Fluticasone plus Salmeterol vs. Fluticasone Alone for Patients with Asthma

In a 2006 industry-sponsored safety study conducted in >26,000 asthma patients, the long-acting β-agonist (LABA) salmeterol (Serevent) — when given in its own inhaler and not as a fixed-dose combination with inhaled corticosteroids — was associated with more asthma-related deaths than was placebo (NEJM JW Gen Med Mar 1 2006 and Chest 2006; 129:15). About half of study participants used inhaled corticosteroids outside the study, but the study was not designed to evaluate whether concomitant use of inhaled corticosteroids protected against death associated with salmeterol. The FDA asked manufacturers of LABA-containing medications to conduct additional studies to evaluate LABA-plus-inhaled-corticosteroid fixed-combination devices versus inhal…