Real-life effectiveness and safety of the inhalation suspension budesonide comparator vs the originator product for the treatment of patients with asthma: a historical cohort study using a US health claims database.

Autor: Price DB; Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.; Observational and Pragmatic Research Institute, Singapore, Singapore., Gefen E; Teva Pharmaceuticals, Petach Tikva, Israel., Gopalan G; Teva Pharmaceuticals, Frazer, PA, USA., Miglio C; Observational and Pragmatic Research Institute, Singapore, Singapore., McDonald R; Observational and Pragmatic Research Institute, Singapore, Singapore., Thomas V; Observational and Pragmatic Research Institute, Singapore, Singapore., Wan Yau Ming S; Observational and Pragmatic Research Institute, Singapore, Singapore.
Jazyk: angličtina
Zdroj: Pragmatic and observational research [Pragmat Obs Res] 2017 May 18; Vol. 8, pp. 69-83. Date of Electronic Publication: 2017 May 18 (Print Publication: 2017).
DOI: 10.2147/POR.S132839
Abstrakt: Objective: The objective of this study was to determine whether the effectiveness of budesonide comparator is non-inferior to budesonide reference in the prevention of asthma exacerbations. Asthma-related hospitalizations and safety were also examined.
Methods: This study used a matched, historic cohort design. Data were drawn from the Clinformatics™ Data Mart US claims database and included a 1-year baseline, starting 1 year before the index prescription date, and a 1-year outcome period. Patients received budesonide comparator or reference treatment. The primary outcome was the rate of asthma exacerbations. Non-inferiority for budesonide comparator vs budesonide reference was established if the 95% confidence interval (CI) upper limit of mean difference in proportions between treatments was <15%. Secondary outcomes examined rate of asthma-related hospitalizations and adverse events (AEs).
Results: The budesonide comparator and reference-matched cohorts each included 3109 patients. The adjusted upper 95% CI for the difference in proportions of patients experiencing asthma exacerbations was 0.035 (3.5%), demonstrating non-inferiority. Cohorts did not significantly differ in the rate of asthma exacerbations (adjusted rate ratio [RR]=1.04, 95% CI: 0.95-1.14) or rate of asthma-related hospitalizations (adjusted RR=1.10, 95% CI: 0.99-1.24) after adjusting for baseline confounders. No asthma exacerbations occurred during the outcome period in 72.9% of budesonide comparator patients and 71.8% of budesonide reference patients. No asthma-related hospitalizations occurred in 77.9% of patients in the budesonide comparator cohort and 79.0% of patients in the budesonide reference cohort. The most frequent AEs were throat irritation (≤0.4% of patients) and hoarseness/dysphonia (0.02% of patients). AEs did not significantly differ between treatment cohorts.
Conclusion: In this real-life study, non-inferiority of the budesonide comparator vs reference was met for the primary end point of asthma exacerbation rates. Asthma-related hospitalization and AE rates did not differ between the two treatment cohorts. The budesonide comparator is an effective and safe treatment alternative for asthma exacerbations.
Competing Interests: Disclosure CM, RM, and VT were employed by OPRI at the time of the study; CM was a project leader. SWYM is an employee of OPRI. OPRI conducted this study and has conducted paid research in respiratory disease on behalf of the following other organizations in the past 5 years: Aerocrine, AKL Research and Development Ltd, Almirall, AstraZeneca, British Lung Foundation, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Orion, REG, Takeda, Teva Pharmaceuticals, and Zentiva, a Sanofi company. EG is an employee of Teva Pharmaceuticals. GG was an employee of Teva Pharmaceuticals during the time of the study. DBP has board membership with Aerocrine, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; consultancy agreements with Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Pfizer, Teva Pharmaceuticals, and Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through OPRI) from Aerocrine, AKL Research and Development Ltd, AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Meda, Mundipharma, Napp, Novartis, Pfizer, REG, Takeda, Teva Pharmaceuticals, Theravance, UK National Health Service, Zentiva; payment for lectures/speaking engagements from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma, Novartis, Pfizer, Skyepharma, Takeda, and Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma and Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma and Novartis; payment for travel/accommodation/meeting expenses from Aerocrine, AstraZeneca, Boehringer Ingelheim, Mundipharma, Napp, Novartis, and Teva Pharmaceuticals; funding for patient enrolment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, and Zentiva; stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd, UK, and 74% of OPRI, Singapore; and is a peer reviewer for grant committees of the Efficacy and Mechanism Evaluation program, Health Technology Assessment, and Medical Research Council. DBP currently serves as Editor-in-Chief for Pragmatic and Observational Research. To be fully transparent and conform with COPE guidelines addressing an editor as author in own journal, the following procedures were implemented: 1) the addressee for the manuscript submission cover letter was journal editorial board member Professor Arora; 2) the manuscript peer review process was handled by journal editorial board member Dr John Haughney and was independent of the editor-in-chief (recognizing that it would not be possible to completely remove bias); and 3) the paper was sent out for review without any names included. The authors report no other conflicts of interest in this work.
Databáze: MEDLINE
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