Update on the Cardiac Safety of Moxifloxacin
Update on the Cardiac Safety of Moxifloxacin
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DOI：
10.2174/157488612802715735
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发表时间：
2012-01-01
影响因子：
1.5
通讯作者：
Arvis, Pierre
中科院分区：
文献类型：
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作者：
Haverkamp, Wilhelm;Kruesmann, Frank;Arvis, Pierre
在来自II-IV期随机活性对照临床试验的大量患者人群中，比较了接受阿托沙星和其他抗菌药物的患者的心脏安全性。莫西沙星400 mg每日一次单药治疗口服（PO）或序贯（静脉/口服，IV/PO）给药。在64项试验中，21，298例患者接受PO治疗（10，613例阿托沙星，10，685例对照药物），6846例接受序贯IV/PO治疗（3431例阿托沙星，3415例对照药物）。在PO（6.6% vs 5.8%）和IV/PO（11.0% vs 12.0%）试验中，阿托沙星和对照药物治疗后出现的心脏不良事件（AE）发生率相似。治疗后出现的心脏药物不良反应在PO（阿托沙星3.2% vs对照药物2.4%）和IV/PO（阿托沙星1.4% vs对照药物1.5%）患者中罕见。有五个（= 65岁）。无非预期心脏事件的证据。经阿托沙星治疗后，QTcB和QTcF出现了预期的小幅延长。对大量临床试验的分析显示，与其他抗生素相比，阿托沙星在适当使用并根据其标签使用时具有良好的心脏安全性。
Cardiac safety was compared in patients receiving moxifloxacin and other antimicrobials in a large patient population from Phase II-IV randomized active-controlled clinical trials. Moxifloxacin 400 mg once-daily monotherapy was administered orally (PO) or sequentially (intravenous/oral, IV/PO). Across 64 trials, 21,298 patients received PO therapy (10,613 moxifloxacin, 10,685 comparators) while 6846 received sequential IV/PO therapy (3431 moxifloxacin, 3415 comparators). Treatment-emergent cardiac adverse event (AE) rates were similar for moxifloxacin and comparators in PO (6.6% vs 5.8%) and IV/PO (11.0% vs 12.0%) trials. Treatment-emergent cardiac adverse drug reactions were rare in PO (moxifloxacin 3.2% vs comparators 2.4%) and IV/PO (moxifloxacin 1.4% vs comparators 1.5%) patients. There were five (= 65 years old). There was no evidence of unexpected cardiac events. After moxifloxacin treatment, an expected small prolongation in QTcB and QTcF was found. This analysis of numerous clinical trials shows the favorable cardiac safety profile of moxifloxacin, when used appropriately and according to its label, versus other antibiotics.