Results for the analysis of exacerbations, mortality, pneumonia and time to treatment discontinuation for fluticasone propionate (FP)-salmeterol (SAL) versus no FP-SAL (compared to TORCH results)
| CPRD non-interventional population | TORCH trial population# | |||
| Unexposed to FP-SAL | Exposed to FP-SAL | Placebo | FP-SAL | |
| Subjects | 4196 | 10 463 | 1524 | 1533 |
| Exacerbations | ||||
| Person-years at risk | 9330 | 22 054 | ||
| Events | 4994 | 15 944 | ||
| Rate per person per year | 0.53 | 0.72 | 1.13 | 0.85 |
| Crude rate ratio | 1 | 1.35 (1.28–1.43) | ||
| Propensity matched rate ratio | 1 | 1.30 (1.19–1.42)+ | 1 | 0.75 (0.69–0.81) |
| Mortality | ||||
| Person-years at risk | 9330 | 22 054 | ||
| Events | 543 | 1245 | ||
| Probability at 3 years¶ % | 16.13 | 16.04 | 15.16 | 12.59 |
| Crude hazard ratio | 1 | 0.98 (0.88–1.08) | ||
| Propensity matched hazard ratio | 1 | 1.11 (0.95–1.26)§ | 1 | 0.83 (0.68–1.00) |
| Pneumonia | ||||
| Events | 350 | 998 | ||
| Percentage of total patients | 8.34 | 9.54 | 12.31 | 19.60 |
| Crude risk ratio | 1 | 1.14 (1.01–1.28) | ||
| Propensity matched risk ratio | 1 | 1.14 (0.96–1.34)ƒ | 1 | 1.59 (1.35–1.88) |
| Time to treatment discontinuation | ||||
| Person-years at risk | ## | 20 402 | ||
| Events | 2255 | |||
| Probability at 3 years¶ % | 28.20 | 43.50 | 33.70 | |
| Crude hazard ratio | ||||
| Propensity matched hazard ratio | 1 | 0.69 (0.62–0.78) | ||
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=2652 in each exposure group after propensity score matching (supplementary table A2-3 for list of variables contributing to propensity score for exacerbations analysis); §: n=2708 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=2779 in each exposure group after propensity score matching (see supplementary table A2-3 for list of variables contributing to propensity score for pneumonia analysis); ##: time to treatment discontinuation analysis not applicable for unexposed to FP-SAL group.