Adding salmeterol to fluticasone propionate or increasing the dose of fluticasone propionate in patients with asthma.

The National Asthma Education and Prevention Program guidelines recommend two options for patients uncontrolled on inhaled corticosteroid (ICS) alone: add a long-acting bronchodilator or increase the dose of the ICS. The purpose of this study was to compare asthma-related exacerbations and asthma control in asthma patients receiving fluticasone propionate (FP) monotherapy with an increased dose of FP compared with maintaining the dose and adding salmeterol (SAL) via a single device (FP/SAL combination [FSC]). A retrospective observational study was performed using health insurance claims spanning from January 2001 to August 2006 ("study period"). Subjects were > or =12 years of age, with asthma (International Classification of Diseases [ICD] 493.xx), and were stepped up from FP 44 microg to either FP 110 microg (FP110) or FP 100 microg/SAL 50 microg (FSC), or from FP110 to either FP 220 microg or FP 250 microg/SAL 50 microg (FSC). There were 1744 subjects identified, 557 (32%) increased FP and 1187 (68%) added SAL. The cohorts were relatively similar, and after adjusting for baseline characteristics, patients who added SAL to their same dose of FP had 41% lower odds of an asthma exacerbation (odds ratio = 0.59; 95% confidence interval [CI] = 0.46-0.76; p < 0.001), 36% fewer prescriptions for a short-acting beta-agonist (rate ratio = 0.64; 95% CI = 0.58-0.70; p < 0.001), and a 32% increase in ICS refill persistence compared with increasing the dose of FP. In asthma patients who are not adequately controlled with ICS (FP), adding SAL as FSC is associated with lower risk of an asthma-related exacerbation and better asthma control compared with increasing the dose of ICS (FP).