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Table 2 Escalation to triple therapy (fixed-dose or any concurrent ICS/LAMA/LABA) during each study period

From: Real-world effectiveness of early intervention with fixed-dose tiotropium/olodaterol vs tiotropium in Japanese patients with COPD: a high-dimensional propensity score–matched cohort analysis

Variable Prespecified study period
(1 April 2015 to 31 March 2019)
Post hoc extension study period
(1 April 2015 to 31 March 2020)
Tio Tio/Olo Tio Tio/Olo
hdPS-matched cohort (primary analysis)     
 Number of patients 1302 1302 1723 1723
 Number of events 8 7 20 14
 Number of patient-years 919 899 1211 1203
 Events per 1000 patient-years (95% CI) 8.71 (4.11–16.43) 7.79 (3.47–15.29) 16.52 (9.28–23.75) 11.64 (5.54–17.73)
Median (IQR) time-to-escalation to triple therapy, days 28.0 (15.0–139.2) 193 (94.5–302.0) 108 (60.5–256.8) 225 (82.2–312.0)
 HR for time-to-escalation (95% CI) 0.89 (0.32–2.46) 0.71 (0.36–1.40)
Unmatched cohort     
 Number of patients 5352 1436 6505 1860
 Number of escalation events 30 8 49 20
 Number of patient-years 4180 981 5065 1291
 Events per 1000 patient-years (95% CI) 7.18 (4.61–9.75) 8.16 (3.52–16.07) 9.67 (6.97–12.38) 15.49 (8.70–22.28)
Median (IQR) time-to-escalation to triple therapy, days 100.5 (28.0–196.8) 191 (117.2–292.0) 112 (56.0–245.0) 255.5 (176.8–311.5)
 HR for time-to-escalation (95% CI) 1.11 (0.51–2.43) 1.60 (0.95–2.69)
  1. CI confidence interval, hdPS high-dimensional propensity score, HR hazard ratio, ICS inhaled corticosteroid, IQR interquartile range, LABA long-acting β2-agonist, LAMA long-acting muscarinic antagonist, Tio tiotropium, Tio/Olo tiotropium/olodaterol