10/18/2024

Janusmed sex and gender

Janusmed sex and gender – Mirabegron

Janusmed Sex and Gender is a knowledge database providing information on sex and gender aspects of drug treatment. The knowledge database is primarily intended to be used by physicians and healthcare professionals. The texts are general and should not be considered as treatment guidelines. The individual patient’s physician is responsible for the patient’s drug treatment.

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Mirabegron

Mirabegron

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  1. EAU Guidelines. Non-neurogenic Female LUTS. Uroweb [www]. [cited 2022-04-14].

  2. EAU Guidelines. Management of Non-neurogenic Male LUTS. Uroweb [www]. [cited 2022-04-14].

  3. Suarez O, Osborn D, Kaufman M, Reynolds WS, Dmochowski R. Mirabegron for male lower urinary tract symptoms. Curr Urol Rep. 2013;14:580-4.

  4. Coyne KS, Sexton CC, Thompson CL, Milsom I, Irwin D, Kopp ZS et al. The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. BJU Int. 2009;104:352-60.

  5. Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006;50:1306-14; discussion 1314-5.

  6. Nabi G, Cody JD, Ellis G, Herbison P, Hay-Smith J. Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2006;18:CD003781.

  7. Lee S, Malhotra B, Creanga D, Carlsson M, Glue P. A meta-analysis of the placebo response in antimuscarinic drug trials for overactive bladder. BMC Med Res Methodol. 2009;9:55.

  8. Mangera A, Chapple CR, Kopp ZS, Plested M. The placebo effect in overactive bladder syndrome. Nat Rev Urol. 2011;8:495-503.

  9. Deeks ED. Mirabegron: A Review in Overactive Bladder Syndrome. Drugs. 2018;78(8):833-844.

  10. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - MYRBETRIQ (mirabegron).

  11. Eltink C, Lee J, Schaddelee M, Zhang W, Kerbusch V, Meijer J et al. Single dose pharmacokinetics and absolute bioavailability of mirabegron, a β₃-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012;50:838-50.

  12. Krauwinkel W, van Dijk J, Schaddelee M, Eltink C, Meijer J, Strabach G et al. Pharmacokinetic properties of mirabegron, a β3-adrenoceptor agonist: results from two phase I, randomized, multiple-dose studies in healthy young and elderly men and women. Clin Ther. 2012;34:2144-60.

  13. Iitsuka H, van Gelderen M, Katashima M, Takusagawa S, Sawamoto T. Pharmacokinetics of Mirabegron, a β3-Adrenoceptor Agonist for Treatment of Overactive Bladder, in Healthy East Asian Subjects. Clin Ther. 2015;37:1031-44.

  14. Lee J, Zhang W, Moy S, Kowalski D, Kerbusch V, van Gelderen M et al. Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults. Clin Ther. 2013;35:333-41.

  15. BETMIGA (mirabegron). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-11-05, cited 2022-06-07]

  16. Food and Drug Administration (FDA). Summary Review - MYRBETRIQ (mirabegron). Drugs@FDA [www]. [updated 2012-06-29, cited 2022-06-07].

  17. Shen YC, Wang HJ, Chuang YC. Efficacy and persistence of low-dose mirabegron (25 mg) in patients with overactive bladder: analysis in a real-world urological practice. Int Urol Nephrol. 2018;50(7):1219-1226.

  18. Chapple CR, Cruz F, Cardozo L, Staskin D, Herschorn S, Choudhury N et al. Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo. Eur Urol. 2020;77(1):119-128.

  19. Nitti VW, Chapple CR, Walters C, Blauwet MB, Herschorn S, Milsom I et al. Safety and tolerability of the β3 -adrenoceptor agonist mirabegron, for the treatment of overactive bladder: results of a prospective pooled analysis of three 12-week randomised Phase III trials and of a 1-year randomised Phase III trial. Int J Clin Pract. 2014;68:972-85.

  20. Katoh T, Kuwamoto K, Kato D, Kuroishi K. Real-world cardiovascular assessment of mirabegron treatment in patients with overactive bladder and concomitant cardiovascular disease: Results of a Japanese post-marketing study. Int J Urol. 2016;23(12):1009-1015.

  21. Matta R, Gomes T, Juurlink D, Jarvi K, Herschorn S, Nam RK. Receipt of Overactive Bladder Drugs and Incident Dementia: A Population-based Case-control Study. Eur Urol Focus. 2021.

  22. Phiri K, Hallas J, Linder M, Margulis A, Suehs B, Arana A et al. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder. Curr Med Res Opin. 2021;37(5):867-877.

  23. Malik M, van Gelderen EM, Lee JH, Kowalski DL, Yen M, Goldwater R et al. 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.

  24. Welk B, McArthur E. Increased risk of dementia among patients with overactive bladder treated with an anticholinergic medication compared to a beta-3 agonist: a population-based cohort study. BJU Int. 2020;126(1):183-190.

