Efficacy and Safety of Montelukast Plus Fexofenadine Fixed Dose Combination in Allergic Rhinitis : Results of Post-Marketing Study In India.
Loading...
Date
2013-08
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Background:Allergic rhinitis is one of the most common
conditions in clinical practice. Motelukast and second
generation antihistamine fexofenadine are routinely used in
the management of allergic rhinitis. Individually both drugs
have been found to be effective in allergic rhinitis. Fixed
dose combination of montelukast 10 mg plus fexofenadine
120 mg is available in India is also used in the treatment of
allergic rhinitis. Objective: To evaluate the efficacy and
safety of montelukast and fexofenadine fixed dose
combination in the management of patients with allergic
rhinitis. Material and methods: Post marketing observational
study was conducted in 809 patients from all over India.
All the patients were treated with montelukast 10 mg plus
fexofenadine 120 mg fixed dose combination once daily
for 14 days. The primary outcome criteria was the change
in total symptom score (Sum of total nasal symptom score
and total ocular symptom score) at the end of study
compared to baseline. The secondary outcome criteria
included change in total nasal symptom score (nasal
congestion, rhinorrhea, nasal itching, and sneezing) and
total ocular symptom score (Itching/burning eyes, tearing/
watering eyes and eye redness) at the end of study compared
to baseline and physician’s and patient’s global assessment
for efficacy and tolerability. The patients were evaluated at
baseline, day 7 and day 14 for efficacy evaluation while the
safety parameters were assessed at screening and day 14.
Results: The fixed dose combination of fexofenadine plus
montelukast was significantly effective in reducing total
symptom score, total nasal symptom score and total ocular
symptom score (p<0.0001 for all parameters). The global
assessment of efficacy evaluation by both patient and
investigators demonstrated “excellent to good” efficacy in
>95% of patients. Most of the study population reported
“good” tolerability with the fixed drug combination. No
adverse events were reported in the study. Conclusion: The
fixed dose combination of fexofenadine plus montelukast
was found to be efficacious and well tolerated in allergic
rhinitis in Indian adult patients.
Description
Keywords
allergic rhinitis, montelukast, fexofenadine
Citation
Naik Manoj, Nayak Ashwini, Khandeparkar Prashant, Mukaddam Qayum. Efficacy and Safety of Montelukast Plus Fexofenadine Fixed Dose Combination in Allergic Rhinitis : Results of Post-Marketing Study In India. Indian Medical Gazette. 2013 Aug ; 147 (8): 314-318.