Gastrointestinal Hemorrhage Clinical Trial
Official title:
Pharmacogenetics of Gastrointestinal Bleeding Under Nonsteroidal Anti-inflammatory Drugs : the Role of Cytochrome P450 2C9
Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination of several NSAIDs. This protein is inactive in 12% of the subjects because of genetic mutations. We hypothesized that individuals carrying such mutations should be at higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.
Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the
use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for
the elimination of most NSAIDs. Several polymorphisms have been observed in CYP2C9. Of
these, the CYP2C9*3 allele, found in 12% of caucasian subjects, leads to reduced function of
the enzyme.
We hypothesized that individuals carrying this mutation should be at higher risk of
gastrointestinal bleeding since they display decreased elimination of some NSAIDs.
The purpose of this study is to determine whether the frequency for CYP2C9*3 variant allele
is increased in subjects using NSAIDs metabolized by CYP2C9 in comparison with subjects
under NSAIDs not metabolized by this enzyme.
The study groups consist of 200 patients suffering from gastrointestinal bleeding after
NSAIDs use, divided in 100 patients using NSAIDs metabolized by CYP2C9 and 100 patients
using other NSAIDs.
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Observational Model: Cohort, Time Perspective: Prospective
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