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| |  AAAAI MEETING: Singulair As Effective As Inhaled Steroid For Asthma Control ORLANDO, FL -- March 8, 1999 -- Results of two studies presented at the 55th annual meeting of the American Academy of Allergy, Asthma and Immunology here this week showed that Merck & Co., Inc.’s once-a-day oral medicine Singulair (montelukast) was similar to an inhaled steroid in its ability to control asthma in adults and was overwhelmingly preferred by children over another leading inhaled asthma control medication studied. These latest findings provide further evidence that leukotriene receptor antagonists (LTRAs) are becoming an important new therapeutic option in the management of asthma. A role for LTRAs -- the first new type of asthma therapy to be introduced in two decades -- in the treatment of mild-to-moderate persistent asthma was endorsed by the Global Initiative for Asthma (GINA) in revised treatment guidelines published in December. Singulair, indicated for once-daily use in both adults and children as young as six, works by blocking leukotrienes, natural substances that are involved in the inflammatory process associated with asthma. A study of 782 adults with chronic asthma was designed to assess the ability of Singulair (one 10 mg tablet once-daily) and beclomethasone (200 mcg twice-daily) to control asthma. The measure was the number of asthma control days, defined as days in which patients used less than or equal to two puffs of a short-acting beta agonist, had no night-time awakenings, did not use oral steroids or have any unscheduled physician or other health care resource visits due to asthma attacks. After a three-week baseline, patients were randomised to either Singulair, beclomethasone or placebo for six weeks. Daily diaries were used by patients to record use of a short-acting beta agonist, night-time awakenings and asthma attacks. At the conclusion of the study, researchers found that there were no differences in asthma control days between the group of patients receiving Singulair (40.3 percent) and the group receiving beclomethasone (40.1 percent). Research has shown that difficulties with inhalation therapy and the number of times a medication has to be taken each day appears to directly affect patient compliance, an essential ingredient to controlling asthma symptoms and the inflammation underlying the disease. Higher compliance with medication is associated with better asthma control. One recent study showed that patients who were taking asthma medications as prescribed were significantly less likely to require oral steroid rescue. Real-world studies such as these have confirmed that patients find it difficult to take medicine four times a day, for example, the frequency recommended for inhaled cromolyn sodium, a leading asthma control medication that was compared with Singulair in the second study presented this week. Results of this study showed that more than four out of five children -- 82 percent -- preferred Singulair as an asthma treatment over inhaled cromolyn. In the study, 333 children (mean age 8.8 years) with mild-to-moderate asthma received treatments of either Singulair, one 5 mg chewable tablet taken at bedtime, or cromolyn, a 1.6 mg dose given by metered-dose inhaler four times daily, for one month, with a two-week interim before switching 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 preferred. Eighty-two percent of the children preferred Singulair compared to 17 percent who preferred 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, New York, NY. “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.” The parents of the children were also asked which medication they preferred. In this study, 87 percent of parents also preferred Singulair, compared to 13 percent who preferred cromolyn. “For parents, managing a child’s asthma can be difficult. The child may be taking several medications with differing doses at different times and the child may not have the skill to take the medicine properly,” Dr. Valacer said. “In this study, parents preferred a treatment that helped control their child’s asthma and yet was easy to take.” The study results demonstrated that the preference for Singulair by both the children and their parents reflected an improvement in compliance with the therapy, an essential component to controlling asthma symptoms. Researchers also reported that nearly twice as many children (78 percent) taking Singulair were highly compliant (taking the correct dose of medicine on more than 95 percent of days) compared to those taking cromolyn (42 percent). The same children were also evaluated for treatment effectiveness, as determined by patient discontinuations due to worsening asthma and redirection in reserve medication use. Only one percent of children treated with Singulair discontinued therapy due to worsening asthma, compared to five percent of children treated with cromolyn.
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