TABLE 3

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 populationTORCH trial population#
Unexposed to FP-SALExposed to FP-SALPlaceboFP-SAL
Subjects419610 46315241533
Exacerbations
 Person-years at risk933022 054
 Events499415 944
 Rate per person per year0.530.721.130.85
 Crude rate ratio11.35 (1.28–1.43)
 Propensity matched rate ratio11.30 (1.19–1.42)+10.75 (0.69–0.81)
Mortality
 Person-years at risk933022 054
 Events5431245
 Probability at 3 years %16.1316.0415.1612.59
 Crude hazard ratio10.98 (0.88–1.08)
 Propensity matched hazard ratio11.11 (0.95–1.26)§10.83 (0.68–1.00)
Pneumonia
 Events350998
 Percentage of total patients8.349.5412.3119.60
 Crude risk ratio11.14 (1.01–1.28)
 Propensity matched risk ratio11.14 (0.96–1.34)ƒ11.59 (1.35–1.88)
Time to treatment discontinuation
 Person-years at risk##20 402
 Events2255
 Probability at 3 years %28.2043.5033.70
 Crude hazard ratio
 Propensity matched hazard ratio10.69 (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.