|San Antonio, TX|
|March 22, 2005|
|Latest Study Findings Presented at the AAAAI 61st Annual Meeting|
New data presented today at the American Academy of Allergy Asthma and Immunology 61st Annual Meeting show that once-daily treatment with the investigational therapy Alvesco® (ciclesonide) is associated with a low incidence of local oropharyngeal side effects (thrush, hoarseness and sore throat), and is well-tolerated in pediatric patients with mild-to-severe asthma.
“Inhaled corticosteroids are often associated with local mouth and throat-related side effects that can negatively impact initiation of treatment and patient compliance, especially among children,” states Erwin W. Gelfand, MD, Chairman of the Department of Pediatrics, National Jewish Medical and Research Center, Denver, and lead investigator of the study. “The low incidence of these side effects in our study demonstrates that Alvesco was well-tolerated in pediatric patients.”
Alvesco is an inhaled corticosteroid with novel release and distribution properties. Inhaled corticosteroids, considered to be the foundation of asthma treatment, work by reducing inflammation – the underlying disease process – in the lungs and airways.
Trial Design and Results
Within the safety population (n=1,025), only three cases (0.4%) of oral candidiasis were reported; all incidences occurred in the CIC groups (CIC80, n=1; CIC160, n=2). The incidence of pharyngitis (sore throat) was similar across all CIC groups, and only one case of hoarseness (0.1%) was reported in the CIC treatment group.
Sanofi-aventis is the world’s 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic disorders, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY)
The sanofi-aventis Group conducts business in the U.S. through its subsidiaries Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc.
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