Table 2.
Risk of pneumonia by type of ICS in permanent users
| Treatment throughout study | Comparison | |||||
|---|---|---|---|---|---|---|
| FP | Other ICS | No ICS | FP versus other ICS HR* or RR† (95% CI); p-value |
FP versus no ICS HR* or RR† (95% CI); p-value |
Other ICS versus no ICS HR* or RR† (95% CI); p-value |
|
| Permanent users, n | 825 | 825 | 825 | – | – | – |
| Patients with pneumonia events, n (%)# | 115 (13.9) | 95 (11.5) | 87 (10.5) | HR 1.28 (0.97, 1.68); p = 0.078 |
HR 1.33 (1.00, 1.75); p = 0.046 |
HR 1.03 (0.77, 1.38); p = 0.830 |
| Pneumonia events, n | 159 | 111 | 98 | – | – | – |
| Adjusted rate of pneumonia events (per patient-year), mean (95% CI) | 0.10 (0.07, 0.14) |
0.07 (0.04, 0.10) |
0.06 (0.04, 0.10) |
RR 1.48 (1.00, 2.19); p = 0.049 |
RR 1.58 (1.05, 2.37); p = 0.028 |
RR 1.07 (0.69, 1.65); p = 0.773 |
| Patients with hospitalized pneumonia events, n (%) | 65 (7.9) | 55 (6.7) | 49 (5.9) | HR 1.24 (0.86, 1.77); p = 0.249 |
HR 1.30 (0.90, 1.88); p = 0.168 |
HR 1.05 (0.71, 1.54); p = 0.802 |
| Hospitalized pneumonia events, n | 78 | 64 | 51 | – | – | – |
| Adjusted rate of hospitalized pneumonia events (per patient-year), mean (95% CI) | 0.05 (0.03, 0.08) |
0.04 (0.03, 0.07) |
0.04 (0.02, 0.06) |
RR 1.25 (0.78, 2.02); p = 0.355 |
RR 1.47 (0.88, 2.44); p = 0.141 |
RR 1.17 (0.69, 1.99); p = 0.560 |
| Patients with pneumonia resulting in death, n (%) | 7 (0.85) | 13 (1.58) | 9 (1.09) | HR 0.54 (0.22, 1.36); p = 0.194 |
HR 0.75 (0.28, 2.01); p = 0.567 |
HR 1.38 (0.59, 3.23); p = 0.460 |
Abbreviations: CI confidence interval, FEV1 forced expiratory volume in 1 s, FP fluticasone propionate, GOLD Global Initiative for Chronic Obstructive Lung Disease, HR hazard ratio, ICS inhaled corticosteroid, RR rate ratio. Matched-subgroup population. *Cox regression analysis with ICS use on-treatment and matching factors as covariates. †Poisson regression with ICS use on-treatment and matching factors (age, FEV1% predicted, GOLD stage, emphysema diagnosis, and courses of antibiotics) as covariates. #In this analysis, 23 patients treated permanently with FP received the treatment for non-pulmonary (mostly nasal) indication only; three of these patients had a pneumonia event during the study. In the subgroup permanently treated with other ICS, these numbers were 10 and 3, respectively