Real-world Comparative Effectiveness in Patients with Asthma Newly Initiating Fluticasone Furoate/Vilanterol or Budesonide/Formoterol: A United Kingdom General Practice Cohort Study.

IF 3 Q2 RESPIRATORY SYSTEM
Ashley Woodcock, John Blakey, Arnaud Bourdin, Giorgio Walter Canonica, Christian Domingo, Alexander Ford, Rosie Hulme, Theo Tritton, Ines Palomares, Sanchayita Sadhu, Arunangshu Biswas, Manish Verma
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引用次数: 0

Abstract

Introduction: It is important that treatment recommendations reflect real-world data when available, as randomised controlled trials have stringent eligibility criteria and do not represent the entire asthma population or their usual ecosystem of care. Limited real-world evidence has compared the effectiveness of fluticasone furoate/vilanterol (FF/VI) and budesonide/formoterol (BUD/FOR) to date in asthma; we explored this in England using patients from general practice.

Methodology: We retrospectively compared new FF/VI users and new BUD/FOR users from 1 December 2015 to 28 February 2019, based on de-identified data from the Clinical Practice Research Datalink. The baseline period pre-index was ≥ 1 year; the follow-up period was 1 year. At index, eligible adults (≥ 18 years) with diagnosed asthma had ≥ 1 prescription for FF/VI or BUD/FOR, ≥ 1 years' general practitioner registration and records eligible for linkage to Hospital Episode Statistics. Chronic obstructive pulmonary disease was an exclusion criterion. The primary study outcome assessed the overall asthma exacerbation rate in new FF/VI or BUD/FOR users. Secondary outcomes included oral corticosteroid (OCS) use and medication persistence (analysed using Kaplan-Meier curves). For each treatment comparison, propensity scores were generated and confounding between baseline group characteristics was adjusted via inverse probability of treatment weighting, separately carried out for each study outcome. Intercurrent events (ICEs) were considered for analyses, such as death, loss to follow-up, rescue-medication use, treatment discontinuation or switching.

Results: Between groups, baseline attributes were well balanced. Annual per-person rates of exacerbation were numerically similar in the while on-treatment population (measuring outcome until ICE; FF/VI, 0.1356; BUD/FOR, 0.1583 [P = 0.3023]). Patients who continued initiation treatment for 1 year without interruption had significantly lower annual per-person exacerbation rates with FF/VI (0.0722 [n = 425]) versus BUD/FOR (0.2258 [n = 546]) (rate ratio 0.3197 [P = 0.0003]). Patients indexed on FF/VI had significantly fewer OCS prescriptions and lower OCS dosage versus BUD/FOR (respective coefficients: - 0.29 [P = 0.0352]; 0.41 [P = 0.0004]) and improved treatment persistence (hazard ratio: 0.62 [P < 0.0001]).

Conclusions: Patients who continued initiation treatment for a year without interruption had reduced exacerbation rates with FF/VI versus BUD/FOR. The FF/VI group also had reduced treatment discontinuation and OCS use.

新开始使用糠酸氟替卡松/维兰特罗或布地奈德/福莫特罗的哮喘患者的实际疗效比较:英国全科队列研究
重要的是,治疗建议在可用时反映真实世界的数据,因为随机对照试验有严格的资格标准,不能代表整个哮喘人群或他们通常的护理生态系统。迄今为止,有限的真实证据比较了糠酸氟替卡松/维兰特罗(FF/VI)和布地奈德/福莫特罗(BUD/FOR)治疗哮喘的有效性;我们在英国用全科医生的病人来研究这个问题。方法:基于临床实践研究数据链的去识别数据,我们回顾性地比较了2015年12月1日至2019年2月28日期间FF/VI新用户和BUD/FOR新用户。指数前基线期≥1年;随访1年。在指数中,诊断为哮喘的合格成人(≥18岁)有≥1个FF/VI或BUD/ for处方,有≥1年的全科医生注册,有与医院发作统计相关的记录。慢性阻塞性肺疾病是排除标准。主要研究结果评估了FF/VI或BUD/FOR新使用者的总体哮喘加重率。次要结局包括口服皮质类固醇(OCS)的使用和用药持久性(使用Kaplan-Meier曲线分析)。对于每个治疗比较,生成倾向得分,并通过治疗加权逆概率调整基线组特征之间的混淆,分别针对每个研究结果进行。在分析中考虑了并发事件(ICEs),如死亡、失去随访、使用救援药物、停止治疗或切换治疗。结果:两组间基线属性平衡良好。在接受治疗的人群中,年人均恶化率在数值上相似(测量结果直到ICE; FF/VI, 0.1356; BUD/FOR, 0.1583 [P = 0.3023])。持续1年不间断治疗的患者FF/VI的年人均加重率(0.0722 [n = 425])明显低于BUD/ for (0.2258 [n = 546])(比率为0.3197 [P = 0.0003])。与BUD/FOR相比,FF/VI指数患者的OCS处方和OCS剂量显著减少(相关系数:- 0.29 [P = 0.0352]; 0.41 [P = 0.0004]),并且治疗持久性得到改善(风险比:0.62 [P])。结论:与BUD/FOR相比,FF/VI持续治疗一年的患者恶化率降低。FF/VI组也减少了治疗停药和OCS的使用。
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来源期刊
Pulmonary Therapy
Pulmonary Therapy Medicine-Pulmonary and Respiratory Medicine
CiteScore
5.20
自引率
3.30%
发文量
24
审稿时长
6 weeks
期刊介绍: Aims and Scope Pulmonary Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the use of pulmonary therapies, devices, and surgical techniques. Areas of focus include, but are not limited to: asthma; chronic obstructive pulmonary disease; idiopathic pulmonary fibrosis; pulmonary hypertension; cystic fibrosis; lung cancer; respiratory tract disorders; allergic rhinitis and other respiratory allergies; influenza, pneumococcal infection, respiratory syncytial virus and other respiratory infections; and inhalers and other device therapies. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Pulmonary Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of pulmonary therapies. Open Access All articles published by Pulmonary Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. Digital Features and Plain Language Summaries Pulmonary Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/ Publication Fees Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €4500/ $5100/ £3650. The journal will consider fee discounts and waivers for developing countries and this is decided on a case by case basis. Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials, and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in one of our journals. Once the manuscript is published, it is the author’s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website. Please follow the link for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Copyright Pulmonary Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0. Contact For more information about the journal, including pre-submission enquiries, please contact christopher.vautrinot@springer.com.
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