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Original Research

Efficacy and safety of glycopyrrolate in patients with COPD by reversibility: pooled analysis of GEM1 and GEM2 12-week studies

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Pages 461-470 | Published online: 19 Feb 2019

Figures & data

Table 1 Pooled population demographics and baseline characteristics of patients in the GEM1 and GEM2 studies by bronchodilator reversibility (FAS)

Figure 1 LSM change from baseline in (A) FEV1 AUC0–12 h and (B) trough FEV1 at week 12 by bronchodilator reversibility status (FAS).

Notes: *P<0.05; ***P<0.001 GLY vs placebo; ^P<0.05; ^^^P<0.001 vs nonreversible subgroup.
Abbreviations: AUC0–12 h, area under the curve from 0 to 12 hours; BID, twice daily; FAS, full analysis set; GLY, glycopyrrolate; LSM, least squares mean; SE, standard error.
Figure 1 LSM change from baseline in (A) FEV1 AUC0–12 h and (B) trough FEV1 at week 12 by bronchodilator reversibility status (FAS).

Figure 2 LSM change from baseline in (A) SGRQ and (B) CAT total scores at week 12 by bronchodilator reversibility status (FAS).

Notes: *P<0.05; **P<0.01; ***P<0.001 GLY vs placebo.
Abbreviations: BID, twice daily; CAT, COPD assessment test; FAS, full analysis set; GLY, glycopyrrolate; LSM, least squares mean; SE, standard error; SGRQ, St George’s Respiratory Questionnaire.
Figure 2 LSM change from baseline in (A) SGRQ and (B) CAT total scores at week 12 by bronchodilator reversibility status (FAS).

Figure 3 LSM TDI focal score at week 12 by bronchodilator reversibility status (FAS).

Notes: ***P<0.001 GLY vs placebo; ^P<0.05 vs reversible subgroup.
Abbreviations: BID, twice daily; FAS, full analysis set; GLY, glycopyrrolate; LSM, least squares mean; SE, standard error; TDI, Transition Dyspnea Index.
Figure 3 LSM TDI focal score at week 12 by bronchodilator reversibility status (FAS).

Figure 4 Pooled analysis of mean total (A) daily, (B) daytime, and (C) nighttime symptom scores over 12 weeks by bronchodilator reversibility status (FAS). Notes: *P<0.05; **P<0.01 vs placebo.

Abbreviations: BID, twice daily; FAS, full analysis set; GLY, glycopyrrolate; LSM, least squares mean; SE, standard error.
Figure 4 Pooled analysis of mean total (A) daily, (B) daytime, and (C) nighttime symptom scores over 12 weeks by bronchodilator reversibility status (FAS). Notes: *P<0.05; **P<0.01 vs placebo.

Figure 5 Pooled analysis of change from baseline in (A) daily, (B) daytime, (C) nighttime rescue medication use, and (D) days with no rescue medication use over 12 weeks of treatment by bronchodilator reversibility status (FAS).

Notes: **P<0.01; ***P<0.001 vs placebo; ^^^P<0.001 vs nonreversible subgroup.
Abbreviations: BID, twice daily; FAS, full analysis set; GLY, glycopyrrolate; LSM, least squares mean; SE, standard error.
Figure 5 Pooled analysis of change from baseline in (A) daily, (B) daytime, (C) nighttime rescue medication use, and (D) days with no rescue medication use over 12 weeks of treatment by bronchodilator reversibility status (FAS).

Table 2 Pooled analysis of the most common AEsTable Footnotea by bronchodilator reversibility (safety population)

Table S1 LSM change from baseline in trough FEV1 (L) by reversibility status and ICS use at baseline (FAS)