To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ALA/ATS MEETING: Accolate Well Tolerated In Children With Asthma URL: http://www.pslgroup.com/dg/F9B82.htm Doctor's Guide April 27, 1999
SAN DIEGO, CA -- April 27, 1999 -- New data from a four-week, double-blind trial and 52-week open-label extension show that treatment with the asthma therapy Accolate™ (zafirlukast) was generally well tolerated throughout the duration of the study in children ages five to 11 years with mild-to-moderate asthma. Accolate, a product of Zeneca Pharmaceuticals, is currently approved for the preventive and chronic treatment of asthma in adults and children 12 years of age and older.
The results from this study demonstrate twice-daily treatment with Accolate provided consistent improvements in lung function and asthma symptoms and decreases the use of Beta2-agonist rescue therapy in these patients over an extended treatment period.
The study results were presented today at the American Lung Association/American Thoracic Society annual meeting in San Diego, California.1
"More than five million children in the United States suffer from asthma," said Kathy L. Lampl, MD, Medical Director of Asthma & Allergy Associates, Rockville, Maryland, and one of the lead investigators for the study. "Results from our study demonstrate that Accolate can be well tolerated in pediatric asthma patients with mild-to-moderate asthma, and that twice daily treatment with Accolate may provide long-term improvements in the control of asthma."
The effects of Accolate (5 mg and 10 mg twice daily) were assessed in a four-week, double-blind, placebo-controlled, parallel-group, multi-center trial followed by an optional 52-week, open-label extension in pediatric asthmatic patients maintained on inhaled short acting Beta2-agonist alone.
Safety was assessed by collecting adverse event data, laboratory tests as well as physical and electrocardiographic examinations. Efficacy was assessed by measuring lung function improvement (forced expiratory volume [FEV1] and percentage change in FEV1) with a spirometer and assessments of diary cards (daytime and nighttime asthma symptoms, Beta2-agonist use, regular measurement of morning and evening PEF, and peak flow variability [PFV]).
Study Results
In the four-week, double-blind portion of the trial, 301 children ages five to 11 years were randomized equally to three groups: Accolate 5 mg twice daily, Accolate 10 mg twice daily, or placebo.
Analyses over the four weeks showed improvements over placebo for FEV1, percentage change in FEV1, evening PEF, and PFV. The occurrence of adverse events was similar in the Accolate and placebo-treated groups, with the most frequently reported adverse events being pharyngitis, aggravation reaction (reported as an adverse event of asthma exacerbation or acute asthma exacerbation), and sinusitis.
In the open-label extension portion of this study, a total of 179 patients received Accolate 10 mg twice daily for up to 52 weeks. At the end point, sustained improvements from baseline for measures of spirometry, asthma symptoms, rescue inhaler use, PEF and PFV were noted.
Accolate
In November 1996, Zeneca Pharmaceuticals introduced Accolate, a leukotriene receptor antagonist (LTRA), which was the first product in the newest class of asthma drugs approved by the Food and Drug Administration in nearly 25 years. Through December 1998, Accolate tablets were prescribed more than 4.0 million times.2
The introduction of LTRAs, the newest class of asthma medications, has had a positive impact on how physicians approach the management of asthma symptoms. Medications such as Accolate help to control asthma symptoms, rather than treating an attack when it occurs. Leukotrienes are chemicals produced within the body that can contribute to the signs and symptoms of asthma. Therefore, blocking leukotrienes may inhibit their ability to cause asthma symptoms in many patients.
Despite the availability of a number of established and widely used anti-asthma medications, including cromolyn sodium and inhaled and oral corticosteroids, hospitalizations and deaths attributable to asthma have risen steadily since 1980. Although inhaled asthma drugs can be effective, compliance (the amount of drug a patient actually takes compared to the amount prescribed by a physician) has been shown to vary widely.3 It has also been shown that steroids may not completely block the effect of leukotrienes.4 These factors may define the clinical role of antileukotriene agents in asthma management.
Accolate 20 mg bid is indicated for the preventative and chronic treatment of asthma in adults and children 12 years of age and older. Accolate is not for use in the reversal of acute asthma attacks. Accolate is an oral controller agent available by prescription only. Accolate is taken twice daily, even during symptom-free periods, at least one hour before or two hours after meals. Accolate tablets are generally well tolerated. Patients should consult with their doctors before changing their current asthma medications, if they are prescribed a blood thinner, if they are nursing, or if their medical condition worsens. Side effects include headache (12.9 percent), infection* (3.5 percent), and nausea (3.1 percent); these were not significantly different from placebo.
REFERENCES:
1. Lampl KL, Dixon SJ, Bonuccelli CM. Long-term safety and efficacy of zafirlukast (Accolate™) in pediatric patients with mild-to-moderate asthma. Am J Respir Crit Care Med 1999; 159 (3): S138.
2. Physician Drug & Diagnosis Audit (PDDA) and Source Prescription Audit (SPA), Weekly Retail Prescriptions, November 1996 - December 1998, Scott-Levin, a division of PMSI, Scott-Levin, Inc.
3. Kelloway JS, Wyatt RA, Adlison SA. Comparison of patients' with prescribed oral and inhaled asthma medications. Arch Intern Med. 1994; 154: 1349-1352.
4. Smith L, Hanby L, Lavins Bernard, Simonson S, A single dose of zafirlukast reduces LTD4-induced brochoconstriction in patients on maintenance inhaled corticosteroid therapy, Annals of Allergy, Asthma & Immunology. 1998; 81, 43-49.
* In clinical trials, an increased proportion of patients on Accolate therapy who are over the age of 55 reported infection compared to those treated with placebo.
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