Adjunctive Atorvastatin for Sepsis in the Acute Medical Unit: A Randomized Controlled Trial.

Q3 Medicine

Acute Medicine Pub Date : 2025-01-01 DOI:10.52964/AMJA.1004

Ch Adrees Rashid, Mohan Kumar H, Mandip Singh Bhatia, Atul Saroch, Navneet Sharma, Saurabh Chandrabhan Sharda

{"title":"Adjunctive Atorvastatin for Sepsis in the Acute Medical Unit: A Randomized Controlled Trial.","authors":"Ch Adrees Rashid, Mohan Kumar H, Mandip Singh Bhatia, Atul Saroch, Navneet Sharma, Saurabh Chandrabhan Sharda","doi":"10.52964/AMJA.1004","DOIUrl":null,"url":null,"abstract":"Background: Sepsis, a devastating syndrome of organ dysfunction triggered by a dysregulated host response to infection, remains a leading cause of global mortality. Statins, renowned for lipid-lowering, also exhibit potent anti-inflammatory and endothelial-stabilizing properties, offering a theoretical advantage in the septic milieu. This study investigated whether adjunctive atorvastatin could improve survival and modulate key sepsis-related outcomes.Methods: In this open-label, randomized controlled trial conducted in the acute medical unit of a tertiary academic center, adult patients with sepsis (defined as suspected infection plus a SOFA score increment of ≥2) were allocated to receive either standard sepsis management plus daily oral atorvastatin 20mg or standard management alone for up to 28 days. The primary endpoint was 28-day all-cause mortality. Secondary endpoints included requirements for organ support, duration of hospitalization, and kinetic changes in C-reactive protein(CRP), procalcitonin(PCT), and lactate. Analysis adhered to intention-to-treat principles.Results: Sixty-eight patients were randomized(36 atorvastatin, 32 control). While 28-day mortality trended lower in the atorvastatin arm(36% vs. 56% in controls; Risk Difference -20%, 95% CI -45% to 5%), this difference did not achieve statistical significance(p=0.10). Similarly, no significant benefits were observed in organ support needs or hospital stay. Critically, atorvastatin administration led to a significant and more pronounced reduction in both procalcitonin (median change -8 vs 0 ng/ml, p=0.005) and lactate levels(median change -0.95 vs -0.62 mmol/l, p=0.048) by day 7.Conclusion: While adjunctive atorvastatin did not demonstrably reduce 28-day mortality in this sepsis cohort, its significant impact on attenuating procalcitonin and lactate levels suggests a beneficial modulation of underlying inflammatory and metabolic derangements.","PeriodicalId":39743,"journal":{"name":"Acute Medicine","volume":"24 1","pages":"27-34"},"PeriodicalIF":0.0000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acute Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.52964/AMJA.1004","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Sepsis, a devastating syndrome of organ dysfunction triggered by a dysregulated host response to infection, remains a leading cause of global mortality. Statins, renowned for lipid-lowering, also exhibit potent anti-inflammatory and endothelial-stabilizing properties, offering a theoretical advantage in the septic milieu. This study investigated whether adjunctive atorvastatin could improve survival and modulate key sepsis-related outcomes.

Methods: In this open-label, randomized controlled trial conducted in the acute medical unit of a tertiary academic center, adult patients with sepsis (defined as suspected infection plus a SOFA score increment of ≥2) were allocated to receive either standard sepsis management plus daily oral atorvastatin 20mg or standard management alone for up to 28 days. The primary endpoint was 28-day all-cause mortality. Secondary endpoints included requirements for organ support, duration of hospitalization, and kinetic changes in C-reactive protein(CRP), procalcitonin(PCT), and lactate. Analysis adhered to intention-to-treat principles.

Results: Sixty-eight patients were randomized(36 atorvastatin, 32 control). While 28-day mortality trended lower in the atorvastatin arm(36% vs. 56% in controls; Risk Difference -20%, 95% CI -45% to 5%), this difference did not achieve statistical significance(p=0.10). Similarly, no significant benefits were observed in organ support needs or hospital stay. Critically, atorvastatin administration led to a significant and more pronounced reduction in both procalcitonin (median change -8 vs 0 ng/ml, p=0.005) and lactate levels(median change -0.95 vs -0.62 mmol/l, p=0.048) by day 7.

Conclusion: While adjunctive atorvastatin did not demonstrably reduce 28-day mortality in this sepsis cohort, its significant impact on attenuating procalcitonin and lactate levels suggests a beneficial modulation of underlying inflammatory and metabolic derangements.

查看原文本刊更多论文

急性内科辅助阿托伐他汀治疗败血症：一项随机对照试验

背景：败血症是一种由宿主对感染反应失调引发的器官功能障碍的破坏性综合征，仍然是全球死亡的主要原因。他汀类药物，以降脂而闻名，也表现出有效的抗炎和内皮稳定特性，在脓毒性环境中提供了理论上的优势。这项研究调查了辅助阿托伐他汀是否可以改善生存和调节败血症相关的关键结局。方法：在一所三级学术中心的急性医疗单元进行的这项开放标签、随机对照试验中，成年脓毒症患者（定义为疑似感染加上SOFA评分≥2）被分配接受标准脓毒症管理加每日口服阿托伐他汀20mg或单独接受标准管理长达28天。主要终点为28天全因死亡率。次要终点包括器官支持需求、住院时间、c反应蛋白（CRP）、降钙素原（PCT）和乳酸的动力学变化。分析遵循意向治疗原则。结果：68例患者随机入选（阿托伐他汀36例，对照组32例）。虽然阿托伐他汀组28天死亡率呈下降趋势（36% vs.对照组56%；风险差异-20%，95% CI -45% ~ 5%），但这一差异没有统计学意义（p=0.10）。同样，在器官支持需求或住院时间方面也没有观察到明显的益处。关键的是，阿托伐他汀治疗导致降钙素原（中位数变化-8 vs -0 ng/ml， p=0.005）和乳酸水平（中位数变化-0.95 vs -0.62 mmol/l, p=0.048）在第7天显著且更显著地降低。结论：虽然辅助阿托伐他汀在脓毒症队列中没有明显降低28天死亡率，但其对降低降钙素原和乳酸水平的显著影响表明，它对潜在的炎症和代谢紊乱有有益的调节作用。

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

Acute Medicine Medicine-Emergency Medicine

CiteScore

1.50

自引率

0.00%

发文量

期刊介绍： These are usually commissioned by the editorial team in accordance with a cycle running over several years. Authors wishing to submit a review relevant to Acute Medicine are advised to contact the editor before writing this. Unsolicited review articles received for consideration may be included if the subject matter is considered of interest to the readership, provided the topic has not already been covered in a recent edition. Review articles are usually 3000-5000 words and may include tables, pictures and other figures as required for the text. Include 3 or 4 ‘key points’ summarising the main teaching messages.