Trial Outcomes & Findings for Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data (NCT NCT05393245)
NCT ID: NCT05393245
Last Updated: 2024-12-04
Results Overview
Incidence rate of adverse events in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From the index date until the earliest: Outcome of interest, disenrollment, the end of the study period, death, discontinuation of the index drug, addition of Inhaled corticosteroids mono on top of Tio/Olo. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other.
COMPLETED
19467 participants
From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
2024-12-04
Participant Flow
This was an observational study based on existing data from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019. This study aimed to estimate the incidence of safety outcomes in Chinese patients with chronic obstructive pulmonary disease (COPD) in routine clinical practice in Taiwan who initiated Tiotropium / Olodaterol (Tio/Olo).
Every patient who fulfilled inclusion and exclusion criteria was selected until the required sample size was achieved.
Participant milestones
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Overall Study
STARTED
|
5820
|
13647
|
|
Overall Study
COMPLETED
|
5820
|
13647
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Total
n=19467 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 Years
n=5820 Participants
|
69 Years
n=13647 Participants
|
70 Years
n=19467 Participants
|
|
Sex: Female, Male
Female
|
653 Participants
n=5820 Participants
|
1384 Participants
n=13647 Participants
|
2037 Participants
n=19467 Participants
|
|
Sex: Female, Male
Male
|
5167 Participants
n=5820 Participants
|
12263 Participants
n=13647 Participants
|
17430 Participants
n=19467 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.Population: Eligible Patients set: All patients who met the criteria and who were treated with Tio/Olo were included in the analysis dataset.
Incidence rate of adverse events in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From the index date until the earliest: Outcome of interest, disenrollment, the end of the study period, death, discontinuation of the index drug, addition of Inhaled corticosteroids mono on top of Tio/Olo. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Pneumonia-Diagnosis codes were primary or secondary diagnosis associated with a hospitalization
|
0.84 Events per 100 person-years
Interval 0.56 to 1.26
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Moderate COPD exacerbation
|
19.71 Events per 100 person-years
Interval 18.05 to 21.52
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Severe COPD exacerbation
|
15.66 Events per 100 person-years
Interval 14.21 to 17.26
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Constipation
|
17.06 Events per 100 person-years
Interval 15.53 to 18.74
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Urinary retention
|
6.17 Events per 100 person-years
Interval 5.3 to 7.19
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Urinary tract infection (2)
|
9.44 Events per 100 person-years
Interval 8.34 to 10.68
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Urinary tract infection (3)
|
13.54 Events per 100 person-years
Interval 12.2 to 15.03
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Rash
|
0.69 Events per 100 person-years
Interval 0.44 to 1.09
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Nasopharyngitis
|
10.63 Events per 100 person-years
Interval 9.45 to 11.96
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Pneumonia- Diagnosis codes were primary inpatient diagnosis associated with a hospitalization
|
0.55 Events per 100 person-years
Interval 0.33 to 0.91
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Diarrhoea
|
1.58 Events per 100 person-years
Interval 1.17 to 2.13
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Urinary tract infection (1)
|
2.53 Events per 100 person-years
Interval 2.0 to 3.21
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
Urticaria
|
6.96 Events per 100 person-years
Interval 6.02 to 8.04
|
—
|
PRIMARY outcome
Timeframe: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.Population: Eligible Patients set: All patients who met the criteria and who were treated with Tio/Olo were included in the analysis dataset.
