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Classification: B

Drug products: Emselex®

ATC code: G04BD10

Substances: darifenacin, darifenacin hydrobromide


Results from clinical studies show conflicting results regarding differences between men and women. Pathogenesis and symptoms of urinary incontinence and overactive bladder differ between men and women. Most studies have included few men and thus it is difficult to evaluate potential sex differences.
The persistence to anticholinergic treatment has been shown for both men and women.

Additional information

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

According to studies conducted by the manufacturer, clearance was 39% higher and AUC 28% lower in men [11]. A population pharmacokinetic analysis of patient data indicated that darifenacin exposure was 23% lower in men [12]. In a population pharmacology study with pooled data from 18 studies (44 men, 293 women), clearance was 31% lower in women [13]. Despite the pharmacokinetic differences of darifenacin, the clinical studies have shown effect with similar doses in men and women, and no sex differentiation in dosing has been suggested [11, 12].


A post-hoc analysis of an open label study of 3766 patients (77% women) treated with darifenacin for overactive bladder symptoms reported a correlation between men and women and efficacy of darifenacin treatment, measured as improvement in urgency, micturition and nocturia episodes. However, the differences were small and probably not clinically relevant according to the authors [14].Both men and women were reported to have long-term effect of darifenacin regarding health-related quality of life in a long term open-label study, designed as a two year extension to two placebo-controlled double-blind studies (41 men, 262 women on darifenacin) [15].According to manufacturer’s documentation to the FDA [11] the magnitude of treatment effect of darifenacin was higher in women. The effect is shown as reduction in incontinence episodes.

Adverse effects

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) [16].

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 [17].

Patterns of adherence and persistence of anticholinergic drugs varies depending on the population studied and type of study [18-24].

Updated: 2022-09-23

Date of litterature search: 2022-07-06


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  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. PubMed
  3. Giannitsas K, Athanasopoulos A. Male overactive bladder: pharmacotherapy for the male. Curr Opin Urol. 2013;23:515-9. PubMed
  4. Andersson KE. The use of pharmacotherapy for male patients with urgency and stress incontinence. Curr Opin Urol. 2014;24:571-7. PubMed
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  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. PubMed
  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. PubMed
  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. PubMed
  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. PubMed
  10. Mangera A, Chapple CR, Kopp ZS, Plested M. The placebo effect in overactive bladder syndrome. Nat Rev Urol. 2011;8:495-503. PubMed
  11. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - ENABLEX (darifenacin) [updated 2004-12-22, cited 2015-03-16]. länk
  12. Emselex (darifenacin). EPAR - Product information. European Medicines Agency (EMA) [updated 2022-09-02, cited 2022-07-06]
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  14. Schneider T, Marschall-Kehrel D, Hanisch JU, Michel MC. Do gender, age or lifestyle factors affect responses to antimuscarinic treatment in overactive bladder patients?. Int J Clin Pract. 2010;64:1287-93. PubMed
  15. Dwyer P, Kelleher C, Young J, Haab F, Lheritier K, Ariely R et al. Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study. Neurourol Urodyn. 2008;27:540-7. PubMed
  16. 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. PubMed
  17. 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. PubMed
  18. 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. PubMed
  19. 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. PubMed
  20. 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. PubMed
  21. 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. PubMed
  22. 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. PubMed
  23. 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. PubMed
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  25. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2021 [cited 2022-03-15.] länk

Authors: Diana Rydberg

Reviewed by: Carl-Olav Stiller, Pauline Raaschou

Approved by: Karin Schenck-Gustafsson