Introduction

The mainstay treatment for allergic rhinitis includes oral/intranasal H1-antihistamines, decongestants, leukotrienes receptor antagonists and intranasal corticosteroids. The use of second-generation antihistamines has also increased due to comparable efficacy and better safety profile as compared to their first-generation counterparts. The combination therapy with levocetirizine, a second-generation H1 receptor antagonist, and montelukast, a leukotriene receptor antagonist, has been compared with monotherapy or placebo. Similarly, there is data comparing combination therapy of montelukast with fexofenadine, a non-sedating second-generation H1 receptor antagonist, with monotherapy or placebo. However, there is paucity of data comparing concomitant montelukast-levocetirizine with montelukast-fexofenadine.

Aim

The safety, efficacy and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine was compared in patients with allergic rhinitis (AR).

Methods

Study design

• Randomized, prospective, double-blind, parallel, active-controlled, comparative 4-week trial
• Subjects aged 18-65 years having moderate-severe intermittent or mild persistent AR
• Patients with total nasal symptom score (TNSS) of 5 or higher
• Randomized to group A receiving montelukast-levocetirizine (10 mg+5 mg) or group B receiving montelukast-fexofenadine (10 mg+120 mg) daily

Endpoints

• Change from baseline in TNSS
• Cost-effectiveness ratio
• Incidence of adverse events (AEs)

Results

• Group A and B comprised of 33 and 32 patients respectively
• Both the groups showed statistically significant reductions in TNSS from baseline at 4^th week
• The comparison of TNSS in both groups at baseline and at weeks 2 and 4 are seen in table 1.

• The mean change of TNSS score was more significant in group B (9.46 vs 8); p<0.0033
• The cost of treatment in group A and B was Rs 184.8 and Rs. 282.8 per patient respectively for the duration of 4 weeks
• The cost effectiveness ratio was less in group A as seen in figure 1.

• The overall incidence of AE was 15% and 22% in group A and B respectively
• There was no incidence of serious AE in either group

Conclusion

• The montelukast-fexofenadine group had a significant decrease in the total nasal symptom score as compared to montelukast-levocetirizine group
• Montelukast-levocetirizine group had a lesser cost-effectiveness ratio as compared to montelukast-fexofenadine group

Indian J Pharmacol 2016; 48:2649-53.