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 µgdesmopressin 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.
RCT Entities:
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.
Authors: Kim Pauwaert; An-Sofie Goessaert; Lynn Ghijselings; Thomas F Monaghan; Herman Depypere; Karel Everaert Journal: Int Urogynecol J Date: 2021-01-13 Impact factor: 2.894
Authors: Siri Drangsholt; Maria Juliana Arcila Ruiz; Benoit Peyronnet; Nirit Rosenblum; Victor Nitti; Benjamin Brucker Journal: World J Urol Date: 2018-10-04 Impact factor: 4.226