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) | Lower | Upper | |||
| 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) | 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.