1. In this cohort study, using generic versus brand-name fluticasone-salmeterol was associated with similar outcomes in chronic obstructive pulmonary disease (COPD) patients.
2. Using generic versus brand-name fluticasone-salmeterol was associated with no significant difference in the incidence of COPD exacerbations or pneumonia hospitalizations.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Chronic obstructive pulmonary disease is associated with substantial morbidity and mortality. However, there can be significant costs associated with the high need for inhalers in these patients. In many cases, generic formulations are available which are typically less expensive than brand-name therapeutics. Wixela Inhub was the first generic maintenance inhaler approved for asthma and COPD in the United States. It was U.S. Food and Drug Administration-approved in 2019 with a branded version already produced by GlaxoSmithKline called Advair Diskus. There is a gap in knowledge as to understanding the comparative effectiveness and safety of the generic versus brand-name inhalers for COPD. Overall, this study found that for patients with COPD, the generic fluticasone-salmeterol inhaler, Wixela Inhub, had virtually identical effectiveness and safety when compared with brand-name Advair Diskus. This study was limited by having short follow-up times and by the possibility of residual confounding. Nevertheless, these study’s findings are significant, as they demonstrate that using generic or brand-name fluticasone salmeterol inhalers for COPD management leads to similar outcomes in these patients.
In-Depth [propensity score-matched cohort study]: This 1:1 propensity score-matched cohort study was performed using a large longitudinal healthcare database. Patients who initiated a new (index) prescription for Wixela Inhub or Advair Diskus from 1 January 2018 to 31 June 2021 were eligible for the study. The patients also had to have made at least three outpatient claims or one inpatient claim in the prior three years (up to and including the index date) for a COPD-related diagnosis. Patients who received any other inhaler from the same therapeutic class, who were younger than 40 years, or who initiated triple therapy for COPD were excluded from the study. The primary outcome measured was time to first moderate or severe COPD exacerbation beginning the day after cohort entry. Outcomes in the primary analysis were assessed via 1:1 propensity score matching and used logistic regression with a Cox proportional hazards regression model. Based on the primary analysis, patients who used the Wixela Inhub as compared to patients who used Advair Diskus had a nearly identical incidence of first moderate or severe COPD exacerbation (Hazard Ratio [HR], 0.97; 95% Confidence Interval [CI], 0.90 to 1.04) and first pneumonia hospitalization (HR, 0.99; 95% CI, 0.86 to 1.15). In summary, this study demonstrates that using generic or brand-name fluticasone-salmeterol leads to similar outcomes in patients with COPD treated with routine management.
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