Abstract
Introduction: Affordable treatment alternatives are needed to prevent and treat chronic obstructive pulmonary disease (COPD) exacerbations and reduce the economic burden of COPD. This study evaluated whether the effectiveness of Steri-Neb™ (Teva Pharmaceuticals, Inc.), the comparator ipratropium/salbutamol (I/S) nebulizer solution, is non-inferior to DuoNeb® (Mylan Specialty L.P.), the originator with the same chemical composition, the first FDA-approved product of this kind, for the prevention of COPD exacerbations. I/S comparator versus originator safety also was examined. Both the I/S comparator and the originator are indicated (EU/USA) for bronchospasm management in patients with COPD.
Methods: This matched, historical USA cohort study used Clinformatics™ claims data and included a 1-year baseline, starting 1 year before the index prescription date, and 1-year outcome period. Patients received either I/S comparator or originator treatment. The primary outcome was rate of moderate and severe COPD exacerbations. Non-inferiority for I/S comparator versus originator was satisfied if the 95% confidence interval (CI) upper limit for mean difference in proportions between treatments was <15%. The secondary outcome examined safety through rate of adverse events (AEs).
Results: After matching, 550 I/S comparator and 1535 originator patients were included. Adjusted upper 95% CI for the difference in proportion of patients experiencing moderate and severe exacerbations between I/S comparator and originator cohorts was 0.092 (9.2%), and for severe exacerbations was 0.040 (4.0%), demonstrating non-inferiority. No significant differences were found in rates of moderate and severe exacerbations (rate ratio [RR] 0.96; 95% CI 0.89, 1.04), severe exacerbations (RR 1.00; 95% CI 0.81, 1.24), or any AE (RR 1.06; 95% CI 0.92, 1.22) after adjusting for baseline confounders.
Conclusion: The real-world clinical outcomes of this matched cohort study support the I/S comparator as non-inferior to the originator, providing an effective and safe treatment alternative for COPD exacerbations.
Study Registration: European Network Centres for Pharmacoepidemiology and Pharmacovigilance: ENCePP/SDPP/7753.
Methods: This matched, historical USA cohort study used Clinformatics™ claims data and included a 1-year baseline, starting 1 year before the index prescription date, and 1-year outcome period. Patients received either I/S comparator or originator treatment. The primary outcome was rate of moderate and severe COPD exacerbations. Non-inferiority for I/S comparator versus originator was satisfied if the 95% confidence interval (CI) upper limit for mean difference in proportions between treatments was <15%. The secondary outcome examined safety through rate of adverse events (AEs).
Results: After matching, 550 I/S comparator and 1535 originator patients were included. Adjusted upper 95% CI for the difference in proportion of patients experiencing moderate and severe exacerbations between I/S comparator and originator cohorts was 0.092 (9.2%), and for severe exacerbations was 0.040 (4.0%), demonstrating non-inferiority. No significant differences were found in rates of moderate and severe exacerbations (rate ratio [RR] 0.96; 95% CI 0.89, 1.04), severe exacerbations (RR 1.00; 95% CI 0.81, 1.24), or any AE (RR 1.06; 95% CI 0.92, 1.22) after adjusting for baseline confounders.
Conclusion: The real-world clinical outcomes of this matched cohort study support the I/S comparator as non-inferior to the originator, providing an effective and safe treatment alternative for COPD exacerbations.
Study Registration: European Network Centres for Pharmacoepidemiology and Pharmacovigilance: ENCePP/SDPP/7753.
| Original language | English |
|---|---|
| Pages (from-to) | 187-205 |
| Number of pages | 19 |
| Journal | Pulmonary Therapy |
| Volume | 3 |
| Issue number | 1 |
| Early online date | 24 Apr 2017 |
| DOIs | |
| Publication status | Published - Jun 2017 |
Bibliographical note
AcknowledgementsThe authors wish to thank Priyanka Raju Konduru of Observational and Pragmatic Research Institute Pte Ltd (OPRI) for assistance with data extraction. This study was sponsored and funded by Teva Branded Pharmaceutical Products, R&D, Inc. Lynanne McGuire, PhD, of MedVal Scientific Information Services, LLC (Princeton, NJ, USA) provided medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals’ ‘Good Publication Practice for Communicating Company-Sponsored Medical Research: the GPP3 Guidelines.’ Funding to support medical writing assistance was provided to MedVal by Teva Branded Pharmaceutical Products R&D, Inc., Frazer, PA, USA. Teva provided a full review of the article and provided funding of the journal’s article processing charges. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
Keywords
- Albuterol
- Drugs, generic/therapeutic use
- DuoNeb®
- Pharmacogenomics
- Real-world
- Steri-Neb™