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Achieving clinically meaningful quality of life benefits in nocturia takes time: Results from a long‐term, multicenter phase 3 study of desmopressin in Japanese patients
Author(s) -
Juul Kristian V.,
Andersson Fredrik L.,
Yamaguchi Osamu
Publication year - 2021
Publication title -
luts: lower urinary tract symptoms
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.451
H-Index - 15
eISSN - 1757-5672
pISSN - 1757-5664
DOI - 10.1111/luts.12347
Subject(s) - nocturia , desmopressin , medicine , quality of life (healthcare) , adverse effect , multicenter study , clinical endpoint , clinical trial , urology , pediatrics , physical therapy , urinary system , randomized controlled trial , nursing
Objectives To investigate the long‐term efficacy, quality of life (QoL), and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese patients with nocturia. Methods A long‐term, multicenter phase 3 study was conducted that enrolled Japanese male and female patients with nocturia (NCT03051009). Male patients received desmopressin 25‐ or 50‐μg ODTs, and female patients received desmopressin 25‐μg ODTs for up to 1 year. The primary endpoint was safety. Secondary endpoints included change from baseline in number of nocturnal voids, time to first awakening to void, and QoL assessments (nocturia‐specific zQoL [N‐QoL], Insomnia Severity Index [ISI], and Hsu bother score). Results Overall, 503 patients were enrolled. Reductions from baseline in mean number of nocturnal voids were observed in all treatment groups from week 1 (−0.62 to −1.00), with improvements continuing through week 52 (−1.39 to −1.71). Changes from baseline above or approximating a clinically meaningful improvement were seen by week 52 in the disease‐specific N‐QoL total score (improved by 11.5‐22.6), ISI (improved by −3.9 to −7.1), and Hsu bother scores (improved by −1.5 to −2.0). Adverse events (AEs) were reported in 54.9% of desmopressin‐treated patients. Most AEs were mild or moderate in severity. Conclusions Desmopressin ODTs (25 and 50 μg) demonstrated long‐term efficacy, improved QoL, and were well tolerated in Japanese male and female patients with nocturia treated for up to 1 year. Clinically meaningful improvements in patients’ QoL, assessed by N‐QoL, sleep quality, and bother, occur later than objective symptom improvements, such as voids.