Although inhaled triple ICS/LABA/LAMA FDC is currently recommended as a controller option in asthma Step 4 and as the preferred treatment for asthma Step 5, no research has been conducted to investigate the potential drawbacks of this therapeutic option in a large asthmatic population. Therefore, a meta-analysis was conducted to quantify the potential drawbacks of triple ICS/LABA/LAMA FDC therapy in the treatment of asthma. Data from a total of 7204 patients with asthma were extracted from the CAPTAIN, IRIDIUM, TRIMARAN, and TRIGGER trials.

  • The use of triple ICS/LABA/LAMA FDC did not increase the risk of overall serious adverse events (SAEs) or cardiac SAEs compared to ICS/LABA FDC.
  • The sensitivity analysis performed to resolve heterogeneity showed an increased risk of vascular SAEs (RR 3.23 95%CI 1.05 – 9.90, p<0.05)
  • The  ICS dose did not modulate the risk of pneumonia.
  • In any case, pneumonia was the most frequent SAE (0.57%).

The meta-analysis concluded that triple ICS/LABA/LAMA FDC is a safe pharmacological treatment in patients with severe asthma, with a favourable safety profile and few potential drawbacks, including an increased risk of vascular SAEs, that warrant further investigations.

European Respiratory Society (ERS) International Congress 2022, 3rd-6th Sept. 2022, Barcelona







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