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| |  AAAAI MEETING: Singulair And Loratadine Reduce Hay Fever Symptoms WASHINGTON, MD -- March 16, 1998 -- The results of an investigational study presented yesterday at the 54th annual meeting of the American Academy of Allergy, Asthma and Immunology showed that Singulair(R) (montelukast sodium) administered with the antihistamine loratadine significantly reduced symptoms in patients who suffered from seasonal allergic rhinitis, commonly known as hay fever. When used alone, both Singulair and loratadine each decreased daytime nasal and eye symptoms compared to placebo. Singulair, developed by Merck & Co., Inc., was approved by the United States Food and Drug Administration in February 1998, for the prophylaxis and chronic treatment of asthma in adults and pediatric patients six years of age and older. It is not for the relief of acute asthma episodes. The use of Singulair for the treatment of allergic rhinitis is investigational. The investigational study presented today suggested the possibility of benefit in allergic rhinitis when Singulair was used concomitantly with the antihistamine loratadine. Allergic rhinitis, the most common of all allergies, is a persistent disease of the upper airway that affects more than 50 million Americans. According to the American Lung Association, up to 58 percent of adults with allergic rhinitis also suffer from asthma, a disease of the lower airway. In the two-week, double-blind study, 458 patients (males and females aged 15 to 75) with seasonal allergic rhinitis were treated with either Singulair (10 or 20 mg), loratadine (10 mg), concomitant administration of both medicines, or placebo. In this investigational study, Singulair and loratadine, when used alone, each decreased daytime nasal symptoms (stuffy, runny, itchy nose and sneezing) by 16 percent. When taken together, Singulair and loratadine decreased nasal symptoms by 28 percent. There was a 12 percent reduction in daytime nasal symptoms with placebo. Loratadine (marketed by Schering-Plough as Claritin(R)) is indicated for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis. The reduction of eye symptoms (itchy, watery, red and puffy eyes) and nasal symptoms was similar for patients treated with Singulair and those treated with loratadine. Eye symptoms in the study were decreased by 18 percent when either Singulair or loratadine were used alone. However, when the two therapies were taken together, eye symptoms were decreased by 30 percent. There was a five percent decrease in eye symptoms with placebo. In this two-week allergic rhinitis study, all treatments were well tolerated. "Though this is an investigational study, we are intrigued by the possibility that a leukotriene blocker, such as Singulair, when added to traditional treatments, may provide additional relief for allergic rhinitis sufferers," said researcher Eli Meltzer, M.D., clinical professor of pediatrics in the division of allergy and immunology at the University of California-San Diego, one of the study's principal investigators. Allergic rhinitis results in a heightened sensitivity and irritability of the upper airways, with such symptoms as itchy watery eyes, scratchy throat, headache, sneezing, stuffy and runny nose. The seasonal pattern of patient symptoms reflects distribution of various pollens or mould spores by the wind. More information on: Merck & Co., Inc.
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