EFFICACY OF ACRIVASTINE WITH PSEUDOEPHEDRINE IN TREATMENT OF ALLERGICRHINITIS DUE TO RAGWEED

Background: Semprex-D capsules contain acrivastine 8 mg (a second gene ration H-1-antagonist) plus pseudoephedrine HCl 60 mg and were develop ed to satisfy the needs of allergy sufferers who prefer combination pr oducts designed to provide broader symptom relief. Approval of combina tion products by the US Food and Drug Administration requires demonstr ation that each component contributes to the overall effectiveness. Ob jective: The objective of the study was to demonstrate that both acriv astine and pseudoephedrine share in the efficacy of the combination in relieving allergy symptoms in patients sensitive to ragweed pollen. M ethods: This was a double-blind, randomized, placebo-controlled, paral lel groups, balanced design, multicenter (13 sites) study. Patients 12 years of age or older with skin test reactivity to ragweed were recru ited. Patients who qualified for the study were dispensed either(1) ac rivastine + pseudoephedrine, (2) acrivastine, (3) pseudoephedrine, or (4) placebo with instructions to take one capsule 4 times daily and to record allergy symptom scores in a symptom diary 3 times daily for 14 days. Assessments of health, global allergy symptoms, protocol compli ance, adverse events, and vital signs were also documented. Results: A total of 702 patients were enrolled in this study. Over the 2-week pe riod, the combination of acrivastine + pseudoephedrine was significant ly more effective than acrivastine, pseudoephedrine, and placebo for r elief of all symptoms (P range .01 to .001); pseudoephedrine for treat ing symptoms responsive to antihistamines (P = .003); and acrivastine for treating symptoms responsive to nasal decongestants (P < .001). Re latively small increases in adverse experience rates were observed for the combination relative to placebo. Conclusions: These findings in a large clinical trial demonstrate that each component of the combinati on of acrivastine 8 mg plus pseudoephedrine HCl 60 mg contributes to t he overall efficacy, thereby supporting the conclusion that the combin ation is rational, safe, and effective for the treatment of allergic r hinitis.