KENILWORTH, New Jersey, November 29 /PRNewswire/ --
Some patients taking Xyzal (levocetirizine) are more likely to experiencedrowsiness and sedation within one month of treatment than patientsprescribed AERIUS [NEOCLARITYN] (desloratadine), according to data publishedin the October issue of Drug Safety.(1)
The observational are al world' study utilizing the Prescription EventMonitoring (PEM) system conducted by Drug Safety Research Unit (DSRU), anindependent research group affiliated with the University of Portsmouth,U.K., compared the incidence of drowsiness and sedation within the first 30days of observation among more than 24,000 patients in the U.K. treated witheither AERIUS [NEOCLARITYN] or Xyzal. The data analysis was supported by anunrestricted grant from Schering-Plough Corporation. The data showed thatamong allergic rhinitis patients without asthma, the incidence ofdrowsiness/sedation alone or in combination with other sedating events wasmore than six times greater in patients using Xyzal compared with patientstreated with AERIUS [NEOCLARITYN]. Allergic rhinitis affects nearly 94million Europeans each year.(2)
"Side effects such as drowsiness and sedation can be key issues forallergic rhinitis patients, especially during the day," said Anthony Frew,professor of allergy and respiratory medicine at Brighton & Sussex MedicalSchool. "Side effect data should always be considered when determining theappropriate treatment for patients."
AERIUS [NEOCLARITYN] is a nonsedating prescription antihistamine for thetreatment of symptoms associated with allergic rhinitis (includingintermittent and persistent allergic rhinitis) and chronic idiopathicurticaria (CIU), or hives of unknown cause. AERIUS [NEOCLARITYN] is availablein two convenient forms. In the European Union, AERIUS [NEOCLARITYN] Tabletsare available for adults and adolescents 12 years of age and older and AERIUS[NEOCLARITYN] Syrup is available for children as young as 1 year of age.(3)
About the Study
To evaluate the frequency with which drowsiness and sedation werereported for AERIUS [NEOCLARITYN] and Xyzal within the first 30 days ofobservation, the DSRU evaluated the records of more than 24,000 patients whowere prescribed the treatments in the U.K within a two-year period.Researchers monitored patients using the observational cohort technique ofprescription-event monitoring (PEM), which collects data on patients who havebeen prescribed new drugs in primary care clinical practice. This is aretrospective analysis of selected PEM event data that had already beencollected for large cohorts of patients who had been prescribed theseantihistamines. Exposure data were derived from dispensed prescriptionswritten by primary care physicians and outcome data were derived fromquestionnaires that were posted to prescribers at least 6 months after thedate of the first prescription for each patient. The odds ratio wascalculated using unconditional logistic regression modeling. The effect ofage, sex, reported prescribing indication (allergic rhinitis withasthma/wheezing, allergic rhinitis without asthma/wheezing or 'other'),pattern of use and reported previous antihistamine use on the odds ratio wasexamined and a time-to-event analysis was performed.
For patients with allergic rhinitis but without asthma/wheezing, thesex-adjusted odds of drowsiness/sedation alone or in combination with othersedating events (selected CNS depressant events such as dizziness, headache,migraine, loss of consciousness, or confusion) were more than six timesgreater in patients using Xyzal than AERIUS [NEOCLARITYN] in the first monthof observation, the OR being statistically significant (6.75; 95 percent CI2.37, 19.22; n = 12 627). There was an approximate 3-fold non-significantincrease in odds for the remaining two reported indication categories ofallergic rhinitis with asthma/wheezing (3.51; 95 percent CI 0.71, 17.43; n =3357) and 'other' (3.11; 95 percent CI 0.86, 11.31; n = 6725). A total of 46reports of drowsiness/sedation were reported for Xyzal (0.36 percent)compared to only nine reporters for AERIUS [NEOCLARITYN] (0.08 percent; p <0.0001). These events tended to occur earlier for AERIUS [NEOCLARITYN] thanXyzal (50 percent at 7 or 14 days of observation, respectively; p = 0.6487),but the cumulative time to event differed, with more events observed forlevocetirizine than expected (46 vs. 28.09; p < 0.0001).
About Allergic Rhinitis
Symptoms of allergic rhinitis may include sneezing, congestion, itchy andrunny nose, and itchy, redness and/or watery eyes.(4) Symptoms can have animpact on everyday activities at work, school and leisure time. There also isa growing body of evidence that points to an association between allergiesand other respiratory conditions, such as asthma.(4)
Survey data show that symptoms are most severe in the morning, and abouttwo-thirds of respondents reported that morning suffering affects the rest ofthe day.(5) Allergy sufferers should minimize early morning activity whenpollen is usually emitted -- between 5 a.m. and 10 a.m.(6) People withallergies also should shower before going to bed to rinse off any pollen orpet dander that may have collected in their hair or on their body during theday.
