PAR15: COMPARISON OF HEALTH CARE RESOURCE UTILIZATION OF COPD PATIENTS ON CILOMILAST, 15 MG BID VERSUS PLACEBO

Abstract

OBJECTIVES: Cilomilast is a potent and selective phosphodiesterase type 4 (PDE4) inhibitor currently under development for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. METHODS: COPD-related health care resource utilization including physician visits, emergency room visits, hospitalizations and medication use were prospectively collected in a 6 month randomized, double-blind, placebo controlled, parallel group study of patients on cilomilast, 15 mg bid (n = 431) versus patients on placebo (n = 216). Methods of analysis included descriptive statistics, Kaplan-Meier estimates and Poisson regression. RESULTS: In the year prior to the study, COPD-related health care resource utilization was comparable between patients eventually randomized to cilomilast and those randomized to placebo; the majority of all patients had no or one emergency room visit or hospitalziation. During the entire 24-week study period, the cumulative incidence of health care utilization was significantly lower in the cilomilast group than the placebo group in terms of all utilization (11.0% vs. 21.1%, p = 0.004); including physician visits (11.9% vs. 23.1%, p = 0.002), emergency room visits (0.6% vs. 4.5%, p = 0.004) and hospitalization (0.5% vs. 3.4%, p = 0.021). The relative utilization rates per patient-month of follow-up for each of the utilization types were lower in the cilomilast group than in the placebo group. Treatment with cilomilast resulted in reduction of all utilization by 51% (C.I.: 31%, 65%), physician visits by 41% (C.I.: 15%, 59%). ER visits and hospitalizations were also significantly reduced. CONCLUSIONS: In this study, cilomilast was associated with significantly less COPD-related health care resource utilization, including hospitalizations, emergency room visits and physician visits than placebo.