HOLLISTER AS, HAVERSTOCK D, CHOUDHRI S; Interscience Conference on Antimicrobial Agents and Chemotherapy.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2000 Sep 17-20; 40: 476.
Bayer Corp., Pharmaceutical Div., West Haven, CT
Purpose: To compare the safety profile and QTc prolonging effects of 400 mg moxifloxacin (MXF) orally with those of other respiratory antibiotics in patients receiving concomitant QTc prolonging drugs.METHODS: Pooled analysis of data from the global clinical safety database of moxifloxacin trials. QTc prolonging drugs were labeled or identified by the literature as agents that prolong the QTc interval. The other respiratory antibiotics used in these trials were clarithromycin, cephalexin, cefuroxime, and amoxicillin.RESULTS: 228 of 4008 moxifloxacin-treated patients received concomitant QTc prolonging drugs versus 199 of 3689 comparator-treated patients. There were no significant differences in cardiovascular adverse events, such as tachycardia, palpitation, arrhythmias, ischemia, or syncope between the four study groups (MXF alone, MXF + QTc prolonging drugs, comparator alone, comparator + QTc prolonging drugs). No MXF-treated patient experienced an adverse event attributable to QTc prolongation, and treatment success was equivalent to the comparator antibiotics. 1546 patients had pre-dose and on-drug ECGs during these trials. 44 MXF-treated patients receiving QTc prolonging drugs had less QTc prolongation (X+/-SD = 1 +/- 35 msec) than the 743 patients who received MXF without QTc prolonging drugs (7 +/- 25 msec), and than the 44 comparator-treated patients receiving QTc prolonging drugs (4 +/- 35 msec).CONCLUSIONS: Use of moxifloxacin 400 mg QD with agents known to prolong the QTc interval does not cause additional QTc prolongation. Moxifloxacin has a favorable cardiovascular safety profile in patients taking concomitant QTc prolonging drugs with no significant differences in the frequency of adverse cardiovascular events compared to comparator-treated patients.KEYWORDS: Moxifloxacin; Quinolones; Safety
Publication Types:
Keywords:
- Anti-Bacterial Agents
- Arrhythmias, Cardiac
- Aza Compounds
- Cefuroxime
- Clarithromycin
- Clinical Trials as Topic
- Hemagglutination Tests
- Humans
- Pharmaceutical Preparations
- Quinolines
- Quinolones
- Safety
- moxifloxacin
Other ID:
UI: 102248196
From Meeting Abstracts