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Sumário

Review Article • Rev Bras Ginecol Obstet 45 (6) • 2023 • https://doi.org/10.1055/s-0043-1770093 copiar

Mirabegron e anticolinérgicos no tratamento da síndrome da bexiga hiperativa: metanálise

Autoria SCIMAGO INSTITUTIONS RANKINGS

Resumo

Objetivo

Comparar o uso de mirabegrom com anticolinérgicos para o tratamento da bexiga hiperativa (BH).

Fonte de Dados

Buscas sistemáticas foram realizadas nas bases de dados EMBASE, PUBMED, Cochrane e LILACS desde o início até setembro de 2021. Incluímos ECR, mulheres com sintomas de BH clinicamente comprovados, estudos que compararam mirabegrom a medicamentos antimuscarínicos e avaliaram a eficácia, segurança ou adesão.

Coleta de Dados

RevMan 5.4 foi usado para combinar os resultados entre os estudos. Derivamos razões de risco (RRs) e diferenças médias com intervalo de confiança (IC) de 95% usando um modelo meta-analítico de efeitos aleatórios. Cochrane Collaboration Tool e GRADE foi aplicado para risco de viés e qualidade da evidência.

Síntese dos Dados

Foram incluídos 14 estudos com um total de 10.774 pacientes. Menos eventos adversos totais foram relatados no grupo mirabegrom do que no grupo antimuscarínicos [RR: 0,93 (0,89–0,98)]. O risco de distúrbios do trato gastrointestinal e boca seca foram menores com mirabegrom [RR: 0,58 (0,48–0,68); 9.375 pacientes; RR: 0,44 (0,35–0,56), 9.375 pacientes, respectivamente]. Nenhuma diferença foi relatada entre mirabegrom e drogas antimuscarínicos para eficácia. A adesão ao tratamento foi de 87,7% em ambos os grupos [RR: 0,99 (0,98–1,00)].

Conclusão

Mirabegrom e antimuscarínicos têm eficácia e taxas de adesão comparáveis, porém o mirabegrom apresentou menos eventos adversos totais e isolados.

Palavras-chave
antimuscarínicos; metanálise; mirabegrom; bexiga hiperativa

Author, year	Country	Intervention group	Comparator group	Number of patients in the intervention group		Number of patients in the comparator group	Percentage of women in the intervention group		Percentage of women in the comparator group	Age of patients in the intervention group (years), mean (SD)		Age of patients in the comparator group (years), mean (SD)
Author, year	Country	Intervention group	Comparator group	MIRA 25mg	MIRA 50mg	Number of patients in the comparator group	MIRA 25mg	MIRA 50mg	Percentage of women in the comparator group	MIRA 25mg	MIRA 50mg	Age of patients in the comparator group (years), mean (SD)
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

		Number of included studies	Number of patients evaluated		Estimated Effect (95% CI)	GRADE	Heterogeneity
		Number of included studies	Mirabegron	Antimuscarinics	Estimated Effect (95% CI)	GRADE	I²	P
Efficacy	Number of urinations/24h	9	4232	3960	MD: -0.00 (-0.16 to 0.16)	Low	47%	0.04
	Urge incontinence episodes/24h	7	2281	1906	MD: 0.08 (-0.02 to 0.17)	Low	0%	0.95
	Emergency episodes/24h	8	3926	3656	MD: 0.04 (-0.10 to 0.19)	Low	0%	0.55
	Episodes of urine leakage/24h	9	2808	2477	MD: 0.06 (-0.09 to 0.20)	Low	34%	0.13
Safety	Total Side Effects	11	1879/4979 (37.7%)	1898/4476 (42.4%)	RR: 0.93 (0.89 to 0.98)	Low	7%	0.38
	Gastrointestinal tract disorders (general)	10	340/4939 (6.9%)	556/4436 (12.5%)	RR: 0.58 (0.48 to 0.68)	Low	31%	0.14
	Dry mouth	10	180/4939 (3.6%)	400/4436 (9.0%)	RR: 0.44 (0.35 to 0.56)	Low	34%	0.11
	Constipation	10	120/4939 (2.4%)	119/4436 (2.7%)	RR: 0.95 (0.73 to 1.22)	Low	0%	0.97
	Diarrhea	2	18/1117 (1.6%)	20/1115 (1.8%)	RR: 0.90 (0.48 to 1.69)	Low	0%	0.78
	Dyspepsia	4	10/2265 (0.4%)	14/1755 (0.8%)	RR: 0.74 (0.32 to 1.72)	Very Low	0%	0.97
	Nausea	2	10/648 (1.5%)	9/410 (2.2%)	RR: 0.76 (0.30 to 1.89)	Low	0%	0.91
	CNS disorders (general)	9	217/4560 (4.8%)	172/4061 (4.2%)	RR: 1,14 (0.93 to 1.39)	Low	0%	0.81
	Headache	7	117/3349 (3.5%)	93/3267 (2.8%)	RR: 1.22 (0.93 to 1.61)	Low	0%	0.91
	Dizziness	5	38/1967 (1.9%)	34/1884 (1.8%)	RR: 1.00 (0.61 to 1.62)	Low	0%	0.55
	Somnolence	3	44/1469 (3.0%)	30/1051 (2.9%)	RR: 1.03 (0.58 to 1.82)	Low	28%	0.25
	Visual blur	4	20/2255 (0.9%)	18/1995 (0.9%)	RR: 1.12 (0.60 to 2.08)	Low	0%	0.69
	Nasopharyngitis	5	81/2131 (3.8%)	76/2292 (3.3%)	RR: 1.18 (0.87 to 1.61)	Low	0%	0.96
	Urinary retention	5	4/3217 (0.1%)	10/2797 (0.4%)	RR: 0.41 (0.14 to 1.26)	Low	0%	0.77
	Urinary tract infection	7	165/3795 (4.3%)	183/3605 (5.1%)	RR: 0.87 (0.70 to 1.07)	Low	0%	0.97
	Cardiac disorders	10	147/4939 (3.0%)	142/4436 (3.2%)	RR: 1.00 (0.74 to 1.35)	Low	18%	0.26
	Hypertension	9	175/4610 (3.8%)	202/4351 (4.6%)	RR: 0.93 (0.76 to 1.13)	Low	0%	0.50
Adherence		11	4175/4762 (87.7%)	3549/4046 (87.7%)	RR: 0.99 (0.98 to 1.00)	Low	2%	0.43

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