39. SYSTEMATIC REVIEW OF THE EFFICARY, SAFETY AND COST-EFFECTIVENESS OF MIRABEGRON IN COMPARISON WITH SOLIFENACIN IN THE TREATMENT OF OVERACTIVE BLADDER

Kieu Thi Tuyet Mai1, Nguyen Cong Minh1, Cao Thi Thuy Linh1, Le Hong Minh2, Nguyen Phuong Chi1
1 Hanoi University of Pharmacy
2 Health Economics Research and Assessment Center

Main Article Content

Abstract

Background: Overactive bladder is a common syndrome, causing a significant burden regarding both health and cost for patients. Mirabegron is a new drug with many clinical and economic advantages compared to the previous antimuscarinic group - represented by Solifenacin, the only drug that is co-paid by Vietnam Health Insurance. This systematic review was performed with the aim of systematically reviewing efficacy, safety, and cost-effectiveness evidences of Mirabegron versus Solifenacin for the treatment of overactive bladder.


Research methods: The literature was comprehensively searched across the databases PubMed and Web of Science up to October 2022. Studies were included if they reported the efficacy, safety, and cost-effectiveness of Mirabegron compared with Solifenacin cleared the inclusion and exclusion criteria. The CONSORT, STROBE and CHEERS checklists were used to assess study quality.


Research results: After two rounds of title/abstract and full text filtering, 16 studies were selected for the systematic review on efficacy and safety and 4 studies were selected for the systematic review on cost-effectiveness. Efficacy and safety studies, including clinical trials and observational studies, were conducted in many countries around the world in many different geographical areas. Studies show that Mirabegron is equally effective compared to Solifenacin, but Mirabegron’s tolerability is better. Cost-effectiveness studies show that Mirabegron is cost-effective compared to Solifenacin in the treatment of overactive bladder.


Conclusion: Studies worldwide show that Mirabegron is equally effective but has better tolerability and is cost-effective when compared to Mirabegron in the treatment of overactive bladder.

Article Details

References

[1] Abrams P, Kelleher C et al, 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, 2015, 67 (3), pp. 577-88.
[2] Batista JE, Kolbl H, Herschorn S et al, The efficacy and safety of Mirabegron compared with Solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial, Ther Adv Urol, 2015, 7 (4), pp. 167-79.
[3] Chen SF, Chuang YC, Wang CC et al, Therapeutic efficacy and cognitive adverse events of overactive bladder medication in patients with central nervous system Disorders-A cohort study, J. Formos Med Assoc, 2022, 121 (10), pp. 2101-2108.
[4] Drake M.J, Chapple C, Esen AA et al, 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, 2016, 70 (1), pp. 136-145.
[5] FDA, Precribing Information for MYRBETRIQ®, Retrieved 15/03/2022, from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202611s011lbl.pdf.
[6] Ganz ML, Smalarz AM et al, Economic costs of overactive bladder in the United States, Urology, 2010, 75 (3), pp. 526-32, 532 e1-18.
[7] Gormley, Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline, 2019, Retrieved 16/3/2022, from https://www.auanet.org /guidelines/overactivebladder-(oab)-guideline.
[8] 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 (4), pp. 501-509.
[9] Hakimi Z, Nazir J, McCrea C et al, Clinical and economic impact of Mirabegron compared with antimuscarinics for the treatment of overactive bladder in Canada, J. Med Econ, 2017, 20 (6), pp. 614-622.
[10] Herschorn S, Chapple C.R 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 (4), pp. 562-575.
[11] Inoue M, Yokoyama T, Comparison of Two Different Drugs for Overactive Bladder, Solifenacin and Mirabegron: A Prospective Randomized Crossover Study”, Acta Med Okayama, 2019, 73 (5), pp. 387-392.
[12] Irwin DE, Kopp ZS, Agatep B et al, Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction, BJU Int, 2011, 108 (7), pp. 1132-8.
[13] Kosilov K, Loparev S, Ivanovskaya M et al, 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, 2015, 61 (2), pp. 212-6.
[14] Maeda T, Kikuchi E, Hasegawa M et al, Solifenacin or Mirabegron could improve persistent overactive bladder symptoms after dutasteride treatment in patients with benign prostatic hyperplasia, Urology, 2015, 85 (5), pp. 1151-1155.
[15] Mueller E.R, van Maanen R et al, Long-term treatment of older patients with overactive bladder using a combination of Mirabegron and Solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study, Neurourol Urodyn, 2019, 38 (2), pp. 779-792.
[16] Nazir J, Berling M, McCrea C et al, Economic Impact of Mirabegron Versus Antimuscarinics for the Treatment of Overactive Bladder in the UK, Pharmacoecon Open, 2017, 1 (1), pp. 25-36.
[17] Ozkidik M, Coskun A, Asutay MK et al, Efficacy and tolerability of Mirabegron in female patients with overactive bladder symptoms after surgical treatment for stress urinary incontinence, Int Braz J. Urol, 2019, 45 (4), pp. 782-789.
[18] Schiavi M.C, Faiano P et al, Efficacy and tolerability of treatment with Mirabegron compared with Solifenacin in the management of overactive bladder syndrome: A retrospective analysis, J. Obstet Gynaecol Res, 2018, 44 (3), pp. 524-531.
[19] Tubaro A, Batista JE, Nitti VW et al, Efficacy and safety of daily Mirabegron 50 mg in male patients with overactive bladder: a critical analysis of five phase III studies, Ther Adv Urol, 2017, 9 (6), pp. 137-154.
[20] Wang CC, Lee CL, Hwang YT et al, Adding Mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder, Low Urin Tract Symptoms, 2021, 13 (4), pp. 440-447.
[21] White W.B, Chapple C et al, Cardiovascular Safety of the beta (3) - Adrenoceptor Agonist Mirabegron and the Antimuscarinic Agent Solifenacin in the SYNERGY Trial, J. Clin Pharmacol, 2018, 58 (8), pp. 1084-1091.
[22] Yamaguchi O, Kakizaki H et al, Safety and efficacy of Mirabegron as 'add-on' therapy in patients with overactive bladder treated with Solifenacin: a post-marketing, open-label study in Japan (MILAI study), BJU Int, 2015, 116 (4), pp. 612-22.