N/A
N=65,406
Cardiovascular Events in Chronic Obstructive Pulmonary Disease Patients Initiating Olodaterol or Other Long-acting beta2 Agonists
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT03405363 ↗Enrolled (actual)
65,406
Serious AEs
—
Results posted
Apr 2021
Primary outcome: Primary: Occurrence of First Hospitalisation or Hospital Outpatient Clinic Visit for Atrial Fibrillation or Flutter (AF) — 246; 725 Events
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of First Hospitalisation or Hospital Outpatient Clinic Visit for Atrial Fibrillation or Flutter (AF) |
246; 725 | — |
| PRIMARY Occurrence of First Hospitalisation or Hospital Outpatient Clinic Visit for Supraventricular Tachycardia (SVT) (Other Than Atrial Fibrillation/Flutter) |
19; 38 | — |
| PRIMARY Occurrence of First Hospitalisation for Ventricular Tachycardia (VT), Including Ventricular Fibrillation/Flutter and Cardiac Arrest |
29; 80 | — |
| PRIMARY Occurrence of First Hospitalisation for Acute Myocardial Infarction (AMI) |
56; 137 | — |
| PRIMARY Occurrence of First Hospitalisation for Serious Acute Coronary Heart Disease (SACHD), Including Angina and Other Acute Ischaemic Heart Disease Events |
41; 147 | — |
| SECONDARY All-cause Mortality. |
859; 1872 | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- COPD diagnosis
- aged 40 years or older (to minimise the likelihood of including individuals who have asthma only)
- New user of olodaterol or a new user of indacaterol, salmeterol, or formoterol (not in fixed-dose combination with an inhaled corticosteroid) and have no dispensing of any LABA in the 6 months before the index date
- at least 1 year of enrolment in the electronic database before their first LABA dispensing (defined as the index LABA)
- Complete data on sex
Exclusion criteria
none
Data sourced from ClinicalTrials.gov (NCT03405363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.