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Population Analysis of Anidulafungin in Infants to Older Adults With Confirmed or Suspected Invasive Candidiasis.
Clinical Pharmacology & Therapeutics ( IF 6.7 ) Pub Date : 2020-03-19 , DOI: 10.1002/cpt.1831
Rujia Xie 1 , Lynn McFadyen 2 , Susan Raber 3 , Robert Swanson 4 , Margaret Tawadrous 5 , Heidi Leister-Tebbe 4 , Michael Cohen-Wolkowiez 6, 7 , Daniel K Benjamin 6, 7 , Ping Liu 8
Affiliation  

In a pooled population analysis, we investigated the pharmacokinetics of i.v. anidulafungin in four studies across a full range of adult and pediatric ages in patients with confirmed, suspected, or at high risk of invasive candidiasis (IC). Relationships between anidulafungin exposure and key efficacy end points (global response of success and all‐cause mortality) and safety end points (all‐cause hepatic or gastrointestinal adverse events) in all patients and separately in pediatric patients and the appropriate dosing regimen for IC treatment in pediatric patients were evaluated. Pediatric patients received a 3.0 mg/kg (maximum 200 mg) i.v. loading dose and 1.5 mg/kg (maximum 100 mg) daily thereafter. Adults received a 200 mg i.v. loading dose and 100 mg daily thereafter. Estimated systemic anidulafungin exposures were similar across age groups (neonates to adults) at the weight‐based doses studied in pediatric patients. No clear associations were identified between anidulafungin exposure and efficacy or safety end points.

中文翻译:

确诊或疑似侵袭性念珠菌病的老年人中阿尼芬净的人口分析。

在汇总的人群分析中,我们在四项研究中,对确诊,怀疑或有浸润性念珠菌病(IC)高风险的成年和小儿年龄范围内的四项研究,研究了静脉注射阿尼芬净的药代动力学。所有患者以及小儿患者分别与阿迪芬净暴露和关键功效终点(成功和全因死亡率的总体反应)和安全终点(全因肝或胃肠道不良事件)之间的关系以及适当的IC治疗剂量方案在儿科患者中进行了评估。小儿患者接受3.0毫克/千克(最大200毫克)的静脉注射剂量,此后每天接受1.5毫克/千克(最大100毫克)的静脉注射剂量。成人接受200毫克的静脉内负荷剂量,此后每天接受100毫克的剂量。在小儿患者中研究的基于体重的剂量下,不同年龄段(对成年人而言是新生儿)的估计系统性抗阿古芬净暴露量相似。阿尼芬净暴露与疗效或安全终点之间没有明确的关联。
更新日期:2020-03-19
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