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.

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL
Pragmatic and Observational Research Pub Date : 2017-05-18 eCollection Date: 2017-01-01 DOI:10.2147/POR.S132839
David B Price, Eran Gefen, Gokul Gopalan, Cristiana Miglio, Rosie McDonald, Vicky Thomas, Simon Wan Yau Ming
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引用次数: 3

Abstract

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.

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吸入悬浮液布地奈德比较剂与初始产品治疗哮喘患者的实际有效性和安全性:使用美国健康声明数据库的历史队列研究
目的:本研究的目的是确定布地奈德比较剂在预防哮喘加重方面是否优于参考剂。哮喘相关的住院和安全性也被检查。方法:本研究采用匹配的历史队列设计。数据来自Clinformatics™Data Mart美国索赔数据库,包括1年基线,从指数处方日期前1年开始,以及1年的结果期。患者接受布地奈德比较或参考治疗。主要结局是哮喘发作率。如果治疗间平均比例差异的95%可信区间(CI)上限为,则布地奈德比较剂与参比剂的非劣效性成立。结果:布地奈德比较剂和参比剂匹配的队列各包括3109例患者。哮喘发作患者比例差异的校正95% CI为0.035(3.5%),显示非劣效性。在调整基线混杂因素后,各队列在哮喘加重率(校正率比[RR]=1.04, 95% CI: 0.95-1.14)或哮喘相关住院率(校正RR=1.10, 95% CI: 0.99-1.24)方面无显著差异。72.9%的布地奈德比较组患者和71.8%的布地奈德对照组患者在结果期内未发生哮喘加重。77.9%的布地奈德对照组患者和79.0%的布地奈德对照组患者未发生哮喘相关住院。最常见的ae是喉咙刺激(≤0.4%的患者)和声音嘶哑/发音困难(0.02%的患者)。ae在治疗组间无显著差异。结论:在这项现实生活中的研究中,布地奈德比较物与参考物的哮喘加重率的主要终点达到了非劣效性。哮喘相关住院率和AE发生率在两个治疗组之间没有差异。布地奈德比较剂是一种有效和安全的治疗哮喘加重的替代方法。
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来源期刊
Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
自引率
0.00%
发文量
11
期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
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