PURPOSE: This study investigated the efficacy and safety of desmopressin orally disintegrating tablet (ODT) 50 and 75 μg in men with nocturia (≥2 nocturnal voids).
MATERIALS AND METHODS: This was a 3-month, randomized, double-blind parallel study comparing 50 and 75 μg desmopressin with placebo. The co-primary efficacy endpoints were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.
RESULTS: The full analysis set comprised 385 men (age range: 20-87 years). Both 50 and 75 μg significantly reduced the number of nocturnal voids (-0.37, p< 0.0001 and -0.41, p=0.0003, respectively) and increased the odds of a ≥33% response (OR=1.98, p=0.0009 and OR=2.04, p=0.0004, respectively) compared with placebo during 3 months. Desmopressin 50 and 75 μg increased the time to first void from baseline by ~40 min compared with placebo (p=0.006 and p=0.003, respectively). The response to desmopressin was seen by 1 week of treatment and sustained. Significant increases in health-related quality of life (HR-QoL) and sleep quality were observed compared with placebo. Desmopressin was well tolerated; only two subjects (aged 74 and 79) on 50 μg had a serum sodium < 130 mmol/L (vs. nine subjects on 75 μg).
CONCLUSIONS: Desmopressin ODT is an effective and well-tolerated treatment for men with nocturia. Treatment with desmopressin 50 μg, the minimum effective dose, provided sustained improvement of nocturia throughout the study and meaningful benefits to patients with an improved safety profile.
Written by:
Weiss JP, Herschorn S, Albei CD, van der Meulen EA. Are you the author?
Department of Urology, SUNY Downstate College of Medicine, Brooklyn, NY, USA.
Reference: J Urol. 2013 Feb 20. pii: S0022-5347(13)00313-3.
doi: 10.1016/j.juro.2012.12.112
PubMed Abstract
PMID: 23454402
