TABLE 4

As-treated sensitivity analyses for the heart failure outcome associated with adding a second long-acting bronchodilator (combination) compared with remaining on a single long-acting bronchodilator (monotherapy) in patients with chronic obstructive pulmonary disease (COPD), with 1 year follow-up

Patients nEvents nPerson-yearsRate per 1000 per yearCrude# HRAdjusted HR (95% CI)
Initiating with a LABA
 LABA monotherapy16 81433710 78131.31.001.00 (reference)
 Adding tiotropium16 81438011 00234.51.101.11 (0.95–1.28)
Initiating on tiotropium
 Tiotropium monotherapy14 360187708926.41.001.00 (reference)
 Adding a LABA14 360318961033.11.301.28 (1.07–1.54)
No recorded COPD diagnosis
 Monotherapy410590256435.11.001.00 (reference)
 Combination262873152847.81.341.18 (0.86–1.62)
Recorded COPD diagnosis
 Monotherapy27 06943415 30628.41.001.00 (reference)
 Combination28 54662519 08432.81.181.18 (1.04–1.33)
No recent COPD exacerbation
 Monotherapy28 12646616 28628.61.001.00 (reference)
 Combination28 09462718 62333.71.191.18 (1.05–1.33)
Recent COPD exacerbation
 Monotherapy304858158436.61.001.00 (reference)
 Combination308071198835.71.041.02 (0.72–1.45)
No baseline ICS use
 Monotherapy429189278432.01.001.00 (reference)
 Combination429197268536.11.111.13 (0.84–1.50)
Baseline ICS use
 Monotherapy26 88343515 08628.81.001.00 (reference)
 Combination26 88360117 92633.51.191.17 (1.03–1.32)
Current use defined within a 30-day period
 Monotherapy31 17440613 64029.81.001.00 (reference)
 Combination31 17448114 50433.21.121.11 (0.97–1.27)
Current use defined within a 90-day period
 Monotherapy31 17456419 21229.41.001.00 (reference)
 Combination31 17479323 03634.41.191.18 (1.05–1.31)
Using probable heart failure outcome definition
 Monotherapy31 17440417 87022.61.001.00 (reference)
 Combination31 17455120 61226.71.211.21 (1.06–1.38)
Tighter match (PS0.05 of each other)
 Monotherapy28 23348416 74028.91.001.00 (reference)
 Combination28 23363218 62133.91.191.18 (1.05–1.33)
Combination defined within ±3 days
 Monotherapy31 17452417 86529.31.001.00 (reference)
 Combination31 17470020 61834.01.181.16 (1.04–1.30)
Eliminating outcome events in first 30 days of follow-up
 Monotherapy29 39239915 46625.81.001.00 (reference)
 Combination30 58956718 07331.41.231.22 (1.07–1.39)
Eliminating outcome events in first 90 days of follow-up
 Monotherapy25 87925511 78621.61.001.00 (reference)
 Combination29 32538013 82627.51.281.28 (1.09–1.51)
No heart failure diagnosis before cohort entry
 Monotherapy29 76334017 19819.81.001.00 (reference)
 Combination29 73747419 82123.91.231.21 (1.05–1.39)
  • LABA: long-acting β2-agonists; ICS: inhaled corticosteroid; PS: propensity score. #: crude, after matching on high-dimensional propensity scores and ICS use in the year prior to cohort entry; : after matching on high-dimensional propensity scores and ICS use in the year prior to cohort entry, adjusted further for patient characteristics (10 year age groups, sex, calendar year of cohort entry), as well as the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.