A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder

Kelesitse Phiri, Jesper Hallas, Marie Linder, Andrea Margulis, Brandon Suehs, Alejandro Arana, Shahram Bahmanyar, Veena Hoffman, Cheryl Enger, Libby Horter, Ingvild Odsbu, Morten Olesen, Susana Perez-Gutthann, Nina Sahlertz Kristiansen, Kwame Appenteng, Stefan de Vogel, John Seeger*

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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Objective: This post-authorization safety study (EU PAS Register Number: EUPAS16088) was designed to compare the incidence of cancer outcomes in patients treated with mirabegron versus antimuscarinic medications. Methods: Cohorts of mirabegron initiators during 2012–2018 were propensity-score matched to antimuscarinic medication initiators within real-world data sources (Danish National Registers, Swedish National Registers, Clinical Practice Research Datalink [UK], Optum [US], and Humana [US]). Incident cancer cases were identified during follow-up from direct linkage to cancer registers or validated through medical record review or through physician questionnaires. Comparisons of sex-specific composite cancer outcomes (cancer of the lung/bronchus, colon/rectum, melanoma of skin, urinary bladder, non-Hodgkin lymphoma, kidney/renal pelvis, pancreas, prostate in men and breast and uterus in women) were made overall and for person-time in the first year and after the first year following start of treatment, for all ages and for the subgroup ≥65 years. Results: Among the 80,637 mirabegron initiators matched to 169,885 antimuscarinic medication initiators, 68% were at least 65 years of age and 66% were women. Over 5000 incident cancer cases were observed overall. Incidence rates were higher for men than women for composite and individual cancer outcomes. The pooled fixed effects hazard ratios for composite cancer outcomes (all ages) were 1.05 (95% confidence interval [CI]: 0.98–1.14) for women and 1.06 (95% CI: 0.98–1.14) for men. Results were similar in persons ≥65 years. Conclusions: The results suggest no association between mirabegron use and risk of cancer, compared with antimuscarinic medications, in either men or women. Registration: EU PAS Register Number: EUPAS16088.

Original languageEnglish
JournalCurrent Medical Research and Opinion
Issue number5
Pages (from-to)867-877
Publication statusPublished - May 2021


  • antimuscarinics
  • mirabegron
  • neoplasms
  • overactive
  • PASS
  • Urinary bladder


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