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.