6/10/2023

Janusmed kön och genus

Janusmed kön och genus – Fesoterodine Medical Valley

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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Fesoterodin

Fesoterodin

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Fesoterodine 2care4, Fesoterodine Accord, Fesoterodine ......

Fesoterodine 2care4, Fesoterodine Accord, Fesoterodine Medical Valley, Fesoterodine STADA, TOVIAZ
ATC-koder

G04BD11

G04BD11
Substanser

fesoterodin, fesoterodinfumarat

fesoterodin, fesoterodinfumarat
Sammanfattning

Data från kliniska studier ger varierande resultat gällande könsskillnader. Eftersom genes och symptombild för urininkontinens och överaktiv blåsa delvis skiljer sig åt mellan kvinnor och män är könsskillnader i effekt av fesoterodin svårtolkade. De flesta studier har inkluderat få män och vilket ytterligare försvårar bedömning av eventuella könsskillnader.
Persistens vid antikolinergikabehandling är låg hos både kvinnor och män.

Data från kliniska studier ger varierande resultat gällande könsskillnader. Eftersom genes och symptombild för urininkontinens och överaktiv blåsa delvis skiljer sig åt mellan kvinnor och män är könsskillnader i effekt av fesoterodin svårtolkade. De flesta studier har inkluderat få män och vilket ytterligare försvårar bedömning av eventuella könsskillnader. Persistens vid antikolinergikabehandling är låg hos både kvinnor och män.
Background

Anticholinergic drugs reduce the bladder detrusor muscle contractions and are used to treat urgency incontinence and symptoms of overactive bladder. Due to sex differences in etiology of these symptoms, drug therapy differs as urinary retention must be ruled out before starting treatment with anticholinergic drugs. In women, anticholinergic drugs are commonly used when non-pharmacological treatments such as bladder training are insufficient [1]. In men, benign prostate hyperplasia is a common cause of urgency symptoms. Non-anticholinergic drugs, primarily alpha-1 blockers, are therefore often used as first-line treatment in men even though anticholinergic drugs are used in addition or as monotherapy [2-5].
The baseline symptoms described in studies differ between men and women regarding prevalence of incontinence episodes and frequency of urgency episodes [6, 7]. Treatment effects on these parameters are common outcomes in clinical studies and differences in treatment effect between men and women need to be interpreted in relation to differences at baseline. The placebo effec......

