Table 2

Dose–response relationship for glycopyrronium bromide treatment regimens: model-averaged analysis of trough FEV1, FEV1AUC0-24h, FEV1AUC0-12h, FEV1AUC0-4h, and FEV1AUC12-24hat steady state
Glycopyrronium bromide dose
12.5 μg OD 25 μg OD 12.5 μg BID 50 μg OD 25 μg BID 100 μg OD 50 μg BID
Trough FEV1at steady state
Absolute increase over placebo (L), (SE) 0.051 (0.019) 0.079 (0.020) 0.115 (0.021) 0.109 (0.020) 0.141 (0.020) 0.137 (0.019) 0.160 (0.020)
90% CI 0.032, 0.081 0.054, 0.108 0.082, 0.142 0.083, 0.135 0.112, 0.163 0.111, 0.160 0.135, 0.181
% of projected maximum effect of any glycopyrronium bromide dose* (SE) 27 (11) 42 (12) 62 (14) 59 (12) 76 (13) 73 (12) 85 (11)
90% CI 16, 44 27, 61 37, 82 38, 76 49, 90 49, 87 60, 95
FEV1AUC0-24hat steady state
Absolute increase over placebo (L), (SE) 0.058 (0.012) 0.089 (0.014) 0.098 (0.015) 0.123 (0.014) 0.131 (0.014) 0.152 (0.012) 0.158 (0.012)
90% CI 0.039, 0.079 0.066, 0.113 0.071, 0.122 0.099, 0.145 0.106, 0.152 0.131, 0.171 0.138, 0.176
% of projected maximum effect of any glycopyrronium bromide dose* (SE) 29 (7) 45 (8) 49 (9) 62 (8) 66 (8) 76 (6) 79 (6)
90% CI 19, 42 32, 59 34, 64 48, 74 51, 78 65, 85 68, 88
FEV1AUC0-12hat steady state
Absolute increase over placebo (L), (SE) 0.085 (0.015) 0.121 (0.016) 0.104 (0.016) 0.152 (0.014) 0.139 (0.015) 0.176 (0.012) 0.166 (0.013)
90% CI 0.061, 0.111 0.094, 0.146 0.078, 0.130 0.128, 0.174 0.113, 0.162 0.155, 0.195 0.144, 0.186
% of projected maximum effect of any glycopyrronium bromide dose* (SE) 41 (8) 58 (8) 51 (8) 74 (6) 67 (7) 85 (4) 80 (5)
90% CI 29, 55 45, 71 37, 64 62, 83 54, 78 76, 91 70, 88
FEV1AUC0-4hat steady state
Absolute increase over placebo (L), (SE) 0.105 (0.016) 0.138 (0.015) 0.122 (0.016) 0.165 (0.013) 0.153 (0.014) 0.183 (0.012) 0.175 (0.012)
90% CI 0.080, 0.132 0.114, 0.162 0.096, 0.148 0.143, 0.185 0.129, 0.174 0.163, 0.203 0.154, 0.195
% of projected maximum effect of any glycopyrronium bromide dose* (SE) 51 (8) 67 (7) 59 (8) 80 (6) 74 (7) 88 (5) 84 (6)
90% CI 39, 64 54, 78 46, 72 67, 87 61, 83 78, 93 73, 91
FEV1AUC12-24hat steady state
Absolute increase over placebo (L), (SE) 0.051 (0.025) 0.079 (0.026) 0.112 (0.027) 0.111 (0.026) 0.141 (0.026) 0.141 (0.027) 0.163 (0.028)
90% CI 0.033, 0.080 0.056, 0.108 0.080, 0.139 0.086, 0.137 0.112, 0.163 0.116, 0.163 0.138, 0.184
% of projected maximum effect of any glycopyrronium bromide dose* (SE) 26 (11) 40 (12) 57 (14) 56 (13) 71 (14) 71 (13) 82 (13)
90% CI 16, 43 24, 60 31, 78 33, 75 42, 88 43, 86 51, 94

*100 x (effect of this dosage/maximum theoretical effect predicted by model).

OD: once daily; BID: twice daily; SE: standard error; CI: confidence interval; FEV1: forced expiratory volume in one second; AUC: area under the curve.

Arievich et al.

Arievich et al. BMC Pulmonary Medicine 2012 12:74   doi:10.1186/1471-2466-12-74

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