J Med Assoc Thai 2001; 84 (2):153

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Multicenter Study of the Efficacy and Safety of Fexofenadine 60 mg. Twice Daily in 108 Thai Patients with Chronic Idiopathic Urticaria
Kulthanan K Mail, Gritiyarangsan P , Sitakalin C , Charuwichitratana S , Korkij W , Aunhachoke K , Janjumratsang P , Jiamton S , Kuntiranont M , Krisadapong J , Gherunpong N , Kullavanijaya P

Fexofenadine is a non-sedating antihistamine indicated for relieving symptoms from
allergic conditions with a rapid onset of action without cardiotoxic risks. Controlled studies
showed that fexofenadine 180 mg daily provides significant relief of symptoms of chronic
idiopathic urticaria (CIU). The purpose of this study was to demonstrate the efficacy and
safety of fexofenadine 60 mg twice daily in Thai patients with CIU in a multicenter trial.
Patients were assigned to receive twice daily doses of fexofenadine 60 mg forเธ— 6 weeks.
Patients rated symptom severity every night, investigators rated patients' signs and
symptoms at recruitment and at 1, 3 and 6 weeks. Ninety eight out of 108 patient (90.7%)
completed the study. The patients reported 95 per cent improvement and, of those, 91 per
cent had very favorable responses (excellent 15%, very good 42%, good 30%, fair 8%).
The objective assessment by their physicians paralleled those responses. Fexofenadine
provided a rapid clinical response that was significantly superior to before treatment in
relieving symptoms of CIU (p
<
0.001). Adverse events occurred in 20 cases (18.5%),
mostly mild headache and drowsiness. Fexofenadine 60 mg twice daily provides effective
relief of the symptoms of CIU with minimal adverse events.
Key word : Chronic Idiopathic Urticaria, Fexofenadine, Efficacy, Safety

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