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Anticholinergic drugs reduce the bladder detrusor muscle contractions and are used to treat urgency incontinence and symptoms of overactive bladder. Due to sex differences in etiology of these symptoms, drug therapy differs as urinary retention must be ruled out before starting treatment with anticholinergic drugs. In **women,** anticholinergic drugs are commonly used when non-pharmacological treatments such as bladder training are insufficient [1]. In **men**, benign prostate hyperplasia is a common cause of urgency symptoms. Non-anticholinergic drugs, primarily alpha-1 blockers, are therefore often used as first-line treatment in men even though anticholinergic drugs are used in addition or as monotherapy [2-5]. The baseline symptoms described in studies differ between men and women regarding prevalence of incontinence episodes and frequency of urgency episodes [6, 7]. Treatment effects on these parameters are common outcomes in clinical studies and differences in treatment effect between men and women need to be interpreted in relation to differences at baseline. The placebo effect seen in clinical studies of overactive bladder treatment is relatively high. According to a meta-analysis, 41% of the patients in placebo groups report cure or symptom improvement [8]. Two other meta-analyses report that changes from baseline with placebo treatment are significant for mean micturitions, mean incontinence episodes and mean voided volume [9, 10]. It should be noted that most studies include more women than men, and the low number of men included can affect the ability to make statistically significant analyses. # Pharmacokinetics and dosing In the manufacturer’s report to FDA no sex differences in the pharmacokinetics of fesoterodine are reported from the Phase I studies [11]. In a randomized study (12 young men, 12 elderly men, 12 elderly women), no clinically relevant differences in pharmacokinetics between men and women were seen. Residual urinary volume was higher in men than in women eight hours after dosing (elderly men 85 ml, young men 55 ml, elderly women 29 ml) [12]. Pooled results from 10 pharmacokinetic studies and 3 efficacy/safety studies showed a 10% lower apparent oral clearance of the active fesoterodine metabolite 5-hydroxymethyl tolterodine in women compared to men. This was not considered to be clinically significant [13]. espite the small pharmacokinetic differences of fesoterodine, the clinical studies have shown effect with similar doses in men and women, and no sex differentiation in dosing has been suggested [11, 14]. # Effects In a post hoc analysis of two open label extension studies long term safety, efficacy and tolerability of fesoterodine treatment was compared in men and women (185 men, 705 women). In both groups improvement of micturations, urgency episodes and urgency incontinence episodes were found up to 24 months. However, only 45% of the men and 50% of the women continued the treatment for >24 months. The majority of these patients remained at the higher dose of 8 mg throughout the study [15]. Data from two open label extension studies (182 men, 682 women) was analyzed for effect of long term (24 months) treatment with fesoterodine. Women had better outcome in the scales in the KHQ (Kings Health Questionnaire) for emotion, severity/coping and in ICIQ-SF (International Consultation on Incontinence Questionnaire–Short Form) scores than men [16]. Pooled data from two randomized double-blind studies compared the effect of fesoterodine, tolterodine extended release, or placebo for 12 weeks in patients with urinary incontinence or urgency (673 men, 3435 women). In women, fesoterodine 8 mg  significantly improved urgency episodes and diary dry rates compared to tolterodine or placebo. In men, 8 mg fesoterodine significantly improved severe urgency episodes and OAB-q scores compared with tolterodine, and micturations, urgency episodes, severe urgency episodes, frequency–urgency sum and PPBC scores compared with placebo [17]. In another analysis based on the same material (643 men, 3191 women) women had generally larger improvements in outcome in symptom bother, health-related quality of life, reduction of urgency episodes and micturitions [18]. # Adverse effects Pooled data from two double-blinded studies [17] shows that total adverse reactions were slightly higher in women, but treatment discontinuation due to adverse reactions were similar. Also, the levels of the most common anticholinergic-associated adverse reactions, dry mouth and constipation were similar between men and women. The risk of dementia among anticholinergic (overactive bladder medication) users (21058 men, 26266 women) compared to beta-3 agonist users (10529 men, 13133 women) was increased in men (HR 1.41; 95%CI 1.23-1.62) but not in women (HR 1.08; 95%CI 0.95-1.23) [19]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information Patient satisfaction with anticholinergic treatment was evaluated in a survey study in Japanese patients with overactive bladder syndrome (in total 514 men, 455 women). In the entire study one third of all patients were satisfied and one third dissatisfied with their treatment, men were overall less satisfied than women. Dissatisfaction was commonly influenced by poor efficacy or adverse effects, mainly constipation [20]. Patterns of adherence and persistence, and the need for dose escalation of anticholinergic drugs depend on the population studied and type of study [21-27].
Försäljning på recept

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Fler kvinnor än män hämtade ut tabletter innehållande fesoterodin (ATC-kod G04BD11) på recept i Sverige år 2021, totalt 3 052 kvinnor och 2 147 män. Det motsvarar 0,6 respektive 0,4 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 70 år och äldre hos båda könen. I genomsnitt var tabletter innehållande fesoterodin 1,7 gånger vanligare hos kvinnor [28].
Referenser

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

  2. Kaplan SA, Roehrborn CG, Abrams P, Chapple CR, Bavendam T, Guan Z. Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review. Int J Clin Pract. 2011;65:487-507.

  3. Giannitsas K, Athanasopoulos A. Male overactive bladder: pharmacotherapy for the male. Curr Opin Urol. 2013;23:515-9.

  4. Andersson KE. The use of pharmacotherapy for male patients with urgency and stress incontinence. Curr Opin Urol. 2014;24:571-7.

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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

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

  11. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - TOVIAZ (fesoterodine)

  12. Malhotra BK, Wood N, Sachse R. Influence of age, gender, and race on pharmacokinetics, pharmacodynamics, and safety of fesoterodine. Int J Clin Pharmacol Ther. 2009;47:570-8.

