts.12276 DB - PRIME DP - Unbound Medicine ER -