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Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial.
Neurourol Urodyn. 2012 Apr; 31(4):441-7.NU

Abstract

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+Show Affiliations

Department of Urology, SUNY Downstate Medical School, Brooklyn, NY, USA. urojock@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22447415

Citation

Weiss, Jeffrey P., et al. "Desmopressin Orally Disintegrating Tablet Effectively Reduces Nocturia: Results of a Randomized, Double-blind, Placebo-controlled Trial." Neurourology and Urodynamics, vol. 31, no. 4, 2012, pp. 441-7.
Weiss JP, Zinner NR, Klein BM, et al. Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. Neurourol Urodyn. 2012;31(4):441-7.
Weiss, J. P., Zinner, N. R., Klein, B. M., & Nørgaard, J. P. (2012). Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. Neurourology and Urodynamics, 31(4), 441-7. https://doi.org/10.1002/nau.22243
Weiss JP, et al. Desmopressin Orally Disintegrating Tablet Effectively Reduces Nocturia: Results of a Randomized, Double-blind, Placebo-controlled Trial. Neurourol Urodyn. 2012;31(4):441-7. PubMed PMID: 22447415.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. AU - Weiss,Jeffrey P, AU - Zinner,Norman R, AU - Klein,Bjarke M, AU - Nørgaard,Jens Peter, Y1 - 2012/03/22/ PY - 2011/10/24/received PY - 2012/02/27/accepted PY - 2012/3/27/entrez PY - 2012/3/27/pubmed PY - 2012/8/21/medline SP - 441 EP - 7 JF - Neurourology and urodynamics JO - Neurourol Urodyn VL - 31 IS - 4 N2 - 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. SN - 1520-6777 UR - https://www.unboundmedicine.com/medline/citation/22447415/Desmopressin_orally_disintegrating_tablet_effectively_reduces_nocturia:_results_of_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://doi.org/10.1002/nau.22243 DB - PRIME DP - Unbound Medicine ER -