RESEARCH TRIANGLE PARK, N.C., Feb. 21 /PRNewswire-FirstCall/ -- An international study published in today’s New England Journal of Medicine showed that patients with Chronic Obstructive Pulmonary Disease (COPD) who took Advair Diskus(R) 500/50 (fluticasone propionate and salmeterol inhalation powder) reduced their risk of death by 17.5 percent over three years compared to patients on placebo (p=0.052)*. COPD is a progressive and debilitating lung disease and is a major cause of illness, death, and the use of health care resources globally.
TORCH showed several other important benefits of Advair compared with placebo. The study demonstrated that treatment with Advair significantly reduced the frequency of COPD-related exacerbations -- defined as the worsening of symptoms requiring systemic steroids, antibiotics, or hospitalizations -- by 25 percent (p<0.001). Improvements in quality of life in patients taking Advair were also seen (p<0.001).** Additionally, the study demonstrated that patients taking Advair experienced significantly improved lung function over three years as measured by spirometry (p<0.001). Improving survival, reducing exacerbations and improving lung function are all primary goals in the management of patients with COPD.
“I view these results as extremely meaningful because the findings in the study consistently pointed to better outcomes for patients with this life-threatening disease,” said study investigator Dr. Bartolome Celli, Professor of Medicine at Tufts University and Chief of the Pulmonary and Critical Care Medicine at St. Elizabeth’s Medical Center. “Helping patients with COPD live longer and live better are the priorities of disease management and what all doctors hope to offer.”
There was an increased risk of pneumonia seen as adverse events or serious adverse events in the inhaled corticosteroid containing arms of the TORCH study. The number of deaths while on treatment which were attributable to pneumonias was 7 in the placebo group, 9 in the salmeterol group, 13 in the fluticasone propionate group, and 8 in the Advair group. Treatment with Advair did not appear to be associated with an increased risk of COPD patients dying from pneumonia. There were no increases in bone or eye disorders in patients treated with Advair compared with placebo.
COPD is a debilitating and progressive lung disease which includes chronic bronchitis and emphysema. In the United States, COPD kills more people each year than breast and lung cancer combined. TORCH is the first study to investigate if medication can affect survival in patients with COPD. Currently, the only interventions proven to increase the rate of survival in patients with COPD are smoking cessation, oxygen therapy and lung volume reduction surgery.
“We conducted the largest study ever in COPD patients and it was the first to examine the potential for a medicine to impact survival in patients with this life-threatening disease,” said Kathy Rickard, Vice-President, Clinical Development Respiratory, MDC North America, GSK. “We believe the findings from TORCH are clinically relevant and important and therefore we have submitted a filing to the FDA to include this information in the prescribing information for Advair.”
Study Design
The TORCH (TOward a Revolution in COPD Health) Survival Study in COPD was conducted over three years in 42 countries with more than 6,000 patients (age 40-80 years) who suffered from moderate to severe COPD (FEV1<60%). Participants were randomized into four treatment groups: 1,533 received fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg in a single device (Advair), 1,534 received fluticasone propionate, 1,521 received salmeterol, and the remaining received a placebo (control group). The primary comparison was between Advair and placebo.
At the conclusion of the study, all groups were assessed for the relative risk reduction in all-cause mortality. Secondary endpoints included the rate of severe and moderate exacerbations (sudden worsening of symptoms) and quality of life as measured by St. George’s Respiratory Questionnaire. All groups were monitored for adverse events throughout the study, and a subset of patients in the U.S. were also measured for bone mineral density and given ocular exams.
In all treatment arms, patients were allowed to take other medications to treat COPD symptoms including anticholinergics, theophylline, and albuterol (similar usage was seen across treatment arms). Patients were instructed not to take inhaled corticosteroids, long-term oral corticosteroids, or long-acting bronchodilators while enrolled in the study.
The study authors suggest that the lack of statistical significance for the mortality endpoint is likely explained by the overall mortality in the study being less than expected. In addition, withdrawals from the placebo arm were especially high; withdrawal patients were free to receive active treatment including Advair, but were counted as placebo patients in the final mortality analyses.
The study was sponsored by GlaxoSmithKline and guided by several independent committees, including a Steering Committee, a Safety and Efficacy Data Monitoring Committee and a Clinical Endpoint Committee.
About COPD
Chronic Obstructive Pulmonary Disease (COPD) is a life-threatening lung disease that primarily includes chronic bronchitis and emphysema. Patients with COPD suffer from shortness of breath that limits their daily activities and quality of life. The gradual loss of lung function, coupled with other symptoms and exacerbations, often leads to hospitalization and can eventually be disabling.
Despite the fact that COPD is not widely recognized, it is a growing public health problem. In fact, COPD is the fourth leading cause of death in the U.S. and is projected to become third in the next decade. Approximately 11.4 million Americans have been diagnosed with some form of COPD and it’s estimated that as many as 20 million people have the disease, indicating COPD is under-diagnosed.
About Advair in COPD
Advair 250/50 is currently indicated for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. Advair does not replace fast-acting inhalers to treat sudden symptoms. Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids, including fluticasone propionate and Advair Diskus. Patients with COPD often have multiple risk factors for reduced bone mineral density. Advair Diskus may increase this risk; therefore, bone mineral density assessment is recommended prior to starting Advair Diskus and periodically thereafter. Long-term use of inhaled corticosteroids, including Advair Diskus, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered.
For more information about Advair please visit www.gsk.com.
About GlaxoSmithKline
Advair was developed and is marketed by GlaxoSmithKline, a research based pharmaceutical company and a world leader in respiratory care. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information please visit www.gsk.com.
* A p value of less than or equal to 0.05 is conventionally recognized as representing statistical significance. ** Although it did not meet the predefined minimally important difference.
GlaxoSmithKline
CONTACT: US Media inquiries: Mary Anne Rhyne, +1-919-483-2839; or LisaBehrens, +1-919-483-2839
Web site: http://www.gsk.com/
