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| |  AAAAI MEETING: Patients Prefer Singulair Over Intal For Treatment Of Asthma ORLANDO, FL -- March 1, 1999 -- Study results presented today at the 55th annual meeting of the American Academy of Allergy, Asthma and Immunology show that 82 percent of children (244/296) and 87 percent of parents (257/295) preferred Merck & Co.’s Singulair(R) (montelukast sodium) for the treatment of chronic asthma over Rhone-Poulenc Rorer’s Intal(R) (inhaled cromolyn sodium), a leading pediatric asthma control medication. Also, parents of children were more satisfied with Singulair, including its ability to control daytime and night-time asthma symptoms, as compared with cromolyn. "Asthma can be extremely limiting, particularly for children who must learn to use special equipment to take their medicine," said David Valacer, M.D., one of the study's investigators and director of the division of pediatric allergy, immunology and pulmonology, Cornell Weill Medical College. "In this study, children preferred taking a chewable tablet once a day over a therapy that they had to inhale four times a day. When children like a treatment and it's easy to take, they are more likely to take it as directed." Singulair is a once-a-day pill indicated for the prevention and chronic treatment of asthma in adults and children as young as six years of age. Since its launch in the U.S. in February 1998, more than one million patients world-wide have been prescribed Singulair to help control their asthma, making it now the most widely-prescribed member of the leukotriene-antagonist class. Singulair works by blocking leukotrienes, substances that are involved in the inflammatory process associated with asthma. Singulair has been studied for the long-term control of asthma, but is not intended for the immediate relief of acute asthma episodes or symptoms. Patients should continue to have appropriate rescue medication available and continue taking their other asthma medications unless instructed by a physician. Cromolyn is a prophylactic agent indicated in the management of bronchial asthma in patients five years and older and for pre-treatment before exposure to exercise or certain environmental/chemical agents. In the study, 333 children (mean age 8.8 years) with mild-to-moderate asthma received treatments of either Singulair, a 5 mg chewable tablet taken at bedtime, or cromolyn, with a 1.6 mg dose given by metered-dose inhaler four times daily. Patients were treated for one month with one of the treatments and, after a two-week interval, they were switched to the other medicine for another month. Using questionnaires, researchers asked the children to describe their likes and dislikes about taking the asthma medications and to indicate which medication they liked better. Of the 296 patients who received both treatments, 82 percent of children preferred Singulair (244/296) compared to 17 percent (52/296) who preferred cromolyn. In this study, the parents were also asked which medication they preferred; 87 percent of parents (257/295) preferred Singulair, compared to only 13 percent (38/295) who preferred cromolyn. "For parents, managing a child's asthma can be tough, often requiring multiple medications that may be dosed several times a day," Dr. Valacer said. "In this study, parents preferred a treatment that helped control their child's asthma and yet was easy to take. A once-daily pill may help to simplify the child's asthma treatment regimen." The study results also demonstrated an improvement in compliance with Singulair, an important component to controlling asthma symptoms. Researchers reported that nearly twice as many children (78 percent) taking Singulair were highly compliant (taking their correct dose of medicine on more than 95 percent of days) compared to those taking cromolyn (42 percent). These preference and compliance data do not imply a comparison of efficacy between the drugs studied. The same children were also evaluated for treatment effectiveness, as determined by reduction in rescue medication use and patient discontinuations due to worsening asthma. Compared to baseline (or before study start), children treated with Singulair used 38 percent less quick-relief inhaled beta-agonist medication as compared to those treated with cromolyn, who used 23 percent less quick-relief treatment. One percent of children treated with Singulair and five percent of children treated with cromolyn discontinued therapy due to worsening asthma. Safety, assessed as the overall incidence of adverse experiences, was comparable between the treatment groups. The most common side effect reported in both groups was upper respiratory infection. In combined clinical trials evaluating the efficacy and safety of Singulair, side effects with Singulair were usually mild and generally did not require patients to stop taking Singulair. Side effects seen in adults and children during the clinical trials were similar for the groups treated with Singulair and for those treated with placebo. The most commonly reported side effects in adults for both placebo and Singulair were headache, influenza and abdominal pain. There was no increase in side effects with extended treatment. The use of Singulair may not eliminate the need for inhaled or oral corticosteroids. Patients who have asthma that is made worse by exercise should continue to use their existing medications prior to exercise, unless instructed otherwise by their doctor. A report issued by the Centers for Disease Control shows that the number of people diagnosed with asthma in the U.S. increased by 75 percent between 1980 and 1994. More than 15 million Americans -- almost one in 20 – suffer from the disease, and in 1995, nearly two million people were treated in hospital emergency rooms for acute attacks.
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