4/23/2024

Janusmed kön och genus

Janusmed kön och genus – Mirabegron

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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C C

Mirabegron

Mirabegron

Klass : C

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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.]