Efficacy and Safety of Baloxavir Marboxil in Influenza Patients aged 75 or Over: A Sub-Group Analysis of CAPSTONE-2 Study

T. Takazono, T. Miyazaki, Yuki Yoshida, S. Kojima, N. Hosogaya, H. Mukae
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Abstract

Background : Elderly subjects aged 75 or over with influenza are considered at high risk of developing severe influenza and influenza-related complications. Therefore, early therapeutic intervention with anti-influenza medications is more important in elderly patients. randomized of global phase III study in patients at high risk of influenza-related complications (CAPSTONE-2, N=2,184) analyzed in a subgroup of patients 75 years of or older (N=156). The primary endpoint the to improvement of (TTIIS). The clinical secondary endpoints the resolution of and the virological secondary endpoints included the change in infectious virus titer. In addition, adverse events were also assessed as the safety endpoint. compared to the placebo or oseltamivir group. In regard to adverse events, no clear differences were observed among three groups. Conclusions : Baloxavir was superior to placebo in alleviating the symptoms of influenza in patients aged 75 or older. The results suggest a larger treatment benefit of baloxavir as compared to that of oseltamivir, based on the greater degree of reduction in the influenza virus titers.
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Baloxavir Marboxil对75岁及以上流感患者的疗效和安全性:CAPSTONE-2研究的亚组分析
背景:75岁或75岁以上的老年流感患者被认为是发生严重流感和流感相关并发症的高危人群。因此,对老年患者进行抗流感药物的早期干预治疗更为重要。一项针对流感相关并发症高风险患者的全球III期随机研究(CAPSTONE-2, N= 2184),分析了75岁及以上患者亚组(N=156)。主要终点为TTIIS的改善。临床次要终点、分辨率和病毒学次要终点包括感染性病毒滴度的变化。此外,不良事件也被评估为安全性终点。与安慰剂或奥司他韦组相比。在不良事件方面,三组间无明显差异。结论:巴洛昔韦在缓解75岁及以上患者流感症状方面优于安慰剂。结果表明,基于流感病毒滴度的更大程度降低,巴洛韦比奥司他韦具有更大的治疗效益。
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