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Desmopressin orally disintegrating tablet effectively reduces nocturia: Results of a randomized, double‐blind, placebo‐controlled trial
Author(s) -
Weiss Jeffrey P.,
Zinner Norman R.,
Klein Bjarke M.,
Nørgaard Jens Peter
Publication year - 2012
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.22243
Subject(s) - nocturia , medicine , desmopressin , tolerability , placebo , post hoc analysis , population , randomized controlled trial , urology , overactive bladder , dosing , anesthesia , adverse effect , urinary system , alternative medicine , environmental health , pathology
Aims The primary objective was to investigate the efficacy of desmopressin orally disintegrating tablet versus placebo in patients with nocturia. Pharmacodynamics, safety and patient‐reported quality of life (QoL) outcomes were also evaluated. One of several benefits of the new formulation is increased bioavailability. Exploring lower doses allows for a better evaluation of therapeutic effect versus tolerability. Methods This was a 4‐week, randomized, double‐blind study comparing 10, 25, 50, or 100 µg desmopressin versus placebo in adults with defined nocturia. Results The intent to treat population comprised 757 patients experiencing ∼3 voids/night and a high prevalence of nocturnal polyuria (∼90%). Increasing doses of desmopressin were associated with decreasing numbers of nocturnal voids and voided volume, greater proportions of subjects with >33% reduction in nocturnal voids, and increased duration of first sleep period. The lowest dose reaching statistical significance ( P < 0.05 vs. placebo) varied by endpoint. Improvements were clinically meaningful, meaning that patients actually had fewer nightly voids. Post hoc analyses by gender suggested a lower minimum effective dose for women. Desmopressin was generally well tolerated. Reductions in serum sodium to <125 mmol/L in six women (taking >25 µg desmopressin) and two men (aged 67 and 82) taking 100 µg, support lower and gender‐specific dosing to reduce the small but clinically significant risk of hyponatraemia. Each void reduced/hour of sleep gained was associated with significant improvements in QoL. Conclusions Desmopressin orally disintegrating tablet is an effective and well‐tolerated treatment for patients with nocturia. Further exploration of the lower dose range is warranted. Neurourol. Urodynam. 31:441–447, 2012. © 2012 Wiley Periodicals, Inc.