Absence of clinically relevant cardiovascular interaction upon add-on of mirabegron or tamsulosin to an established tamsulosin or mirabegron treatment in healthy middle-aged to elderly men

International Journal of Clinical Pharmacology and Therapeutics

Volumn 52, Issue 8, 2014, Pages 693-701

  Van Gelderen, Marcel ^a   Tretter, Reiner ^a   Meijer, John ^a   Dorrepaal, Caroline ^a   Gangaram Panday, Shanti ^a   Brooks, Ashley ^b   Krauwinkel, Walter ^a   Dickinson, James ^a  

^a Astellas Pharma Global Development   (Netherlands)

^b 206 Carnegie Center   (United Kingdom)

Author keywords

Cardiovascular safety; Mirabegron; Overactive bladder; Tamsulosin

Indexed keywords

ACETANILIDES; ADULT; AGED; AREA UNDER CURVE; BLOOD PRESSURE; CROSS-OVER STUDIES; DRUG INTERACTIONS; EXERCISE TEST; HALF-LIFE; HEART RATE; HUMANS; MALE; MIDDLE AGED; SULFONAMIDES; THIAZOLES; UROLOGICAL AGENTS;

EID: 84905826940     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP201979     Document Type: Article

References (30)

1. Takasu T, Ukai M, Sato S, Matsui T, Nagase I, Maruyama T, Sasamata M, Miyata K, Uchida H, Yamaguchi O. Effect of (R)-2-(2-aminothiazol-4- yl)-4′-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl} acetanilide (YM178), a novel selective β3-adrenoceptor agonist, on bladder function. J Pharmacol Exp Ther. 2007; 321: 642-647. Cross-Ref PubMed (Pubitemid 46624504)
2. 3-adrenoceptors in urinary bladder. Neurourol Urodyn. 2007; 26: 752-756. CrossRef PubMed
3. Chapple CR, Amarenco G, López-Aramburu MA, Everaert K, Liehne J, Lucas M, Vik V, Ridder A, Snijder R, Yamaguchi O; BLOSSOM Investigator Group. A proof-of-concept study: Mirabegron, a new therapy for overactive bladder. Neurourol Urodyn. 2013; 32: 1116-1122. CrossRef PubMed
4. 3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013; 63: 283-295. CrossRef PubMed
5. Nitti VW, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol. 2013; 189: 1388-1395. CrossRef PubMed
6. Malik M, van Gelderen EM, Lee JH, Kowalski DL, Yen M, Goldwater R, Mujais SK, Schaddelee MP, de Koning P, Kaibara A, Moy SS, Keirns JJ. Proarrhythmic safety of repeat doses of mirabegron in healthy subjects: a randomized, double-blind, placebo-, and active-controlled thorough QT study. Clin Pharmacol Ther. 2012; 92: 696-706. CrossRef PubMed
7. Michel MC, Büscher R, Kerker J, Kraneis H, Erdbrügger W, Brodde OE. Alpha 1-adrenoceptor subtype affinities of drugs for the treatment of prostatic hypertrophy. Evidence for heterogeneity of chloroethylclonidine- resistant rat renal alpha 1-adrenoceptor. Naunyn Schmiedebergs Arch Pharmacol. 1993; 348: 385-395. CrossRef PubMed (Pubitemid 23297677)
8. 1-adrenoceptors to characterize subtype selectivity of drugs for the treatment of prostatic hypertrophy. Eur J Pharmacol. 1995; 288: 201-207. CrossRef PubMed
9. 1-blockers for BPH: are there differences? Eur Urol. 1999; 36 (Suppl 3): 52-63. doi:52349
10. Fine SR, Ginsberg P. Alpha-adrenergic receptor antagonists in older patients with benign prostatic hyperplasia: issues and potential complications. J Am Osteopath Assoc. 2008; 108: 333-337. PubMed
11. 1-adrenoceptor blocker tamsulosin in human liver microsomes. Xenobiotica. 1998; 28: 909-922. CrossRef PubMed
12. Lyseng-Williamson KA, Jarvis B, Wagstaff AJ. Tamsulosin: an update of its role in the management of lower urinary tract symptoms. Drugs. 2002; 62: 135-167. CrossRef PubMed (Pubitemid 34169429)
13. Franco-Salinas G, de la Rosette JJ, Michel MC. Pharmacokinetics and pharmacodynamics of tamsulosin in its modified-release and oral controlled absorption system formulations. Clin Pharmacokinet. 2010; 49: 177-188. CrossRef PubMed
