Sotagliflozin: Efficacy, Safety, and Potential Therapeutic Applications in Heart Failure.

IF 2.3 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Annals of Pharmacotherapy Pub Date : 2024-09-01 Epub Date: 2023-11-28 DOI:10.1177/10600280231211179
Allissa Long, Marissa Salvo
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引用次数: 0

Abstract

Objective: To describe the pharmacology, clinical efficacy, and safety evidence of sotagliflozin, the first approved dual inhibitor of sodium-glucose cotransporter (SGLT) 1 and SGLT2, in heart failure (HF) management.

Data sources: A literature search of studies published between January 2012 and September 2023 were identified using PubMed, MEDLINE, and clinicaltrials.gov with search terms of "sotagliflozin," "Inpefa," or "LX4211."

Study selection and data extraction: All available studies in English were considered. Studies were included if they investigated drug pharmacology, efficacy, or safety information.

Data synthesis: Two phase 3 trials of sotagliflozin, SOLOIST-WHF and SCORED, evaluated sotagliflozin compared with placebo in patients with type 2 diabetes mellitus (T2DM). SOLOIST-WHF reported a statistically decreased rate of cardiovascular and HF events with sotagliflozin (hazard ratio [HR] = 0.67, 95% CI = 0.52-0.85), while SCORED found a statistically significant decrease in incidence of cardiovascular events in patients with T2DM, chronic kidney disease (CKD), and risk factors for cardiovascular disease in patients in the sotagliflozin group (HR = 0.74, 95% CI = 0.63-0.88).

Relevance to patient care and clinical practice in comparison to existing agents: While approval of sotagliflozin expands treatment options for patients with HF, the SGLT2 inhibitors, dapagliflozin and empagliflozin, have more data supporting their use in HF, additional risk reduction benefits in patients with CKD, and approval for use in T2DM. Landmark trials of sotagliflozin required a previous diagnosis of T2DM, despite the broader approved indication. Where sotagliflozin will be adopted into the treatment of HF is unclear due to the evidence and benefits of already established SGLT2 inhibitors and the need for comparison with SGLT2 inhibitors.

Conclusion: Given the limitations of currently available evidence, including difficulty in fully interpreting the trial results due to changes in primary endpoints, not adjudicating the events, and not reaching the original power calculations, more investigation is warranted to determine the benefit of sotagliflozin compared with SGLT2 inhibitors.

索他列净:心力衰竭的疗效、安全性和潜在治疗应用。
目的:描述首个获批的钠-葡萄糖共转运蛋白(SGLT) 1和SGLT2双重抑制剂sotagliflozin治疗心力衰竭(HF)的药理学、临床疗效和安全性证据。数据来源:通过PubMed、MEDLINE和clinicaltrials.gov检索2012年1月至2023年9月间发表的研究文献,检索词为“sotagliflozin”、“Inpefa”或“LX4211”。研究选择和数据提取:考虑了所有可用的英文研究。如果研究涉及药物药理、疗效或安全性信息,则纳入研究。数据综合:SOLOIST-WHF和score两项3期试验评估了sotagliflozin与安慰剂在2型糖尿病(T2DM)患者中的疗效。SOLOIST-WHF报告sotagliflozin组的心血管和心力衰竭事件发生率有统计学意义降低(风险比[HR] = 0.67, 95% CI = 0.52-0.85),而score发现sotagliflozin组的T2DM、慢性肾脏疾病(CKD)患者的心血管事件发生率和心血管疾病危险因素有统计学意义降低(HR = 0.74, 95% CI = 0.63-0.88)。与现有药物相比,与患者护理和临床实践的相关性:虽然批准sotagliflozin扩大了HF患者的治疗选择,但SGLT2抑制剂dapagliflozin和empagliflozin有更多的数据支持其在HF中的应用,在CKD患者中有额外的风险降低益处,并批准在T2DM中使用。sotagliflozin具有里程碑意义的试验要求患者既往诊断为T2DM,尽管适应症被批准的范围更广。由于已经建立的SGLT2抑制剂的证据和益处以及需要与SGLT2抑制剂进行比较,sotagliflozin将在何处用于HF治疗尚不清楚。结论:考虑到现有证据的局限性,包括由于主要终点的变化而难以完全解释试验结果、无法对事件进行裁决、无法达到最初的功效计算,有必要进行更多的研究来确定sotagliflozin与SGLT2抑制剂相比的益处。
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
CiteScore
5.70
自引率
0.00%
发文量
166
审稿时长
3-8 weeks
期刊介绍: Annals of Pharmacotherapy (AOP) is a peer-reviewed journal that advances pharmacotherapy throughout the world by publishing high-quality research and review articles to achieve the most desired health outcomes.The articles provide cutting-edge information about the most efficient, safe and cost-effective pharmacotherapy for the treatment and prevention of various illnesses. This journal is a member of the Committee on Publication Ethics (COPE). Average time from submission to first decision: 14 days
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