Incidence rate of Adverse Events (AEs) in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From index date until the earliest: Outcome of interest, disenrollment, end of the study period, death, discontinuation, use of Inhaled corticosteroids. Incident events. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Arrhythmia
|
6.80 Events per 100 person-years
Interval 5.83 to 7.94
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Myocardial ischemia
|
4.02 Events per 100 person-years
Interval 3.31 to 4.9
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Supraventricular tachycardia
|
0.33 Events per 100 person-years
Interval 0.17 to 0.63
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Glaucoma
|
1.13 Events per 100 person-years
Interval 0.79 to 1.62
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Nonfatal myocardial infarction (1)
|
0.59 Events per 100 person-years
Interval 0.36 to 0.96
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Nonfatal myocardial infarction (2)
|
1.11 Events per 100 person-years
Interval 0.78 to 1.59
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Nonfatal hemorrhagic stroke (1)
|
0.18 Events per 100 person-years
Interval 0.08 to 0.44
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Nonfatal hemorrhagic stroke (2)
|
0.66 Events per 100 person-years
Interval 0.42 to 1.05
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Nonfatal ischemic stroke (1)
|
1.03 Events per 100 person-years
Interval 0.71 to 1.5
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Nonfatal ischemic stroke (2)
|
1.67 Events per 100 person-years
Interval 1.25 to 2.24
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Nonfatal, Acute, but ill-defined, cerebrovascular disease (1)
|
0 Events per 100 person-years
Interval 0.0 to 0.0
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Nonfatal, Acute, but ill-defined, cerebrovascular disease (2)
|
0 Events per 100 person-years
Interval 0.0 to 0.0
|
—
|
|
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
Death
|
19.15 Events per 100 person-years
Interval 17.58 to 20.85
|
—
|
SECONDARY outcome
Timeframe: At index date between 2014-2019. Up to 2160 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by sex according to whether they started Tio+Olo or another LAMA/LABA
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex
Male
|
5167 Participants
|
12263 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex
Female
|
653 Participants
|
1384 Participants
|
SECONDARY outcome
Timeframe: At index date between 2014-2019Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by age groups according to whether they started Tio+Olo or another LAMA/LABA. The reported age groups are: 40-59, 60-79 and 80+.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age
40-59 years old
|
905 Participants
|
2826 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age
60-79 years old
|
3151 Participants
|
8080 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age
80+ years old
|
1764 Participants
|
2741 Participants
|
SECONDARY outcome
Timeframe: At index date between 2014-2019Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by Calendar year of cohort entry according to whether they started Tio+Olo or another LAMA/LABA. The reported year groups are: 2014, 2015, 2016, 2017, 2018 and 2019.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
2014
|
0 Participants
|
218 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
2015
|
150 Participants
|
945 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
2016
|
241 Participants
|
2477 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
2017
|
908 Participants
|
3491 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
2018
|
1944 Participants
|
3262 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
2019
|
2577 Participants
|
3254 Participants
|
SECONDARY outcome
Timeframe: At index date between 2014-2019Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by season of cohort entry date according to whether they started Tio+Olo or another LAMA/LABA. The reported seasons are: Spring (Mar-May), Summer (Jun-Aug), Fall (Sep-Nov) and Winter (Dec-Feb).
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date
Spring
|
1535 Participants
|
3748 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date
Summer
|
1484 Participants
|
3369 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date
Fall
|
1469 Participants
|
3273 Participants
|
|
Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date
Winter
|
1332 Participants
|
3257 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by specific previous COPD treatment during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Long-acting muscarinic antagonists (LAMA) monotherapy, Long-acting β2-agonists (LABA) monotherapy, Inhaled corticosteroids (ICS) monotherapy, ICS containing therapy and LAMA+LABA free combinations.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment
Long-acting muscarinic antagonists (LAMA) monotherapy
|
75 Participants
|
465 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment
Long-acting β2-agonists (LABA) monotherapy
|
112 Participants
|
670 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment
Inhaled corticolsteroids (ICS) monotherapy
|
76 Participants
|
44 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment
ICS containing therapy
|
668 Participants
|
1318 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment
LAMA+LABA free combinations
|
699 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by use of other respiratory drugs during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Mucolytics, Theophylline, Short-acting beta-agonists and Short-acting muscarinic antagonists.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs
Mucolytics
|
4324 Participants
|
9541 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs
Theophylline
|
2468 Participants
|
5913 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs
Short-acting beta-agonists
|
1670 Participants
|
2719 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs
Short-acting muscarinic antagonists.
|
911 Participants
|
1300 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+ according to the frequency of previous acute COPD exacerbation in 1 year for each patient.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date
0
|
5209 Participants
|
12556 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date
1
|
483 Participants
|
968 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date
2+
|
128 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date
0
|
5222 Participants
|
12738 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date
1
|
520 Participants
|
809 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date
2+
|
78 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date
0
|
4738 Participants
|
11791 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date
1
|
802 Participants
|
1548 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date
2+
|
280 Participants
|
308 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date
0
|
5628 Participants
|
13115 Participants
|
|
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date
1
|
192 Participants
|
532 Participants
|
|
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date
2+
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date
0
|
5564 Participants
|
13111 Participants
|
|
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date
1
|
256 Participants
|
536 Participants
|
|
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date
2+
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date
0
|
5390 Participants
|
12612 Participants
|
|
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date
1
|
412 Participants
|
1002 Participants
|
|
Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date
2+
|
18 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of hospitalizations caused by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date
0
|
5475 Participants
|
13149 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date
1
|
296 Participants
|
443 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date
2+
|
49 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of all-cause hospitalizations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date
0
|
3405 Participants
|
9273 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date
1
|
1311 Participants
|
2902 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date
2+
|
1104 Participants
|
1472 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of participants with comorbidities in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following comorbidities are reported: Cardiovascular disease, Cerebrovascular disease, Diabetes, Chronic kidney disease, Pneumonia, Cancer and Cirrhosis.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Pneumonia
|
71 Participants
|
218 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Cancer
|
274 Participants
|
469 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Cirrhosis.
