This study and the journal’s rapid service fee were funded by MSD, Greece.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
List of Investigators
The authors wish to thank the investigators in the GLANCE study: Agathi Vasileiou, Ekaterini Santipantaki, Ekaterini Trikkalinou, Antigoni Krasanaki, Antonios Antoniadis, Apostolos Xylomenos, Christos Manthakos, Chryssoula Gioti-Polyzou, Dimitra Zianni, Dimitrios Chrisis, Efrosini Tsirogianni, Eleni Pourou, Georgia Georgakopoulou, Georgia Katsigianni, Georgia Talampouka, Georgios Andreopoulos, Konstantinos Balampanis, Georgios Marinos, Haralampos Basoukos, Ilias Mazokopakis, Ioannis Giannakakis, Ioannis Katsakoulas, Iordanis Dimitsikoglou, Konstantinos Halkias, Konstantinos Lefkaditis, Kyros Siomos, Labrini Gkouva, Lazaros Chatziioannidis, Leonidas Peltekis, Louiza Ventzi, Maria Horianopoulou, Leonidas Lanaras, Nikolaos Valvis, Panagiotis Mylonas, Savvas Symeonidis, Spiridon Karras, Thekla Chatziadamidou, Vasileios Christakis, Vasileios Pikounis
Nikolaos Papanas has been an advisory board member of TrigoCare International, Abbott, AstraZeneca, Elpen, MSD, Novartis, Novo Nordisk, Sanofi-Aventis and Takeda; has participated in sponsored studies by Eli Lilly, MSD, Novo Nordisk, Novartis and Sanofi-Aventis; received honoraria as a speaker for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Elpen, Galenica, MSD, Mylan, Novartis, Novo Nordisk, Pfizer, Sanofi-Aventis, Takeda and Vianex; and attended conferences sponsored by TrigoCare International, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Pfizer and Sanofi-Aventis. Moses Elisaf reports honoraria from MSD, Novartis, Chiesi, Bayer, Astra Zeneca, Pfizer, Abbott, Mylan, Sanofi, Amgen, Boehringer Ingelheim, Eli Lilly, GSK, Angelini, Winmedica, grants and personal fees from MSD and Astra Zeneca; has given talks and attended conferences sponsored by Bristol-Myers Squibb, Novartis, Chiesi, Bayer, Astra Zeneca, Pfizer, Abbott, Mylan, Sanofi, Amgen, Boehringer Ingelheim, Eli Lilly, Angelini, Winmedica and MSD. Kalliopi Kotsa has given talks, attended conferences, acted as a consultant and participated in trials sponsored by Astra Zeneca, Boehringer Ingelheim, Eli-Lilly, Elpen, MSD, Novo Nordisk, Sanofi and Servier. Alexandra Bargiota has received travel grands and/or participated in advisory boards for Astra-Zeneca, ELPEN, NovoNordisk,, MSD, Lilly, Novartis, Boehringer–Ingelheim and Sanofi-Aventis. John Doupis has been an advisory board member of, Abbott, AstraZeneca, Elpen, MSD, Novo Nordisk and Sanofi-Aventis; has participated in sponsored studies by Eli Lilly, MSD, Novo Nordisk, AstraZeneca Boehringer Ingelheim and Sanofi-Aventis; received honoraria as a speaker for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Elpen, MSD, Novo Nordisk, Sanofi-Aventis and Vianex; and attended conferences sponsored by AstraZeneca, MSD, Boehringer Ingelheim, Eli Lilly, Novo Nordisk and Sanofi-Aventis. Iakovos Avramidis has participated in advisory panels, speaker honoraria, clinical trials with: Sanofi - Aventis, Eli Lilly, Novo Nordisk, Astra Zeneca, Boehringer Ingelheim, Novartis, MSD/Vianex, Elpen, GSK. Ioannis Ioannidise, Andreas Melidonis, Stavros Bousboulas, Angelos Pappas, Gerasimos Karousos, Eleni Arvaniti, Magdalini Bristianou and Emmanouel Pagkalos report no potential conflicts of interest. Eugenia Karamousouli, Voss Bernd and Katerina Pietri are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, who may own stock and/or hold stock options in the Company. Ilias Migdalis reports honoraria from MSD. Nikolaos Tentolouris has participated in advisory panels for MSD, AstraZeneca, Sanofi, Novo Nordisk, ELPEN, Eli Lilly, Boehringer Ingelheim and Novartis, and received research support from MSD, Eli Lilly, Novo Nordisk, Sanofi, Pfizer, AstraZeneca, Janssen Cilag, GSK, Trigocare, Elpen, Libytec and Novartis.
Compliance with Ethic Guidelines
The study was conducted in accordance with the International Society for Pharmacoepidemiology guidelines for Good Pharmacoepidemiology Practice, the ethical principles of the Declaration of Helsinki of 1964 and its later amendments and all standing regulations. The study was approved by the ethics committees of all participating hospitals (see Electronic Supplementary Material Table S1). Signed written informed consent was obtained from all participants.
Part of the manuscript was presented as an abstract in ISPOR Europe 2019 Congress, Copenhagen, Denmark.
The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request. MSD is committed to providing qualified scientific researchers access to anonymised patient-level data and clinical study reports from the company’s clinical trials for the purpose of conducting legitimate scientific research. The company is also obliged to protect the rights and privacy of trial participants and, as such, has a procedure in place for evaluating and fulfilling requests for sharing company clinical trial data with qualified external scientific researchers. The process includes submission of data requests to the Merck data sharing website (available at http://engagezone.merck.com/ds_documentation.php). There are circumstances that may prevent Merck from sharing the requested data.