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Table 4 Treatment comparison of time to first CID in the overall population and by GOLD stage

From: Composite endpoints in COPD: clinically important deterioration in the UPLIFT trial

 

Event, n (%)

Time to first event treatment comparison (tiotropium–placebo)

Tiotropium 18 μg

Placebo

HR (95% CI)

Pvalue

Overall

2811 (100.0)

2841 (100.0)

  

 SGRQ deterioration, trough FEV1 decline ≥100 mL, moderate/severe exacerbation

2310 (82.2)

2431 (85.6)

0.71 (0.67, 0.75)

< 0.0001

 Moderate/severe exacerbation

1884 (67.0)

1930 (67.9)

0.86 (0.81, 0.92)

< 0.0001

 Trough FEV1 decline ≥100 mL

1028 (36.6)

1475 (51.9)

0.53 (0.49, 0.58)

< 0.0001

 SGRQ score increase ≥4 units

1077 (38.3)

1262 (44.4)

0.72 (0.66, 0.78)

< 0.0001

GOLD 2

1310 (100.0)

1293 (100.0)

  

 SGRQ deterioration, trough FEV1 decline ≥100 mL, moderate/severe exacerbation

1053 (80.4)

1122 (86.8)

0.70 (0.65, 0.77)

< 0.0001

 Moderate/severe exacerbation

780 (59.5)

835 (64.6)

0.83 (0.75, 0.92)

0.0002

 Trough FEV1 decline ≥100 mL

564 (43.1)

780 (60.3)

0.54 (0.49, 0.61)

< 0.0001

 SGRQ score increase ≥4 units

487 (37.2)

594 (45.9)

0.71 (0.63, 0.80)

< 0.0001

GOLD 3

1239 (100.0)

1266 (100.0)

  

 SGRQ deterioration, trough FEV1 decline ≥100 mL, moderate/severe exacerbation

1036 (83.6)

1091 (86.2)

0.69 (0.63, 0.75)

< 0.0001

 Moderate/severe exacerbation

896 (72.3)

900 (71.1)

0.86 (0.78, 0.94)

0.0010

 Trough FEV1 decline ≥100 mL

413 (33.3)

618 (48.8)

0.51 (0.45, 0.58)

< 0.0001

 SGRQ score increase ≥4 units

491 (39.6)

563 (44.5)

0.71 (0.63, 0.81)

< 0.0001

GOLD 4

231 (100.0)

250 (100.0)

  

 SGRQ deterioration, trough FEV1 decline ≥100 mL, moderate/severe exacerbation

197 (85.3)

191 (76.4)

0.90 (0.74, 1.10)

0.3079

 Moderate/severe exacerbation

186 (80.5)

171 (68.4)

1.00 (0.81, 1.23)

0.9798

 Trough FEV1 decline ≥100 mL

41 (17.7)

59 (23.6)

0.57 (0.39, 0.86)

0.0066

 SGRQ score increase ≥4 units

90 (39.0)

88 (35.2)

0.83 (0.62, 1.11)

0.2105

  1. CI confidence interval, CID clinically important deterioration, FEV1 forced expiratory volume in 1 s, GOLD Global Initiative for Chronic Obstructive Lung Disease, HR hazard ratio, SGRQ St. George’s Respiratory Questionnaire