PMID- 28572742
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 1179-7266 (Print)
IS  - 1179-7266 (Electronic)
IS  - 1179-7266 (Linking)
VI  - 8
DP  - 2017
TI  - 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.
PG  - 69-83
LID - 10.2147/POR.S132839 [doi]
AB  - 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.
FAU - Price, David B
AU  - Price DB
AD  - Academic Primary Care, Division of Applied Health Sciences, University of 
      Aberdeen, Aberdeen, UK.
AD  - Observational and Pragmatic Research Institute, Singapore, Singapore.
FAU - Gefen, Eran
AU  - Gefen E
AD  - Teva Pharmaceuticals, Petach Tikva, Israel.
FAU - Gopalan, Gokul
AU  - Gopalan G
AD  - Teva Pharmaceuticals, Frazer, PA, USA.
FAU - Miglio, Cristiana
AU  - Miglio C
AD  - Observational and Pragmatic Research Institute, Singapore, Singapore.
FAU - McDonald, Rosie
AU  - McDonald R
AD  - Observational and Pragmatic Research Institute, Singapore, Singapore.
FAU - Thomas, Vicky
AU  - Thomas V
AD  - Observational and Pragmatic Research Institute, Singapore, Singapore.
FAU - Wan Yau Ming, Simon
AU  - Wan Yau Ming S
AD  - Observational and Pragmatic Research Institute, Singapore, Singapore.
LA  - eng
PT  - Journal Article
DEP - 20170518
PL  - New Zealand
TA  - Pragmat Obs Res
JT  - Pragmatic and observational research
JID - 101688693
PMC - PMC5441674
OTO - NOTNLM
OT  - asthma control
OT  - asthma medication
OT  - exacerbation
OT  - generic/therapeutic use
OT  - hospitalization
COIS- 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.
EDAT- 2017/06/03 06:00
MHDA- 2017/06/03 06:01
PMCR- 2017/05/18
CRDT- 2017/06/03 06:00
PHST- 2017/06/03 06:00 [entrez]
PHST- 2017/06/03 06:00 [pubmed]
PHST- 2017/06/03 06:01 [medline]
PHST- 2017/05/18 00:00 [pmc-release]
AID - por-8-069 [pii]
AID - 10.2147/POR.S132839 [doi]
PST - epublish
SO  - Pragmat Obs Res. 2017 May 18;8:69-83. doi: 10.2147/POR.S132839. eCollection 2017.