Ipratropium/Salbutamol Comparator Versus Originator for Chronic Obstructive Pulmonary Disease Exacerbations

USA Observational Cohort Study Using the Clinformatics™ Health Claims Database

Vicky Thomas, Eran Gefen, Gokul Gopalan, Rafael Mares, Rosie McDonald, Simon Wan Yau Ming, David B. Price

Research output: Contribution to journalArticle

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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.
Original languageEnglish
Pages (from-to)187-205
Number of pages19
JournalPulmonary Therapy
Volume3
Issue number1
Early online date24 Apr 2017
DOIs
Publication statusPublished - Jun 2017

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Ipratropium
Albuterol
Chronic Obstructive Pulmonary Disease
Observational Studies
Disease Progression
Cohort Studies
Databases
Health
Confidence Intervals
Pharmacoepidemiology
Pharmacovigilance
Safety
Bronchial Spasm
Nebulizers and Vaporizers
Therapeutics
Prescriptions
Economics

Keywords

  • Albuterol
  • Drugs, generic/therapeutic use
  • DuoNeb®
  • Pharmacogenomics
  • Real-world
  • Steri-Neb™

Cite this

Ipratropium/Salbutamol Comparator Versus Originator for Chronic Obstructive Pulmonary Disease Exacerbations : USA Observational Cohort Study Using the Clinformatics™ Health Claims Database. / Thomas, Vicky; Gefen, Eran ; Gopalan, Gokul; Mares, Rafael; McDonald, Rosie; Ming, Simon Wan Yau ; Price, David B.

In: Pulmonary Therapy, Vol. 3, No. 1, 06.2017, p. 187-205.

Research output: Contribution to journalArticle

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title = "Ipratropium/Salbutamol Comparator Versus Originator for Chronic Obstructive Pulmonary Disease Exacerbations: USA Observational Cohort Study Using the Clinformatics™ Health Claims Database",
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{\circledR} (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.",
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author = "Vicky Thomas and Eran Gefen and Gokul Gopalan and Rafael Mares and Rosie McDonald and Ming, {Simon Wan Yau} and Price, {David B.}",
note = "Acknowledgements The 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.",
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TY - JOUR

T1 - Ipratropium/Salbutamol Comparator Versus Originator for Chronic Obstructive Pulmonary Disease Exacerbations

T2 - USA Observational Cohort Study Using the Clinformatics™ Health Claims Database

AU - Thomas, Vicky

AU - Gefen, Eran

AU - Gopalan, Gokul

AU - Mares, Rafael

AU - McDonald, Rosie

AU - Ming, Simon Wan Yau

AU - Price, David B.

N1 - Acknowledgements The 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.

PY - 2017/6

Y1 - 2017/6

N2 - 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.

AB - 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.

KW - Albuterol

KW - Drugs, generic/therapeutic use

KW - DuoNeb®

KW - Pharmacogenomics

KW - Real-world

KW - Steri-Neb™

U2 - 10.1007/s41030-017-0041-7

DO - 10.1007/s41030-017-0041-7

M3 - Article

VL - 3

SP - 187

EP - 205

JO - Pulmonary Therapy

JF - Pulmonary Therapy

SN - 2364-1746

IS - 1

ER -