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Published on: August 24, 2019
Cardiovascular events and all-cause mortality in patients with chronic obstructive pulmonary disease using olodaterol
Cristina Rebordosa1, Dóra Körmendiné Farkas2, Jukka Montonen3
1RTI Health Solutions, Barcelona, Spain.
Insights
Olodaterol showed similar risks for cardiac events as other long-acting beta2-agonists (LABAs). However, an initial increased risk of death was attenuated after controlling for channelling bias, suggesting potential confounding factors.
Area of Science:
- Cardiology
- Pulmonology
- Pharmacovigilance
Background:
- Long-acting beta2-agonists (LABAs) are crucial in managing chronic obstructive pulmonary disease (COPD).
- Olodaterol is a newer LABA, and its comparative safety profile requires thorough investigation.
- Potential biases, such as channelling bias, can influence observational study outcomes.
Purpose of the Study:
- To compare the risks of myocardial ischemia, cardiac arrhythmia, and all-cause mortality between olodaterol and other LABAs.
- To investigate and control for channelling bias in the assessment of olodaterol's safety.
Main Methods:
- Danish population-based cohort study utilizing linked registry data.
- Inclusion of patients aged ≥40 years with COPD initiating olodaterol or another LABA.
- Application of matching, propensity score stratification, and Poisson regression for incidence rate ratio (IRR) calculations.
Main Results:
- Olodaterol users exhibited similar risks for cardiac arrhythmias and myocardial ischemia compared to other LABA users.
- Initial analyses indicated a higher risk of all-cause mortality with olodaterol (IRR: 1.63).
- After adjusting for confounding factors and channelling bias, the excess mortality risk was attenuated (e.g., IRR: 1.26-1.32).
Conclusions:
- Olodaterol use is associated with similar cardiac event risks as other LABAs.
- The observed excess mortality risk with olodaterol may be attributable to uncontrolled channelling bias.
- Further research may be needed to fully elucidate the long-term safety of olodaterol in COPD management.
Purpose:
We examined the effect of olodaterol on the risk of myocardial ischaemia, cardiac arrhythmia, and all-cause mortality compared with use of other long-acting beta2-agonists (LABAs). Channelling bias was also explored.
Methods:
This Danish population-based cohort study used data linked from registries of hospital diagnoses, outpatient dispensings, and deaths. It included patients (aged ≥40 years) with a diagnosis of chronic obstructive pulmonary disease (COPD) who initiated olodaterol or another LABA. Using matching and propensity score (PS) stratification, we calculated adjusted incidence rate ratios (IRRs) using Poisson regression, followed by several additional analyses to evaluate and control channelling bias.
Results:
The IRRs of cardiac arrhythmias or myocardial ischaemia among users of olodaterol (n = 14 239) compared to users of other LABAs (n = 51 167) ranged from 0.96 to 1.65 in various analyses, although some estimates had low precision. Initial analysis suggested an increased risk for death with olodaterol compared with other LABAs (IRR, 1.63; 95% CI, 1.44-1.84). Because olodaterol prescribing was associated with COPD severity, the mortality association was attenuated by using different methods of tighter confounding control: the IRRs were 1.26 (95% CI, 0.97-1.64) among LABA-naïve LABA/LAMA users without recent COPD hospitalisation; 1.27 (95% CI, 1.03-1.57) in a population with additional trimming from the tails of the PS distribution; and 1.32 (95% CI, 1.19-1.48) after applying overlap-weights analysis.
Conclusions:
Olodaterol users had a similar risk for cardiac arrhythmias or myocardial ischaemia as other LABA users. The observed excess all-cause mortality associated with olodaterol use could be due to uncontrolled channelling bias.
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