Representation of women and racial minorities in SGLT2 inhibitors and heart failure clinical trials

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

IJC Heart and Vasculature Pub Date : 2024-10-20 DOI:10.1016/j.ijcha.2024.101539

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引用次数: 0

Abstract

Background

Inadequate representation of women and racial minorities in heart failure (HF) clinical trials continues to limit the generalizability of the results. This could create a disparity in treatment for future heart failure therapies and devices. The study aims to assess the representation of women and racial minorities in recent heart failure studies involving sodium-glucose cotransporter-2 (SGLT-2) inhibitors.

Methods

PubMed was used to search randomized controlled trials (RCTs) looking at SGLT-2 inhibitors and heart failure, which were published from inception to August 2024.

Results

A total of 43 RCTs with 27,703 participants were identified. The studies were published between 2018 and 2024. Seven studies (41 %) were multi-country, with 45 countries represented. The overall proportion of women enrolled in the studies was 35.6 %. The proportion of women was 24.06 % in studies that recruited only patients with HFrEF, 44.33 % in those that recruited only patients with HFpEF, and 41.4 % in those that recruited both HFrEF and HFpEF. Data on race was partially reported in 25 studies (58 %). 76 % of the pharmaceutical industry-funded studies reported race data. However, only 33.3 % of the unfunded or non-industry-funded studies reported race data. In the studies that reported race data, 72.91 % were Caucasians, 15.48 % were Asians, 5.62 % were African-American and 4.1 % were mixed race or others.

In the bivariate analysis, race was more likely to be reported in studies done in the US (p < 0.001), multi-country studies (p = 0.013), and studies sponsored by pharmaceutical companies. More than a third of the study participants were more likely to be women in more recently published studies than older studies (p < 0.001). Additionally, more than a third of the study participants were more likely to be women in studies done in the US (p = 0.055). The multivariate analysis showed an increased odds of having more than a third of the study participants being women in more recently published studies (OR 1.83, 95 % CI 1.06–3.17, p = 0.031) and in studies done in the US (OR 7.69, 95 % CI 1.53–38.59, p = 0.013).

Conclusion

Our study found that women and racial minority individuals have remained underrepresented in recent heart failure studies. Although some progress has been made over the years, more work is needed to improve data reporting and address barriers to enrollment for women and racial minority individuals in clinical trials.

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SGLT2 抑制剂和心力衰竭临床试验中妇女和少数民族的代表性

背景在心力衰竭（HF）临床试验中，女性和少数民族的代表性不足，这继续限制了试验结果的推广性。这可能会造成未来心衰疗法和设备在治疗上的差异。本研究旨在评估近期涉及钠-葡萄糖共转运体-2（SGLT-2）抑制剂的心衰研究中女性和少数种族的代表性。方法使用PubMed搜索从开始到2024年8月发表的有关SGLT-2抑制剂和心衰的随机对照试验（RCT）。这些研究发表于 2018 年至 2024 年。7项研究（41%）涉及多个国家，共有45个国家参与。参与研究的女性总比例为 35.6%。仅招募 HFrEF 患者的研究中女性比例为 24.06%，仅招募 HFpEF 患者的研究中女性比例为 44.33%，同时招募 HFrEF 和 HFpEF 患者的研究中女性比例为 41.4%。有 25 项研究（58%）部分报告了种族数据。制药业资助的研究中有 76% 报告了种族数据。然而，只有 33.3% 的未获资助或非制药业资助的研究报告了种族数据。在报告种族数据的研究中，72.91%为白种人，15.48%为亚洲人，5.62%为非裔美国人，4.1%为混血或其他种族。在双变量分析中，在美国进行的研究（p <0.001）、多国研究（p = 0.013）和制药公司赞助的研究更有可能报告种族数据。与较早的研究相比，在最近发表的研究中，超过三分之一的研究参与者更可能是女性（p < 0.001）。此外，在美国进行的研究中，超过三分之一的研究参与者更可能是女性（p = 0.055）。多变量分析表明，在最近发表的研究中，超过三分之一的研究参与者为女性的几率增加（OR 1.83，95 % CI 1.06-3.17，p = 0.031），在美国进行的研究中，超过三分之一的研究参与者为女性的几率增加（OR 7.69，95 % CI 1.53-38.59，p = 0.013）。尽管多年来取得了一些进展，但还需要做更多的工作来改进数据报告，解决女性和少数种族患者参与临床试验的障碍。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

IJC Heart and Vasculature Medicine-Cardiology and Cardiovascular Medicine

CiteScore

4.90

自引率

10.30%

发文量

216

审稿时长

56 days

期刊介绍： IJC Heart & Vasculature is an online-only, open-access journal dedicated to publishing original articles and reviews (also Editorials and Letters to the Editor) which report on structural and functional cardiovascular pathology, with an emphasis on imaging and disease pathophysiology. Articles must be authentic, educational, clinically relevant, and original in their content and scientific approach. IJC Heart & Vasculature requires the highest standards of scientific integrity in order to promote reliable, reproducible and verifiable research findings. All authors are advised to consult the Principles of Ethical Publishing in the International Journal of Cardiology before submitting a manuscript. Submission of a manuscript to this journal gives the publisher the right to publish that paper if it is accepted. Manuscripts may be edited to improve clarity and expression.