TABLE 2

Efficacy end-points for gefapixant compared to matched placebo in studies 1 and 2

Study 1Study 2
GefapixantPlaceboGefapixantPlacebo
Day 0Day 4Day 8Day 12Day 16Day 0Day 4Day 8Day 12Day 16Day 0Day 4Day 8Day 12Day 16Day 0Day 4Day 8Day 12Day 16
Baseline50 mg100 mg150 mg200 mgBaselinePlaceboPlaceboPlaceboPlaceboBaseline7.5 mg15 mg30 mg50 mgBaselinePlaceboPlaceboPlaceboPlacebo
Awake cough frequency events·h−154.5±41.1
(41.3)
29.9±22.5*
(22.7)
25.7±19.1*
(18.2)
26.0±17.9*
(18.7)
28.0±23.8* (18.7)52.8±40.4 (38.2)51.1±39.5 (36.0)51.0±39.1 (36.2)56.0±48.7 (35.2)54.0±39.3 (39.5)49.6±44.0 (24.6)39.3±36.0 (19.7)34.8±31.4*
(16.8)
26.8±26.3* (13.4)27.0±27.4* (12.1)46.1±39.8 (27.7)44.8±34.9 (31.2)41.4±33.3 (24.5)48.2±42.4 (22.8)50.6±34.4 (35.8)
Night cough frequency events·h−18.3±9.34.8±6.64.6±8.95.5±6.74.3±6.48.3±9.38.5±10.47.5±9.910.1±13.28.3±10.610.1±26.88.9±12.35.5±7.96.2±8.45.6±10.05.6±7.67.0±9.55.0±7.45.8±7.810.1±18.4
24-h cough frequency events·h−139.7±28.422.7±17.0*20.4±16.4*19.9±13.7*21.3±18.0*37.9±27.537.5±27.837.7±27.241.3±34.640.6±28.436.3±32.329.1±25.724.8±21.919.5±17.6*20.8±20.5*32.2±28.031.5±23.829.4±23.334.5±30.837.3±25.9
Cough severity VAS mm58.4±18.745.0±25.333.2±25.6*30.6±26.1*28.0±26.2*52.2±19.248.4±20.846.9±21.250.8±24.055.6±24.154.5±24.341.8±26.237.1±26.831.2±23.3*30.4±25.3*57.2±23.750.9±24.347.3±26.349.5±24.748.0±27.0
Cough severity diary4.2±1.93.6±1.93.1±1.9*2.6±1.8*2.6±2.0*3.7±1.63.6±1.93.8±1.93.8±1.83.8±2.04.5±2.03.6±2.13.3±2.1*2.9±1.9*3.0±2.2*4.5±1.94.1±1.94.0±2.04.0±1.73.8±1.7
Total LCQ score12.3±3.115.4±4.2*13.1±3.412.3±3.412.6±4.016.2±4.1*13.3±3.813.4±3.9

Data are presented as arithmetic mean±sd (geometric mean). Bold type represents statistical significance. VAS: visual analogue scale; LCQ: Leicester Cough Questionnaire. *: p<0.05 for analysis of change from baseline for gefapixant compared with placebo.