OVERVIEW OF THE EFFICACY OF ISEPAMICIN IN THE ADULT CORE CLINICAL-TRIAL PROGRAM

The efficacy of once-daily administration of isepamicin in hospitalise d adult patients has been assessed in a multinational clinical trials programme. Following a small phase II programme, the phase III program me assessed four main indications: lower respiratory tract infections (including nosocomial pneumonia), urinary tract, intra-abdominal and s kin and soft tissue infections. The phase III trials were open, prospe ctive, multicentre studies in which 1443 patients were randomised to r eceive either isepamicin (n=1005) or amikacin (n=438). The daily dose of isepamicin was dependent on the severity of infection (8 or 15 mg/k g once daily) while all patients received amikacin 7.5 mg/kg twice dai ly. A study of patients with nosocomial pneumonia had an additional tr eatment arm of isepamicin 7.5 mg/kg twice daily. The aminoglycosides w ere combined with other antimicrobial agents in accordance with curren t clinical practice depending on the site and severity of the infectio n and the type of organism isolated. Overall, clinical cure or improve ment response rates of the isepamicin and amikacin regimens were compa rable, ranging from 76-95% in the intent-to-treat population. Lower cl inical response rates (62-63%) were observed in severely ill patients with nosocomial pneumonia in both the isepamicin and amikacin treatmen t groups. In the efficacy population, organism elimination rates of 90 % were achieved with isepamicin and amikacin. Therefore, in adult pati ents with a wide range of infections requiring aminoglycoside therapy, once-daily dosing with isepamicin is as effective as twice-daily dosi ng with amikacin.