The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.
Results of a Randomized Phase III Trial of Mirabegron in Patients with Overactive Bladder
Abstract
PURPOSE: Many patients with overactive bladder discontinue pharmacotherapy due to suboptimal efficacy or side effects. Mirabegron, a β3-adrenoceptor agonist, may offer an effective and well tolerated alternative treatment for overactive bladder. MATERIALS AND METHODS: A randomized, double-blind, placebo controlled trial was conducted in the United States and Canada. After a 2-week placebo run-in period, adults with overactive bladder symptoms for 3 or more months were randomized 1:1:1 to receive placebo, 50 or 100 mg mirabegron once daily for 12 weeks. Efficacy data were collected via patient completed diaries and quality of life assessments. Co-primary efficacy end points were changes from baseline to final visit in mean number of incontinence episodes per 24 hours and micturitions per 24 hours. Key secondary micturition and incontinence end points were also evaluated. Safety assessments included treatment emergent adverse events, laboratory assessments, vital signs, electrocardiograms and post-void residual volume. RESULTS: Compared to placebo, 50 and 100 mg mirabegron groups demonstrated statistically significantly greater mean decreases (95% CI) from baseline for incontinence episodes (-1.13 [-1.35, -0.91], -1.47 [-1.69, -1.25] and -1.63 [-1.86, -1.40]) and micturitions (-1.05 [-1.31, -0.79], -1.66 [-1.92, -1.40] and -1.75 [-2.01, -1.48]) per 24 hours (p <0.05). Significant improvements in all key secondary end points were observed for both mirabegron doses vs placebo. The incidence of frequently reported treatment emergent adverse events (hypertension, urinary tract infection, headache, nasopharyngitis) was similar in the mirabegron and placebo groups. Dry mouth was reported for 1.5%, 0.5% and 2.1% of patients in the placebo, 50 and 100 mg mirabegron groups, respectively. CONCLUSIONS: Once daily mirabegron in a 50 or 100 mg dose is an effective treatment for overactive bladder symptoms with a low occurrence of side effects.
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Cites
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Chapple, C. R., Khullar, V., Gabriel, Z., Muston, D., Bitoun, C. E., & Weinstein, D. (2008) · European Urology · doi:10.1016/j.eururo.2008.06.047 · Cited by 769
Patient‐reported reasons for discontinuing overactive bladder medication
Benner, J. S., Nichol, M. B., Rovner, E. S., Jumadilova, Z., Alvir, J., Hussein, M., Fanning, K., Trocio, J. N., & Brubaker, L. (2010) · BJU International · doi:10.1111/j.1464-410x.2009.09036.x · Cited by 392
CARDOZO, L., LISEC, M., MILLARD, R., van VIERSSEN TRIP, O., KUZMIN, I., DROGENDIJK, T. E., HUANG, M., & RIDDER, A. M. (2004) · Journal of Urology · doi:10.1097/01.ju.0000140729.07840.16 · Cited by 335
Takasu, T., Ukai, M., Sato, S., Matsui, T., Nagase, I., Maruyama, T., Sasamata, M., Miyata, K., Uchida, H., & Yamaguchi, O. (2007) · The Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.106.115840 · Cited by 311
Sexton, C. C., Notte, S. M., Maroulis, C., Dmochowski, R. R., Cardozo, L., Subramanian, D., & Coyne, K. S. (2011) · International Journal of Clinical Practice · doi:10.1111/j.1742-1241.2010.02626.x · Cited by 254
D'Souza, A. O., Smith, M. J., Miller, L.-A., Doyle, J., & Ariely, R. (2008) · Journal of Managed Care Pharmacy · doi:10.18553/jmcp.2008.14.3.291 · Cited by 213
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Self-citationThe responsiveness of the Overactive Bladder Questionnaire (OAB-q)
Coyne, K. S., Matza, L. S., & Thompson, C. L. (2005) · Quality of Life Research · doi:10.1007/s11136-004-0706-1 · Cited by 136
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Cited by
Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline
Gormley, E. A., Lightner, D. J., Burgio, K. L., Chai, T. C., Clemens, J. Q., Culkin, D. J., Das, A. K., Foster, H. E., Scarpero, H. M., Tessier, C. D., et al. (2012) · Journal of Urology · doi:10.1016/j.juro.2012.09.079 · Cited by 710
Chapple, C. R., Kaplan, S. A., Mitcheson, D., Klecka, J., Cummings, J., Drogendijk, T., Dorrepaal, C., & Martin, N. (2013) · European Urology · doi:10.1016/j.eururo.2012.10.048 · Cited by 364
Self-citationClinical guideline for female lower urinary tract symptoms
TAKAHASHI, S., TAKEI, M., NISHIZAWA, O., YAMAGUCHI, O., KATO, K., GOTOH, M., YOSHIMURA, Y., TAKEYAMA, M., OZAWA, H., SHIMADA, M., et al. (2016) · LUTS: Lower Urinary Tract Symptoms · doi:10.1111/luts.12111 · Cited by 47
Metadata
- Authors
- Nitti, V. W., Auerbach, S., Martin, N., Calhoun, A., Lee, M., & Herschorn, S.
- Venue
- Journal of Urology
- Published
- 2013-04
- Volume
- 189
- Issue
- 4
- Pages
- 1388-1395
- ISSN
- 0022-5347 (ISSN-L)
- 1527-3792
- OpenAlex
- W2110991424
- Cited by
- 375
- References
- 10
- FWCI
- 46.26
- Type
- journal article
- Language
- en
- Open access
- closed
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