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| |  EAACI: Singulair (Montelukast) With Inhaled Corticosteroids Offers Better Protection Against Activity Induced Asthma LISBON, PORTUGAL -- July 3, 2000 -- New asthma studies presented at the 19th Congress of the European Academy of Allergology and Clinical Immunology (EAACI) showed that complementary therapy with Singulair™ (montelukast sodium) and inhaled corticosteroids (ICS) improved several important measures of asthma control. In a study of adults, administering Singulair with the ICS fluticasone improved patients' response to an asthma rescue medication and provided significantly better protection against activity induced asthma attacks (p<0.005) compared with either combined therapy with the ICS and the long-acting beta-agonist (LABA) salmeterol, or ICS alone. In a separate study of asthmatic children taking the ICS budesonide, adding therapy with Singulair significantly reduced the incidence of asthma exacerbations (p=0.001) and the use of asthma rescue medications (p=0.013). Singulair is a once-daily oral tablet therapy in the class of asthma drugs known as leukotriene receptor antagonists (LTRAs) and was the first new type of asthma therapy since inhaled steroids became available two decades ago. A role for LTRAs in the treatment of mild-to-moderate chronic asthma, either as stand-alone therapy or with other asthma medications, was endorsed by the Global Initiative for Asthma (GINA) in revised treatment guidelines introduced in December 1998. The response to a rescue bronchodilator (albuterol) after asthma worsening was assessed in patients taking either oral Singulair or inhaled salmeterol, both in addition to inhaled fluticasone, was compared in a study of 122 adults (ages 15-58) with asthma. All patients entered into the double-blind placebo-controlled trial had a history of exercise intolerance and were receiving inhaled fluticasone (100 mcg twice daily), but still developed activity induced asthma despite ICS therapy. Patients continued fluticasone therapy and were randomized to receive either inhaled salmeterol (50 mcg twice daily), oral Singulair (10 mg once daily), or a matching placebo control. One week and four weeks after the introduction of complementary therapy, patients’ response to rescue bronchodilator was evaluated after an exercise challenge test, performed two to four hours after the morning dose of the salmeterol inhaler. The response to rescue bronchodilator was significantly better (p<0.05) on Singulair compared to the ICS/LABA combination at both weeks one and four. Data showed that adding salmeterol to the inhaled steroid resulted in a diminished response to rescue treatment with the short-acting beta-agonist (SABA) albuterol compared to the pre-treatment baseline. At the four week evaluation, the majority of patients receiving Singulair (89.7 percent) and less than half of patients receiving salmeterol (47.2 percent) recovered to pre-exercise lung function levels within five minutes following rescue bronchodilator administration. All patients receiving Singulair (100 percent) and approximately three-quarters of patients receiving salmeterol (75.7 percent) achieved this recovery within 30 minutes. "People with asthma must feel confident that their rescue medication will work quickly when they need it most," said study co-author Jonathan Edelman, M.D., senior director of clinical development with Merck & Co. "This study shows that, unlike the long-acting beta-agonist salmeterol, the efficacy of a rescue inhaler is protected when Singulair is added to an inhaled steroid." Findings of earlier clinical studies indicate that patients may experience tolerance to the protection afforded by regular use of LABA therapy, even when combined with ICS. This may lead to a deteriorating protection against asthma triggers such as exercise and could potentially lead to activity avoidance in patients who fear developing asthma symptoms despite chronic treatment. Recent studies reveal that many patients are concerned about traditional asthma therapies, with a considerable number particularly anxious about corticosteroids, while others are failing to take therapy as prescribed. Earlier long-term clinical studies using consistent daily doses of steroids have demonstrated that these medications may adversely affect growth in children, and are associated with side effects such as dysphonia (hoarseness), "thrush" infections, bone loss, and skin bruising. In a study of children with persistent asthma using the inhaled steroid budesonide, the addition of Singulair 5 mg significantly improved asthma control. The placebo-controlled study enrolled 279 children ages six to 14 years stabilised on a daily dose of 400 mcg budesonide delivered via Turbuhaler. Children continued on their ICS therapy and were randomized to also receive either Singulair 5 mg once daily, or a matching placebo. Patients taking Singulair had fewer days suffering from asthma exacerbations (p<0.001) and used less rescue medication (p=0.013). Study results also showed that morning and evening peak flow rates were significantly higher (p=0.023 and p=0.012, respectively) in children receiving Singulair plus ICS. In addition, peripheral blood eosinophil counts-which are a marker of asthmatic inflammation-were lowered significantly (p<0.001) in the group receiving Singulair. "The improvements in overall asthma control among children with persistent asthma in this study were significant," says study investigator and co-author Estelle Simons, M.D., University of Manitoba, Winnipeg, Manitoba, Canada. "Singulair offers an effective and convenient treatment option, with a side-effect profile similar to placebo, for paediatricians to consider when looking for a therapy to improve asthma control in children." According to the World Health Organisation, asthma affects one in 10 children, making it the most common chronic illness of childhood. The condition is the single most prevalent cause of childhood disability and has contributed to a substantial rise in the overall prevalence of disability among children during the past 25 years. Asthma is now estimated to affect more than 100 million people world-wide. The U.S. Food and Drug Administration recently approved Singulair (4 mg tablets) for the prevention and chronic treatment of asthma in children aged two to five.
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