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Article History

Accepted: 22 November 2022

First Online: 30 December 2022

Declarations

:

: Sponsorship for the 2 described post-authorization safety studies, medical writing support, and the article-processing charge were provided by AstraZeneca.

: HED, CBJ, JBL, RZ, AA, BC, MPV, and AG are full-time employees of RTI Health Solutions, an independent nonprofit research organization, which was retained by AstraZeneca to conduct the research that is the subject of this manuscript. DCB is an employee of HealthCore, a wholly owned subsidiary of Anthem Inc, which was also retained by AstraZeneca to conduct this research. JD and LL were employees of HealthCore at the time these studies were conducted. RTI Health Solutions and HealthCore associates’ compensation is unconnected to the studies on which they work. PRH, HC, CK, and KJ are employees of AstraZeneca and hold shares and/or stock options in the company.

: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article. HED contributed to project administration and resources (including data acquisition), interpretation of the results, writing of the original draft, and supervision. CBJ contributed to the study design, methodology, interpretation of the results, writing of the original draft, and supervision. DCB and JBL contributed to the study design, methodology, and interpretation of the results. RZ contributed to the methodology, data curation, and formal analysis. JD contributed to project administration and resources (including data acquisition), and the interpretation of the results. LL and BC contributed to data curation and formal analysis. AA and MPV contributed to the study design and methodology. PH and HC contributed to the methodology and interpretation of the results. CK and KJ contributed to interpretation of results. AG contributed to the conceptualization, study design, interpretation of the results, project administration and resources, and supervision. All authors critically reviewed the draft versions of the manuscript and approved the final version.

: The study protocols for both post-authorization safety studies were reviewed and approved by the RTI International Institutional Review Board (study ID 13887). For the CPRD and Medicare aspects, the UK Medicines Healthcare products Regulatory Agency’s (MHRA) Independent Scientific Advisory Committee (ISAC) and the US Centers for Medicare and Medicaid Services (CMS) Privacy Board approved the use of the respective data for these studies (ISAC protocol ID 15_220; CMS data use agreement RSCH-2018-51681). The HealthCore-specific components were reviewed and approved by the New England Institutional Review Board (study ID 120180081). A waiver of informed consent was obtained, as data used in these studies were obtained from databases of anonymized medical, claims, and pharmacy records and not directly from human subjects.

: The CMS Privacy Board approved access to Medicare Research Identifiable Files for use in these studies under a data use agreement with RTI Health Solutions (ExternalRef removed). Data in CPRD are provided by patients and collected by the National Health Service (NHS) as part of patient care and support; the UK MHRA ISAC approved the use of CPRD GOLD and accompanying linkage data (including Hospital Episode Statistics [HES], death registration data from the Office for National Statistics [ONS; Copyright © 2019, reused with the permission of The Health & Social Care Information Centre. All rights reserved.], and data from the Index of Multiple Deprivation [IMD]) for these studies, and the data were obtained under a data license from the UK MHRA (ExternalRef removed). Data in the HIRD are provided by members of Anthem Inc. Data cannot be shared given privacy regulations. There was no active enrollment or active follow-up of study subjects, and no data were collected directly from individuals. Further information can be requested from each of the data entities as described above. The interpretation and conclusions of the studies described in this manuscript are those of the authors alone.

: Not applicable.

: Individual-level consent was not required for these analyses of secondary data from anonymized medical, claims, and pharmacy records and not directly from human subjects.

: Not applicable.