To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Singulair Shown To Help Control Asthma Following Exercise URL: http://www.pslgroup.com/dg/8ED5E.htm Doctor's Guide July 16, 1998
WEST POINT, PA -- July 16, 1998 -- A new study published today in the New England Journal of Medicine showed that Merck & Co., Inc.'s once-a-day asthma pill Singulair(R) (montelukast sodium), when used with rescue medicines, may help control the disease in patients with mild asthma and exercise-induced bronchoconstriction (EIB). EIB is a common asthmatic condition marked by diminished breathing capacity, shortness of breath or laboured breathing following physical exertion. The multi-centre study showed that Singulair helped to provide improvement in EIB, without a decrease in effect over the 12-week study period. While Singulair can be part of an overall strategy for EIB, Singulair is not indicated for EIB and should not be used by itself for the treatment and management of this condition. Patients should be advised to continue using their usual regimen of bronchodilators before exercise. They must always have rescue medication with them in case an attack should occur during exercise. Singulair was approved by the FDA in February for the prevention and chronic treatment of asthma in adults and children as young as six. Singulair should not be used as rescue medication to treat acute asthma episodes. Patients should not decrease the dose or stop taking any other asthma medications unless instructed by a physician. In the double-blind study, which was supported by a grant from the Merck Research Laboratories, 110 patients with mild asthma (aged 15 to 45 years) received either 10 mg of Singulair or placebo once daily at bedtime for 12 weeks. This was followed by a two-week period in which all patients received placebo only. Exercise challenges were performed at baseline; 20 to 24 hours after dosing at weeks four, eight and 12; and at the end of the placebo-only period. After 12 weeks of therapy during the study, participants receiving Singulair experienced a 47 percent greater inhibition of EIB than those in the placebo group. The results were measured by comparing the post-exercise fall in lung function (using FEV1, a standard test that measures breathing capacity) and the time for lung function to return to the pre-exercise state. Singulair did not, however, prevent clinically significant EIB in 52 percent of patients studied. In this study, patients receiving Singulair also reported significantly improved asthma, as measured by their global assessment scores (patients' personal evaluation of their level of asthma control). In the group receiving Singulair, 73.1 percent of patients characterised their asthma as better, 21.2 percent as unchanged and 5.8 percent as worse. The respective placebo values were 44.4 percent better, 46.3 percent unchanged and 9.3 percent worse. Significantly fewer patients (14.3 percent) in the group receiving Singulair required rescue therapy with a beta-agonist after the exercise challenge than those in the placebo group (36 percent). "People with mild asthma may only experience troubling symptoms such as shortness of breath or laboured breathing while they are exercising," said James Kemp, M.D., of the Allergy and Asthma Medical Group and Research Center, San Diego and a clinical investigator for Singulair. "Although Singulair is not indicated as a monotherapy for EIB, this study shows that many patients who consistently took Singulair benefited from its ability to help control asthma." Patients in this study used fast-acting inhaled beta-agonists, commonly called rescue medications, as needed. However, they did not use any preventive, or controller, medications other than Singulair during the study. Importantly, those patients who benefited from Singulair during this study did not experience a loss of protective effect over time, nor did the EIB worsen after Singulair was discontinued. In the study, the most commonly reported adverse effects were generally similar for the groups treated with Singulair and placebo. The three most commonly reported adverse effects were headache (20 percent in the group treated with Singulair versus 32 percent of placebo patients), upper respiratory tract infections (28 percent Singulair versus 23 percent placebo) and worsening asthma (four percent Singulair versus 10 percent placebo). Singulair is the newest anti-asthma medication in the leukotriene receptor antagonist class. It works by blocking leukotrienes, substances that are associated with the inflammatory process of asthma. Singulair is indicated for the control of asthma in adults and children six and older, but not for the treatment of acute asthma attacks. A recent report issued by the Centers for Disease Control shows that asthma in the U.S. increased by 75 percent between 1980 and 1994. Some 15 million Americans suffer from the disease and in 1995, nearly two million were treated in hospital emergency rooms for treatment of acute asthma attacks. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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