  13. Oishi M, Tomono Y, Yamagami H, Malhotra B. Population pharmacokinetics of the 5-hydroxymethyl metabolite of tolterodine after administration of fesoterodine sustained release tablet in Western and East Asian populations. J Clin Pharmacol. 2014;54:928-36.

  14. Toviaz (fesoterodine). EPAR - Product information. European Medicines Agency (EMA) [updated 2021-10-26, cited 2022-07-06]

  15. Scarpero H, Sand PK, Kelleher CJ, Berriman S, Bavendam T, Carlsson M. Long-term safety, tolerability, and efficacy of fesoterodine treatment in men and women with overactive bladder symptoms. Curr Med Res Opin. 2011;27:921-30.

  16. Kelleher CJ, Dmochowski RR, Berriman S, Kopp ZS, Carlsson M. Sustained improvement in patient-reported outcomes during long-term fesoterodine treatment for overactive bladder symptoms: pooled analysis of two open-label extension studies. BJU Int. 2012;110:392-400.

  17. Ginsberg D, Schneider T, Kelleher C, Van Kerrebroeck P, Swift S, Creanga D et al. Efficacy of fesoterodine compared with extended-release tolterodine in men and women with overactive bladder. BJU Int. 2013;112:373-85.

  18. Herschorn S, Kaplan SA, Sun F, Ntanios F. Do patient characteristics predict responsiveness to treatment of overactive bladder with antimuscarinic agents?. Urology. 2014;83:1023-9.

  19. 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.

  20. Akino H, Namiki M, Suzuki K, Fuse H, Kitagawa Y, Miyazawa K et al. Factors influencing patient satisfaction with antimuscarinic treatment of overactive bladder syndrome: results of a real-life clinical study. Int J Urol. 2014;21:389-94.

  21. Johnell K, Weitoft GR, Fastbom J. Sex differences in inappropriate drug use: a register-based study of over 600,000 older people. Ann Pharmacother. 2009;43:1233-8.

  22. Kalder M, Pantazis K, Dinas K, Albert US, Heilmaier C, Kostev K. Discontinuation of treatment using anticholinergic medications in patients with urinary incontinence. Obstet Gynecol. 2014;124:794-800.

  23. Krhut J, Gärtner M, Petzel M, Sykora R, Nemec D, Tvrdik J et al. Persistence with first line anticholinergic medication in treatment-naïve overactive bladder patients. Scand J Urol. 2014;48:79-83.

  24. Cardozo L, Hall T, Ryan J, Ebel Bitoun C, Kausar I, Darekar A et al. Safety and efficacy of flexible-dose fesoterodine in British subjects with overactive bladder: insights into factors associated with dose escalation. Int Urogynecol J. 2012;23:1581-90.

  25. Wagg A, Darekar A, Arumi D, Khullar V, Oelke M. Factors associated with dose escalation of fesoterodine for treatment of overactive bladder in people >65 years of age: A post hoc analysis of data from the SOFIA study. Neurourol Urodyn. 2015;34:438-43.

  26. Lua LL, Pathak P, Dandolu V. Comparing anticholinergic persistence and adherence profiles in overactive bladder patients based on gender, obesity, and major anticholinergic agents. Neurourol Urodyn. 2017;36(8):2123-2131.

  27. Goodson AB, Cantrell MA, Shaw RF, Lund BC. Comparative Effectiveness of Anticholinergic Agents for Lower Urinary Tract Symptoms. J Manag Care Spec Pharm. 2018;24(1):65-72.

