Rivero-Ferrer, Elena http://orcid.org/0000-0001-5093-2445
Olesen, Morten http://orcid.org/0000-0002-0937-4952
Plana, Estel http://orcid.org/0000-0001-8675-7503
Aguado, Jaume http://orcid.org/0000-0002-9575-0212
Saigí-Morgui, Núria http://orcid.org/0000-0003-2503-1818
Rubino, Annalisa
Daoud, Sami Z.
Lei, Alejhandra
Perez-Gutthann, Susana http://orcid.org/0000-0001-5798-3691
Schink, Tania http://orcid.org/0000-0003-2252-1475
Kristiansen, Nina Sahlertz http://orcid.org/0000-0002-8097-8708
Hallas, Jesper http://orcid.org/0000-0001-9314-5679
Pottegård, Anton http://orcid.org/0000-0002-8064-5997
Rebordosa, Cristina http://orcid.org/0000-0002-0224-1866
Funding for this research was provided by:
AstraZeneca
Almirall S.A
Article History
Accepted: 16 January 2022
First Online: 15 March 2022
Declarations
:
: The aclidinium PASS programme was funded by Almirall S.A. In June 2015, AstraZeneca became the marketing authorisation holder of Eklira® and continued funding the programme, including this study. The contracts provide the research team independent publication rights. The authors had complete autonomy in the process of establishing the protocol, carrying out the analyses, and interpreting the results. The sponsors had no role in the data collection or analysis; however, in line with the Guideline on Good Pharmacovigilance Practices (GVP): Module VIII—Post-authorisation Safety Studies of the European Medicines Agency, the sponsors had the opportunity to view the results and interpretations included in the manuscript and provide comments prior to submission of the manuscript for publication.
: Elena Rivero-Ferrer, Cristina Rebordosa, Estel Plana, Jaume Aguado, Núria Saigí-Morgui, and Susana Perez-Gutthann are employees of RTI Health Solutions and work on projects funded by pharmaceutical companies. As an employee of RTI Health Solutions, Susana Perez-Gutthann also participates in scientific advisory boards (for studies and medications) that are funded by pharmaceutical companies. Nina Sahlertz Kristiansen, Morten Olsen, Anton Pottegård and Jesper Hallas are employees of the University of Southern Denmark, Clinical Pharmacology, Pharmacy and Environmental Medicine. They have participated in studies funded by pharmaceutical companies (Alcon, Almirall, Astellas, Astra-Zeneca, Boehringer-Ingelheim, Pfizer, Menarini, Servier, Takeda), with money paid to their employer. Tania Schink is an employee of the independent, nonprofit scientific organisation Leibniz Institute for Prevention Research and Epidemiology—BIPS. Unrelated to this study, BIPS occasionally conducts studies financed by the pharmaceutical industry. Almost exclusively, these are post-authorisation safety studies (PASS) requested by health authorities. The design and conduct of these studies as well as the interpretation and publication are not influenced by the pharmaceutical industry. Annalisa Rubino, Sami Z Daoud, and Alejhandra Lei are employees of AstraZeneca.
: This study uses a national healthcare database, a general practitioner database, and a claims database. Only the aggregated data, in the form of study results in the main manuscript and in the supplementary material can be shared.
: Programming codes are archived at BIPS (GePaRD, Germany), Southern Denmark University (Danish registers), and RTI Health Solutions (UK CPRD and aggregated tables across sites).
: ERF, AJW, MO, EP, JA, NSM, SPG, TS, NSK, JH, AP and CR provided substantial contributions to study design and interpretation of the data, performed the research, and wrote or critically reviewed the work for important intellectual content. MO, NSK, EP and JA also analysed the data. AR, SZD and AL provided substantial contributions to study design and interpretation of the data and critically reviewed the work for important intellectual content. All authors approved the final version of the manuscript and are accountable for all aspects of this research.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. For this type of study, based exclusively on routinely collected data, formal consent is not required. For more details on site-specific approvals, refer to the Methods section in the article.
: Not applicable.
: Not applicable.
: The summary of the regulatory report of the study is available in the EU PAS register [ExternalRef removed]. Partial results of this study have been presented at international conferences: Rebordosa C, Rubino A, Witzleb AJ, Olesen M, Plana E, Aguado J, Saigi N, Daoud SZ, Lei A, Perez-Gutthann S, Schink T, Kristiansen NS, Pottegård A, Rivero-Ferrer E. Characteristics of new users of aclidinium, aclidinium/formoterol, and other COPD medications in three European countries. Poster presented at the 2020 Virtual ERS International Congress; October 2020. [abstract] Eur Respir J. 2020 Oct 28; 56(Suppl 64):2071. ExternalRef removed. Rivero-Ferrer E, Witzleb AJ, Olesen M, Plana E, Aguado J, Saigí-Morgui N, Rubino A, Daoud SZ, Lei A, Perez-Gutthann S, Schink T, Kristiansen NS, Pottegård A, Rebordosa C. Are aclidinium and aclidinium/formoterol used according to their approved indication in Europe? Results of a multicountry drug utilization postauthorization safety study. Poster presented at the 36th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Virtual, September 16-17, 2020. [abstract] Pharmacoepidemiol Drug Saf. 2020 Oct; 29(Suppl 3):175.