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Examine the risk of cardiovascular events (cardiac arrhythmia or myocardial ischemia) or all-cause mortality in Chronic Obstructive Pulmonary Disease (COPD) patients who are new users of Olodaterol or other LABAs available for the treatment of COPD.
Purpose:
Time Perspective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new users of Olodaterol | COPD patients using Olodaterol for the first time | ||
| new users of other LABAs | COPD patients using other long-acting beta2 agonists for the first time |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of First Hospitalisation or Hospital Outpatient Clinic Visit for Atrial Fibrillation or Flutter (AF) | Cases of AF were ascertained by at least one (=first occurrence) International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) code for primary hospital inpatient discharge diagnosis or as a diagnosis code in a hospital outpatient specialist visit in the Danish National Patient Registry while being new users of olodaterol or of any Long-Acting Beta2-Agonist (LABA) other than olodaterol. The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). | Up to 4 years and 11 months |
| Occurrence of First Hospitalisation or Hospital Outpatient Clinic Visit for Supraventricular Tachycardia (SVT) (Other Than Atrial Fibrillation/Flutter) | Cases of SVT were ascertained by at least one (=first occurrence) ICD-10 code for primary hospital inpatient discharge diagnosis or as a diagnosis code in a hospital outpatient specialist visit in the Danish National Patient Registry while being new users of olodaterol or of any Long-Acting Beta2-Agonist (LABA) other than olodaterol. The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). | Up to 4 years and 11 months |
| Occurrence of First Hospitalisation for Ventricular Tachycardia (VT), Including Ventricular Fibrillation/Flutter and Cardiac Arrest | Cases of VT were ascertained by at least one (=first occurrence) ICD-10 code for primary hospital inpatient discharge diagnosis in the Danish National Patient Registry while being exposed to olodaterol and other LABA monotherapy or in free or fixed-dose combination with long-acting muscarinic antagonist (LAMA). The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality. | Death ascertained from Danish Civil Registration System (fact and date of death, but not cause of death) while being new users of olodaterol or any Long-Acting Beta2-Agonist (LABA) other than olodaterol. Exposure window: first episode of continuous use (= time comprising consecutive dispensing's separated by up to 14 days). Termination dates of the follow up: date of outcome of interest, disenrollment from database, 14 days after estimated discontinuation of last dispensing for index LABA, date patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). To assess possible impact of imbalanced baseline characteristics, all-cause mortality was further assessed in two post-hoc analyses with restricted populations that would be more similar at baseline, post-hoc population 1 and post-hoc population 2. |
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Inclusion criteria:
Exclusion criteria:
none
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COPD patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitets hospital Skejby | Aarhus | Denmark |
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| Label | URL |
|---|---|
| Related Info | View source |
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Only subjects that met all inclusion and none of the exclusion criteria were included. The matched cohort study design and propensity score methodology were used to establish two comparable treatment cohorts, the Olodaterol cohort and the other LABA cohort.
This cohort study, used data from the Danish National Patient Registry (diagnoses), Danish Prescription Database (dispensings), and Danish Register of Causes of Death (cause of death information) to examine the risk of cardiovascular events in patients with chronic obstructive pulmonary disease (COPD) exposed to olodaterol compared to other long-acting beta2-agonists (LABAs) between 01 March 2014 and 31 January 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olodaterol | Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry initiating olodaterol (either alone or in free- or fixed-dose combination with a Long-Acting Muscarinic Antagonist (LAMA)), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut). Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year. |
| FG001 | Other Long-acting beta2-agonist (LABAs) | Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry (March 2014 to January 2019) initiating LABA (alone or in a free- or fixed-dose combination with a LAMA), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut). Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry initiating olodaterol (either alone or in free- or fixed-dose combination with a LAMA) or an alternative LABA (alone or in a free- or fixed-dose combination with a LAMA).