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

  1. EAU Guidelines. Non-neurogenic Female LUTS. Uroweb [www]. [cited 2022-04-14].
  2. Kaplan SA, Roehrborn CG, Abrams P, Chapple CR, Bavendam T, Guan Z. Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review. Int J Clin Pract. 2011;65:487-507.
  3. Giannitsas K, Athanasopoulos A. Male overactive bladder: pharmacotherapy for the male. Curr Opin Urol. 2013;23:515-9.
  4. Andersson KE. The use of pharmacotherapy for male patients with urgency and stress incontinence. Curr Opin Urol. 2014;24:571-7.
  5. EAU Guidelines. Management of Non-neurogenic Male LUTS. Uroweb [www]. [cited 2022-04-14].
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Mangera A, Chapple CR, Kopp ZS, Plested M. The placebo effect in overactive bladder syndrome. Nat Rev Urol. 2011;8:495-503.
  11. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - TOVIAZ (fesoterodine)
  12. Malhotra BK, Wood N, Sachse R. Influence of age, gender, and race on pharmacokinetics, pharmacodynamics, and safety of fesoterodine. Int J Clin Pharmacol Ther. 2009;47:570-8.
  13. Oishi M, Tomono Y, Yamagami H, Malhotra B. Population pharmacokinetics of the 5-hydroxymethyl metabolite of tolterodine after administration of fesoterodine sustained release tablet in Western and East Asian populations. J Clin Pharmacol. 2014;54:928-36.
  14. Toviaz (fesoterodine). EPAR - Product information. European Medicines Agency (EMA) [updated 2021-10-26, cited 2022-07-06]
  15. Scarpero H, Sand PK, Kelleher CJ, Berriman S, Bavendam T, Carlsson M. Long-term safety, tolerability, and efficacy of fesoterodine treatment in men and women with overactive bladder symptoms. Curr Med Res Opin. 2011;27:921-30.
  16. Kelleher CJ, Dmochowski RR, Berriman S, Kopp ZS, Carlsson M. Sustained improvement in patient-reported outcomes during long-term fesoterodine treatment for overactive bladder symptoms: pooled analysis of two open-label extension studies. BJU Int. 2012;110:392-400.
  17. Ginsberg D, Schneider T, Kelleher C, Van Kerrebroeck P, Swift S, Creanga D et al. Efficacy of fesoterodine compared with extended-release tolterodine in men and women with overactive bladder. BJU Int. 2013;112:373-85.
  18. Herschorn S, Kaplan SA, Sun F, Ntanios F. Do patient characteristics predict responsiveness to treatment of overactive bladder with antimuscarinic agents?. Urology. 2014;83:1023-9.
  19. 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.
  20. Akino H, Namiki M, Suzuki K, Fuse H, Kitagawa Y, Miyazawa K et al. Factors influencing patient satisfaction with antimuscarinic treatment of overactive bladder syndrome: results of a real-life clinical study. Int J Urol. 2014;21:389-94.
  21. Johnell K, Weitoft GR, Fastbom J. Sex differences in inappropriate drug use: a register-based study of over 600,000 older people. Ann Pharmacother. 2009;43:1233-8.
  22. Kalder M, Pantazis K, Dinas K, Albert US, Heilmaier C, Kostev K. Discontinuation of treatment using anticholinergic medications in patients with urinary incontinence. Obstet Gynecol. 2014;124:794-800.
  23. Krhut J, Gärtner M, Petzel M, Sykora R, Nemec D, Tvrdik J et al. Persistence with first line anticholinergic medication in treatment-naïve overactive bladder patients. Scand J Urol. 2014;48:79-83.
  24. Cardozo L, Hall T, Ryan J, Ebel Bitoun C, Kausar I, Darekar A et al. Safety and efficacy of flexible-dose fesoterodine in British subjects with overactive bladder: insights into factors associated with dose escalation. Int Urogynecol J. 2012;23:1581-90.
  25. Wagg A, Darekar A, Arumi D, Khullar V, Oelke M. Factors associated with dose escalation of fesoterodine for treatment of overactive bladder in people >65 years of age: A post hoc analysis of data from the SOFIA study. Neurourol Urodyn. 2015;34:438-43.
  26. Lua LL, Pathak P, Dandolu V. Comparing anticholinergic persistence and adherence profiles in overactive bladder patients based on gender, obesity, and major anticholinergic agents. Neurourol Urodyn. 2017;36(8):2123-2131.
  27. Goodson AB, Cantrell MA, Shaw RF, Lund BC. Comparative Effectiveness of Anticholinergic Agents for Lower Urinary Tract Symptoms. J Manag Care Spec Pharm. 2018;24(1):65-72.
  28. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2021 [cited 2022-03-15.]
Uppdaterat

Litteratursökningsdatum 3/12/2015

Litteratursökningsdatum 3/12/2015