PURPOSE: COPD patients with impaired QOL are more likely to experience exacerbations and thereby utilize more healthcare resources. The objective of the present analysis was to quantify the impact of cilomilast, a selective phosphodiesterase 4 inhibitor, on QOL in patients with higher St. George's Respiratory Questionnaire (SGRQ) scores at baseline (higher SGRQ score is indicative of greater impairment in QOL).
METHODS: The analysis was based on a 24-week, randomized, double blind, placebo-controlled study, which evaluated cilomilast (15 mg twice daily) in patients with COPD. Patients’ QOL was measured using the SGRQ, a disease specific QOL questionnaire. Significant QOL benefit was observed in the overall study population. The present analysis focused on patients with a baseline SGRQ score of greater than or equal to the median SGRQ score. The change from baseline and the difference between cilomilast and placebo on total SGRQ score were evaluated.
RESULTS: A total of 293 patients (cilomilast = 192, placebo = 101) who had baseline SGRQ score that was greater than or equal to the median SGRQ score of 43.22 were included in the analysis. The mean baseline SGRQ score in the cilomilast group was 56.40 (SEM: 0.78) compared to the mean baseline score of 56.93 (SEM: 1.05) in the placebo group. A clinically meaningful and statistically significant QOL improvement of –7.50 units (95% CI: −9.49 to – 5.50) was observed in the cilomilast group at endpoint compared to a non-significant change of –1.34 units (95% CI: −4.02 to 1.34) in the placebo group. This statistical and clinically meaningful improvement in QOL was maintained when difference from placebo was analyzed (−6.15 units, 95% CI: −9.24 to –3.07).
CONCLUSION: This post hoc analysis of the effect of cilomilast on SGRQ scores in COPD patients with impaired QOL at baseline confirms the benefit of maintenance therapy with cilomilast for 24-weeks within this group of COPD patients.
