Linezolid - a new alternative to treat diabetic foot ulcers

In late October 2002, representatives of Pharmacia announced the completion of an 11-month comparative clinical trial of linezolid (Zivox) in the treatment of patients with diabetic foot ulcers. The results of the study were presented by a team of scientists led by Dr. B. Lipsky at the 40th conference of the American Society for Infectious Diseases (IDSA), held in Chicago. According to the data presented, linezolid has shown the same efficacy in the treatment of diabetic foot ulcers caused by Gram-positive microorganisms as the combined antibacterial drugs traditionally used in these patients.

The main indications for linezolid administration are infections in adult patients caused by Staphylococcus aureus (strains resistant to methicillin and sensitive to methicillin), Streptococcus pyogenes and Streptococcus agalactiae. It is known that the most common causative agent of diabetic foot ulcers is S. aureus. In addition, recently in these patients, methicillin-resistant strains of this microorganism (MRSA) are increasingly isolated. In a study by B. Lipsky et al. in all patients with diabetic foot ulcers (n = 371) included in the period from April 2001 to March 2002, the causative agent of the infection was S. aureus.

During the study, all patients were randomized into 2 groups: 248 patients received linezolid orally or intravenously, 123 patients were one of the standard antibiotic regimens: ampicillin / sulbactam (intravenous) or amoxicillin / clavulanate (inside). The duration of treatment varied from 7 to 28 days. If necessary, actions on gram-negative microorganisms were additionally prescribed to aztreons in patients of both groups.

According to the manufacturer, linezolid has shown greater clinical efficacy than the aminopenicillin / beta-lactamase inhibitor combinations, which amounted to 81.3% and 71.3% respectively.

According to representatives of Pharmacia, most of the patients included in the study were treated on an outpatient basis and received only one antibacterial drug. In patients receiving linezolid, a higher frequency of adverse drug reactions has been noted, mainly in the blood and gastrointestinal tract. At the same time, it was noted that all of the adverse drug reactions were reversible.

In summary, Dr. B. Lipsky noted that the results of the study suggest that linezolid is an effective alternative to traditional antibiotic regimens for diabetic foot ulcers, particularly in cases caused by S.aureusmethicillin resistant.