Linezolid is superior to vancomycin in the treatment of nosocomial pneumonia caused by MRSA
Unlike the results of two recently published meta-analyzes and a systematic review previously presented on the ANTIBIOTIC.ru website (“Comparison of linezodide with vancomycin and teicoplanin in the treatment of nosocomial pneumonia: results of a meta- analysis "and" Linezolid vs vancomycin or teicoplanin in the treatment of nosocomial pneumonia: results of a systematic review and meta-analysis ") which did not reveal the benefits of linezolid over vancomycin or teicoplanin in the treatment of nosocomial pneumonia (NP), a group of researchers dstvom JE Chastre, at the 48th annual conference of the American Society for Infectious Diseases (IDSA), held in October 2010 in Vancouver, a presented data on the higher efficacy of linezolid compared to vancomycin in the treatment of NP caused by strains resistant to methicillin S. aureus (MRSA).
The data presented was obtained in the international multicentre randomized double-blind phase IV clinical trial, conducted in 156 centers in different countries of the world. The study included 1,225 adult patients with PN, specifically caused by MRSA, who were randomized 1: 1 for two treatment groups. Patients in the first group received 600 mg of linezolid 2 times a day, the second - 15 mg / kg of vancomycin twice a day for 7 to 14 days.
Analysis of the study results was carried out in the ITT patient population (i.e. in the patient population to be treated), in the modified ITT population (m-ITT, including patients with infection confirmed by MRSA), and in the patient population corresponding to the protocol (PP- a population which included m-ITT patients who met all the basic requirements of the study protocol).
Among 1,184 patients treated, 38% were included in the mITT population and 29% in the PP population. The two treatment groups were comparable in terms of basic characteristics and clinical parameters. The APACHE-II score was 17.2 and 17.4 points in the linezolid and vancomycin treatment groups, respectively. Mechanical ventilation was performed in 67% of patients in the linezolid group and in 74% of patients who received vancomycin therapy.
An analysis of the treatment results showed that the efficacy of the treatment at the time of treatment was observed in 57.6% of the patients in the linezolid group and in 46.6% of the patients in the vancomycin group. Thus, the effectiveness of treatment with linezolid met not only the statistical criterion "no worse" (95% CI 0.5% to 21.6%), but also significantly higher than vancomycin (p = 0.042). The absolute difference in the efficacy of linezolid and vancomycin was 11%. Similar results were obtained when analyzing data from the mITT population and the PP population: efficacy was observed in 83% and 83% of patients in the linezolid group respectively and in 70% and 68 % respectively in the group treated with vancomycin. The frequency of pathogen eradication was also significantly higher with linezolid (80% vs 61%).
In the linezolid group, 54 deaths and 145 cases of serious adverse events (SIAs) were noted, of which 5 were considered to be drug related. In the vancomycin treatment group, 59 cases of death and 141 SJS were recorded, of which 13 were considered to be associated with vancomycin treatment. In total, in 378 patients receiving linezolid, 1471 cases of adverse events (AEs) were recorded, and in the vancomycin treatment group (n = 410), 1580 AEs were recorded.