Patients Rate Rupatadine, Ebastine, and Loratadine Effective in Treating Allergic Rhinitis: Presented at EAACI

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Title: Patients Rate Rupatadine, Ebastine, and Loratadine Effective in Treating Allergic Rhinitis: Presented at EAACI
URL: http://www.pslgroup.com/dg/22357E.htm
Doctor's Guide
June 10, 2008

By Chris Berrie

BARCELONA, Spain -- June 10, 2008 -- Second-generation antihistamines rupatadine, ebastine, and loratadine provide significant, clinically relevant benefits for patients with seasonal allergic rhinitis, according to results of a pooled responder analysis presented here at the 27th Congress of the European Academy of Allergology and Clinical Immunology (EAACI).

Iñaki Izquierdo, MD, PhD, J. Uriach and Company S.A., Palau de Plegamans, Barcelona, Spain, presented this analysis here on June 8, noting that second-generation antihistamines are a first-choice treatment option for patients with seasonal allergic rhinitis, based on efficacies derived from symptom reductions. Some therapies perform better than others, in this regard, and as Dr. Izquierdo indicated, "It is important to … identify the clinical meaningful differences in response."

Data from seven 2- and 4-week trials were pooled, with a total of 2,019 seasonal allergic rhinitis patients evaluated together. The antihistamines evaluated versus placebo (n = 334) were as follows: rupatadine 10 mg (n = 665) and 20 mg (n = 479); cetirizine 10 mg (n = 115); ebastine 10 mg (n = 82); loratadine 10 mg (n = 227); and desloratadine 5 mg (n = 117).

All subjects were aged 12 to 65 years with diagnosed seasonal allergic rhinitis for at least 2 years. They also required a positive prick test at inclusion and acute-stage disease with a nasal-symptom score over 5 on a total symptom scale (TSS) that measures 6 symptoms (rhinorrhoea, nasal itching, nasal obstruction, sneezing, ocular itching, and watery eyes).

For the responder analysis, TSS scores were calculated by combining the individual symptom scores. These TSS scores then were graded according to a 4-point severity score (0 = absence, 3 = severe), and response rates were initially defined as percentages of patients who achieved improvements in TSS scores over 50% from baseline at end of study.

According to the responder analysis for greater than 50% reduction from baseline, placebo (36.5%) was similar to desloratadine 5 mg (41.0%), and neither reached significance. Significant benefits (P < .05) were seen for the following: rupatadine 10/20 mg (54.0%/63.1%); cetirizine 10 mg (51.3%); ebastine 10 mg (63.4%); and loratadine 10 mg (61.2%).

According to the responder analysis for greater than 75% reduction from baseline, significance (P < .05) was lost for cetirizine 10 mg, but maintained for the rest: placebo (9.3%); desloratadine 5 mg (12.8%); rupatadine 10/20 mg (22.1%/28.9%); cetirizine 10 mg (13.9%); ebastine 10 mg (29.3%); and loratadine 10 mg (26.0%).

Similarly, for mean absolute change from baseline, no significance was seen for desloratadine 5 mg (53.9%) and cetirizine 10 mg (47.0%), with significance (P < .05) maintained for rupatadine 10/20 mg (61.1%/66.4%), ebastine 10 mg (65.8%), and loratadine 10 mg (63.0%). Placebo was 47.3%.

Dr. Izquierdo concluded, "This responder analysis is a very important tool to analyse the efficacy of these drugs in comparison with placebo or another standard." He added that this analysis should therefore be considered for assessing the effectiveness of antiallergic agents in clinical practice.

[Presentation title: Evaluation of Second Generation Antihistamines Following a 2- or 4-Week Treatment by Means of a Pooled Responder Analysis in Patients Suffering From Seasonal Allergic Rhinitis. Abstract #: P200]

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