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| ID | Title | Description |
|---|---|---|
| BG000 | Olodaterol | Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry initiating olodaterol (either alone or in free- or fixed-dose combination with a Long-Acting Muscarinic Antagonist (LAMA)), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut). Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of First Hospitalisation or Hospital Outpatient Clinic Visit for Atrial Fibrillation or Flutter (AF) | Cases of AF were ascertained by at least one (=first occurrence) International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) code for primary hospital inpatient discharge diagnosis or as a diagnosis code in a hospital outpatient specialist visit in the Danish National Patient Registry while being new users of olodaterol or of any Long-Acting Beta2-Agonist (LABA) other than olodaterol. The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). | Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry | Posted | Number | Events | Up to 4 years and 11 months |
Up to 4 years and 11 months
This is a non-interventional study using electronic health care records, with data retrieved from Danish National Patient Registry, Danish National Prescription Registry and Danish Register of Causes of Death. No adverse events were collected on an individual case level.
All-cause mortality (ACM) is an outcome of this study and thus additionally reported below. Please note, adjusted incidence rate ratios of ACM are displayed as statistical analyses 1, 2, 3 of the secondary outcome measure 6.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olodaterol | Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry initiating olodaterol (either alone or in free- or fixed-dose combination with a Long-Acting Muscarinic Antagonist (LAMA)), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut). Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2016 | Jan 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Up to 4 years and 11 months |
| Occurrence of First Hospitalisation for Acute Myocardial Infarction (AMI) | Cases of AMI were ascertained by at least one (=first occurrence) ICD-10 code for primary hospital inpatient discharge diagnosis in the Danish National Patient Registry while being new users of olodaterol or of any Long-Acting Beta2-Agonist (LABA) other than olodaterol. The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). | Up to 4 years and 11 months |
| Occurrence of First Hospitalisation for Serious Acute Coronary Heart Disease (SACHD), Including Angina and Other Acute Ischaemic Heart Disease Events | Cases of SACHD were ascertained by at least one (=first occurrence) ICD-10 code for primary hospital inpatient discharge diagnosis in the Danish National Patient Registry while being new users of olodaterol or of any Long-Acting Beta2-Agonist (LABA) other than olodaterol. The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). | Up to 4 years and 11 months. |
| Up to 4 years and 11 months. |
| BG001 | Other Long-acting beta2-agonist (LABAs) | Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry (March 2014 to January 2019) initiating LABA (alone or in a free- or fixed-dose combination with a LAMA), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut). Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Olodaterol | Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry initiating olodaterol (either alone or in free- or fixed-dose combination with a Long-Acting Muscarinic Antagonist (LAMA)), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut). Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year. |
| OG001 | Other Long-acting beta2-agonist (LABAs) | Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry (March 2014 to January 2019) initiating LABA (alone or in a free- or fixed-dose combination with a LAMA), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut). Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year. |
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|
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| Primary | Occurrence of First Hospitalisation or Hospital Outpatient Clinic Visit for Supraventricular Tachycardia (SVT) (Other Than Atrial Fibrillation/Flutter) | Cases of SVT were ascertained by at least one (=first occurrence) ICD-10 code for primary hospital inpatient discharge diagnosis or as a diagnosis code in a hospital outpatient specialist visit in the Danish National Patient Registry while being new users of olodaterol or of any Long-Acting Beta2-Agonist (LABA) other than olodaterol. The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). | Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry. | Posted | Number | Events | Up to 4 years and 11 months |
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|
