Funding for this research was provided by:
Shire Pharmaceuticals, now part of the Takeda group of companies
First Online: 27 May 2019
Compliance with Ethical Standards
: This study was performed under a research contract between RTI Health Solutions and Shire Pharmaceuticals, 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, Abenah Harding, 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-Alberto Garcia-Rodriguez, Oscar F. Cantero, and Ana Ruigómez are employed at the Spanish Centre for Pharmacoepidemiologic Research (CEIFE Madrid, Spain), which has received research funding from RTI Health Solutions. Robert W.V. Flynn is an employee of the University of Dundee and has received research grants from Novartis and GlaxoSmithKline. Thomas M. MacDonald is an employee 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. Thomas M. MacDonald is also 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 from 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 been paid consulting fees by Novartis. Pär Karlsson, Love Linnér, and Ingvild Odsbu are employed at the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities and contract research organizations) for the performance of drug safety and drug utilization studies. 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.
: All relevant authorities reviewed and approved the study on ethical grounds in the UK, Germany, and Sweden. The data used in this study were obtained from databases of anonymized medical and pharmacy records and not directly from human subjects.
: Not applicable.