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Analysis of spontaneous adverse events reports of hypolipidemics
Škabradová, Anežka ; Malá, Kateřina (advisor) ; Doseděl, Martin (referee)
Analysis of spontaneous adverse events reports of hypolipidemics Author: Anežka Škabradová Supervisor: PharmDr. Kateřina Malá, Ph.D. Consultant: PharmDr. Josef Malý, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Hypolipidemic drugs are widely used in today's medicine and their consumption is still rising. Besides all benefits, their usage includes also some risks that needs to be reconsidered regularly. Analysis of spontaneous adverse effects (AEs) reports contributes to a safer therapy by detecting especially serious and unexpected adverse drug reactions. Objective: The aim of this thesis was to analyse spontaneous adverse events reports of hypolipidemic drugs, which were sent to the State Institute for Drug Control (SÚKL) database in the period from June 2004 to October 2017. Methods: The data obtained from SÚKL during the above mentioned period was analysed using descriptive statistics. The frequency of occurrence of certain AEs, which were categorized according to MedDRA and distinguished by hypolipidemics, was analysed, as well as their severity and expectability. Part of the analysis was for example also by whom was the report submitted and which way they used to submit it. Results: Overall 290 reports were obtained,...
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