Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2 V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the sample size planned, a mean difference of total body water delta between groups (control vs. polymorphic) of at least allow 10% could be observed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
20
50 mg po, b.i.d for 6 days
Placebo po, b.i.d. for 6 days
Unidade de Pesquisa Clínica HCRP-USP
Ribeirão Preto, São Paulo, Brazil
Edema
Presence of edema, measured by the estimative of total body water (deuterium oxide dilution technique). The measurements will be done in the end of 6 days of use of placebo and diclofenac, and the delta between diclofenac and placebo will be used as endpoint
Time frame: after 6 days of diclofenac and placebo
Blood Pressure
Variation (delta) of 24h diastolic blood pressure between placebo and diclofenac phases, measured by ambulatory blood pressure monitoring (ABPM)
Time frame: after 6 days of diclofenac and placebo
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