Chapple et al. (2013)88 Chapple CR, Dvorak V, Radziszewski P, et al; Dragon Investigator Group. A phase II dose-ranging study of mirabegron in patients with overactive bladder. Int Urogynecol J Pelvic Floor Dysfunct. 2013;24(09):1447-1458. Doi: 10.1007/s00192-013-2042-x https://doi.org/10.1007/s00192-013-2042-...
|
Multicentric |
MIRA 25 e 50mg |
TOL ER 4mg |
167 |
167 |
85 |
88% |
89.2% |
81.2% |
57,2 (12,1) |
56,9 (12,5) |
56,6 (12,8) |
Chapple et al. (2013)99 Chapple CR, Kaplan SA, Mitcheson D, et al. Randomized doubleblind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013;63(02):296-305. Doi: 10.1016/j.eururo.2012.10.048 https://doi.org/10.1016/j.eururo.2012.10...
|
Multicentric |
MIRA 50mg |
TOL ER 4mg |
NA |
812 |
812 |
NA |
74.1% |
73.9% |
NA |
59.2 (12.6) |
59.6 (12.5) |
Khullar et al. (2013)1010 Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a β(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013;63(02):283-295. Doi: 10.1016/j. eururo.2012.10.016 https://doi.org/10.1016/j.eururo.2012.10...
|
Multicentric |
MIRA 50mg |
TOL ER 4mg |
NA |
493 |
495 |
NA |
72.4% |
72.9% |
NA |
59.1 (12.3) |
59.1 (12.9) |
Yamaguchi et al. (2014)1111 Yamaguchi O, Marui E, Kakizaki H, et al. Phase III, randomised, double-blind, placebo-controlled study of the β3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder. BJU Int. 2014;113(06):951-960. Doi: 10.1111/bju.12649 https://doi.org/10.1111/bju.12649...
|
Multicentric |
MIRA 50mg |
TOL ER 4mg |
NA |
369 |
368 |
NA |
84.3% |
82.6% |
NA |
58.3 (13.9) |
58.3 (13.7) |
Abrams et al. (2015)1212 Abrams P, Kelleher C, Staskin D, et al. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: effi cacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015;67 (03):577-588. Doi: 10.1016/j.eururo.2014.02.012 https://doi.org/10.1016/j.eururo.2014.02...
|
Multicentric |
MIRA 25 e 50mg |
SOL 2.5mg, 5mg e 10mg |
77 |
78 |
313 |
67.5% |
66.67% |
66.1% |
55.2 (14.5) |
53.4 (14.0) |
54,88 (13,9) |
Batista et al. (2015)1313 Batista JE, Kölbl H, Herschorn S, et al; BEYOND study group. The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimus- carinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial. Ther Adv Urol. 2015;7(04): 167-179. Doi: 10.1177/1756287215589250 https://doi.org/10.1177/1756287215589250...
|
Multicentric |
MIRA 50mg |
SOL 5mg |
NA |
936 |
934 |
NA |
76.1% |
75.9% |
NA |
56.7 (14.3) |
57.4 (13.6) |
Kuo et al. (2015)1414 Kuo HC, Lee KS, Na Y, et al. Results ofa randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder in Asia. Neurourol Urodyn. 2015;34(07):685-692. Doi: 10.1002/nau.22645 https://doi.org/10.1002/nau.22645...
|
Multicentric |
MIRA 50mg |
TOL ER 4mg |
NA |
338 |
333 |
NA |
67.5% |
64% |
NA |
54.3 (14.2) |
53.9 (14.5) |
Kuo et al. (2015)1515 Kuo HC, Lin HH, Yu HJ, Cheng CL, Hung MJ, Lin AT. Results of a randomized, double-blind, placebo-controlled study of mirabe-gron in a Taiwanese population with overactive bladder and comparison with other clinical trials. Urol Sci. 2015;26(01): 41-48. Doi: 10.1016/j.urols.2014.12.010 https://doi.org/10.1016/j.urols.2014.12....
