Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder in Asia

Neurourology and Urodynamics

Volumn 34, Issue 7, 2015, Pages 685-692

  Kuo, Hann Chorng ^a   Lee, Kyu Sung ^b   Na, Yanqun ^c   Sood, Rajeev ^d   Nakaji, Shigeru ^e   Kubota, Yosuke ^f   Kuroishi, Kentarou ^f  

^a TZU CHI UNIVERSITY   (Taiwan)

^b Sungkyunkwan University School of Medicine   (South Korea)

^c PEKING UNIVERSITY PEOPLE S HOSPITAL   (China)

^d DR RAM MANOHAR LOHIA HOSPITAL   (India)

^e Astellas Pharma China Inc   (China)

^f ASTELLAS PHARMA INC   (Japan)

Author keywords

clinical trial; efficacy; mirabegron; overactive bladder; phase III; randomized; safety

Indexed keywords

MIRABEGRON; PLACEBO; TOLTERODINE; ACETANILIDE DERIVATIVE; BETA 3 ADRENERGIC RECEPTOR STIMULATING AGENT; MUSCARINIC RECEPTOR BLOCKING AGENT; THIAZOLE DERIVATIVE; URINARY TRACT AGENT;

ADULT; AGED; ARTICLE; CHINA; CONSTIPATION; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ELEVATED BLOOD PRESSURE; FAINTNESS; FEMALE; HEART ARRHYTHMIA; HUMAN; HYPERTENSION; INDIA; KOREA; MAJOR CLINICAL STUDY; MALE; MICTURITION; MULTICENTER STUDY; NOCTURIA; OVERACTIVE BLADDER; PHASE 3 CLINICAL TRIAL; QT PROLONGATION; QUALITY OF LIFE ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; TAIWAN; TREATMENT DURATION; TREATMENT WITHDRAWAL; URGE INCONTINENCE; URINARY URGENCY; URINE INCONTINENCE; URINE VOLUME; XEROSTOMIA; ASIA; BLADDER; CLINICAL TRIAL; CONVALESCENCE; DRUG EFFECTS; MIDDLE AGED; PATHOPHYSIOLOGY; QUALITY OF LIFE; QUESTIONNAIRE; TIME FACTOR; TREATMENT OUTCOME; URINARY BLADDER, OVERACTIVE; URODYNAMICS;

ACETANILIDES; ADRENERGIC BETA-3 RECEPTOR AGONISTS; ADULT; AGED; ASIA; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; QUALITY OF LIFE; RECOVERY OF FUNCTION; SURVEYS AND QUESTIONNAIRES; THIAZOLES; TIME FACTORS; TOLTERODINE TARTRATE; TREATMENT OUTCOME; URINARY BLADDER; URINARY BLADDER, OVERACTIVE; URINATION; URODYNAMICS; UROLOGICAL AGENTS;

EID: 84939267730     PISSN: 07332467     EISSN: 15206777     Source Type: Journal    
DOI: 10.1002/nau.22645     Document Type: Article

References (23)

1. Abrams P, Cardozo L, Fall M, et al., The standardisation of terminology of lower urinary tract function: Report from the Standardisation Sub-Committee of the International Continence Society. Am J Obstet Gynecol 2002; 187: 116-26.
2. 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: 1132-38.
3. Moorthy P, Lapitan MC, Quek PL, et al., Prevalence of overactive bladder in Asian men: An epidemiological survey. BJU Int 2004; 93: 528-31.
4. Yamaguchi O, Nishizawa O, Takeda M, et al., Clinical guidelines for overactive bladder. Int J Urol 2009; 16: 126-42.
5. Benner JS, Nichol MB, Rovner ES, et al., Patient reported reasons for discontinuing overactive bladder medication. BJU Int 2010; 105: 1276-82.
6. D'Souza AO, Smith MJ, Miller LA, et al., Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. J Manag Care Pharm 2008; 14: 291-301.
7. Brostrom S, Hallas J,. Persistence of antimuscarinic drug use. Eur J Clin Pharmacol 2009; 65: 309-14.
8. Yamaguchi O,. β3-adrenoceptors in human detrusor muscle. Urology 2002; 59: 25-9.
9. Yamanishi T, Chapple CR, Yasuda K, et al., Role of beta-adrenoceptor subtypes in mediating relaxation of the pig bladder trigonal muscle in vitro. Neurourol Urodyn 2003; 22: 338-42.
10. Yamaguchi O, Chapple CR,. β3-adrenoceptors in urinary bladder. Neurourol Urodyn 2007; 26: 752-56.
11. Aizawa N, Igawa Y, Nishizawa O, et al., Effects of CL316,243, a beta 3-adrenoceptor agonist, and intravesical prostaglandin E2 on the primary bladder afferent activity of the rat. Neurourol Urodyn 2010; 29: 771-76.
12. Takasu T, Ukai M, Sato S, et al., Effect of (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(2-hydroxy-2-phenylethyl) amino]ethyl} acetanilide (YM178), a novel selective beta3-adrenoceptor agonist, on bladder function. J Pharmacol Exp Ther 2007; 321: 642-7.
13. Nitti VW, KHullar V, van Kerrebroeck P, et al., Mirabegron for the treatment of overactive bladder: A prespecified pooled efficacy analysis and pooled safety analysis of three randomised, double-blind, placebo-controlled, phase III studies. Int J Clin Pract 2013; 67: 619-32.
14. Khullar V, Amarenco G, Angulo JC, et al., Efficacy and tolerability of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder: Results from a randomised European-Australian Phase 3 trial. Eur Urol 2013; 63: 283-95.
15. Herschorn S, Barkin J, Castro-Diaz D, et al., A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta-3 adrenoceptor agonist, mirabegron in patients with symptoms of overactive bladder. Urology 2013; 82: 313-20.
16. Nitti V, Auerbach S, Martin N, et al., Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol 2013; 189: 1388-95.
17. Yamaguchi O, Marui E, Kakizaki H, et al., Phase III, randomised, double-blind, placebo-contrplled study of the β3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder. BJU Int 2014; 113: 951-60.
18. Chapple CR, Khullar V, Gabriel Z, et al., The effects of antimuscarinic treatments in overactive bladder: An update of a systematic review and meta-analysis. Eur Urol 2008; 54: 543-62.
19. Kelleher CJ, Pleil AM, Reese PR, et al., How much is enough and who says so? The case of the King's Health Questionnaire and overactive bladder. BJOG 2004; 111: 605-12.
20. Lee S, Malholtra B, Creanga D, et al., A meta-analysis of the placebo response in antimuscarinic drug trials for overactive bladder. BMC Med Res Methodol 2009; 9: 55.
21. Mangera A, Chapple CR, Kopp ZS, et al., The placebo effect in overactive bladder syndrome. Nat Rev Urol 2011; 8: 495-503.
22. Nabi G, Cody JD, Ellis G, et al., Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database Syst Rev 2006; (4): CD003781.
23. Yalcin I, Bump RC,. The effect of previous treatment experience and incontinence severity on the placebo response of stress urinary incontinence. Am J Obstet Gynecol 2004; 191: 194-97.