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Ebastine Effective in Both Moderate, Severe Seasonal Allergic Rhinitis: Presented at EAACI

By Michael Smith


AMSTERDAM, THE NETHERLANDS -- June 14, 2004 -- Ebastine, a second-generation antihistamine, works equally well in patients with either moderate or severe seasonal allergic rhinitis (SAR) symptoms, according to new research.

In another presentation based on the same data, the researchers also concluded that the drug works to control nasal congestion in SAR, through a mechanism that remains unclear, although probably anti-inflammatory.

Paul H. Ratner, MD, of Sylvana Research in San Antonio, Texas, United States, presented in a poster session at the 23rd Congress of the European Academy of Allergology and Clinical Immunotherapy (EAACI) the findings of a pooled analysis of 4 randomized double-blind, placebo-controlled studies of ebastine compared to placebo.

In total, 1365 patients with SAR were studied, although 15 were excluded from the analysis for various reasons.

The efficacy of ebastine was measured by the change in scores for 5 rhinitis symptoms: nasal discharge, nasal congestion, nasal itching, sneezing, and total eye symptoms, which were rated before the morning dose and before bedtime.

Each symptom was rated from 0 to 3; the combined scores were expressed as a total symptom score. At baseline, all of the patients had a total symptom score of greater than 6; a score between 6 and 11.5 was classed as moderate and a score above 11.5 was classed as severe.

The improvement in total score was highly statistically significant in both groups, Dr. Ratner said, and the improvement started quickly and was sustained through the 4-week treatment period in all the studies.

In the placebo groups, patients with moderate symptoms saw their scores decline by an average of 1.85. Patients with severe symptoms decreased by 3.28. By comparison, those taking ebastine with moderate symptoms saw their scores drop 3.17 and those with severe symptoms by 4.74.

While nasal congestion is not primarily histamine-driven, there is some evidence that ebastine has anti-inflammatory as well as antihistamine properties, Dr. Ratner said. With that in mind, the researchers examined the data to see what were the effects of the drug on nasal congestion in particular.

In the placebo groups, moderate patients saw their nasal congestion scores fall by an average of 0.4 and severe patients by 0.53. Those with moderate symptoms who were taking ebastine saw their scores drop by 0.58 and those with severe symptoms by 0.81. Both differences were highly statistically significant, Dr. Ratner reported.

More research is needed to understand exactly how this effect occurs, he concluded, but there is some evidence from pre-clinical studies that ebastine reduces inflammatory markers.

263 - Ebastine 20 mg is an effective treatment of seasonal allergic rhinitis (SAR), in both moderate and severe patients

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