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Correlation of inhaled long-acting bronchodilators with cardiovascular adverse events in COPD patients: A real-world analysis of post-marketing surveillance data
  • +2
  • erxi che,
  • Li Yi,
  • Ling-qing Ding,
  • Zhiwen Yan,
  • Jiayong Yang
Ling-qing Ding
Fuzhou General Hospital of Nanjing Command PLA
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Zhiwen Yan
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Jiayong Yang

Corresponding Author:[email protected]

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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.