|
119 Participants
|
279 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Carrdiovascular disease
|
2979 Participants
|
5741 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Cerebrovascular disease
|
857 Participants
|
1155 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Diabetes
|
1217 Participants
|
2407 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
Chronic kidney disease
|
58 Participants
|
224 Participants
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Charlson Comorbidity Index (CCI) according to whether they started Tio+Olo or another LAMA/LABA is reported. The CCI (using Deyo version) is a comorbidity index used to evaluate survival rate in patients with multiple comorbidities. 17 comorbidities were assessed with different weights, and the total score was determined by adding the scores of each comorbidity. The total score goes from 0 to 37, with higher values predicting a higher mortality rate.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date
|
1.33 Score on a scale
Standard Deviation 1.14
|
0.97 Score on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.Population: Eligible Patients set: All patients who met the criteria were included in the analysis dataset.
Number of participants with history of medications dispensed in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following medications are reported: Antihypertensives, Antiarrhythmics, Nitrates, Heart failure medications, Lipid-lowering medications, Blood glucose-lowering medications, Anticoagulants and antiplatelet agents, Antibiotics and Antineoplastic agents.
Outcome measures
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
Other LABA/LAMA
n=13647 Participants
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of other Long-acting β2-agonists + Long-acting muscarinic antagonists (LAMA+LABA) (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|---|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Antihypertensives
|
4027 Participants
|
8720 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Antiarrhythmics
|
2192 Participants
|
2192 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Nitrates
|
1064 Participants
|
2227 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Heart failure medications
|
2004 Participants
|
4086 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Lipid-lowering medications
|
1636 Participants
|
3823 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Blood glucose-lowering medications
|
1386 Participants
|
2785 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Anticoagulants and antiplatelet agents
|
2473 Participants
|
5073 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Antibiotics
|
4127 Participants
|
9103 Participants
|
|
Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
Antineoplastic agents.
|
286 Participants
|
502 Participants
|
Adverse Events
Tiotropium/Olodaterol (Tio/Olo)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tiotropium/Olodaterol (Tio/Olo)
n=5820 participants at risk
Patients with Chronic Obstructive Pulmonary Disease (COPD) new initiators of Tiotropium+Olodaterol (fixed dose combination (FDC) or free combination) between the 1st January 2014 and 31st December 2019 from the Taiwan National Health Insurance (NHI) claims data.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
15.5%
904/5820 • From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
The primary objective of the study was to explore the safety outcomes of Tiotropium/Olodaterol, so safety information was extracted from existing data only on these patients. Adverse Events (AEs) on patients treated with Other LABA/LAMA was not collected, only baseline characteristics were collected on these patients. Only AEs pre-specified in the protocol and deaths are reported. Seriousness of AEs was not collected. All patients who met the criteria were included in the analysis dataset
|
|
Gastrointestinal disorders
Constipation
|
7.5%
435/5820 • From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
The primary objective of the study was to explore the safety outcomes of Tiotropium/Olodaterol, so safety information was extracted from existing data only on these patients. Adverse Events (AEs) on patients treated with Other LABA/LAMA was not collected, only baseline characteristics were collected on these patients. Only AEs pre-specified in the protocol and deaths are reported. Seriousness of AEs was not collected. All patients who met the criteria were included in the analysis dataset
|
|
Infections and infestations
Urinary tract infection
|
11.6%
675/5820 • From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
The primary objective of the study was to explore the safety outcomes of Tiotropium/Olodaterol, so safety information was extracted from existing data only on these patients. Adverse Events (AEs) on patients treated with Other LABA/LAMA was not collected, only baseline characteristics were collected on these patients. Only AEs pre-specified in the protocol and deaths are reported. Seriousness of AEs was not collected. All patients who met the criteria were included in the analysis dataset
|
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