The post-marketing surveillance of meropenem (Meropen®) administered over 2g/day for serious infectious diseases was conducted between August 2011 and June 2013 to evaluate safety and efficacy under actual clinical use. There were 382 and 322 evaluable cases for safety and efficacy respectively, of 399 case cards collected from 87 institutions.
In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 19.1% (73/382 cases) and the main ADRs were hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, liver disorder, and diarrhoea, which were similar to these observed in the post-marketing surveillances of meropenem conducted before. In efficacy analysis, the efficacy was 73.6% (237/322 cases), which is as same as 71.4% (3214/4504 cases) of post marketing surveillance of meropenem conducted after first approval under 2g/day for infectious diseases.
These results confirmed meropenem (Meropen®) is one of the useful antimicrobial agents for serious infectious diseases.
We examined regional surveillance of antimicrobial susceptibility of community acquired bacterial pathogens from patients in Saitama, Japan. The fourth-year survey was conducted in three of the period 2007–2010 (period I, 2007–2008; period II, 2008–2009; period III, 2009–2010. Antimicrobial susceptibility testing was conducted at the central reference laboratory according to the method recommended by Japanese Society of Chemotherapy using maximum 13 antibacterial agents. Susceptibility testing was evaluable with 789 strains (227 Streptococcus pneumoniae, 148 Streptococcus pyogenes, 220 Haemophilus influenzae, and 194 Moraxella catarrhalis). Ratio of penicillin-susceptible S. pneumoniae (PSSP, MIC of benzylpenicillin ≦0.06 μg/mL) was 43.5% (period I), 43.5% (period II) and 55.8% (period III), and those of erythromycin-sensitive and azithromycin-sensitive S. pyogenes were 100% and 65.5% (period I), 47.9% and 47.9% (period II), 29.4%, and 29.4% (period III), respectively. Among H. influenzae, β-lactamase-nonproducing ampicillin-resistant isolates were 34.9% (period I), 25.8%(period II), and 17.1% (period III); however, β-lactamase-nonproducing ampicillin-intermediately resistant isolates were 19.8% (period I), 26.9% (period II), and 29.3% (period III). Regarding M. catarrhalis, macrolides showed potent activities, with MIC90s of ≦0.25~0.5 μg/mL, and fluoroquinolones showed strong activities, with MIC90s≦0.03~0.125 μg/mL. The result of this survey indicated that the trends observed were similar to the results of previous nationwide surveillance.