Correlation of inhaled long-acting bronchodilators with cardiovascular
adverse events in COPD patients: A real-world analysis of post-marketing
surveillance data
Abstract
Background: The question of whether inhaled long-acting bronchodilators
(iLABs) increase the incidence of cardiovascular adverse events (CVAEs)
remains unresolved. The present study analyzed real world data using the
U.S. Food and Drug Administration Adverse Events Reporting System
(FAERS) database to evaluate iLABs-related CVAEs in patients with COPD.
Methods: Disproportionality analysis was used in data mining to screen
the suspected CVAEs after different iLABs based on the FAERS database
(0/12014-12/2022). The times to onset, outcomes of iLABs-associated
CVAEs were also investigated. Results: We identified 12152 reports of
adverse events related to three classes of drugs (LABAs, LAMAs, and
LABAs combined with LAMAs), of which 591(4.86%) were CVAEs specific to
cardiac failure, ischemic heart disease and cardiac arrhythmia. The
percentage of men who were affected was higher than that of women
(66.80% vs. 30.73%), and elderly patients were more vulnerable than
middle-aged patients (52.81% vs. 21.53%). Compared with the full
database, the use of iLABs was associated with a higher reporting rate
of major CVAEs (n=591, ROR=1.44, 95%CI, 1.30-1.60). LABAs may have a
stronger association, based on the highest ROR value (n=304, ROR=1.91,
95%CI, 1.67-2.18). The majority of cardiovascular events related to
iLABs occurred within the first 30 days after drug initiation.
iLABs-associated CVAEs generally led to mortality and hospitalization
rates of 46.19% and 62.61%, respectively. Conclusions: According to
the FAERS database, we profiled CVAEs related to various iLABs with more
details on occurrences, clinical characteristics, and prognosis.
Concerns should be placed on patients with new initiation of iLABs.