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Mechanism
of Action of Tranilast:
Tranilast has been shown to inhibit release or production of chemical
mediators, cytokines and reactive oxygen interactions (by virtue
of its membrane stabilizing action) by various inflammatory cells
and macrophages as well as to interfere with the proliferation and
migration of vascular medical smooth muscle cells induced by PDGF
and TGF-B1.
Clinical
Trials:
Two placebo controlled clinical trials were conducted in Japan using
quantitative coronary angiography. Tranilast was found to be effective
in reducing the risk of restenosis. In both studies, tranilast,
200 mg TID was significantly (p<0.001) more effective in preventing
restenosis whether measured angiographically by lesion or by patient.
Based on these trials, tranilast is hypothesized to be effective
in preventing restenosis and its sequelae, but the effective dose
and regimen in Western populations is not known.
Most Common
Side Effects:
Elevated Liver function tests, elevated eosinophils, elevated urinary
uric acid excretion, decreased serum uric acid, skin reactions (1%)
such as rash/eruption/eczema/ pruritis/urticaria, minor gastrointestinal
symptoms like nausea, indigestion, stomach pain (1%) and 3) cystitis-like
symptoms (e.g., frequency of urination, pain with urination) (less
than 1%). Because tranilast decreases serum uric acid it may cause
a gouty attack.
Special Precautions:
Concurrent use of warfarin or phenytoin
with study medication is prohibited.
Population:
Patients who have had a successful percutaneous coronary intervention.
Treatment
Procedures:
Placebo (an inactive substance) twice a day for 3 months, or Tranilast
300 mg twice a day for 3 months, or Tranilast 450 mg twice a day
for 3 months, or Tranilast 300 mg twice a day for 1 month then placebo
for 2 months, or Tranilast 450 mg twice a day for 1 month then placebo
for 2 months.
Contact Numbers:
Andrew Michaels, M.D.:
Office 476-1614
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