Exploring pharmacogenetic difference using adverse event database: an example of clopidogrel and cardiovascular...

Area of Science:

• Pharmacogenomics
• Cardiovascular Medicine
• Drug Safety

Background:

• Cytochrome P450 2C19 (CYP2C19) loss-of-function alleles are more prevalent in East Asian populations.
• This genetic variation impacts clopidogrel metabolism, potentially increasing cardiovascular event risk.

Purpose of the Study:

• To investigate the association between clopidogrel use and cardiovascular events in Koreans.
• To compare the safety profile of clopidogrel with ticagrelor in a real-world setting.

Main Methods:

• Utilized a case/noncase study design analyzing the Korea Adverse Event Reporting System (KAERS) database.
• Compared findings with data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

Main Results:

• KAERS data showed a reporting odds ratio (ROR) of 7.34 for cardiovascular events with clopidogrel, more than double that of ticagrelor.
• FAERS data indicated a clopidogrel ROR of 4.69, which was lower than ticagrelor's.
• Covariate adjustment did not alter these observed trends.

Conclusions:

• The high prevalence of poor clopidogrel metabolizers among Koreans, coupled with reported cardiovascular events, underscores the need for enhanced clinical vigilance.
• Rigorous patient management strategies are essential for clopidogrel users in this demographic to mitigate risks.