Effectiveness, safety, and cost-effectiveness of fixed-dose combination of montelukast–bilastine versus montelukast–levocetirizine in allergic rhinitis: A prospective, randomized, open-label, parallel-group study
Abstract
Abstract Introduction: Several fixed-dose combinations (FDCs) have been available for the treatment of allergic rhinitis (AR), of which montelukast and levocetirizine is one of the highly prescribed FDC. The FDC of bilastine with montelukast was approved by the drug controller general of India (DCGI) in March 2020. Due to the availability of limited evidence, the present study was planned to evaluate and compare the effectiveness, safety, and cost-effectiveness of montelukast/bilastine versus montelukast/levocetirizine in relieving symptoms of AR. Methodology: After getting approval from the Institutional Ethics Committee, a prospective, open-label comparative study was conducted from March 2024 to September 2024 at the Research Institute of Central India. Patients of either gender, in the age group of 18–65 years suffering from AR having total nasal symptom score (TNSS) >8 were enrolled. Selected patients were randomly assigned to Group A (montelukast–bilastine) or Group B (montelukast–levocetirizine) for 4 weeks. Results: TNSS score was significantly reduced in Group A ( χ 2 = 62, df-2, P ≤ 0.001) and Group B ( χ 2 = 60, df-2, P ≤ 0.001) at week 2 and week 4 when compared with baseline. Comparative analysis of reduction in TNSS at 4 weeks among two groups shows no significant difference ( P = 0.86). When analyzed by Fisher’s exact test, the incidence of adverse events was significantly higher in Group B than in Group A ( P = 0.04). The cost-effectiveness ratio in Group A…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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