The Real‐World Analysis of Adverse Events With Two Types of Single‐Inhaler Triple Therapy: A VigiAccess Database Study

Background The advent of single‐inhaler triple therapies (SITTs), including fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FOR/GLY), has expanded treatment options for chronic obstructive pulmonary disease (COPD). This study explores adverse drug reactions (ADRs) related to these SITTs using data from the WHO‐VigiAccess database and compares their safety profiles. Methods A retrospective analysis was conducted using ADR reports associated with FF/UMEC/VI and BDP/FOR/GLY from the WHO‐VigiAccess database. Data included patient demographics and reported adverse events (AEs). Disproportionality analysis was performed using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) to assess the association between SITTs and specific AEs. Results A total of 21,539 AEs related to FF/UMEC/VI and BDP/FOR/GLY were identified in the VigiAccess database. Commonly reported ADRs included dyspnoea, cough, COPD, headache, dizziness and pneumonia. FF/UMEC/VI was more frequently associated with injuries, poisoning and procedural complications (39.46%), whereas BDP/FOR/GLY showed a higher incidence of respiratory, thoracic and mediastinal disorders (42.06%). Disproportionality analysis revealed an increased ROR (3.04) and PRR (2.76) for FF/UMEC/VI regarding injury‐related events, indicating a stronger signal compared to BDP/FOR/GLY. These findings underscore the diversity of ADRs associated with SITTs and highlight the need for careful clinical monitoring. However, the voluntary nature of VigiAccess and inherent reporting biases, such as visibility and selection bias, may affect the completeness and reliability of the data. Conclusion analysis of WHO‐VigiAccess reports reveals both shared and distinct ADRs between FF/UMEC/VI and BDP/FOR/GLY. Due to limitations, such as under‐reporting and reporting bias inherent to spontaneous databases, these findings should be interpreted with caution. Clinicians are encouraged to tailor COPD treatment based on both efficacy and potential ADR profiles to ensure optimal and personalized care.