Safety profile of meropenem: results of use in over 6,000 patients
A review published in 2007 confirmed the data on a favorable safety profile and good tolerability of meropenem in various categories of patients with severe infectious diseases.
Meropenem is a parenteral carbapenem with a broad spectrum of activity against gram-positive, gram-negative and anaerobic bacteria. Meropenem is the second parenteral carbapenem that appeared on the world pharmaceutical market in 1994. To date, 3 large-scale studies on the safety of meropenem have been published. The last review was conducted after approval of meropenem in the United States in 2005 for the treatment of patients with complicated skin and soft tissue infections in addition to the previously approved indications (intra-abdominal infections and bacterial meningitis in children) and published in 2007. This work included the results of clinical trials already used in the two previous publications on the safety of meropenem, as well as new information obtained in a large-scale international study in patients with complicated infections E skin and soft tissue, and new data on the experience of using meropenem in patients with intra-abdominal infections and bacterial meningitis.
The review included information on the use of meropenem in 6154 patients who received 6308 courses of this antibiotic, compared to the use of 4594 courses of other SAP in 4483 patients, as well as safety data in the pediatric population (more than 1000 children). The data presented in the review confirmed the favorable safety profile of meropenem, which was demonstrated in the two previous studies. In general, the frequency and spectrum of adverse events (AEs) recorded during the use of meropenem are comparable to those of the treatment of imipenem, cephalosporins and clindamycin in combination with aminoglycosides. The most common AEs associated with meropenene treatment were diarrhea (2.5%), rash (1.4%) and nausea / vomiting (1.2%). In general, the incidence of AE during treatment with meropenem did not exceed 3%, which is a very low indicator and indicates good tolerability of the drug. There were no unexpected ARs, and the frequency of seizures during treatment with meropenem in meningitis patients was low, and the seizures were considered by the researchers to be unrelated to the drug. In other infectious diseases, the incidence of seizures associated with the use of meropenem was 0.07% compared to 0.04% for cephalosporins and 0.23% for imipenem. The frequency of withdrawal from the study due to adverse events was 2.5% in the meropenem and cephalosporin groups, 3.2% in the imipenem group and 1.1% in the clindamycin + aminoglycoside group.
Thus, based on the analysis of the above data, it can be concluded that meropenem is well tolerated and has a favorable safety profile in patients with severe bacterial infections, including special patient populations, for example, bacterial meningitis and children.