|
Multicentric |
MIRA 50mg |
TOL ER 4mg |
NA |
76 |
74 |
NA |
61.8% |
59.5% |
NA |
59.0 (15.1) |
56.4 (15.8) |
Vecchioli Scaldazza and Morosetti (2016)1616 Vecchioli Scaldazza C, Morosetti C. Comparison of therapeutic efficacy and urodynamic findings of solifenacin succinate versus mirabegron in women with overactive bladder syndrome: results ofa randomized controlled study. Urol Int. 2016;97(03):325-329. Doi: 10.1159/000445808 https://doi.org/10.1159/000445808...
|
Italy |
MIRA 50mg |
SOL 5mg |
NA |
31 |
29 |
NA |
100% |
100% |
NA |
56 (6.25) |
58 (7.0) |
Herschorn et al. (2017)1717 Herschorn S, Chapple CR, Abrams P, et al. Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study). BJU Int. 2017;120(04):562-575. Doi: 10.1111/bju.13882 https://doi.org/10.1111/bju.13882...
|
Multicentric |
MIRA 25 e 50mg |
SOL 5mg |
423 |
422 |
423 |
77.3% |
76.5% |
78.3% |
56.9 (13.6) |
56.7 (13.3) |
58.2 (12.8) |
Hsiao et al. (2018)1818 Hsiao SM, Chang TC, Chen CH, Wu WY, Lin HH. Comparisons of the clinical outcomes and urodynamic effects of mirabegron versus tolterodine treatment for female overactive bladder syndrome: a subgroup analysis ofa controlled, randomised, prospective study. Low Urin Tract Symptoms. 2018;10(03):215-220. Doi: 10.1111/luts.12167 https://doi.org/10.1111/luts.12167...
|
Multicentric |
MIRA 50mg |
TOL ER 4mg |
NA |
12 |
12 |
NA |
100% |
100% |
NA |
53 (3.5) |
48,75 (2.6) |
Gratzke et al. (2018)1919 Gratzke C, van Maanen R, Chapple C, et al. Long-term safety and efficacy of mirabegron and solifenacin in combination compared with monotherapy in patients with overactive bladder: a randomised, multicentre phase 3 study (SYNERGY II). Eur Urol. 2018;74(04):501-509. Doi: 10.1016/j.eururo.2018. 05.005 https://doi.org/10.1016/j.eururo.2018.05...
|
Multicentric |
MIRA 50mg |
SOL 5mg |
NA |
302 |
299 |
NA |
79% |
81% |
NA |
61 (10.7) |
60 (11.2) |
Staskin et al. (2018)2020 Staskin D, Herschorn S, Fialkov J, Tu LM, Walsh T, Schermer CR. A prospective, double-blind, randomized, two-period crossover, multicenter study to evaluate tolerability and patient preference between mirabegron and tolterodine in patients with overactive bladder (PREFER study). Int Urogynecol J Pelvic Floor Dysfunct. 2018;29(02):273-283. Doi: 10.1007/s00192-017-3377-5 https://doi.org/10.1007/s00192-017-3377-...
|
Multicentric |
MIRA 25mg |
TOL ER 4mg |
316 |
NA |
310 |
73.4% |
NA |
75.2% |
53.4 (13.9) |
NA |
53.2 (13.7) |
White et al. (2018)2121 White WB, Chapple C, Gratzke C, et al. Cardiovascular safety of the β3 -adrenoceptor agonist mirabegron and the antimuscarinic agent solifenacin in the SYNERGY trial. J Clin Pharmacol. 2018; 58(08):1084-1091. Doi: 10.1002/jcph.1107 https://doi.org/10.1002/jcph.1107...
|
Multicentric |
MIRA 25 e 50mg |
SOL 5mg |
423 |
422 |
423 |
77,3% |
76,5% |
78,3% |
56,9 |
56,7 |
58,2 |