Multicenter Study of the Efficacy and Safety of Fexofenadine 60 mg. Twice Daily in 108 Thai Patients with Chronic Idiopathic Urticaria
KANOKVALAI KULTHANAN,M.D.*, PIMONPUN GRITIYARANGSAN, M.D., Ph.D.**,
CHASUREE SITAKALIN, M.D.***, SOMYOT CHARUWICillTRATANA, M.D.****,
WIWAT KORKU, M.D.*****, KOBKUL AUNHACHOKE, M.D.***,
PATCHARIN JANJUMRATSANG, M.D.**, SUKHUM JIAMTON, M.D., M.Sc.*,
MONNATE KUNTIRANONT, M.D.*****, JANTHORN KRISADAPONG, M.D.*,
NANTHACHAK GHERUNPONG, M.D.*, PRISANA KULLA V ANUAYA, M.D.****
Affiliation : * Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700,
* * Institute of Dermatology, Bangkok 10320,
*** Dermatology Unit, Department of Medicine, Pramongkutklao Hospital, Bangkok 10400,
** * * Division ofDermatology, Department ofMedicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University,
Bangkok 10400,
***** Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok
10330, Thailand.
AbstractFexofenadine 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 for· 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.
Keywords : Chronic Idiopathic Urticaria, Fexofenadine, Efficacy, Safety
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