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Urodynamics and safety of the β₃-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction.
J Urol. 2013 Oct; 190(4):1320-7.JU

Abstract

PURPOSE

Bladder outlet obstruction often presents as storage and voiding symptoms. We investigated urodynamic parameters in men with lower urinary tract symptoms and bladder outlet obstruction treated with the β₃ agonist mirabegron, a new therapy for overactive bladder symptoms.

MATERIALS AND METHODS

A total of 200 men 45 years old or older with lower urinary tract symptoms and bladder outlet obstruction were randomized to receive once daily mirabegron 50 mg (70) or 100 mg (65), or placebo (65) for 12 weeks. The primary urodynamic parameters assessed were change from baseline to end of treatment in maximum urinary flow and detrusor pressure at maximum urinary flow (noninferiority margins -3 ml per second and 15 cm H2O, respectively). We evaluated adverse events and vital signs.

RESULTS

Treatment with mirabegron 50 and 100 mg was noninferior to placebo based on the lower and upper limits of the 95% CI, respectively, for maximum urinary flow and detrusor pressure at maximum urinary flow. The adjusted mean difference vs placebo was 0.40 (95% CI -0.63, 1.42) and 0.62 ml per second (95% CI -0.43, 1.68) for maximum urinary flow, and -5.94 (95% CI -13.98, 2.09) and -1.39 cm H2O (95% CI -9.73, 6.96), respectively, for detrusor pressure at maximum urinary flow. The incidence of adverse events was similar for mirabegron and placebo.

CONCLUSIONS

Mirabegron did not adversely affect voiding urodynamics (maximum urinary flow and detrusor pressure at maximum urinary flow) compared with placebo after 12 weeks of treatment.

Authors+Show Affiliations

Department of Urology, New York University Langone Medical Center, New York, New York. Electronic address: victor.nitti@nyumc.org.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23727415

Citation

Nitti, Victor W., et al. "Urodynamics and Safety of the Β₃-adrenoceptor Agonist Mirabegron in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction." The Journal of Urology, vol. 190, no. 4, 2013, pp. 1320-7.
Nitti VW, Rosenberg S, Mitcheson DH, et al. Urodynamics and safety of the β₃-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013;190(4):1320-7.
Nitti, V. W., Rosenberg, S., Mitcheson, D. H., He, W., Fakhoury, A., & Martin, N. E. (2013). Urodynamics and safety of the β₃-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. The Journal of Urology, 190(4), 1320-7. https://doi.org/10.1016/j.juro.2013.05.062
Nitti VW, et al. Urodynamics and Safety of the Β₃-adrenoceptor Agonist Mirabegron in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction. J Urol. 2013;190(4):1320-7. PubMed PMID: 23727415.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Urodynamics and safety of the β₃-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. AU - Nitti,Victor W, AU - Rosenberg,Steven, AU - Mitcheson,David H, AU - He,Weizhong, AU - Fakhoury,Allam, AU - Martin,Nancy E, Y1 - 2013/05/30/ PY - 2013/05/17/accepted PY - 2013/6/4/entrez PY - 2013/6/4/pubmed PY - 2013/12/16/medline KW - AE KW - BCI KW - BOO KW - BOO index KW - BOOI KW - BPH KW - BVE KW - ECG KW - FAS KW - LUTS KW - OAB KW - PPS KW - PVR KW - PdetQmax KW - Qmax KW - SAF KW - TEAE KW - adverse event KW - beats per minute KW - benign prostatic hyperplasia KW - bladder contractility index KW - bladder outlet obstruction KW - bladder voiding efficiency KW - bpm KW - detrusor pressure at Qmax KW - electrocardiogram KW - full analysis set KW - lower urinary tract symptoms KW - maximum urinary flow rate KW - mirabegron KW - overactive bladder KW - per protocol set KW - post-void residual urine KW - safety analysis set KW - treatment emergent AE KW - urinary bladder KW - urinary bladder neck obstruction KW - urodynamics SP - 1320 EP - 7 JF - The Journal of urology JO - J Urol VL - 190 IS - 4 N2 - PURPOSE: Bladder outlet obstruction often presents as storage and voiding symptoms. We investigated urodynamic parameters in men with lower urinary tract symptoms and bladder outlet obstruction treated with the β₃ agonist mirabegron, a new therapy for overactive bladder symptoms. MATERIALS AND METHODS: A total of 200 men 45 years old or older with lower urinary tract symptoms and bladder outlet obstruction were randomized to receive once daily mirabegron 50 mg (70) or 100 mg (65), or placebo (65) for 12 weeks. The primary urodynamic parameters assessed were change from baseline to end of treatment in maximum urinary flow and detrusor pressure at maximum urinary flow (noninferiority margins -3 ml per second and 15 cm H2O, respectively). We evaluated adverse events and vital signs. RESULTS: Treatment with mirabegron 50 and 100 mg was noninferior to placebo based on the lower and upper limits of the 95% CI, respectively, for maximum urinary flow and detrusor pressure at maximum urinary flow. The adjusted mean difference vs placebo was 0.40 (95% CI -0.63, 1.42) and 0.62 ml per second (95% CI -0.43, 1.68) for maximum urinary flow, and -5.94 (95% CI -13.98, 2.09) and -1.39 cm H2O (95% CI -9.73, 6.96), respectively, for detrusor pressure at maximum urinary flow. The incidence of adverse events was similar for mirabegron and placebo. CONCLUSIONS: Mirabegron did not adversely affect voiding urodynamics (maximum urinary flow and detrusor pressure at maximum urinary flow) compared with placebo after 12 weeks of treatment. SN - 1527-3792 UR - https://www.unboundmedicine.com/medline/citation/23727415/Urodynamics_and_safety_of_the_β₃_adrenoceptor_agonist_mirabegron_in_males_with_lower_urinary_tract_symptoms_and_bladder_outlet_obstruction_ L2 - https://www.jurology.com/doi/10.1016/j.juro.2013.05.062?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -