Efficacy and Safety of the Fixed-Dose Combination of Atorvastatin/Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients with Type 2 Diabetes and Dyslipidemia.
IF 3
Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
引用次数: 0
Abstract
Introduction: In dyslipidemia associated with type 2 diabetes (T2DM), elevated triglycerides (TG), increased low-density lipoprotein cholesterol (LDL-C), and decreased high-density lipoprotein cholesterol (HDL-C) levels are commonly found, resulting in a high prevalence of mixed dyslipidemia among patients with T2DM. Therefore, the combination therapy of atorvastatin/fenofibrate may be useful for simplifying pharmacological regimens, enhancing adherence, and requiring fewer doses of each drug to achieve the target, which decreases the number of adverse events.
Methods: We conducted a randomized multicenter, double-blind clinical trial of patients with T2DM and mixed dyslipidemia to evaluate the magnitude of change in lipid profile with a fixed-dose combination (FDC) therapy group of atorvastatin 20 mg/fenofibrate 160 mg (G_FDC) versus atorvastatin 20 mg monotherapy group (G_M), both oral route, one tablet every 24 h. The magnitude of change in the lipid profile at 2 and 4 months was compared within each group and between groups using the analysis of variance (ANOVA) test. A p value ≤ 0.05 was considered statistically significant.
Results: A total of 76 patients were included (38 per group), with an age of 56.7 ± 10.2 years, and 56.6% were women. The values at 4 months for G_FDC vs. G_M were as follow: TG mg/dL (-144.3 vs. -64.0, p = 0.004), TG percentage change (%C) (-47.9 vs. -33.1, p = 0.007); LDL-C mg/dL (-50.5 vs. -51.7, p = 0.784), LDL-C %C (-42.5 vs. -45.6, p = 0.899). The percentage of patients who achieved the targets for triglycerides (TG) was 56.7% compared to 43.8% (p = 0.309), while for LDL-C, it was 73.3% compared to 78.1% (p = 0.660). Finally, the predictive cardiovascular risk indices (∆ of change) showed a TG/HDL index of -3.9 ± 4.6 vs. -1.5 ± 2.9 (p = 0.015) and a Tg/glucose index of -0.7 ± 0.5 vs. -0.3 ± 0.4 (p = 0.003).
Conclusion: The FDC therapy of atorvastatin 20 mg/fenofibrate 160 mg achieved a greater percentage reduction in lipid profile than atorvastatin alone. No differences in adverse events were observed between the groups.
Clinical trials registration: ClinicalTrials.gov No. NCT04882293, registration date: February 28, 2022.
阿托伐他汀/非诺贝特固定剂量联合用药与阿托伐他汀对2型糖尿病合并血脂异常患者血脂的疗效和安全性
在2型糖尿病（T2DM）相关的血脂异常中，通常发现甘油三酯（TG）升高，低密度脂蛋白胆固醇（LDL-C）升高，高密度脂蛋白胆固醇（HDL-C）水平降低，导致混合性血脂异常在T2DM患者中高发。因此，阿托伐他汀/非诺贝特联合治疗可能有助于简化药理学方案，增强依从性，减少每种药物达到目标所需的剂量，从而减少不良事件的发生。方法:我们对T2DM和混合性血脂异常患者进行了一项随机、多中心、双盲临床试验，以评估阿托伐他汀20mg /非诺贝特160mg （G_FDC）固定剂量联合（FDC）治疗组与阿托伐他汀20mg单药治疗组（G_M）的血脂变化程度。每24小时一片。使用方差分析（ANOVA）检验比较各组内和各组间2个月和4个月时血脂变化的幅度。p值≤0.05认为有统计学意义。结果：共纳入76例患者（每组38例），年龄56.7±10.2岁，女性占56.6%。G_FDC与G_M在4个月时的数值如下：TG mg/dL (-144.3 vs -64.0, p = 0.004)， TG百分比变化（%C） （-47.9 vs -33.1, p = 0.007）；低密度mg / dL (-50.5 vs -51.7, p = 0.784),低密度脂蛋白% C (-42.5 vs -45.6, p = 0.899)。甘油三酯（TG）达标的患者比例分别为56.7%和43.8% (p = 0.309)， LDL-C达标的患者比例分别为73.3%和78.1% （p = 0.660）。最后，预测心血管危险指数（变化∆）显示TG/HDL指数为-3.9±4.6 vs -1.5±2.9 (p = 0.015)， TG/ glucose指数为-0.7±0.5 vs -0.3±0.4 （p = 0.003）。结论：阿托伐他汀20 mg/非诺贝特160 mg的FDC治疗比单独使用阿托伐他汀更能降低血脂。两组间不良事件发生率无差异。临床试验注册：ClinicalTrials.govNCT04882293，注册日期：2022年2月28日。
本文章由计算机程序翻译，如有差异，请以英文原文为准。
求助全文
约1分钟内获得全文
求助全文
来源期刊
Cardiology and Therapy
CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
5.30
自引率
0.00%
发文量
38
审稿时长
6 weeks
期刊介绍：
Aims and Scope
Cardiology and Therapy is an international, open access, peer reviewed (single-blind), rapid-publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of cardiovascular therapies and interventions, including devices. Studies relating to diagnosis and diagnostics, pharmacoeconomics, public health, quality of life, as well as patient care, management and education are also encouraged.
Areas of focus include, but are not limited to, ischaemic heart disease and acute cardiac care, myocardial, valvular, pericardial and congenital heart disease, vascular and pulmonary disease (including hypertension), arrhythmias, heart failure, non-invasive diagnostic techniques, and invasive and interventional cardiology as well as cardiovascular surgery.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols and short communications such as commentaries and editorials. Cardiolology and 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 cardiovascular therapies.
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
Cardiology and 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 your article for publication, authors will be required to pay the mandatory Rapid Service Fee of £3650/€4500/$5100. The journal will consider fee discounts for developing countries and this is decided on a case by case basis.
Open Access
All articles published by Cardiology and Therapy are published open access.
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 preprint 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.
Copyright
Cardiology and Therapy is published 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 matthew.evans@springer.com
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
