Abstract
BackgroundEarly studies with desloratadine demonstrated efficacy in treating seasonal allergic rhinitis (SAR). A dose-ranging study was conducted to characterize its 24-hour efficacy in patients with SAR.MethodsPatients (N = 1,026) were randomly assigned once-daily (QD) desloratadine (2.5, 5, 7.5, 10, or 20 mg) for 2 weeks in a placebo-controlled, double-blind study. The end point of 24-hour efficacy was assessed by the mean change from baseline in the average AM instantaneous total symptom score (TSS) over the treatment period. Day 2 data were assessed for efficacy of desloratadine following the first dose. Other efficacy variables included AM/PM previous total nasal and nonnasal symptom scores and individual symptom scores.ResultsDesloratadine 5–20 mg was significantly (P < .01) more effective than placebo in improving total AM instantaneous TSS and AM/PM previous total nasal and nonnasal symptom scores. This dosing range also was significantly (P < .01) more effective than placebo for reducing AM instantaneous TSS beginning with the first dose; thus, demonstrating the full 24-hour efficacy of desloratadine. AM/PM previous scores for all individual symptoms, including nasal congestion, were also significantly improved versus placebo (P < .05) with desloratadine at 5, 7.5, and 20 mg. All treatments were well tolerated. There were no clinically meaningful changes in electrocardiogram parameters.ConclusionDesloratadine 5–20 mg provided significant 24-hour relief of SAR signs and symptoms. There were no statistically significant differences between the 4 largest doses suggesting that desloratadine 5 mg QD offers the best therapeutic profile for patients with SAR.
Highlights
Studies with desloratadine demonstrated efficacy in treating seasonal allergic rhinitis (SAR)
Discontinuations due to adverse events were similar across all study groups, including placebo, and are discussed further
This study demonstrates that once-daily desloratadine therapy at the approved 5-mg dose is significantly more effective than placebo in relieving the symptoms of SAR and retains its effectiveness to the end of the once-daily dosing interval
Summary
Studies with desloratadine demonstrated efficacy in treating seasonal allergic rhinitis (SAR). Desloratadine, a new nonsedating antihistamine, was recently approved by the Food and Drug Administration This agent has a very high affinity for histamine (H1)-receptors and a very low affinity for H2 and muscarinic receptors [2]. Earlier reports suggested that desloratadine has 24-hour efficacy in patients with SAR [6,7] and in patients with chronic idiopathic urticaria [8]. This hypothesis was further explored by analysis of data from a large placebo-controlled dose-ranging study in subjects with SAR that characterized the efficacy of five once-daily desloratadine regimens (2.5 to 20 mg/d) at the end of the 24-hour dosing interval
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