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Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study.
J Urol. 2013 Sep; 190(3):965-72.JU

Abstract

PURPOSE

We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).

MATERIALS AND METHODS

In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo. The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.

RESULTS

The full analysis set comprised 385 men (age range 20 to 87 years). The 50 and 75 μg doses significantly reduced the number of nocturnal voids (-0.37, p <0.0001 and -0.41, p = 0.0003, respectively) and increased the odds of a 33% or greater response (OR 1.98, p = 0.0009 and OR 2.04, p = 0.0004, respectively) compared with placebo during 3 months. Desmopressin 50 and 75 μg increased the time to first void from baseline by approximately 40 minutes compared to placebo (p = 0.006 and p = 0.003, respectively). The response to desmopressin was seen by 1 week of treatment and was sustained. Significant increases in health related quality of life and sleep quality were observed compared to placebo. Desmopressin was well tolerated as only 2 subjects (age 74 and 79 years) on 50 μg had a serum sodium level of less than 130 mmol/L (vs 9 subjects on 75 μg).

CONCLUSIONS

Desmopressin (orally disintegrating tablet) is an effective and well tolerated treatment for men with nocturia. Treatment with 50 μg desmopressin, the minimum effective dose, provided sustained improvement of nocturia throughout the study and meaningful benefits to patients with an improved safety profile.

Authors+Show Affiliations

Department of Urology, SUNY Downstate College of Medicine, Brooklyn, New York 11203, USA. urojock@aol.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

23454402

Citation

Weiss, Jeffrey P., et al. "Efficacy and Safety of Low Dose Desmopressin Orally Disintegrating Tablet in Men With Nocturia: Results of a Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Study." The Journal of Urology, vol. 190, no. 3, 2013, pp. 965-72.
Weiss JP, Herschorn S, Albei CD, et al. Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013;190(3):965-72.
Weiss, J. P., Herschorn, S., Albei, C. D., & van der Meulen, E. A. (2013). Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. The Journal of Urology, 190(3), 965-72. https://doi.org/10.1016/j.juro.2012.12.112
Weiss JP, et al. Efficacy and Safety of Low Dose Desmopressin Orally Disintegrating Tablet in Men With Nocturia: Results of a Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Study. J Urol. 2013;190(3):965-72. PubMed PMID: 23454402.
* 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 men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. AU - Weiss,Jeffrey P, AU - Herschorn,Sender, AU - Albei,Cerasela D, AU - van der Meulen,Egbert A, Y1 - 2013/02/20/ PY - 2012/12/19/received PY - 2012/12/19/accepted PY - 2013/3/5/entrez PY - 2013/3/5/pubmed PY - 2013/12/16/medline KW - ADR KW - AE KW - BOO KW - BPH KW - FAS KW - N-QoL KW - ODT KW - QoL KW - WPAI KW - adverse drug reaction KW - adverse event KW - benign prostatic hyperplasia KW - bladder outlet obstruction KW - deamino arginine vasopressin KW - full analysis set KW - nocturia KW - nocturia quality of life KW - orally disintegrating tablet KW - quality of life KW - sleep KW - work productivity and activity impairment SP - 965 EP - 72 JF - The Journal of urology JO - J Urol VL - 190 IS - 3 N2 - PURPOSE: We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids). MATERIALS AND METHODS: In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo. The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period. RESULTS: The full analysis set comprised 385 men (age range 20 to 87 years). The 50 and 75 μg doses significantly reduced the number of nocturnal voids (-0.37, p <0.0001 and -0.41, p = 0.0003, respectively) and increased the odds of a 33% or greater response (OR 1.98, p = 0.0009 and OR 2.04, p = 0.0004, respectively) compared with placebo during 3 months. Desmopressin 50 and 75 μg increased the time to first void from baseline by approximately 40 minutes compared to placebo (p = 0.006 and p = 0.003, respectively). The response to desmopressin was seen by 1 week of treatment and was sustained. Significant increases in health related quality of life and sleep quality were observed compared to placebo. Desmopressin was well tolerated as only 2 subjects (age 74 and 79 years) on 50 μg had a serum sodium level of less than 130 mmol/L (vs 9 subjects on 75 μg). CONCLUSIONS: Desmopressin (orally disintegrating tablet) is an effective and well tolerated treatment for men with nocturia. Treatment with 50 μg desmopressin, the minimum effective dose, provided sustained improvement of nocturia throughout the study and meaningful benefits to patients with an improved safety profile. SN - 1527-3792 UR - https://www.unboundmedicine.com/medline/citation/23454402/Efficacy_and_safety_of_low_dose_desmopressin_orally_disintegrating_tablet_in_men_with_nocturia:_results_of_a_multicenter_randomized_double_blind_placebo_controlled_parallel_group_study_ L2 - https://www.jurology.com/doi/10.1016/j.juro.2012.12.112?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -