Corresponding Author: Harlan M. Krumholz, MD, SM, Center for Outcomes Research and Evaluation (CORE), Yale New Haven Hospital, One Church St, Ste 200, New Haven, CT 06510 (harlan.krumholz@yale.edu).
Accepted for Publication: August 10, 2020.
Author Contributions: Dr You had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs You and Rho contributed equally. Drs Rae Woong Park and Krumholz are cosenior authors.
Concept and design: You, Rho, Bikdeli, Weaver, Londhe, Schuemie, Suchard, Madigan, Hripcsak, Ryan, R. W. Park, Krumholz.
Acquisition, analysis, or interpretation of data: You, Rho, Bikdeli, Kim, Siapos, Weaver, Londhe, Cho, J. Park, Schuemie, Suchard, Hripcsak, Gupta, Reich, Ryan, R. W. Park, Krumholz.
Drafting of the manuscript: You, Cho, J. Park, Suchard, Hripcsak, Gupta.
Critical revision of the manuscript for important intellectual content: You, Rho, Bikdeli, Kim, Siapos, Weaver, Londhe, Schuemie, Suchard, Madigan, Hripcsak, Gupta, Reich, Ryan, R. W. Park, Krumholz.
Statistical analysis: You, Rho, Kim, Siapos, Weaver, Londhe, Cho, J. Park, Schuemie, Suchard, Madigan, Hripcsak, Ryan.
Obtained funding: Hripcsak, R. W. Park.
Administrative, technical, or material support: You, Rho, Weaver, Londhe, Cho, Park, Hripcsak, Reich, R. W. Park.
Supervision: Bikdeli, Suchard, Ryan, R. W. Park.
Other - Providing suggestions for revisions, and additional analyses: Bikdeli.
Conflict of Interest Disclosures: Mr Weaver reports holding shares in Janssen Research and Development, and that it is a subsidiary of Johnson & Johnson. Dr Schuemie reports holding shares in Janssen Research and Development, and that it is a subsidiary of Johnson & Johnson. Dr Ryan reports holding shares in Johnson & Johnson and that his employer, Janssen Research and Development, is a subsidiary of Johnson & Johnson. Mr Londhe reports being employed by Amgen but was an employee of Janssen Research and Development (a subsidiary of Johnson & Johnson) at the time of analysis, and he reports holding shares with Johnson & Johnson and Amgen. Dr Krumholz reports working under contract with the Centers for Medicare & Medicaid Services; receipt of research grants through Yale from Medtronic and the US Food and Drug Administration and from Medtronic and Johnson & Johnson; receipt of a research agreement through Yale from the Shenzhen Center for Health Information; personal fees from the National Center for Cardiovascular Diseases in Beijing, the law firms of Arnold & Porter (work related to Sanofi clopidogrel litigation), Martin/Baughman (work related to Cook IVC filter litigation), and Siegfried & Jensen (work related to Vioxx litigation), UnitedHealth (chairing a cardiac scientific advisory board), IBM Watson Health Life Sciences Board (participant/participant representative), Element Science (advisory board), Facebook, and Aetna (physician advisory board); consultancy with F-Prime; and being a cofounder of HugoHealth and Refactor Health. Dr Bikdeli reports being an expert (on behalf of the plaintiff) in litigation related to a specific type of IVC filter. Dr Gupta reports receipt of personal fees from the law firms of Arnold & Porter (work related to Sanofi clopidogrel litigation) and Martin/Baughman (work related to Cook IVC filter litigation); and consulting fees from Edwards Lifesciences. Dr Madigan reports having testified as an expert in litigation related to a number of drugs and devices but not related to any of the products considered in this study. Dr Hripcsak reports receipt of grant funding from Janssen through his university outside the submitted work and grants from the National Institutes of Health National Library of Medicine during the conduct of the study. Dr Suchard reported grants from Janssen Research & Development, grants from IQVIA, and grants from National Institutes of Health outside the submitted work. No other disclosures were reported.
Funding/Support: This work was supported by the Bio Industrial Strategic Technology Development Program (20001234) funded by the Ministry of Trade, Industry, & Energy (MOTIE, Korea); a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (HI16C0992); and a grant from the National Institutes of Health (R01 LM006910).
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: Amgen, Janssen, and IQVIA did not have input in the design, execution, interpretation of results, or decision to publish.
Additional Contributions: We thank the Korean Health Insurance Review and Assessment Service for providing the data, Woohyun Cho, MFA, (Medical Information and Media Center, Ajou University) for graphical assistance, and Maria Johnson, MBA (Research Associate, Internal Medicine, Cardiology, Yale University) for her contribution to proofreading the manuscript. None of them received compensation for their contributions.
Additional Information: The analysis is based in part on work from the Observational Health Sciences and Informatics collaborative (OHDSI, http://ohdsi.org).
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