A randomized trial of icosapent ethyl in ambulatory patients with COVID-19.

A randomized trial of icosapent ethyl in ambulatory patients with COVID-19.
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DOI:
10.1016/j.isci.2021.103040
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发表时间:
2021-09-24
期刊:
影响因子:
5.8
通讯作者:
Mazer CD
Mazer CD
中科院分区:
综合性期刊2区
文献类型:
--
作者:
Kosmopoulos A;Bhatt DL;Meglis G;Verma R;Pan Y;Quan A;Teoh H;Verma M;Jiao L;Wang R;Juliano RA;Kajil M;Kosiborod MN;Bari B;Berih AA;Aguilar M;Escano A;Leung A;Coelho I;Hibino M;Díaz R;Mason RP;Steg PG;Simon T;Go AS;Ambrosy AP;Choi R;Kushner AM;Leiter LA;Al-Omran M;Verma S;Mazer CD

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2019 年冠状病毒病(COVID-19)大流行仍然是全世界发病率和死亡率相当高的一个来源。减轻症状、炎症反应或疾病进展的治疗选择是有限的。这项随机开放标签试验在加拿大多伦多招募了 100 名有症状的 COVID-19 门诊患者。结果表明,与接受常规治疗的患者相比,二十碳五烯乙酯(每天 8 g,持续 3 天,随后每天 4 g,持续 11 天)显着降低了高敏 C 反应蛋白 (hs-CRP),并改善了症状。具体而言,在接受治疗的患者中,主要生物标志物终点(hs-CRP 的变化)显着降低了 25%(-0.5 mg/L,四分位距 [IQR] [-6.9,0.4],组内 p = 0.011)。相反,在常规护理患者中观察到不显着的 5.6% 降低(-0.1 mg/L,IQR [-3.2,1.7],组内 p = 0.51)。未经调整的组间主要生物标志物分析不显着(p = 0.082)。总体而言,本报告提供了少量样本中二十碳五烯乙酯对有症状的 COVID-19 门诊患者的早期抗炎作用的证据,包括初始耐受良好的负荷剂量。 ClinicalTrials.gov 标识符:NCT04412018。二十碳五烯乙酯队列中的 hs-CRP 显着降低(p 值 = 0.011) 与常规护理相比,治疗中的总症状患病率显着降低 与常规护理相比,治疗参与者的 FLU-PRO 评分显着降低 二十碳五烯乙酯负荷剂量(8 克/天,持续 3 天)耐受性良好的第一个证据 健康科学;药品
The coronavirus disease 2019 (COVID-19) pandemic remains a source of considerable morbidity and mortality throughout the world. Therapeutic options to reduce symptoms, inflammatory response, or disease progression are limited. This randomized open-label trial enrolled 100 ambulatory patients with symptomatic COVID-19 in Toronto, Canada. Results indicate that icosapent ethyl (8 g daily for 3 days followed by 4 g daily for 11 days) significantly reduced high-sensitivity C-reactive protein (hs-CRP) and improved symptomatology compared with patients assigned to usual care. Specifically, the primary biomarker endpoint, change in hs-CRP, was significantly reduced by 25% among treated patients (−0.5 mg/L, interquartile range [IQR] [−6.9,0.4], within-group p = 0.011). Conversely, a non-significant 5.6% reduction was observed among usual care patients (−0.1 mg/L, IQR [−3.2,1.7], within-group p = 0.51). An unadjusted between-group primary biomarker analysis was non-significant (p = 0.082). Overall, this report provides evidence of an early anti-inflammatory effect of icosapent ethyl in a modest sample, including an initial well-tolerated loading dose, in symptomatic outpatients with COVID-19. ClinicalTrials.gov Identifier: NCT04412018. hs-CRP was significantly reduced within the icosapent ethyl cohort (p value = 0.011) Total symptom prevalence was significantly reduced in treatment versus usual care Treated participants had significant FLU-PRO score reductions versus usual care First evidence of a well-tolerated icosapent ethyl loading dose (8 g/day for 3 days) Health sciences; Medicine
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