| Primary | Occurrence of First Hospitalisation for Ventricular Tachycardia (VT), Including Ventricular Fibrillation/Flutter and Cardiac Arrest | Cases of VT were ascertained by at least one (=first occurrence) ICD-10 code for primary hospital inpatient discharge diagnosis in the Danish National Patient Registry while being exposed to olodaterol and other LABA monotherapy or in free or fixed-dose combination with long-acting muscarinic antagonist (LAMA). The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). | Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry. | Posted | Number | Events | Up to 4 years and 11 months |
|
|
|
|
| Primary | Occurrence of First Hospitalisation for Acute Myocardial Infarction (AMI) | Cases of AMI were ascertained by at least one (=first occurrence) ICD-10 code for primary hospital inpatient discharge diagnosis in the Danish National Patient Registry while being new users of olodaterol or of any Long-Acting Beta2-Agonist (LABA) other than olodaterol. The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). | Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry. | Posted | Number | Events | Up to 4 years and 11 months |
|
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|
| Primary | Occurrence of First Hospitalisation for Serious Acute Coronary Heart Disease (SACHD), Including Angina and Other Acute Ischaemic Heart Disease Events | Cases of SACHD were ascertained by at least one (=first occurrence) ICD-10 code for primary hospital inpatient discharge diagnosis in the Danish National Patient Registry while being new users of olodaterol or of any Long-Acting Beta2-Agonist (LABA) other than olodaterol. The exposure window considered only the first episode of continuous use, defined as the time comprising consecutive dispensing's separated by up to 14 days. Termination dates of the follow up: date of outcome of interest, disenrollment from the database, 14 days after estimated discontinuation of the last dispensing for index LABA, the date the patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). | Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry. | Posted | Number | Events | Up to 4 years and 11 months. |
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| Secondary | All-cause Mortality. | Death ascertained from Danish Civil Registration System (fact and date of death, but not cause of death) while being new users of olodaterol or any Long-Acting Beta2-Agonist (LABA) other than olodaterol. Exposure window: first episode of continuous use (= time comprising consecutive dispensing's separated by up to 14 days). Termination dates of the follow up: date of outcome of interest, disenrollment from database, 14 days after estimated discontinuation of last dispensing for index LABA, date patient switched to another LABA, dispensing of a second LABA, death, end of study period (= 31 January 2019). To assess possible impact of imbalanced baseline characteristics, all-cause mortality was further assessed in two post-hoc analyses with restricted populations that would be more similar at baseline, post-hoc population 1 and post-hoc population 2. | Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry. Post-hoc population 1 was based on propensity score-trimmed population restricted to users of fixed-dose combination of LABA/LAMA who were LABA-treatment naïve (= no LABA dispensing in the 180 days before cohort entry). Post-hoc population 2 was post-hoc population 1 further restricted to users without hospitalizations for COPD in the last 90 days. | Posted | Number | Events | Up to 4 years and 11 months. |
|
|
|
|
| 859 |
| 14,239 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Other Long-acting beta2-agonist (LABAs) | Cohort of patients with Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry (March 2014 to January 2019) initiating LABA (alone or in a free- or fixed-dose combination with a LAMA), with first dispensing as index date occurred from 01 March 2014 (launch of olodaterol in Denmark) to 31 January 2019 (last date with data available for the final data cut). Participants were matched 1:4 ('olodaterol' : 'other LABAs') by age, sex, and calendar year. | 1,872 | 51,167 | 0 | 0 | 0 | 0 |
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.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
No formal hypotheses were tested.
| Analysis based on post-hoc population 1. Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications, fixed-dose combinations of Short-Acting Beta2- Agonist and Short-Acting Muscarinic Antagonist and systemic antibacterials. COPD severity, number of: all-cause hospitalisations 365 and 180 days, COPD exacerbations 180 and 90 days, COPD hospitalisations 180 and 90 days, and COPD exacerbations 90 days before index date. | Poisson regression model | Adjusted Incidence Rate Ratio | 1.48 | 2-Sided | 95 | 1.23 | 1.78 | Olodaterol compared to 'other LABA' as reference | Other | No formal hypotheses were tested. |
| Analysis based on post-hoc population 2. Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications. COPD severity, number of all-cause hospitalisations 180 days, COPD exacerbations 180 days before cohort entry. | Poisson regression model | Adjusted Incidende Rate Ratio | 1.26 | 2-Sided | 95 | 0.97 | 1.64 | Olodaterol compared to 'other LABA' as reference | Other | No formal hypotheses were tested. |