Comparative Effectiveness and Safety of Generic vs Brand-Name Fluticasone–Salmeterol in Patients With COPD
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
In 2019, the U.S. Food and Drug Administration (FDA) approved the first generic maintenance inhaler for asthma and chronic obstructive pulmonary disease (COPD). The inhaler, Wixela Inhub (fluticasone-salmeterol; Viatris), is a substitutable version of the dry powder inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline). When approving complex generic products like inhalers, the FDA applies a special "weight-of-evidence" approach. In this case, manufacturers were required to perform a randomized controlled trial in patients with asthma but not COPD, although the product received approval for both indications.
OBJECTIVE
To compare the effectiveness and safety of generic (Wixela Inhub) and brand-name (Advair Diskus) fluticasone-salmeterol among patients with COPD treated in routine care.
DESIGN
A 1:1 propensity score-matched cohort study.
SETTING
A large, longitudinal health care database.
PATIENTS
Adults older than 40 years with a diagnosis of COPD.
MEASUREMENTS
Incidence of first moderate or severe COPD exacerbation (effectiveness outcome) and incidence of first pneumonia hospitalization (safety outcome) in the 365 days after cohort entry.
RESULTS
Among 45 369 patients (27 305 Advair Diskus users and 18 064 Wixela Inhub users), 10 012 matched pairs were identified for the primary analysis. Compared with Advair Diskus use, Wixela Inhub use was associated with a nearly identical incidence of first moderate or severe COPD exacerbation (hazard ratio [HR], 0.97 [95% CI, 0.90 to 1.04]) and first pneumonia hospitalization (HR, 0.99 [CI, 0.86 to 1.15]).
LIMITATIONS
Follow-up times were short, reflecting real-world clinical practice. The possibility of residual confounding cannot be completely excluded.
CONCLUSION
Use of generic and brand-name fluticasone-salmeterol was associated with similar outcomes among patients with COPD treated in routine practice.
PRIMARY FUNDING SOURCE
National Heart, Lung, and Blood Institute.
Click on any of these tags to subscribe to Topic Alerts. Once subscribed, you can get a single, daily email any time PracticeUpdate publishes content on the topics that interest you.
Visit your Preferences and Settings section to Manage All Topic Alerts
Additional Info
Disclosure statements are available on the authors' profiles:
Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone-Salmeterol to Treat Chronic Obstructive Pulmonary Disease
Ann. Intern. Med 2023 Aug 01;176(8)1047-1056, WB Feldman, AS Kesselheim, J Avorn, M Russo, SV WangFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
In recent years, guideline-based therapy for chronic obstructive pulmonary disease (COPD) has favored the use of LAMA-LABA over ICS-LABA therapy except in patients who have asthma overlap, high eosinophil counts, or those with frequent exacerbation. In 2023, the GOLD guidelines recommended the use of triple therapy (ie, ICS-LAMA-LABA) as opposed to dual therapy with ICS-LABA for patients who needed an inhaled corticosteroid component. This may make inhaler combinations such as Wixela (fluticasone paired with salmeterol) obsolete in patients with COPD. Nevertheless, many who need triple therapy due to cost considerations may still be prescribed ICS-LABA inhaler along with a LAMA inhaler. And guideline-discordant usage of ICS-LABA prescriptions is still common. In this light, ensuring comparative effectiveness and safety of generic versus brand-name fluticasone–salmeterol for patients with COPD is important (especially given that the generic drug–approval process by FDA only required manufacturers to test the inhaler on patients with asthma but not COPD). In this large study, Wixela was shown to be equivalent to Advair in terms of first moderate to severe COPD exacerbation as well as pneumonia hospitalization among patients with COPD.