Long Term Advair Diskus Use Doesn't Adversely Affect Bone Loss
GlaxoSmithKline (NYSE: GSK) announced today that data from a three-year study of patients with Chronic Obstructive Pulmonary Disease (COPD) found that the inhaled corticosteroid in Advair Diskus 250/50, fluticasone propionate, did not show an adverse effect on bone mineral density (BMD) measured at the lumbar spine and total hip compared to salmeterol alone. In this study, designed to show equivalent rate of change in BMD for Advair and salmeterol, results for bone mineral density in the lumbar spine did not meet clinical equivalence although the rate of change favored Advair. The data was presented in Philadelphia at CHEST 2008, the annual meeting of the American College of Chest Physicians.
"These data are very encouraging for patients with COPD since most patients with this debilitating disease are at an age where they may also be at risk for bone loss," said Richard ZuWallack, MD of St. Francis Hospital and Medical Center, Hartford CT. "These data inform on the long-term impact of inhaled corticosteroids on bone mineral density."
About the Study
Effects of treatment with Advair Diskus 250/50 or salmeterol 50 mcg on BMD were evaluated in 186 patients (females and males 43 to 87 years of age) with COPD in a 3-year double-blind study. BMD evaluations were conducted at baseline and at 6-month intervals. The study was designed to show equivalence in the rate of change of BMD at the L1-L4 lumbar spine and total hip between Advair and salmeterol (defined as a difference in BMD of +/-1% per year). The difference in the rate of change of BMD for Advair versus salmeterol at the lumbar spine was +0.8% per year (95% CI: 0.06, 1.49). The study was powered for equivalence but instead showed a trend favoring Advair. The study showed equivalence between the two groups in the rate of change at the hip (-0.3% per year (95% CI: -0.78, 0.24)).
In summary, the study showed no adverse effect on BMD attributable to the corticosteroid component of Advair, and provides support for the long term use of Advair in patients with COPD.
About Advair in COPD
Advair Diskus 250/50 was approved in 2003 for COPD. Advair Diskus 250/50 is currently indicated for the twice-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Advair Diskus 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Advair Diskus 250/50 is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength Advair Diskus 500/50 over Advair Diskus 250/50 has not been demonstrated.
Patients should only take one inhalation of Advair twice a day. People with COPD taking Advair may have a higher chance of pneumonia. Patients should call their doctor if they notice any of the following symptoms: change in amount or color of sputum, fever, chills, increased cough, or increased breathing problems. Advair may increase the risk of osteoporosis and some eye problems (cataracts or glaucoma). Patients should have regular eye exams. Thrush in the mouth and throat may occur. Patients should tell their doctor if they have a heart condition or high blood pressure before taking Advair. Do not use Advair with long-acting beta2-agonists for any reason. Advair does not replace fast-acting inhalers for sudden symptoms.