Desloratadine/Pseudoephedrine Combination More Effective Than Individual Components for Treatment of Seasonal Allergic Rhinitis: Presented at EAACI

To print: Select File and then Print from your browser's menu
---------------------------------------------------------------------------------------
Title: Desloratadine/Pseudoephedrine Combination More Effective Than Individual Components for Treatment of Seasonal Allergic Rhinitis: Presented at EAACI
URL: http://www.pslgroup.com/dg/223412.htm
Doctor's Guide
June 9, 2008

By Chris Berrie

BARCELONA, SPAIN -- June 8, 2008 -- The combination of desloratadine and pseudoephedrine is well tolerated and significantly more effective than either agent alone for treatment of patients with symptomatic seasonal allergic rhinitis (SAR).

This analysis of combined data from 2 multicentre, randomised, double-blind, double-dummy, parallel-group studies was presented by principal investigator Robert E. Grubbe, MD, CORE Allergy and Asthma Centre, Oxford, Alabama, here on June 8 at the 17th Congress of the European Academy of Allergology and Clinical Immunology (EAACI).

Allergic rhinitis now shows a 24% prevalence in the European Union, "with over 80% of those complaining that nasal congestion is a significant component," Dr. Grubbe stressed. The second generation, nonsedating antihistamines are recommended as first-line therapy, although desloratadine can also improve nasal congestion symptoms.

The aim of the analysis was to directly compare data from these 2 large trials investigating the combination of the antihistamine desloratadine with the decongestant pseudoephedrine for better symptom control for patients with SAR.

The study enrolled healthy patients aged 12 years of more with confirmed symptoms of SAR for 2 or more years and a positive skin test. During 3 to 14 days of screening, patients had active SAR, defined as a total nasal symptoms score (TNSS) of 6 or more, total nonnasal symptom score (TNNSS) of 5 or more, congestion score of 2 or more, and a rhinorrhoea score of 2 or more.

Efficacy was based on patient diaries for SAR severity, which assessed nasal and nonnasal symptoms on 4-point scales (0, no symptoms; 1, mild; 2, moderate; 3, severe). TNSS and TNNSS were calculated as sums of individual symptom scores, and total symptom score (TSS) as sums of the TNSS and TNNSS.

The primary endpoints included antihistamine and decongestant components of ragweed allergy, as relevant mean changes from baseline. For safety assessments, all patients underwent 12-lead electrocardiogram (ECG), as well as haematological, serum chemistry, and urine analyses at screening and at the end of the study. Adverse events (AEs) during the study were recorded and classified.

The 2 studies randomised 191 and 214 patients to desloratadine 2.5 mg, 181 and 222 patients to pseudoephedrine 120 mg, as well as 189 and 214 patients to a combination of the 2 agents, all given twice daily.

During the 15 days of study, the 2-drug combination was significantly more effective than desloratadine or pseudoephedrine alone (P <= .001 for all). Similar enhanced efficacy was seen for the 15-day decongestant component for desloratadine/pseudoephedrine compared with desloratadine (P <= .015; P <= .023) and pseudoephedrine alone (P <= .015; NS).

"The combination works better than what you would expect as an additive of the two," Dr. Grubbe said.

In all cases, the overall incidences of AEs in the 2 studies were similar across treatment groups (46.5%, 41.0%; 38.4%, 37.0%; 48.0%, 42.0%; respectively). Treatment-related AEs were fewer with desloratadine alone and comprised insomnia, headache, and dry mouth. There were no clinically relevant changes in laboratory parameters or ECG readings across treatments and studies.

Thus, Dr. Grubbe stressed, "[Desloratadine] is a good drug to use in an armamentarium of day-to-day medical practice for patients with severe allergic rhinitis who suffer from a lot of nasal congestion, which is probably the number one complaint."

These enhanced beneficial effects of desloratadine/pseudoephedrine combination were also seen as early as day 2.

Funding for this study was provided by the Schering-Plough Research Institute.

[Presentation title: A Combination of Desloratadine 2.5 mg and Pseudoephedrine 120 mg BD Is More Effective Than the Individual Components for the Treatment of Allergic Rhinitis: Evidence From Randomised, Double-Blind Clinical Trials. Abstract P190]

http://www.docguide.com

Return to News Story Page

webmaster@pslgroup.com