EFFICACY AND SAFETY OF BEPOTASTINE, A NEWER 2ND GENERATION ANTIHISTAMINE, COMPARED TO FEXOFENADINE IN ALLERGIC RHINITIS
*Dr. Swapnil Deshmukh, Dr. Varsha Narayanan and Dr. Amit Bhargava
ABSTRACT
Background: Second-generation antihistamines are recommended as a first-line treatment option for adult allergic rhinitis (AR). Bepotastine is new oral selective H1 antihistamine. This study was done to evaluate comparative efficacy and safety of bepotastine with fexofenadine. Material and methods: This was a phase III, multicenter randomized double blind, prospective comparative study in 239 patients with AR. Patients were divided into two groups receiving either Bepotastine 10 mg tablets or Fexofenadine 60 mg capsule twice daily for 4 weeks. Change in Total symptom score(TSS), Total nasal symptom score (TNSS), Total ocular symptom score (TOSS), Rhino-conjunctivitis quality of life (RQOL), individual nasal & ocular symptom scores. Intergroup comparison was also done on TSS. Investigator’s & patients’ global assessment were also compared between two treatment groups. Results: After 4 weeks of treatment, both the groups showed statistically significant improvement in all the parameters like TOSS, TNSS, TSS, RQOL, individual nasal and ocular symptom score compared to baseline. Intergroup comparison did not show any statistically significant difference. Greater improvement from baseline score was seen in bepotastine group compared to fexofenadine (29.17+7.54 Vs 23.85+9.95) on six digit cancellation test score for assessing psychomotor performance, though the difference was not statistically significant. Conclusion: The trial concluded that bepotastine showed comparable efficacy to fexofenadine in the management of AR. Bepotastine caused less sedation and greater improvement in psychomotor performance. Both treatment groups demonstrated good safety profile.
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