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Advair Reduces Exacerbations in COPD Patients With a History of Exacerbations
Positive Data Used by the FDA to Expand Use of Advair Last Month
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TORONTO and RESEARCH TRIANGLE PARK, N.C., May 18 /PRNewswire-FirstCall/ --The use of Advair Diskus(R) 250/50 (fluticasone propionate and salmeterolinhalation powder) demonstrated a 30% reduction in exacerbations in patientswith chronic obstructive pulmonary disease (COPD) who have a history ofexacerbations as compared with salmeterol alone, according to new datapresented today at the International Conference of the American ThoracicSociety meeting in Toronto.
COPD is a progressive, life-threatening lung disease that includes chronicbronchitis, emphysema or both. Exacerbations are flare-ups or episodes ofworsening COPD symptoms that often require additional treatment, such asantibiotics, oral corticosteroids and in some cases hospitalization. Symptomsmay include shortness of breath, or coughing up excess mucus beyond normalday-to-day variations. Seventy-seven (77) percent of patients with COPD reportexperiencing at least one exacerbation within the past year.
The randomized study of 797 patients was a replicate study which foundthat after a year of treatment, patients treated with Advair Diskus 250/50 hada 30% reduction in the rate of annual exacerbations compared to salmeterol(p<0.001). In an analysis of time to first moderate/severe exacerbation,there was a 25 percent reduction in risk with Advair compared to salmeterol(p=0.003). And Advair also reduced the annual rate of exacerbations requiringoral corticosteroids by 34 percent (p<0.001).
The study was one of two new studies reviewed by the U.S. Food and DrugAdministration prior to granting approval last month for the expanded use ofAdvair for the reduction of COPD exacerbations in patients with a history ofexacerbations and in a broader COPD patient population which includes patientswith chronic bronchitis, emphysema or both. The studies conducted to supportthe new indication were one year in duration thus lengthening the duration ofestablished efficacy and safety.
"Reducing exacerbations is one of the primary goals of COPD treatment, andthis second study presented today shows convincingly that Advair effectivelyaddresses this pressing need," said Antonio Anzueto, MD, University of TexasHealth Science Center. "This data reaffirms my belief in Advair as aneffective treatment for my patients with COPD."
Advair contains two medications, an inhaled corticosteroid and along-acting beta-agonist, that work together to improve lung function andreduce exacerbations, two primary goals in the management of COPD.
Background on COPD
An estimated 24 million Americans suffer from COPD, which is the fourthleading cause of death in the United States. COPD is a progressive,life-threatening lung disease that includes chronic bronchitis and emphysema.It is characterized by airflow obstruction, a limitation in lung function,which makes it difficult to breathe. Most patients have components of bothchronic bronchitis and emphysema. Symptoms of COPD include chronic cough,chest tightness, shortness of breath, an increased effort to breathe andincreased mucus production. Typically, patients with COPD develop shortness ofbreath during exertion, which continues and gradually worsens. Most patientsalso develop a productive, chronic cough. Over time, many patients sufferfrom shortness of breath so severe that it inter