14. Astellas Pharma US. Inc. 2012. Myrbetriq® US prescriber information. http://www.us.astellas.com/docs/myrbetriq-full-pi.pdf. Accessed 29 April 2013.
15. 3)-adrenoceptor agonist, after oral administration to healthy male volunteers. Drug Metab Dispos. 2012; 40: 815-824. CrossRef PubMed
16. Lee J, Moy S, Meijer J, Krauwinkel W, Sawamoto T, Kerbusch V, Kowalski D, Roy M, Marion A, Takusagawa S, van Gelderen M, Keirns J. Role of cytochrome p450 isoenzymes 3A and 2D6 in the in vivo metabolism of mirabegron, a β3-adrenoceptor agonist. Clin Drug Investig. 2013; 33: 429-440. CrossRef PubMed
17. 3-adrenoceptor agonist, on the pharmacokinetics of CYP2D6 substrates desipramine and metoprolol. Eur J Drug Metab Pharmacokinet. 2013; CrossRef. Epub ahead of print PubMed
18. Teijlingen R, Meijer J, Takusagawa S, Gelderen M, Beld C, Usui T. Development and validation of LC-MS/MS methods for the determination of mirabegron and its metabolites in human plasma and their application to a clinical pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2012; 887-888: 102-111. CrossRef PubMed
19. Matsushima H, Takanuki KI, Kamimura H, Watanabe T, Higuchi S. Highly sensitive method for the determination of tamsulosin hydrochloride in human plasma dialysate, plasma and urine by high-performance liquid chromatography-electrospray tandem mass spectrometry. J Chromatogr B Biomed Sci Appl. 1997; 695: 317-327. CrossRef PubMed (Pubitemid 27339039)
20. European Medicines Agency. Guideline on the Investigation of Drug Interactions. 2012.http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2012/07/WC500129606.pdf.
21. US Food and Drug Administration. Draft Guidance for Industry. Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing and Labeling Recommendations. 2012. http://www.fda.gov/downloads/Drugs/Guidance- ComplianceRegulatoryInformation/Guidances/ucm292362.pdf.
22. Michel MC, Korstanje C, Krauwinkel W, Shear M, Davies J, Quartel A. Cardiovascular safety of the oral controlled absorption system (OCAS) formulation of tamsulosin compared to the modified release (MR) formulation. Eur Urol. 2005; 4 (Suppl): 53-60. (Pubitemid 40125737)
23. McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011; 185: 1793-1803. CrossRef PubMed
24. Zhang H, Cui D, Wang B, Han YH, Balimane P, Yang Z, Sinz M, Rodrigues AD. Pharmacokinetic drug interactions involving 17alpha-ethinylestradiol: a new look at an old drug. Clin Pharmacokinet. 2007; 46: 133-157. CrossRef PubMed (Pubitemid 46193058)
25. Swart PJ, Krauwinkel WJ, Smulders RA, Smith NN. Pharmacokinetic effect of ketoconazole on solifenacin in healthy volunteers. Basic Clin Pharmacol Toxicol. 2006; 99: 33-36. CrossRef PubMed (Pubitemid 44034392)
26. Troost J, Tatami S, Tsuda Y, Mattheus M, Mehlburger L, Wein M, Michel MC. Effects of strong CYP2D6 and 3A4 inhibitors, paroxetine and ketoconazole, on the pharmacokinetics and cardiovascular safety of tamsulosin. Br J Clin Pharmacol. 2011; 72: 247-256. CrossRef PubMed
27. 3-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012; 50: 838-850. CrossRef PubMed
28. Michel MC, de la Rosette JJ. Efficacy and safety of tamsulosin in the treatment of urological diseases. Expert Opin Pharmacother. 2004; 5: 151-160. CrossRef PubMed (Pubitemid 38072726)
29. Nickel JC, Sander S, Moon TD. A meta-analysis of the vascular-related safety profile and efficacy of alpha-adrenergic blockers for symptoms related to benign prostatic hyperplasia. Int J Clin Pract. 2008; 62: 1547-1559. CrossRef PubMed
30. Boehringer Ingelheim Pharmaceuticals Inc. 2011. Flomax® US prescriber information. http://www.accessdata.fda.gov/drugsatfda-docs/label/2011/ 020579s027lbl.pdf. Accessed 13 May 2013.