Khảo sát biến cố bất lợi của ticagrelor ở bệnh nhân mắc hội chứng mạch vành cấp thông qua chương trình giám sát an toàn hậu mãi

Abstract

To ensure the positive benefit-risk balance of ticagrelor in clinical practice, a post-authorisation safety surveillance was implemented. The tolerability and safety of ticagrelor in real-life settings were evaluated on a cohort of 608 patients with acute coronary syndrome during the one year’s period. A total of 397 AEs were detected, and 30.1 % of the ticagrelor users were found likely disposed to the incidence of adverse events (AE). The possibility of adverse drug reactions (ADRs) rated at 24.4 %. Amongst, only one AE led to hospitalization but without persistent complications. Compared with the period previous to this surveillance, the number of ADR reports increased by 15 times. However, this study recorded a rate of dyspnea quite lower than that previously reported as evidences and data from the WHO global database of individual case safety reports (Vigibase). Maybe, this raised concerns about the ignorance of the risks explainable by baseline diseases of patients. In conclusion, ticagrelor caused no significant ADRs to Vietnamese patients with acute coronary disease within the year of this study. Besides, post-authorisation safety surveillances would be worthy of encouraging in Vietnam to provide additional information to national adverse events database for continous evaluation of drug benefit - risk balance in clinical practice.