Patient Care - Allergy & Immunology - October 2007 - (Page 23)

Allergic rhinitis I TABLE 2 Key clinical trials of montelukast versus oral antihistamines for seasonal allergic rhinitis Study design Treatment regimen Key end points/results Randomized, double-blind, placebo-controlled, parallel-group, 460 randomized patients1 MON, 10 mg each evening MON, 20 mg qd LOR, 10 mg qd MON, 10 mg plus LOR, 10 mg qd Placebo MON, 10 mg qd LOR, 10 mg qd Placebo Daytime total nasal symptom score, improvement from baseline: MON-LOR vs placebo ( 0.36, P 0.001) MON, 10 mg, vs placebo ( 0.11, P NS) MON, 20 mg, vs placebo ( 0.04, P NS) LOR vs placebo ( 0.09, P NS) Conclusion: Combination better than either MON or LOR alone. Daytime total nasal symptom score, improvement from baseline: MON vs placebo ( 0.13, P 0.001) LOR vs placebo ( 0.24, P 0.001) Conclusion: MON and LOR superior to placebo and equal to each other. Daytime total nasal symptom score, improvement from baseline: MON-LOR vs placebo ( 0.32, P 0.001) MON vs placebo ( 0.23, P 0.001) LOR vs placebo ( 0.26, P 0.001) MON-LOR vs MON vs LOR (P NS) Conclusion: MON and LOR alone and in combination more effective than placebo and equal to each other. Average AM/PM nasal peak inspiratory flow, improvement from baseline: FEX vs placebo ( 9 L/min, P 0.05) MON-LOR vs placebo ( 11 L/min, P 0.05) Mean difference in daytime total nasal symptom score: FEX vs placebo ( 2.4, P 0.05) MON-LOR vs placebo ( 3.4, P 0.05) Conclusion: FEX qd equal to MON-LOR combination. Daytime total nasal symptom scores, improvement from baseline: MON vs placebo ( 0.09, P 0.003) LOR vs placebo ( 0.19, P 0.001) Conclusion: MON and LOR better than placebo. Randomized, double-blind, parallel-group, 1302 randomized patients2 Randomized, double-blind, parallel-group, placebo-controlled, 907 randomized patients3 LOR, 10 mg at bedtime MON, 10 mg qd MON, 10 mg plus LOR, 10 mg qd Placebo Randomized, placebo-controlled, single-blind, double-dummy, crossover, 37 evaluable patients4 FEX, 120 mg qd MON, 10 mg plus LOR, 10 mg qd Placebo Randomized, double-blind, placebo- and activecontrolled, 1214 randomized patients5 MON, 10 mg qd LOR, 10 mg qd Placebo Key: CET, cetirizine; FEX, fexofenadine; LOR, loratadine; MON, montelukast; NS, not significant. 1. Meltzer EO, Prenner BM, Nayak A, et al. Efficacy and tolerability of once-daily 5 mg desloratadine, an H1-receptor antagonist, in patients with seasonal allergic rhinitis. Clin Drug Invest. 2001;21:25-32. 2. Philip G, Malmstrom K, Hampel FC, et al. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002;32:1020-1028. 3. Nayak AS, Philip G, Lu S, et al. Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002;88:592-600. 4. Wilson AM, Orr LC, Coutie WJ, et al. A comparison of once daily fexofenadine versus the combination of montelukast plus loratadine on domiciliary nasal peak flow and symptoms in seasonal allergic rhinitis. Clin Exp Allergy. 2002;32:126-132. 5. van Adelsberg J, Philip G, LaForce CF, et al. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003;90:214-222. OCTOBER 2007 PATIENT CARE ALLERGY & IMMUNOLOGY 23

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Patient Care - Allergy & Immunology - October 2007 Research Digest Contents Medicine in the News When to Suspect Celiac Disease and How to Proceed From There Averting Angioedema’s Potentially Dire Consequences Is There a Role for Leukotriene Receptor Antagonists in Treating Allergic rhinitis? Clinical Clips Dermatology Case Challenge Classified Advertising

Patient Care - Allergy & Immunology - October 2007

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