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Abstract
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
Transparency
Declaration of funding
The Mirabegron PMR-PASS study was supported by Astellas Pharma Global Development.
Declaration of financial/other relationships
M.L., I.O. and S.B. were employees at the time of the study of the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organizations), including Astellas and Pfizer, for performance of drug safety and drug utilization studies. K.P and V.H. were employees of Optum; C.E. and J.S. are employees of Optum. K.P., C.E., V.H., J.S. hold stock in UnitedHealth Group, Optum’s parent company; UnitedHealthcare, a UnitedHealth subsidiary, is a major purchaser of pharmaceutical products. The work was funded with a research contract between Optum and Astellas. J.H., M.O. and N.S.K. are employees at Clinical Pharmacology and Pharmacy at the University of Southern Denmark. The university received grants from Astellas for the conduct of this study. No grants were paid directly to any of the researchers. A.A., A.M. and S.P-G. are employees of RTI Health Solutions. RTI Health Solutions is a unit of RTI International, an independent, nonprofit organization that conducts work for government, public, and private organizations, including pharmaceutical companies. The authors participated in this work in the course of employment as work for hire, pursuant to a contract to conduct an independent research study for a client (Astellas). Authors received no compensation other than annual salary from employer. B.S. and L.H. are employees of Humana Healthcare Research, which received funding from Astellas in connection with the performance of this study. S. de V. and K.A. are employees of Astellas. A reviewer on this manuscript has disclosed that they have received payment from Astellas Pharma for consultancy and as a speaker in the past; they have also participated in research on mirabegron. All other peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.
Author contributions
Conception and design: All authors
Analysis and interpretation of the data: All authors
Drafting of the paper or revising it critically for intellectual content: All authors
Final approval of the version to be published: All authors
All authors agree to be accountable for all aspects of the work.
Acknowledgements
The authors would like to thank all the Mirabegron PMR-PASS study investigators. Additional thanks are due to Nicole Brooks, Sara Yuewen Gao, Laura Karslake, Nan Liu, Katherine Reed, Bruce Turnbull and Jing Yang (Optum) and Kathleen Mortimer (former Optum employee); Ryan Ziemiecki and Lisa McQuay (statistician-analysts from RTI-Health Solutions) and Christine Bui (epidemiologist from RTI-Health Solutions). This study was funded by Astellas Pharma Global Development. Medical writing support was provided by Sue Cooper and Catherine Elliott of Envision Pharma Group and funded by Astellas Pharma Global Development.
This study is based in part on data from the Clinical Practice Research Datalink obtained under licence from the UK Medicines and Healthcare products Regulatory Agency. The data is provided by patients and collected by the NHS as part of their care and support. The interpretation and conclusions contained in this study are those of the author/s alone. Copyright © (2018), re-used with the permission of The Health & Social Care Information Centre. All rights reserved.
Data availability statement
This observational study is based on individual patient data. Therefore, we are not able to make this data fully available to the public.