Evaluation of a Therapeutic Interchange from Fluticasone/Salmeterol to Mometasone/Formoterol in Patients with Chronic Obstructive Pulmonary Disease

BACKGROUND: Combination treatment with an inhaled corticosteroid and long-acting beta2-agonist is among the many treatment options for chronic obstructive pulmonary disease (COPD) that has been shown to improve clinical outcomes. While mometasone/formoterol does not currently have an FDA-approved indication for COPD, evidence from 2 phase 3 trials demonstrated that mometasone/formoterol can improve lung function and was well tolerated in patients with moderate-to-very severe COPD. Based on these data, a therapeutic interchange was implemented in the Kaiser Permanente Mid-Atlantic States region to convert patients with a COPD diagnosis from fluticasone/salmeterol to mometasone/formoterol. OBJECTIVE: To evaluate the impact of a therapeutic interchange from fluticasone/salmeterol to mometasone/formoterol on health outcomes in patients with COPD in a large ambulatory and managed care setting. METHODS: The investigators retrospectively reviewed the electronic medical records of patients with a COPD diagnosis who had a prescription for fluticasone/salmeterol converted to mometasone/formoterol between March 6, 2011, to March 6, 2013. Kaiser Permanente’s Pharmacy and Therapeutics Committee provided recommended equivalent doses for conversion from fluticasone/salmeterol to mometasone/formoterol. Nonetheless, the final approval for the change in medication and selection of the dose was left to each physician’s clinical judgment. Patients were excluded if they were (a) prescribed fluticasone/salmeterol 100/50 mcg, which has no equivalent mometasone/formoterol dose; (b) less than aged 18 years; or (c) prescribed fluticasone/salmeterol for a duration of less than 6 months preconversion to mometasone/formoterol. In addition, patients who left the Kaiser Permanente network or became deceased during the study period of interest were excluded. After the application of the inclusion and exclusion criteria, 521 patients were included in the data analysis. The primary endpoint was the determination of the difference in the occurrence of COPD exacerbations 6 months pre- and postconversion from fluticasone/salmeterol to mometasone/formoterol. COPD exacerbations were defined by the diagnosis or documentation of a COPD exacerbation during any hospitalizations, urgent care (UC)/emergency department (ED) visits, or clinic encounters. Secondary outcomes included the determination of the difference in the occurrence of intensive care unit admissions, hospitalizations, UC/ED visits, and clinic encounters for COPD exacerbations 6 months pre- and postconversion; number of patients who required modification in therapy; and any reasons for mometasone/for-moterol discontinuation postconversion. Patients served as their own controls to compare any differences in outcomes while taking mometasone/formoterol versus fluticasone/salmeterol. RESULTS: Within our patient population, 34.2% (n = 178) of patients experienced at least 1 COPD exacerbation while prescribed fluticasone/salme-terol compared with 28.6% (n = 149) of patients while prescribed mometa-sone/formoterol (P = 0.030). Mometasone/formoterol therapy did not demonstrate any statistically significant differences in the secondary outcomes (P < 0.050). A later subgroup analysis of the primary outcome revealed that factors associated with a statistically significant decrease in the occurrence of COPD exacerbations were male sex (P = 0.023), comorbid asthma (P = 0.026), and conversion from fluticasone/salmeterol to a more potent dose of mometasone/formoterol (P = 0.014). CONCLUSIONS: There was a statistically significant decrease in the proportion of patients who experienced COPD exacerbations postconversion from fluticasone/salmeterol to mometasone/formoterol. This study is an example of a real-world therapeutic interchange that provides additional data to support the use of mometasone/formoterol for its unlabeled COPD indication.