Telfast/Allegra Provides Sustained Allergy Relief

 Telfast/Allegra Provides Sustained Allergy Relief While Effects of Loratadine Diminish Over Time According to Comparison Study

FRANKFURT, Germany,  July 3, 2000 -- Only Telfast/ Allegra (fexofenadine HCl) 120 milligram (mg) once-daily provides significantly effective relief from the symptoms of seasonal allergic rhinitis (SAR) during prolonged therapy when compared to loratadine 10 mg and placebo (p£ 0.05, p£ 0.0001, respectively), according to data presented at the annual Congress of the European Academy of Allergology and Clinical Immunology (EAACI) underway in Lisbon, Portugal.

"In this current study, only fexofenadine, a non-sedating antihistamine, showed an ability to maintain efficacy and relieve the suffering of allergy patients over time," said Ralph Mösges, M.D., professor of Medical Informatics and Otorhinolaryngologist/Allergist at the University Hospital in Cologne, Germany. "Patients using loratadine experienced a waning effect during the second half of the study, making it less effective at the end of the study than fexofenadine. This waning effect has also been observed with some of the older, first-generation, sedating antihistamines. This phenomenon is clearly a concern and needs further investigation."

In this subanalysis of the Study of Telfast in Allergic Rhinitis (STAR), Mösges and his colleagues randomized nearly 700 patients with SAR to receive the standard European daily doses of either of the medications or placebo for two weeks of therapy. Patients taking either fexofenadine or loratadine had a rapid onset of relief of SAR symptoms as demonstrated by an improvement in

their total symptom scores (TSS) during the first week of the study. Both medications significantly reduced the average of each patient's TSS compared to placebo, however, Telfast/Allegra maintained its efficacy throughout the duration of the study while a waning effect was observed with loratadine.

The study investigators determined effectiveness by measuring the change in the mean 24-hour reflective total symptom score, instantaneous trough TSS (recorded in the morning one hour before study medication) and 24-hour reflective individual symptom scores.

During the first week of the study the effect of loratadine and fexofenadine on SAR symptoms significantly differed from that of the placebo (p£0.0001 for both reflective; p£0.001 and p£0.0001, respectively for instantaneous). However, during the second week loratadine did not significantly differ from placebo in changes measured from baseline in both instantaneous and 24-hour reflective TSS. In contrast, Telfast®/Allegra® significantly improved SAR symptoms in week two for both instantaneous and 24 hour reflective TSS when compared with both placebo (p£0.0001 for both) and loratadine (p£0.05 for both).

Methodology
Patients evaluated the severity of their SAR symptoms throughout the placebo run-in and treatment periods using a five-point scale (0 = absent, 4 = very severe). The symptoms assessed included: sneezing, runny and itchy nose, itchy palate and/or throat, nasal congestion and itchy, watery, red eyes. The sum of the individual scores, excluding nasal congestion, resulted in the TSS. Researchers measured efficacy changes from the baseline by evaluating the instantaneous and 24-hour reflective TSS as well as through individual symptom scores.

The STAR study was a multinational, double-blind, randomized, placebo-controlled, parallel group-study comparing the efficacy of Telfast/Allegra and loratadine in the treatment of SAR during a two-week study period. Following a run-in phase of three to seven days, researchers randomized patients to receive either Telfast/Allegra 120 mg, loratadine 10 mg, or placebo once-daily in the morning for 14 days. Patients visited the physician four times during a four-week period and were contacted by telephone seven days after the final visit. The study followed a group of 688 patients (12 to 75 years old) with a history of SAR for at least two years and a positive skin test to pollen. The intention-to-treat population consisted of 639 patients.

What Is Seasonal Allergic Rhinitis?
Seasonal allergic rhinitis (SAR), sometimes referred to as hay fever, is a condition caused by the body's immune reaction to allergens that enter through the respiratory tract. Approximately 20 percent of individuals worldwide have SAR. Typical outdoor allergens that cause SAR are grass, tree and weed pollens. SAR often remains undiagnosed and untreated because people mistake their symptoms as related to a "cold" or the "flu." Symptoms of SAR include sneezing, itching and excess mucus production, which can result in allergic rhinitis (runny nose) and result from the body's reaction to the allergens, including the release of a chemical called histamine. SAR patients can take antihistamines to reduce or eliminate such symptoms.

Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.

Note: This press release may contain information about a product and/or indications not authorized/registered in all countries. Before publishing in the medical press, please observe local pharmaceutical laws or codes. Contact
 
 
Your Contact in the US:
Lauren Parran
Aventis Pharma
Global Communications
(908) 231-4971
21 892 1811 - or - 21 91 9730226 (at EAACI)

 

Posted: June 2004

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