Efficacy and Safety of Azelastine and Levocetirizine in Allergic Rhinitis

BACKGROUND: Allergic rhinitis is an inflammatory disease with worldwide prevalence of 10-40%. Clinically, the condition manifests as nasal itching (pruritus), sneezing, rhinorrhea, congestion and itchy eyes. The second generation antihistamines are commonly used either as nasal sprays (azelastine) or orally (levocetirizine). Studies have demonstrated equal efficacy of azelastine and levocetirizine, but the data on Indian population is lacking. Hence, we designed this study to evaluate the effectiveness and safety of azelastine in comparison to levocetirizine in patients with allergic rhinitis. METHODS: This prospective, randomized, parallel group study was conducted in the otorhinolaryngology outpatient department. Both male and female patients between the ages of 18 to 55 years were enrolled in the study after informed consent. Patients were randomized into two groups. Subjects in group 1 received azelastine whereas group 2 received levocetirizine. Clinic visits were scheduled at baseline and after every 2 weeks of treatment for 4 weeks. The primary outcome measure was mean change in the total daytime nasal symptom scores (PDTS) and secondary outcomes were mean change in the nighttime nasal symptom scores (PNTS) and composite symptom scores (PCS). RESULTS: We enrolled 40 patients, 20 in each group. Both groups were comparable at baseline and tolerated treatment well. There was significant (p<0.05) improvement in mean PDTS, PNTS and PCS scores in both groups from second week onwards. There was significant (p<0.05) improvement in patients in group 1 at 4 weeks in the mean PDTS and PCS score. There was no significant difference in mean PNTS scores in both groups. There were no reported adverse events. CONCLUSION: In our study, both azelastine and levocetirizine improved the symptoms of patients with allergic rhinitis but azelastine showed better improvement in symptoms at the end of 4 weeks. Conflict of Interest: None declared This article has been peer reviewed. Article Submitted on: 4 April 2013 Article Accepted on: 18 June 2013 Funding Sources: The project has been supported by Indian Council of Medical Research – Short term Studentship Program (ICMR-STS) 2012 program Correspondence to: Dr. Prithpal S. Matreja Address: Department of Pharmacology, Gian Sagar Medical College and Hospital, Patiala, India Email: [email protected] Cite this article: Mahajan S, Gupta V, Gupta AK, Matreja PS, Singh A, Khanna PML, Singh S. Efficacy and safety of azelastine and levocetirizine in allergic rhinitis. J Pak Med Stud 2013; 3(3):143-147 asthma [3]. AR involves inflammation of mucous membranes of nose, eyes, eustachian tubes, middle ear, sinuses, and pharynx, and is characterized by a complex interaction of inflammatory mediators but ultimately is triggered by an immunoglobulin E (IgE)– mediated response to an extrinsic antigen [1]. Clinically, the condition manifests as nasal itching (pruritus), sneezing, rhinorrhea (runny nose), congestion and itchy eyes [1, 4]. Management of the disease involves allergen INTRODUCTION Allergic rhinitis (AR) has high prevalence worldwide, varying from 10-40% [1]. Allergic rhinitis affects approximately 40 to 50 million people in the United States [2]. The prevalence of allergic rhinitis may vary within and among countries. This may be due to geographic differences in types and potency of different allergens and overall aeroallergen burden [2]. A recent survey in India shows that 20–30% of the population suffers from AR and that 15% has