Presentation Authors: Cosimo De Nunzio*, Giorgia Tema, Riccardo Lombardo, Olivia Voglino, Valeria Baldassarri, Fabiana Cancrini, Angela Sica, Luca Sarchi, Antonio Nacchia, Antonio Cicione, Andrea Tubaro, Rome, Italy
Introduction: Aim of our study was to analyze adverse events (AEs) associated with ENZ and ABI over time and to compare real life data from Eudra-Vigilance to registry studies.
Methods: Eudra-Vigilance database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). AEs were analyzed in two frame times: from 2013 to 2015 and from 2016 to 2018 as well a meta-analysis of registry studies was performed. Pooled Relative Risk (PRR) were used to compare data.
Results: Data from the registry study indicates that patients treated with ENZ had a statistically significant higher risk of asthenia, fatigue, nervous system and vascular disorders when compared to placebo. As well AAP had a statistically significant higher risk of asthenia, fatigue, pain, cardiac, gastrointestinal and metabolism disorders when compared to placebo. Real life data from Eudra Vigilance database reports: ear, eye, endocrine, immune, psychiatric, renal, respiratory and skin disorders which are not reported in the registry study (Table1). Number of adverse events comparing the two frame times has increased in relation to the widespread use of both drugs and particularly ENZ in the last three years. The distribution of different AEs has not significantly changed, except the reduction in the last three years of cardiac and Ear/labyrinth events in patients treated with AAP and blood/lymphatic and hepatobiliary disorders in patients treated with ENZ (Table 1).
Conclusions: Real life data are not consistent with registry study data in the evaluation of AAP and ENZ complications particularly regarding psychiatric, respiratory and skin disorder. Number of AEs has increased in the past three years in relation to the widespread use of these new drugs. Change over time in some adverse events could be related to a better confidence in managing these new drugs and/or to a better patients â€˜selection