Improving the evaluation of COPD exacerbation treatment effects by accounting for early treatment discontinuations: a post-hoc analysis of randomized clinical trials

Table 4 Estimated exacerbation treatment effects and 95% confidence intervals for the different models in Datasets A-E

	Joint frailty model	Shared frailty model	Negative binomial model
	Exacerbation treatment ratio (95% confidence interval)*
Dataset A
BUD/FM 320 vs PBO	0.59 (0.45–0.77)	0.63 (0.49–0.81)	0.63 (0.49–0.80)
BUD/FM 160 vs PBO	0.58 (0.44–0.75)	0.60 (0.46–0.77)	0.60 (0.47–0.77)
FM vs PBO	0.90 (0.69–1.17)	0.90 (0.70–1.16)	0.90 (0.71–1.14)
Dataset B
BUD/FM 320 vs FM	0.67 (0.54–0.82)	0.68 (0.55–0.83)	0.68 (0.55–0.83)
BUD/FM 160 vs FM	0.74 (0.60–0.92)	0.74 (0.60–0.90)	0.73 (0.59–0.89)
Dataset C
BUD/FM 320 vs PBO	0.73 (0.50–1.08)	0.87 (0.60–1.25)	0.88 (0.62–1.24)
BUD/FM 160 vs PBO	0.70 (0.47–1.04)	0.83 (0.58–1.20)	0.84 (0.59–1.20)
BUD 320 + FM vs PBO	0.57 (0.38–0.85)	0.67 (0.46–0.98)	0.68 (0.47–0.98)
BUD 320 vs PBO	0.72 (0.48–1.07)	0.81 (0.55–1.18)	0.82 (0.57–1.17)
FM vs PBO	1.09 (0.74–1.61)	1.15 (0.80–1.66)	1.16 (0.82–1.63)
Dataset D
SOC + RFL vs SOC	0.82 (0.68–0.98)	0.76 (0.64–0.90)	0.76 (0.64–0.90)
Dataset E
SOC + RFL vs SOC	0.95 (0.85–1.07)	0.91 (0.81–1.02)	0.91 (0.81–1.02)

BUD budesonide, FM formoterol, PBO placebo, RFL roflumilast, SOC standard of care * - Hazard ratios are estimated for the joint and shared frailty models. A rate ratio is estimated for the negative binomial model. Only treatment is included as a covariate (for the joint frailty model, a treatment effect is included both in the exacerbation and discontinuation hazard)

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