Head-To-Head Studies Show Zyrtec(R) (Cetirizine HCl) Is No More Effective Than Allegra(R) (Fexofenadine HCl) And Causes More Drowsiness

Market Wire, 20050229

Two separate studies presented today at the annual American College of Allergy, Asthma and Immunology (ACAAI) meeting showed that Allegra(R) (fexofenadine HCl) 180 mg once daily is equally effective as Zyrtec(R) (cetirizine HCl) 10 mg once daily in relieving allergy symptoms up to the 24th hour, but patients treated with Zyrtec experienced more drowsiness than patients treated with Allegra.

The data released today demonstrate not only that Allegra and Zyrtec offer similar symptom reduction in patients with seasonal allergies, but that there is a significant increase in drowsiness seen in patients taking Zyrtec compared with patients taking Allegra. Since antihistamines are not all the same, it is important for patients to consult their physicians about which medication is right for them.

More than 35 million Americans suffer from seasonal allergies and many of them depend on antihistamines to control their symptoms.

ADouble-Blind, Randomized Comparison of Allegra and Zyrtec Measuring Effect on Drowsiness

Anew study presented at the ACAAI annual meeting compared drowsiness experienced with Allegra and Zyrtec in people with moderate to severe seasonal allergic rhinitis (SAR). The study found that treatment with Allegra resulted in less drowsiness than treatment with Zyrtec.

The multi-center, randomized, double-blind, parallel group study enrolled 495 subjects with moderate to severe SAR. Patients received once-daily treatment (taken at 7 am) with either fexofenadine 180 mg or cetirizine 10 mg for 14 days. Drowsiness was measured three times a day (7 am, 10 am, 3 pm) using a 10-cm visual analog scale (0=wide awake, 100=extremely sleepy). Changes from baseline in visual analog score were measured and compared between the fexofenadine and cetirizine groups.

Poster P38 Poster Session Saturday, Sunday, November 16th & 17th, 12-1 pm Exhibit Hall A Poster P39 Poster Session Saturday, Sunday, November 16th & 17th, 12-1 pm Exhibit Hall A

Comparative Efficacy of Allegra and Zyrtec

Data also presented at the meeting analyzed the efficacy of Allegra and Zyrtec at the 24th hour, which is the time immediately preceding dosing, in patients with moderate to severe SAR. The study found that Allegra and Zyrtec produce similar symptom reduction. The multi-center, randomized, double-blind, parallel group study included 495 subjects with moderate to severe SAR who received once-daily treatment with either fexofenadine 180 mg or cetirizine 10 mg for 14 days. Patients self-assessed symptoms daily through an instantaneous symptom score obtained at the 24th hour immediately preceding dosing. The symptoms of sneezing; rhinorrhea; itchy nose/palate/throat; and itchy/watery/red eyes were scored on a five-point scale (0=symptom not present, 4=symptom very severe).

"These results demonstrate that both Allegra and Zyrtec provide patients with equivalent relief of their seasonal allergy symptoms for a full 24 hours," said Gary Gross, M.D., Clinical Professor of Internal Medicine at Southwestern Medical School in Dallas.

This data provides further support for a previous head-to-head study, published in the Journal of Allergy and Clinical Immunology (Nov. 1999), (1)showing that Allegra provides comparable efficacy in symptom relief when compared to Zyrtec. This study also showed that the combined incidence of drowsiness and fatigue was significantly greater for Zyrtec.

About Allegra

Allegra (fexofenadine HCl) 180 mg once daily is a powerful, safe and effective non-sedating antihistamine for the treatment of seasonal allergy symptoms in patients 12 years and older. Side effects with Allegra 180 mg once daily are low and may include headache, cold or back pain. Allegra is available by prescription only, and seasonal allergy sufferers should consult their physician or healthcare professional with questions. For additional product information, log on to www.allegra.com.

About Aventis

Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes, respiratory/allergy, anti-infectives, as well as on human vaccines. In 2001, Aventis generated sales of 17.7 billion euro ($15.8 billion), invested approx. 3 billion euro ($2.7 billion) in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters is in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. Aventis Pharmaceuticals was recently named one of the top companies to work for by Working Mother magazine. For more information about Aventis in the U.S., please visit: www.aventis-us.com.

Full prescribing information is available by visiting the Aventis Pharmaceuticals U.S. Web site at www.aventis-us.com. Also available at this U.S. Web site are copies of this release or any recent release.