Comparative effectiveness of budesonide/formoterol combination and fluticasone/salmeterol combination among chronic obstructive pulmonary disease patients new to controller treatment: a US administrative claims database study

Table 2 COPD exacerbation rates and pneumonia events during the post-index period

	Adjusted rate ¹		Rate ratio	95% CI		P-value ¹
	BFC (n = 3,697)	FSC (n = 3,697)	Rate ratio	Lower	Upper	P-value ¹
Primary Outcome: COPD exacerbation rate	0.88	0.86	1.02	0.96	1.09	0.5637
COPD-related inpatient hospitalization	0.06	0.07	0.96	0.79	1.16	0.6644
COPD-related ED visit	0.14	0.13	1.11	0.97	1.28	0.1304
OCS and/or antibiotics filled within 10 days after a COPD-related outpatient/office visit	0.67	0.66	1.01	0.94	1.09	0.7153
Sensitivity analysis of primary outcome
Stopping follow-up at ICS/LABA switch² (within first 12 months of follow-up)	0.87	0.86	1.01	0.95	1.08	0.6787
Using all follow-up³ (≥12 months follow-up)	0.86	0.86	1.01	0.95	1.07	0.7678
Severe COPD exacerbation⁴ (12 month post-index period)	0.21	0.20	1.03	0.92	1.16	0.5760
	% with ≥1 event		Odds Ratio	95% CI
	BFC (n = 3,697)	FSC (n = 3,697)	Odds Ratio	Lower	Upper	P-value ¹
Pneumonia events: any event	17.3	19.0	0.92	0.81	1.04	0.1926
Inpatient hospitalization	8.9	10.3	0.87	0.75	1.02	0.0937
ED visit	1.0	1.3	0.80	0.51	1.23	0.3052
Outpatient/office visit	12.0	12.6	0.97	0.84	1.12	0.6404

¹: Statistical comparisons are comparing BFC to FSC (reference group). Model covariates include sum of inpatient hospital stays >5 days (yes vs. no), LTRA use (0, 1, 2+), geographic region, peripheral vascular disease / atherosclerosis (yes vs. no), index prescribing physician specialty, and analogous pre-index variable (e.g., when analyzing the number of COPD related hospitalizations in the post-index, the model controlled for the number of pre-index COPD related hospitalizations).
²: Patients who filled an ICS/LABA that was different than the index medication during the 12 month post-index period had follow-up stopped on the date of the switch.
³: Using all follow-up: Patients were followed as long as possible until the end of the continuous health plan enrollment, or the end of the study period.
⁴: Severe COPD exacerbation includes only events due to COPD related inpatient hospitalization and COPD related ED visit.
CI: confidence interval; ED: emergency department.

ISSN: 1465-993X