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Update on the cardiac safety of moxifloxacin.
Curr Drug Saf. 2012 Apr; 7(2):149-63.CD

Abstract

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.

Authors+Show Affiliations

Department of Cardiology, Campus Virchow Clinic, Charité University Medicine Berlin, Germany. wilhelm.haverkamp@charite.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22873499

Citation

Haverkamp, Wilhelm, et al. "Update On the Cardiac Safety of Moxifloxacin." Current Drug Safety, vol. 7, no. 2, 2012, pp. 149-63.
Haverkamp W, Kruesmann F, Fritsch A, et al. Update on the cardiac safety of moxifloxacin. Curr Drug Saf. 2012;7(2):149-63.
Haverkamp, W., Kruesmann, F., Fritsch, A., van Veenhuyzen, D., & Arvis, P. (2012). Update on the cardiac safety of moxifloxacin. Current Drug Safety, 7(2), 149-63.
Haverkamp W, et al. Update On the Cardiac Safety of Moxifloxacin. Curr Drug Saf. 2012;7(2):149-63. PubMed PMID: 22873499.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Update on the cardiac safety of moxifloxacin. AU - Haverkamp,Wilhelm, AU - Kruesmann,Frank, AU - Fritsch,Anna, AU - van Veenhuyzen,David, AU - Arvis,Pierre, PY - 2012/03/09/received PY - 2012/05/18/revised PY - 2012/06/14/accepted PY - 2012/8/10/entrez PY - 2012/8/10/pubmed PY - 2013/1/5/medline SP - 149 EP - 63 JF - Current drug safety JO - Curr Drug Saf VL - 7 IS - 2 N2 - 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. SN - 2212-3911 UR - https://www.unboundmedicine.com/medline/citation/22873499/Update_on_the_cardiac_safety_of_moxifloxacin_ L2 - http://www.eurekaselect.com/100867/article DB - PRIME DP - Unbound Medicine ER -