A safety comparison of LABA+LAMA vs LABA+ICS combination therapy for COPD.

INTRODUCTION: LABA+LAMA and LABA+ICS combinations are key pharmacological approaches to the treatment of COPD. However, both combination types can induce adverse events (AEs). AREAS COVERED: Current literature on LABA+LAMA and LABA+ICS combinations has been reviewed with a specific focus on their safety profile in the treatment of COPD. EXPERT OPINION: Several meta-analyses have compared the pooled safety data from randomized clinical trials (RCTs) of LABA+LAMA combinations with LABA+ICS combinations. LABA+LAMA caused significantly less AEs and SAEs. However, this evidence in real life is less solid because of the lack of appropriate studies. A statistically significant reduction in the risk for pneumonia with LABA+LAMA compared with LABA+ICS has been repeatedly documented by various meta-analyses. The meta-analytic signal indicates that an equal number of patients would die or have cardiac SAEs on LABA+LAMA or LABA+ICS, and in an observational, real-life study the LABA+LAMA combination had similar or lower risk of these events in comparison to LABA+ICS. Nonetheless, since RCTs are conducted under widely varying conditions and, consequently, AE rates of a drug observed in a RCT cannot be directly compared with rates in the RCTs of another drug and may not reflect the rates observed in practice, we need more specific data.

RCT Entities:   Population Interventions Outcomes