The survey also showed that even though allergies are frequently aself-diagnosed condition, patients rely on medical experts to help properlymanage their symptoms.(5)
About AERIUS(R) [NEOCLARITYN(R)]
AERIUS [NEOCLARITYN] (desloratadine) is a nonsedating prescriptionantihistamine for the treatment of symptoms associated with allergic rhinitis(including intermittent and persistent allergic rhinitis) and chronicidiopathic urticaria (CIU), or hives of unknown cause. According to newclassification of the labeling, AERIUS Tablets and AERIUS Syrup is nowapproved to treat symptoms of allergic rhinitis (including intermittent andpersistent allergic rhinitis), in patients 12 years of age and older andpatients 1 year of age and older, respectively.(3)
The most common side effects in adults and adolescents with allergicrhinitis and CIU were fatigue, dry mouth and headache. In clinical trials ina pediatric population (children aged 6 months through 11 years), the overallincidence of adverse events in children 2 through 11 years of age was similarfor the AERIUS syrup and placebo groups. In infants and toddlers aged 6 to 23months, the most frequent adverse events reported in excess of placebo werediarrhea, fever and insomnia.
Research shows AERIUS [NEOCLARITYN] provides powerful morning symptomrelief. In a study of 346 people with moderate-to-severe seasonal allergicrhinitis, patients receiving AERIUS experienced significant improvement inmorning scores versus placebo for both nasal and non-nasal symptoms.(7)AERIUS offers demonstrated efficacy at the end of the dosing interval.(3)AERIUS also has a half-life of approximately 27 hours.(3)
Schering-Plough markets desloratadine under the brand names AERIUS andNEOCLARITYN in Europe and as CLARINEX(R) in the United States. AERIUS[NEOCLARITYN] builds upon Schering-Plough's heritage as a leader in discoveryand development. Additional products from the company's research effortsinclude the CLARITIN(R) (loratadine) family of nonsedating antihistamines andNASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg.(i)
About Schering-Plough Corporation
Schering-Plough is a global science-based health care company withleading prescription, consumer and animal health products. Through internalresearch and collaborations with partners, Schering-Plough discovers,develops, manufactures and markets advanced drug therapies to meet importantmedical needs. Schering-Plough's vision is to earn the trust of thephysicians, patients and customers served by its more than 32,000 peoplearound the world. The company is based in Kenilworth, N.J., and its Web siteis http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press releaseincludes certain "forward-looking statements" within the meaning of theSecurities Litigation Reform Act of 1995, including statements relating toAERIUS [NEOCLARITYN] and the potential market for AERIUS [NEOCLARITYN].Forward-looking statements relate to expectations or forecasts of futureevents. Schering-Plough does not assume the obligation to update anyforward-looking statement. Many factors could cause actual results to differmaterially from Schering-Plough's forward-looking statements, includingmarket forces, economic factors, product availability, patent and otherintellectual property protection, current and future branded, generic orover-the-counter competition, the regulatory process, and any developmentsfollowing regulatory approval, among other uncertainties. For further detailsabout these and other factors that may impact the forward-looking statements,see Schering-Plough's Securities and Exchange Commission filings, includingItem 1A. Risk Factors in the Company's second quarter 2006 10-Q.
(i) Calculated on the anhydrous basis.
References: 1. Layton, Deborah, Lynda Wilton, Andrew Boshier, Victoria Cornelius, Scott Harris, and Saad A.W. Shakir. "Comparison of the Risk of Drowsiness and Sedation Between Levocetirizine and Desloratadine." Drug Safety 2006; 29 (10): 897-909. 2. http://www.wrongdiagnosis.com/p/pollen_allergy/stats-country.htm. Statistics for Northern, Western, Central, Eastern, Southwestern, Southern and Southeastern Europe combined. 3. AERIUS [NEOCLARITYN] (summary of product characteristics). Schering Corporation. 4. Management of Allergic Rhinitis and Its Impact on Asthma: Pocket Guide. 2001. 5. "Understanding the Dynamics Surrounding Allergy Suffering and Treatment" Forbes Consulting Group. 2005. 6. "Tips to Remember: Outdoor Allergens." American Academy of Allergy, Asthma and Immunology. 6 Nov. 2006 < http://www.aaaai.org/patients/publicedmat/tips/outdoorallergens.stm >. 7. Meltzer EO, Prenner MB, Nayak A, and the Desloratadine Study Group. Efficacy and tolerability of once-daily 5mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic rhinitis: assessment during the spring and fall allergy seasons. Clin Drug Invest. 2001; 21:25-32.
Web site: http://www.schering-plough.com
Schering-Plough Corporation
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