Meta-Analysis of the Efficacy and Safety of Mirabegron Add-On Therapy to Solifenacin for Overactive Bladder
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Purpose: We performed a meta-analysis to evaluate the efficacy and safety of mirabegron add-on therapy to solifenacin for patients with overactive bladder (OAB). Methods: We conducted a systematic literature review to identify all randomized, double-blind, controlled trials (RCTs) of this combination (mirabegron and solifenacin) for OAB. Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials were searched. A manual search was also performed to investigate relevant references from the retrieved studies. Results: Four publications describing 5 RCTs that compared combination therapy with solifenacin, including a total of 3,309 patients, were analyzed. The mean number of micturitions per 24 hours (mean difference [MD], -0.45; 95% confidence interval [CI], -0.65 to -0.26; P<0.00001), number of episodes of incontinence per 24 hours (MD, -0.71; 95% CI, -0.14 to -0.02; P=0.04), volume voided per micturition, and number of urgency episodes per 24 hours demonstrated that combination therapy was more effective than solifenacin therapy alone. Safety assessments, including common treatment-emergent adverse events (odds ratio, 1.09; 95% CI, 0.95–1.27; P=0.23) and discontinuations due to adverse events (P=0.30), demonstrated that the combination therapy was well tolerated. Conclusions: This meta-analysis suggests that mirabegron therapy as an add-on to solifenacin provides a satisfactory therapeutic effect for OAB symptoms with a low occurrence of side effects.
Abstract
Purpose: We performed a meta-analysis to evaluate the efficacy and safety of mirabegron add-on therapy to solifenacin for patients with overactive bladder (OAB). Methods: We conducted a systematic literature review to identify all randomized, double-blind, controlled trials (RCTs) of this combination (mirabegron and solifenacin) for OAB. Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials were searched. A manual search was also performed to investigate relevant references from the retrieved studies. Results: Four publications describing 5 RCTs that compared combination therapy with solifenacin, including a total of 3,309 patients, were analyzed. The mean number of micturitions per 24 hours (mean difference [MD], -0.45; 95% confidence interval [CI], -0.65 to -0.26; P<0.00001), number of episodes of incontinence per 24 hours (MD, -0.71; 95% CI, -0.14 to -0.02; P=0.04), volume voided per micturition, and number of urgency episodes per 24 hours demonstrated that combination therapy was more effective than solifenacin therapy alone. Safety assessments, including common treatment-emergent adverse events (odds ratio, 1.09; 95% CI, 0.95–1.27; P=0.23) and discontinuations due to adverse events (P=0.30), demonstrated that the combination therapy was well tolerated. Conclusions: This meta-analysis suggests that mirabegron therapy as an add-on to solifenacin provides a satisfactory therapeutic effect for OAB symptoms with a low occurrence of side effects.
참고문헌 (27)
- Abrams P, "The standardisation of terminology of lower urinary tract function : report from the Standardisation Subcommittee of the International Continence Society", Neurourol Urodyn, 21, pp.167~178 (2002)
- Sacco E, "Social, economic, and health utility considerations in the treatment of overactive bladder", Open Access J Urol, 2, pp.11~24 (2010)
- Homma Y, "An epidemiological survey of overactive bladder symptoms in Japan", BJU Int, 96, pp.1314~1318 (2005)
- Benner JS, "Patient-reported reasons for discontinuing overactive bladder medication", BJU Int, 105, pp.1276~1282 (2010)
- Cui Y, "The efficacy and safety of mirabegron in treating OAB : a systematic review and meta-analysis of phase III trials", Int Urol Nephrol, 46, pp.275~284 (2014)
- ethyl} acetanilide (YM178), a novel selective beta3-adrenoceptor agonist, on bladder function, "J Pharmacol Exp Ther", 2007, 642~647
- Serati M, "Is mirabegron equally as effective when used as first- or second-line therapy in women with overactive bladder?", Int Urogynecol J, 28, pp.1033~1039 (2017)
- Nomura Y, "Pharmacokinetic drug interaction study between overactive bladder drugs mirabegron and tolterodine in Japanese healthy postmenopausal females", Drug Metab Pharmacokinet, 31, pp.411~416 (2016)
- Jadad AR., "Randomised controlled trials" (1998), BMJ Publishing Group
- DerSimonian R, "Meta-analysis in clinical trials", Control Clin Trials, 7, pp.177~188 (1986)
- Higgins JP, "Measuring inconsistency in meta-analyses", BMJ, 327, pp.557~560 (2003)
- Drake MJ, "Efficacy and safety of mirabegron add-on therapy to solifenacin in incontinent overactive bladder patients with an inadequate response to initial 4-week solifenacin monotherapy : a randomised double-blind multicentre phase 3B study(BESIDE)", Eur Urol, 70, pp.136~145 (2016)
- Abrams P, "Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony)", Eur Urol, 67, pp.577~588 (2015)
- Kosilov K, "A randomized, controlled trial of effectiveness and safety of management of OAB symptoms in elderly men and women with standard-dosed combination of solifenacin and mirabegron", Arch Gerontol Geriatr, 61, pp.212~216 (2015)
- Sender Herschorn, "Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study)", BJU International, 120(4), pp.562~575 (2017), Wiley-Blackwell[DOI]
- Agarwal A, "What is the most bothersome lower urinary tract symptom? Individual-and population-level perspectives for both men and women", Eur Urol, 65, pp.1211~1217 (2014)
- Cornu JN, "Combination of solifenacin and mirabegron for overactive bladder management", BJU Int, 116, pp.498~499 (2015)
- Griebling TL., "Re: A randomized, controlled trial of effectiveness and safety of management of OAB symptoms in elderly men and women with standard-dosed combination of solifenacin and mirabegron", J Urol, 195, pp.1834~ (2016)
- Abrams P, "Combination treatment with mirabegron and solifenacin in patients with overactive bladder: exploratory responder analyses of efficacy and evaluation of patient-reported outcomes from a randomized, double-blind, factorial, dose-ranging, Phase II study (SYMPHONY)", World J Urol, 35, pp.827~838 (2017)
- Yamaguchi O, "Safety and efficacy of mirabegron as ‘add-on’ therapy in patients with overactive bladder treated with solifenacin: a postmarketing, open-label study in Japan (MILAI study)", BJU Int, 116, pp.612~622 (2015)
- Imamura T, "Combined treatment with a β3-adrenergic receptor agonist and a muscarinic receptor antagonist inhibits detrusor overactivity induced by cold stress in spontaneously hypertensive rats", Neurourol Urodyn, 36, pp.1026~1033 (2017)
- Lips KS, "Acetylcholine and molecular components of its synthesis and release machinery in the urothelium", Eur Urol, 51, pp.1042~1053 (2007)
- Iijima K, "Effects of the M3 receptor selective muscarinic antagonist darifenacin on bladder afferent activity of the rat pelvic nerve", Eur Urol, 52, pp.842~847 (2007)
- Otsuka A, "Expression and functional role of beta-adrenoceptors in the human urinary bladder urothelium", Naunyn Schmiedebergs Arch Pharmacol, 377, pp.473~481 (2008)
- Frazier EP, "Signal transduction underlying the control of urinary bladder smooth muscle tone by muscarinic receptors and beta-adrenoceptors", Naunyn Schmiedebergs Arch Pharmacol, 377, pp.449~462 (2008)
- Chapple CR, "The effects of antimuscarinic treatments in overactive bladder : an update of a systematic review and meta-analysis", Eur Urol, 54, pp.543~562 (2008)
