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Abstract: Poster Presentations |

Safety and Tolerability of Gemifloxacin: A Review of Clinical Trial Data FREE TO VIEW

Glenn S. Tillotson, MS; Lionel Mandell, MD*; Paul Iannini, MD; Thomas File, MD; Gary Patou, MD
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McMaster University, Hamilton, ON, Canada


Chest


Chest. 2004;126(4_MeetingAbstracts):848S. doi:10.1378/chest.126.4_MeetingAbstracts.848S
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Published online

Abstract

PURPOSE:  Gemifloxacin is a newly approved fluoroquinolone for the treatment of respiratory tract infections. Tolerability data from 20 clinical trials was reviewed to assess the safety profile of gemifloxacin.

METHODS:  A meta-analysis of 20 Phase II and III clinical studies was conducted to determine the frequency of adverse events (AEs), serious adverse events (SAEs) and withdrawals from the study as compared to levofloxacin, trovafloxacin, ciprofloxacin, ceftriaxone, cefuroxime, clarithromycin, or amox/clav).

RESULTS:  6775 patients were treated with gemifloxacin and 5248 with comparator agents. The overall incidence of AEs with gemifloxacin and comparators was similar (44.7% gemifloxacin; 47.5% comparators). The most common drug-related AEs were diarrhea, rash, and nausea for the gemifloxacin group (3.6%, 2.8% and 2.7%, respectively) and were diarrhea, nausea, and headache for the comparator group (4.6%, 3.2% and 1.5%, respectively). Patients with at least one SAE were identified among 3.6% of gemifloxacin-treated and 4.3% of comparator-treated patients. The most common SAEs were pneumonia (gemifloxacin 0.3%; comparators 0.5%) and chronic obstructive airway disease (gemifloxacin 0.2%; comparators 0.3%). Withdrawals due to drug-related AEs occurred in 2.2% of gemifloxacin-treated and 2.1% of comparator-treated patients. The most common reasons for withdrawal among the gemifloxacin-treated patients were rash (0.9%), nausea (0.3%), and diarrhea (0.3%). The most common reasons for withdrawal among the comparator-treated patients were diarrhea (0.5%), and nausea, rash, and vomiting (all 0.3%).

CONCLUSION:  In these studies, gemifloxacin 320 mg once daily was shown to be as safe and well tolerated as other commonly prescribed antibiotics. Mild rash was more common in gemifloxacin treated patients and diarrhea was more common with comparators.

CLINICAL IMPLICATIONS:  Gemifloxacin represents a safe and effective addition to the current treatment options for lower respiratory tract infections.

DISCLOSURE:  L. Mandell, None.

Wednesday, October 27, 2004

12:30 PM- 2:00 PM


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