Haverkamp Wilhelm, Kruesmann Frank, Fritsch Anna, van Veenhuyzen David, Arvis Pierre
Department of Cardiology, Campus Virchow Clinic, Charité University Medicine Berlin, Germany.
Curr Drug Saf. 2012 Apr;7(2):149-63. doi: 10.2174/157488612802715735.
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 (<0.02%) treatment-emergent drug-related deaths due to cardiac events out of 28,144 patients; one PO patient died treated with comparators, one patient died treated with IV/PO moxifloxacin, and three patients died after treatment with IV/PO comparators. Only one case of treatment-related non-fatal torsade de pointes occurred in the comparator arm. Incidence rates of cardiac AEs remained low in populations at elevated risk of cardiac events predisposed to QTc prolongation (i.e. community-acquired pneumonia patients admitted to the intensive care unit and/or mechanical ventilation, patients with documented prolongation of baseline QTc interval, women, and patients ≥ 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.
在一项来自II-IV期随机活性对照临床试验的大型患者群体中，对接受莫西沙星和其他抗菌药物治疗的患者的心脏安全性进行了比较。莫西沙星400mg每日一次单药治疗采用口服（PO）或序贯给药（静脉/口服，IV/PO）。在64项试验中，21298例患者接受PO治疗（10613例使用莫西沙星，10685例使用对照药物），而6846例患者接受序贯IV/PO治疗（3431例使用莫西沙星，3415例使用对照药物）。在PO试验（6.6%对5.8%）和IV/PO试验（11.0%对12.0%）中，莫西沙星和对照药物的治疗中出现的心脏不良事件（AE）发生率相似。在PO患者（莫西沙星3.2%对对照药物2.4%）和IV/PO患者（莫西沙星1.4%对对照药物1.5%）中，治疗中出现的心脏药物不良反应很少见。在28144例患者中，有5例（<0.02%）因心脏事件导致治疗中出现的药物相关死亡；1例接受对照药物治疗的PO患者死亡，1例接受IV/PO莫西沙星治疗的患者死亡，3例接受IV/PO对照药物治疗的患者在治疗后死亡。对照药物组仅发生1例与治疗相关的非致命性尖端扭转型室性心动过速。在有QTc延长倾向的心脏事件高风险人群（即入住重症监护病房和/或接受机械通气的社区获得性肺炎患者、记录有基线QTc间期延长的患者、女性以及≥65岁的患者）中，心脏AE的发生率仍然很低。没有证据表明存在意外的心脏事件。莫西沙星治疗后，发现QTcB和QTcF有预期的小幅延长。对众多临床试验的分析表明，与其他抗生素相比，莫西沙星在适当使用并遵循其标签时具有良好的心脏安全性。
