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Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study.
J Urol. 2013 Sep; 190(3):958-64.JU

Abstract

PURPOSE

Previous studies suggest a lower dose of desmopressin orally disintegrating tablet may be effective in females compared to males with nocturia. We confirm the efficacy and safety of 25 μg desmopressin orally disintegrating tablet compared to placebo in female patients.

MATERIALS AND METHODS

In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids). The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).

RESULTS

The full analysis set comprised 261 patients (age range 19 to 87 years). Desmopressin significantly reduced the mean number of nocturnal voids and increased the odds of a 33% or greater response compared to placebo during 3 months, assessed by longitudinal analysis (-0.22, p = 0.028 and OR 1.85, p = 0.006, respectively). Desmopressin increased the mean time to first nocturnal void by 49 minutes compared to placebo at 3 months (p = 0.003). The response to desmopressin was seen by week 1 of treatment and was sustained throughout the trial. Significant increases in health related quality of life and sleep quality were observed compared to placebo. Desmopressin was well tolerated. Serum sodium levels remained greater than 125 mmol/L throughout the trial and 3 transient decreases to less than 130 mmol/L were recorded.

CONCLUSIONS

At a dose of 25 μg, desmopressin orally disintegrating tablet is an effective and well tolerated treatment for women with nocturia. Treatment provides rapid and sustained improvement in nocturia and quality of life.

Authors+Show Affiliations

NorthShore University HealthSystem, Evanston, Illinois 60201, USA. peterksand@gmail.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23454404

Citation

Sand, Peter K., et al. "Efficacy and Safety of Low Dose Desmopressin Orally Disintegrating Tablet in Women With Nocturia: Results of a Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Study." The Journal of Urology, vol. 190, no. 3, 2013, pp. 958-64.
Sand PK, Dmochowski RR, Reddy J, et al. Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013;190(3):958-64.
Sand, P. K., Dmochowski, R. R., Reddy, J., & van der Meulen, E. A. (2013). Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. The Journal of Urology, 190(3), 958-64. https://doi.org/10.1016/j.juro.2013.02.037
Sand PK, et al. Efficacy and Safety of Low Dose Desmopressin Orally Disintegrating Tablet in Women With Nocturia: Results of a Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Study. J Urol. 2013;190(3):958-64. PubMed PMID: 23454404.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. AU - Sand,Peter K, AU - Dmochowski,Roger R, AU - Reddy,Jyotsna, AU - van der Meulen,Egbert A, Y1 - 2013/02/20/ PY - 2013/02/13/received PY - 2013/02/13/accepted PY - 2013/3/5/entrez PY - 2013/3/5/pubmed PY - 2013/12/16/medline KW - ADR KW - AEs KW - MED KW - N-QoL KW - NP KW - OAB KW - ODT KW - QoL KW - WPAI KW - adverse drug reaction KW - adverse events KW - deamino arginine vasopressin KW - minimum effective dose KW - nocturia KW - nocturia quality of life KW - nocturnal polyuria KW - orally disintegrating tablet KW - overactive bladder KW - placebos KW - quality of life KW - work productivity and activity impairment SP - 958 EP - 64 JF - The Journal of urology JO - J Urol VL - 190 IS - 3 N2 - PURPOSE: Previous studies suggest a lower dose of desmopressin orally disintegrating tablet may be effective in females compared to males with nocturia. We confirm the efficacy and safety of 25 μg desmopressin orally disintegrating tablet compared to placebo in female patients. MATERIALS AND METHODS: In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids). The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders). RESULTS: The full analysis set comprised 261 patients (age range 19 to 87 years). Desmopressin significantly reduced the mean number of nocturnal voids and increased the odds of a 33% or greater response compared to placebo during 3 months, assessed by longitudinal analysis (-0.22, p = 0.028 and OR 1.85, p = 0.006, respectively). Desmopressin increased the mean time to first nocturnal void by 49 minutes compared to placebo at 3 months (p = 0.003). The response to desmopressin was seen by week 1 of treatment and was sustained throughout the trial. Significant increases in health related quality of life and sleep quality were observed compared to placebo. Desmopressin was well tolerated. Serum sodium levels remained greater than 125 mmol/L throughout the trial and 3 transient decreases to less than 130 mmol/L were recorded. CONCLUSIONS: At a dose of 25 μg, desmopressin orally disintegrating tablet is an effective and well tolerated treatment for women with nocturia. Treatment provides rapid and sustained improvement in nocturia and quality of life. SN - 1527-3792 UR - https://www.unboundmedicine.com/medline/citation/23454404/Efficacy_and_safety_of_low_dose_desmopressin_orally_disintegrating_tablet_in_women_with_nocturia:_results_of_a_multicenter_randomized_double_blind_placebo_controlled_parallel_group_study_ L2 - https://www.jurology.com/doi/10.1016/j.juro.2013.02.037?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -