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Pfizer Announces Study Results Showing That Zyrtec(R) Provides Greater Symptom Relief Than Allegra(R) for Allergy Sufferers Exposed to Ragweed Pollen in an Environmental Exposure Unit

Posted on: Wednesday, 17 November 2004, 12:00 CST

BOSTON, Mass., Nov. 17 /PRNewswire-FirstCall/ -- New data show that Zyrtec(R) (cetirizine HCl 10 mg) provides on average 14 percent greater symptom relief than Allegra(R) (fexofenadine 180 mg) during the entire period of five to 12 hours after dosing in patients who suffer from seasonal allergic rhinitis and documented ragweed sensitivity. In addition, at the end of the 12-hour dosing period, Zyrtec patients reported even greater total relief as compared to Allegra patients. The difference in efficacy achieved statistical significance at 5.5 hours, and Zyrtec provided statistically significant allergy relief compared to Allegra at 11 of the 15 time points measured. Study results were presented at the 62nd annual meeting of the American College of Allergy, Asthma and Immunology. The study was funded by Pfizer Inc.

These results are consistent with the findings of a similar environmental exposure unit (EEU) study published earlier this year in Allergy and Asthma Proceedings that showed 33 percent greater symptom relief for Zyrtec patients compared with Allegra patients at 21-24 hours after dosing. "The data presented coupled with the results of the previous study provides the clinician with a more complete picture of how these two products will perform over the 24-hour dosing period," said James H. Day, M.D., the study's principal investigator and Head, Division of Allergy and Immunology, Kingston General Hospital, Kingston, Ontario.

Study Results

The current study was a randomized, double-blind, placebo-controlled, parallel group study that examined 599 subjects. Each subject was randomly assigned to receive either Zyrtec (n=249), Allegra (n=250), or placebo (n=100). Subjects were exposed to ragweed pollen in an environmental exposure unit, which is designed to actively manage levels of the allergen to ensure controlled contact. In this way, pollen levels comparable to concentrations observed during peak ragweed season can be consistently maintained, and the course of exposure can be monitored to determine whether there is symptomatic variability over the exposure period, which can last for hours. Participants' symptoms were assessed using the total symptom severity complex (TSSC) score, defined as the sum of self-assessed severity scores for the following four rhinoconjunctivitis symptoms: runny nose, sneezing, itchy nose/palate/throat, and itchy/watery eyes.

The results show that:

* For total symptom improvement at 12 hours, the primary efficacy

endpoint, patients treated with Zyrtec had 26 percent greater relief

than those who received Allegra.

* Overall relief during the entire period from five to 12 hours following

dosing was 14 percent greater in Zyrtec-treated patients than in those

treated with Allegra.

* In addition, patients in the Zyrtec group had greater reductions in

TSSC scores than those in the Allegra group at all time points from

five through 12 hours post-dose.

* Zyrtec scored better on all four TSSC scores than Allegra at 12 hours:

runny nose (P=0.003 at the 12-hour post-dose endpoint and P=0.001 at

the overall endpoint), sneezing (P=0.001 at the 12-hour post-dose

endpoint, and P=0.024 at the overall endpoint), itchy

nose/palate/throat (P=0.058 at the 12-hour post-dose endpoint and

P=0.049 at the overall endpoint), itchy/watery eyes (P=0.045 at the 12-

hour post-dose endpoint and P=0.149 at the overall endpoint).

* Both Zyrtec and Allegra were well tolerated with low levels of

discontinuation because of treatment-related adverse events.

Study Design

The primary objective of the study was to compare the relative efficacy of cetirizine HCl 10 mg daily, fexofenadine HCl 180 mg daily, and placebo in controlling the symptoms of seasonal allergic rhinitis at 12 hours post dose. The study involved 599 subjects 16 years of age and older who suffered from seasonal allergic rhinitis to ragweed pollen for the last two consecutive allergy seasons. Specifically, subjects with documented seasonal allergy to ragweed pollen as confirmed by a recognized skin test within the previous 15 months were qualified for the study.

Seasonal Allergic Rhinitis and Ragweed

Seasonal allergic rhinitis, or seasonal allergy, describes nasal and ocular allergies caused by pollen from plants that change with the seasons. Nearly 36 million Americans are affected by seasonal allergic rhinitis. People with allergies are often sensitive to more than one substance, and common causes of seasonal allergies during the spring and fall months include trees, pollens from weeds and grass, ragweed, and mold spores. Pollen released from ragweed, which blooms from mid-August to October in many parts of the country, is the airborne allergen that causes symptoms for the majority of allergy sufferers in the U.S. Allergy sufferers affected by seasonal allergies experience many symptoms including watery eyes, postnasal drip, coughing, sneezing, runny/itchy nose, and congestion. For consumers faced with a wide range of allergies and treatment options, the findings from this study comparing Zyrtec to Allegra may be significant for allergy sufferers seeking a treatment that offers consistent, long-lasting allergy relief.

About Zyrtec

Zyrtec is a prescription antihistamine for the treatment of seasonal and perennial allergies, as well as chronic hives in adults and children. No other antihistamine is approved to treat more allergies than Zyrtec. Zyrtec is available in tablet, syrup, and chewable tablet formulations and can be used in adults and children down to two years old. Zyrtec syrup can even be used in infants as young as 6 months old for indoor allergies. In infants six to 23 months old, side effects were like those of a sugar pill. Some were being cranky, fussy, and not able to sleep. Others were feeling tired and looking uncomfortable. In studies with children age 2-11 years old, side effects included drowsiness, headache, sore throat, and stomach ache. Most were mild or moderate. Most children weren't bothered by them enough to stop taking Zyrtec. In studies with adults and children 12 years and older, the most common side effect was drowsiness; other side effects included dry mouth and tiredness. Most were mild to moderate, but most people weren't bothered enough to stop taking Zyrtec.

For additional information about allergies and for a copy of Zyrtec's full prescribing information, please visit the Zyrtec Web site at http://www.zyrtec.com/, or call 1-800-4-ZYRTEC.

About Pfizer Inc and UCB Pharma

Pfizer Inc is a research-based global pharmaceutical company that discovers, develops, manufactures, and markets innovative medicines for humans and animals.

UCB Pharma is a global, research-based pharmaceutical company dedicated to the development and commercialization of innovative pharmaceutical products for the treatment of diseases associated with the central nervous system and allergy-immunology. The company's research activities aim to promote well- being and quality of life. UCB Pharma, with U.S. headquarters in Smyrna, Georgia, is a member of the UCB Group of Companies, which has core businesses in pharmaceuticals and films. UCB employs approximately 10,000 people and operates in more than 100 countries. Worldwide headquarters are located in Brussels, Belgium.

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Pfizer Inc

CONTACT: Sri Ramaswami, +1-212-733-8734, for Pfizer Inc

Web site: http://www.pfizer.com/

Company News On-Call: Pfizer's press releases are available through PRNewswire's Company News On-Call service on PRN's Web Site. Visithttp://www.prnewswire.com/comp/688250.html

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Source: PRNewswire-FirstCall

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