Johannes, Catherine B. http://orcid.org/0000-0002-0586-9886
Beachler, Daniel C. http://orcid.org/0000-0003-2788-3061
Layton, J. Bradley http://orcid.org/0000-0003-0994-5820
Danysh, Heather E. http://orcid.org/0000-0003-3014-7508
Ziemiecki, Ryan http://orcid.org/0000-0002-1774-7034
Arana, Alejandro http://orcid.org/0000-0002-1593-3124
Dinh, Jade http://orcid.org/0000-0003-0386-2776
Li, Ling
Calingaert, Brian http://orcid.org/0000-0001-8177-6326
Pladevall-Vila, Manel http://orcid.org/0000-0002-9359-6055
Hunt, Phillip R. http://orcid.org/0000-0002-9559-175X
Chen, Hungta
Karlsson, Cecilia http://orcid.org/0000-0002-4299-8775
Johnsson, Kristina
Gilsenan, Alicia http://orcid.org/0000-0002-9266-1417
Funding for this research was provided by:
AstraZeneca
Article History
Accepted: 23 November 2022
First Online: 17 December 2022
Declarations
:
: Sponsorship for the described post-authorization safety study, medical writing support, and the article-processing charge were provided by AstraZeneca.
: CBJ, JBL, HED, 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 this study was 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.
: The study protocol was reviewed and approved by the RTI International Institutional Review Board (IRB) (study ID 13887). The UK Medicines Healthcare products Regulatory Agency’s (MHRA) Independent Scientific Advisory Committee (ISAC) approved the Clinical Practice Research Datalink (CPRD) component of the study (ISAC protocol ID 15_220). The US Centers for Medicare and Medicaid Services (CMS) Privacy Board approved the use of Medicare data for this study (CMS data use agreement RSCH-2018-51681). The study components specific to the HealthCore Integrated Research Database (HIRD) were reviewed and approved by the New England IRB (study ID 120180081).
: 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.
: The data that support the findings of this study are available from the UK MHRA (CPRD data), Elevance Health Inc. (formerly Anthem, Inc.) (HIRD data), and the US CMS (Medicare data), but restrictions apply to the availability of these data, which were used under a separate license from each data custodian for the current study and are not publicly available. The authors are not authorized to release data due to the privacy policies of each of the data custodians. Data from CPRD and Medicare are available with permission from the UK MHRA (ExternalRef removed) and the US CMS (ExternalRef removed), respectively, upon the establishment of a license and/or data use agreement with each of these entities. Data in CPRD are provided by patients and collected by the National Health Service (NHS) as part of patient care and support; this study used CPRD GOLD data and accompanying linkage data including Hospital Episode Statistics, death registration data from the Office for National Statistics (Copyright © 2019, reused with the permission of The Health & Social Care Information Centre. All rights reserved.), and data from the Index of Multiple Deprivation; all data were obtained by RTI Health Solutions under a data license from the UK MHRA. Data in the HIRD are provided by US members of Anthem Blue Cross Blue Shield health plans and were accessed by HealthCore. Data from the Medicare Research Identifiable Files were accessed by RTI Health Solutions under a data use agreement with CMS. The interpretation and conclusions of this study are those of the authors alone.
: Not applicable.
: CBJ contributed to the study design, methodology, interpretation of the results, and writing of the original draft. DCB and JBL contributed to the study design, methodology, and interpretation of the results. HED contributed to project administration and resources (including data acquisition), interpretation of the results, and writing of the original draft. 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, methodology, and case validation. PRH and HC contributed 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 read and approved the final version.