Results for the analysis of exacerbations, mortality, pneumonia and time to treatment discontinuation for fluticasone propionate (FP)-salmeterol (SAL) versus SAL (compared to TORCH results)
| CPRD non-interventional population | TORCH trial population# | |||
| SAL | FP-SAL | SAL | FP-SAL | |
| Subjects | 1146 | 11 235 | 1521 | 1533 |
| Exacerbations | ||||
| Person-years at risk | 2566 | 24 062 | ||
| Events | 1515 | 14 034 | ||
| Rate per person per year | 0.73 | 0.59 | 0.97 | 0.85 |
| Crude rate ratio | 1 | 0.80 (0.72–0.88) | ||
| Propensity matched rate ratio | 1 | 0.85 (0.74–0.97)+ | 1 | 0.88 (0.81–0.95) |
| Mortality | ||||
| Person-years at risk | 2566 | 24 062 | ||
| Events | 138 | 1445 | ||
| Probability at 3 years¶ % | 15.09 | 16.84 | 13.48 | 12.59 |
| Crude hazard ratio | 1 | 1.12 (0.94–1.34) | ||
| Propensity matched hazard ratio | 1 | 0.93 (0.65–1.32)§ | 1 | 0.93 (0.77–1.13) |
| Pneumonia | ||||
| Events | 86 | 1137 | ||
| % of total patients | 7.50 | 10.12 | 13.29 | 19.60 |
| Crude risk ratio | 1 | 1.35 (1.09–1.66) | ||
| Propensity matched risk ratio | 1 | 1.39 (1.04–1.87)ƒ | 1 | 1.47 (1.25–1.73) |
| Time to treatment discontinuation | ||||
| Person-years at risk | 1251 | 21 587 | ||
| Events | 740 | 2449 | ||
| Probability at 3 years¶ % | 77.02 | 28.04 | 36.40 | 33.70 |
| Crude hazard ratio | 1 | 0.22 (0.20–0.23) | ||
| Propensity matched hazard ratio | 1 | 0.23 (0.20–0.27)## | 1 | 0.89 (0.79–0.99) |
Data are presented as n, unless otherwise stated. CPRD: Clinical Practice Research Datalink. #: only results reported in the TORCH trial publication are shown; ¶: calculated using a Cox proportional-hazards model; +: n=991 in each exposure group after propensity score matching (see supplementary table A2-3 for list of variables contributing to propensity score for exacerbations analysis); §: n=443 in each exposure group after propensity score matching (see supplementary table A2-3 for list of variables contributing to propensity score for mortality analysis); ƒ: n=996 in each exposure group after propensity score matching. (see supplementary table A2-3 for list of variables contributing to propensity score for pneumonia analysis); ##: n=935 in each exposure group after propensity score matching (see supplementary table A2-3 for list of variables contributing to propensity score for time to treatment discontinuation analysis).