  25. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2021 [cited 2022-03-15.]

  1. EAU Guidelines. Non-neurogenic Female LUTS. Uroweb [www]. [cited 2022-04-14].
  2. EAU Guidelines. Management of Non-neurogenic Male LUTS. Uroweb [www]. [cited 2022-04-14].
  3. Suarez O, Osborn D, Kaufman M, Reynolds WS, Dmochowski R. Mirabegron for male lower urinary tract symptoms. Curr Urol Rep. 2013;14:580-4.
  4. Coyne KS, Sexton CC, Thompson CL, Milsom I, Irwin D, Kopp ZS et al. The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. BJU Int. 2009;104:352-60.
  5. Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006;50:1306-14; discussion 1314-5.
  6. Nabi G, Cody JD, Ellis G, Herbison P, Hay-Smith J. Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2006;18:CD003781.
  7. Lee S, Malhotra B, Creanga D, Carlsson M, Glue P. A meta-analysis of the placebo response in antimuscarinic drug trials for overactive bladder. BMC Med Res Methodol. 2009;9:55.
  8. Mangera A, Chapple CR, Kopp ZS, Plested M. The placebo effect in overactive bladder syndrome. Nat Rev Urol. 2011;8:495-503.
  9. Deeks ED. Mirabegron: A Review in Overactive Bladder Syndrome. Drugs. 2018;78(8):833-844.
  10. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - MYRBETRIQ (mirabegron).
  11. Eltink C, Lee J, Schaddelee M, Zhang W, Kerbusch V, Meijer J et al. Single dose pharmacokinetics and absolute bioavailability of mirabegron, a β₃-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012;50:838-50.
  12. Krauwinkel W, van Dijk J, Schaddelee M, Eltink C, Meijer J, Strabach G et al. Pharmacokinetic properties of mirabegron, a β3-adrenoceptor agonist: results from two phase I, randomized, multiple-dose studies in healthy young and elderly men and women. Clin Ther. 2012;34:2144-60.
  13. Iitsuka H, van Gelderen M, Katashima M, Takusagawa S, Sawamoto T. Pharmacokinetics of Mirabegron, a β3-Adrenoceptor Agonist for Treatment of Overactive Bladder, in Healthy East Asian Subjects. Clin Ther. 2015;37:1031-44.
  14. Lee J, Zhang W, Moy S, Kowalski D, Kerbusch V, van Gelderen M et al. Effects of food intake on the pharmacokinetic properties of mirabegron oral controlled-absorption system: a single-dose, randomized, crossover study in healthy adults. Clin Ther. 2013;35:333-41.
  15. BETMIGA (mirabegron). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-11-05, cited 2022-06-07]
  16. Food and Drug Administration (FDA). Summary Review - MYRBETRIQ (mirabegron). Drugs@FDA [www]. [updated 2012-06-29, cited 2022-06-07].
  17. Shen YC, Wang HJ, Chuang YC. Efficacy and persistence of low-dose mirabegron (25 mg) in patients with overactive bladder: analysis in a real-world urological practice. Int Urol Nephrol. 2018;50(7):1219-1226.
  18. Chapple CR, Cruz F, Cardozo L, Staskin D, Herschorn S, Choudhury N et al. Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo. Eur Urol. 2020;77(1):119-128.
  19. Nitti VW, Chapple CR, Walters C, Blauwet MB, Herschorn S, Milsom I et al. Safety and tolerability of the β3 -adrenoceptor agonist mirabegron, for the treatment of overactive bladder: results of a prospective pooled analysis of three 12-week randomised Phase III trials and of a 1-year randomised Phase III trial. Int J Clin Pract. 2014;68:972-85.
  20. Katoh T, Kuwamoto K, Kato D, Kuroishi K. Real-world cardiovascular assessment of mirabegron treatment in patients with overactive bladder and concomitant cardiovascular disease: Results of a Japanese post-marketing study. Int J Urol. 2016;23(12):1009-1015.
  21. Matta R, Gomes T, Juurlink D, Jarvi K, Herschorn S, Nam RK. Receipt of Overactive Bladder Drugs and Incident Dementia: A Population-based Case-control Study. Eur Urol Focus. 2021.
  22. Phiri K, Hallas J, Linder M, Margulis A, Suehs B, Arana A et al. A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder. Curr Med Res Opin. 2021;37(5):867-877.
  23. Malik M, van Gelderen EM, Lee JH, Kowalski DL, Yen M, Goldwater R et al. 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.
  24. Welk B, McArthur E. Increased risk of dementia among patients with overactive bladder treated with an anticholinergic medication compared to a beta-3 agonist: a population-based cohort study. BJU Int. 2020;126(1):183-190.
  25. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2021 [cited 2022-03-15.]