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Linezolid Is Well-Tolerated in Ventilator–Associated Pneumonia

Pharmacia, High Wycombe, UK

PURPOSE: Linezolid, the first approved oxazolidinone, has activity against gram-positive bacteria, including strains resistant to other antibiotics. We report the adverse event (AE) profile during linezolid use in nosocomial pneumonia for the subset of patients with ventilator-associated pneumonia (VAP).

METHODS: AE data were pooled for the subset of patients with VAP from 2 identical, randomized, double blind, IV studies comparing linezolid (LZD) and vancomycin (VAN) in patients with gram positive nosocomial pneumonia. The investigator recorded and rated AEs as serious or non-serious, with judgment on severity by standard definitions, and assessed the relationship of AEs to study medication.

RESULTS: 544 VAP patients were treated (282 LZD, 262 VAN). There were no significant differences between groups in the number of patients with at least one AE (82% vs 84%, respectively), drug-related AEs (14% vs 12%), discontinuation due to drug-related AEs (1.4% vs 1.5%), serious AEs (37% vs 38%), or deaths (16% vs 20%). AEs 5%, regardless of causality, in LZD vs VAN groups, respectively, were diarrhea (13.1% vs 11.1%), fever (5.7% vs 6.1%), pneumonia (6.0% vs 7.3%), respiratory failure (8.2% vs 5.0%), sepsis (7.4% vs 9.5%), urinary tract infection (8.2% vs 7.3%), and vomiting (5.3% vs 5.3%). Additional AEs 5% were pressure sore (5.3%), nausea (5.0%) and hypertension (5.0%) in the LZD group, and rash (7.3%) and hypotension (5.0%) in the VAN group. The only AE in 2% of patients that was considered drug-related was diarrhea (4.3% LZD vs 2.3% VAN, p=.20). The most common serious AEs (3%) were related to patients’ underlying disease: respiratory and multi-organ failure for LZD and sepsis, pneumonia and respiratory failure for VAN.

CONCLUSIONS: IV LZD is generally well tolerated in patients with ventilator-associated pneumonia. The nature and frequency of AEs were comparable in the LZD and VAN groups and were influenced by the severity of patients’ underlying disease.

CLINICAL IMPLICATIONS: Linezolid is a reasonable therapeutic option, with no increased risk of adverse events, in the treatment of patients with VAP.

DISCLOSURE: G.J. Hooper, Pharmacia employee, Industry.