Trial Outcomes & Findings for Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events (NCT NCT02096731)
NCT ID: NCT02096731
Last Updated: 2017-02-15
Results Overview
The acute myocardial infarction (MI) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry. No. = Number
COMPLETED
115397 participants
Up to 12 months
2017-02-15
Participant Flow
The base cohort included 115,397 new users of tiotropium or a LABA (+/- ICS) between 01Jan2002 \& 31Aug2013.These patients included 26,442 new users of tiotropium \& 88,955 new users of LABA.Patients initiating treatment with both bronchodilators on the same date were excluded.
Patients receiving combination therapy were those who either added tiotropium to LABA, or added LABA to tiotropium. In the Participant Flow \& Baseline Characteristics modules, no participants were represented in both the "Tiotropium" \& the "LABA" Arms/Groups.
Participant milestones
| Measure |
Tiotropium
Participants who were new users of tiotropium.
|
LABA
Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
|
|---|---|---|
|
Overall Study
STARTED
|
26442
|
88955
|
|
Overall Study
COMPLETED
|
26442
|
88955
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events
Baseline characteristics by cohort
| Measure |
Tiotropium
n=26442 Participants
Participants who were new users of tiotropium.
|
LABA
n=88955 Participants
Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
|
Total
n=115397 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
69.4 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
69.9 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Gender
Female
|
11741 Participants
n=5 Participants
|
48912 Participants
n=7 Participants
|
60653 Participants
n=5 Participants
|
|
Gender
Male
|
14701 Participants
n=5 Participants
|
40043 Participants
n=7 Participants
|
54744 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.
The acute myocardial infarction (MI) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry. No. = Number
Outcome measures
| Measure |
Monotherapy
n=31138 Participants
Participants remaining on a single long-acting bronchodilator - monotherapy.
|
Combination Therapy
n=31138 Participants
Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
|
|---|---|---|
|
Myocardial Infarction
|
10.1 No. of incident MI/1000patients/ year
|
11.3 No. of incident MI/1000patients/ year
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.
The stroke rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.
Outcome measures
| Measure |
Monotherapy
n=31123 Participants
Participants remaining on a single long-acting bronchodilator - monotherapy.
|
Combination Therapy
n=31123 Participants
Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
|
|---|---|---|
|
Stroke
|
8.3 No. of incident stroke/1000patients/year
|
7.0 No. of incident stroke/1000patients/year
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.
The heart failure (HF) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.
Outcome measures
| Measure |
Monotherapy
n=31174 Participants
Participants remaining on a single long-acting bronchodilator - monotherapy.
|
Combination Therapy
n=31174 Participants
Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
|
|---|---|---|
|
Heart Failure
|
29.3 No. of incident HF/1000patients/year
|
33.9 No. of incident HF/1000patients/year
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.
The cardiac arrhythmia (CA) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.
Outcome measures
| Measure |
Monotherapy
n=18861 Participants
Participants remaining on a single long-acting bronchodilator - monotherapy.
|
Combination Therapy
n=18861 Participants
Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
|
|---|---|---|
|
Cardiac Arrhythmia
|
10.0 No. of incident CA/1000patients /year
|
10.7 No. of incident CA/1000patients /year
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.
The community acquired pneumonia rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry. Pt. = Patient
Outcome measures
| Measure |
Monotherapy
n=18867 Participants
Participants remaining on a single long-acting bronchodilator - monotherapy.
|
Combination Therapy
n=18867 Participants
Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
|
|---|---|---|
|
Community Acquired Pneumonia
|
63.0 No.of incident Pneumonia/1000 pt./year
|
84.6 No.of incident Pneumonia/1000 pt./year
|
Adverse Events
Tiotropium
LABA
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER