Fortuny, Joan
Gilsenan, Alicia
Cainzos-Achirica, Miguel
Cantero, Oscar F.
Flynn, Robert W. V.
Garcia-Rodriguez, Luis
Kollhorst, Bianca
Karlsson, Pär
Linnér, Love
MacDonald, Thomas M.
Plana, Estel
Ruigómez, Ana
Schink, Tania
Ziemiecki, Ryan
Andrews, Elizabeth B.
Funding for this research was provided by:
Shire Pharmaceuticals, now part of the Takeda group of companies
Article History
First Online: 27 May 2019
Compliance with Ethical Standards
:
: This study was performed under a research contract between RTI Health Solutions and Shire, now part of the Takeda group of companies, and was funded by Shire. The research contract granted independent publication rights to the research team, and the content of the publications was developed independently from the study sponsor. Alicia Gilsenan, Joan Fortuny, Estel Plana, Ryan Ziemiecki, and Elizabeth B. Andrews are salaried employees of RTI Health Solutions. Miguel Cainzos-Achirica was a salaried employee of RTI Health Solutions when this research was conducted and is currently affiliated with the Hospital Universitari de Bellvitge Department of Cardiology, Feixa Llarga, Hospitalet de Llobregat, Barcelona, Spain. Luis Garcia-Rodriguez, Oscar F. Cantero, and Ana Ruigómez are employed at the Spanish Centre for Pharmacoepidemiologic Research (CEIFE Madrid, Spain). Robert W. V. Flynn and Professor Thomas M. MacDonald are employees of the University of Dundee, an academic organization that received financial support under the research contract between RTI Health Solutions and Shire, now part of the Takeda group of companies, to carry out the study. Robert W. V. Flynn has received research grants from Novartis and GlaxoSmithKline. Professor Thomas M. MacDonald is the director of MEMO Research at the University of Dundee, an organization that has received research funding from Pfizer, Novartis, Amgen, Ipsen, GlaxoSmithKline, Teijin, and Menarini, mostly for post-licensing studies requested by regulatory authorities, and has personally received honoraria for educational lectures from Takeda. He has been the principal investigator on trials paid for by Pfizer, Novartis, Ipsen, Teijin, GlaxoSmithKline, and Menarini (mostly post-licensing regulatory requested studies). In the last 3 years, he has received consulting fees from Novartis. Pär Karlsson and Love Linnér are employed at the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities and contract research organizations) for performance of drug safety and drug utilization studies. These entities had no role in the data collection and analysis and were not involved in the interpretation of results, writing, revision, and approval of the manuscript. Miguel Cainzos-Achirica has participated in a research study funded by a non-conditioned research grant from Vifor. Tania Schink and Bianca Kollhorst are working at an independent, non-profit research institute, the 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-authorization safety studies 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.
: This study was funded by Shire, now part of the Takeda group of companies.
: All relevant authorities reviewed and approved the study on ethical grounds in the UK, Germany, and Sweden.
: Not applicable; the data used in this study were obtained from databases of medical records and not directly from human subjects.