Key result
Rivaroxaban adverse reactions reported in the Russian database showed a predominance of cardiovascular events and fewer hemorrhagic complications compared to the international VigiBase.
Why the study?
How do the reported adverse reactions to rivaroxaban in the Russian national database compare to those in the international database?
Observational
Yes
How do the reported adverse reactions to rivaroxaban in the Russian national database compare to those in the international database?
There are regional differences in the reporting of rivaroxaban adverse events, with cardiovascular events more frequently reported and hemorrhagic complications less frequently reported in Russia compared to international data.
Answers are grounded in this paper and cite their sources.
Regional rivaroxaban ADR differences should not yet alter monitoring or prescribing; leaves open questions on reporting biases and true event rates.
Information about rivaroxaban adverse reactions (ADRs) submitted to the national spontaneous reporting database from 1 January 2008 to 31 March 2016 was analyzed and compared with the international database (VigiBase) for the same time period. The marked increase in reporting ADRs after rivaroxaban treatment was detected in the Russian database. The comparison of the two databases showed that the relative ratio of ADRs from organs and body systems did not differ significantly except for ADRs of the cardiovascular system that predominated according to the Russian database. Moreover, the Russian database contained much fewer reports of hemorrhagic complications than the international database.
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Затолочина et al. (2017) conducted an observational in Rivaroxaban adverse reactions. Rivaroxaban vs. International database (VigiBase) was evaluated on Adverse drug reactions (ADRs). Rivaroxaban adverse reactions reported in the Russian database showed a predominance of cardiovascular events and fewer hemorrhagic complications compared to the international VigiBase.
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