Patient and Clinical Demographics of New Users to Single-Inhaler Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease.

IF 2.3 Q2 RESPIRATORY SYSTEM Pulmonary Therapy Pub Date : 2022-06-01 Epub Date: 2022-04-25 DOI:10.1007/s41030-022-00189-6

Benjamin Wu, David Mannino, George Mu, Marjorie Stiegler, Michael Bogart

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Abstract

Introduction: Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy was approved by the United States Food and Drug Administration in 2017 as a maintenance therapy for chronic obstructive pulmonary disease (COPD). Patient characteristics and treatment patterns prior to initiating FF/UMEC/VI are currently unknown. This study assessed patient characteristics, exacerbation, and medication history in patients with COPD before the initiation of FF/UMEC/VI or multiple-inhaler triple therapy (MITT).

Methods: This was a retrospective study using the Optum Clinformatics^® Data Mart. Patients who initiated FF/UMEC/VI triple therapy or MITT (consisting of a long-acting muscarinic antagonist [LAMA], long-acting β2-agonist [LABA], and inhaled corticosteroid [ICS]) between October 2017 and September 2018, were enrolled in commercial or Medicare Advantage Prescription Drug plans, were aged > 40 years, and had a COPD diagnosis were eligible. Patient characteristics, comorbidities, COPD medication use, exacerbations, and eosinophil counts were assessed in the 12-month baseline period prior to initiation of FF/UMEC/VI triple therapy or MITT.

Results: The study population included 3933 FF/UMEC/VI users and 18,244 MITT users. Mean (standard deviation) patient age was 72.2 (8.6) years in FF/UMEC/VI users and 70.7 (9.7) years in MITT users. Prior to initiating triple therapy, the majority of FF/UMEC/VI (89.1%) and MITT (93.8%) users experienced a moderate or severe exacerbation or used a COPD maintenance therapy during the baseline period. In addition, 41.2% of FF/UMEC/VI users received overlapping ICS/LAMA/LABA, 20.3% received ICS/LABA, and 9.7% received LAMA/LABA.

Conclusion: In this population of COPD patients, triple therapy was frequently initiated after previous maintenance medication use or an exacerbation, in line with treatment guideline recommendations.

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慢性阻塞性肺疾病患者单吸入器三联治疗新使用者的患者和临床人口统计学

导言：单吸入剂糠酸氟替卡松/优甲乐胺/维兰特罗（FF/UMEC/VI）三联疗法于2017年获得美国食品和药物管理局批准，作为慢性阻塞性肺疾病（COPD）的维持疗法。目前尚不清楚患者特征和开始使用 FF/UMEC/VI 之前的治疗模式。本研究评估了慢性阻塞性肺病患者在开始使用 FF/UMEC/VI 或多吸入器三联疗法（MITT）前的患者特征、病情加重和用药史：这是一项使用 Optum Clinformatics® Data Mart 进行的回顾性研究。在2017年10月至2018年9月期间开始接受FF/UMEC/VI三联疗法或MITT（由长效毒蕈碱类拮抗剂[LAMA]、长效β2-受体激动剂[LABA]和吸入性皮质类固醇[ICS]组成）的患者，参加了商业或医疗保险优势处方药计划，年龄大于40岁，并确诊为慢性阻塞性肺病，均符合条件。在开始 FF/UMEC/VI 三联疗法或 MITT 之前的 12 个月基线期内，对患者特征、合并症、慢性阻塞性肺病药物使用、病情加重和嗜酸性粒细胞计数进行了评估：研究对象包括3933名FF/UMEC/VI使用者和18244名MITT使用者。FF/UMEC/VI使用者的平均年龄（标准差）为72.2（8.6）岁，MITT使用者的平均年龄为70.7（9.7）岁。在开始使用三联疗法之前，大多数 FF/UMEC/VI 用户（89.1%）和 MITT 用户（93.8%）在基线期间经历过中度或重度病情加重或使用过慢性阻塞性肺病维持疗法。此外，41.2%的FF/UMEC/VI用户接受了ICS/LAMA/LABA重叠治疗，20.3%接受了ICS/LABA治疗，9.7%接受了LAMA/LABA治疗：在这部分慢性阻塞性肺病患者中，根据治疗指南的建议，三联疗法通常是在之前使用过维持性药物或病情加重后开始使用的。

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来源期刊

Pulmonary Therapy Medicine-Pulmonary and Respiratory Medicine

CiteScore

5.20

自引率

3.30%

发文量

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. 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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.