Desmopressin orally disintegrating tablet effectively reduces nocturia: Results of a randomized, double-blind, placebo-controlled trial

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