title: Update on the cardiac safety of moxifloxacin.
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.affiliation: Department of Cardiology, Campus Virchow Clinic, Charité University Medicine Berlin, Germany. wilhelm.haverkamp@charite.de
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Haverkamp
authors.forename: Frank
authors.initials: F
authors.lastname: Kruesmann
authors.forename: Anna
authors.initials: A
authors.lastname: Fritsch
authors.forename: David
authors.initials: D
authors.lastname: van Veenhuyzen
authors.forename: Pierre
authors.initials: P
authors.lastname: Arvis
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D000818:Animals; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001372:Aza Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D004348:Drug Labeling; D005260:Female; D024841:Fluoroquinolones; D006331:Heart Diseases / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D006801:Humans; D007262:Infusions, Intravenous; D008133:Long QT Syndrome / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D000077266:Moxifloxacin; D011804:Quinolines / Q000008:administration & dosage / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D012737:Sex Factors
chemical_list: D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D000077266:Moxifloxacin