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Journal of Antimicrobial Chemotherapy (1993) 31, 939-948
© 1993 The British Society for Antimicrobial Chemotherapy
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Once- versus twice-daily amikacin regimen: efficacy and safety in systemic Gram-negative infections
aDepartment of Infectious Diseases, University Hospital S-581 85 Linköping, Sweden bDepartment of Infectious Diseases, Central Hospital Borås, Sweden cDepartnwnt of Infectious Diseases, Central Hospital Boden, Sweden dDepartment of Surgery F, Bispebjerg Hospital Copenhagen, Denmark eDepartment of Microbiology, University Hospital Linköping, Sweden fDepartment of Infectious Diseases, Central Hospital Västerås, Sweden
Received 10 March 1992; accepted 16 January 1993
Three hundred and sixteen patients with serious infections verified or suspected to be of Gram-negative aetiology were treated in an open, randomized, comparative multicentre study with amikacin 15 mg/kg/day given either as a single dose or in two divided doses at 12 h intervals. Two hundred patients were evaluated for efficacy and all 316 for safety. The efficacy of both dosage regimens was very good with a satisfactory clinical response in 90% of the patients. There were no significant differences between the two regimens regarding efficacy and safety. This was also confirmed in an analysis according to the principle of ‘intention-to-treat’ including all randomized patients. In 218 patients additional therapy, most commonly with piperacillin or ampicillin, was considered necessary. The mean peak serum concentration of amikacin was 40·9 mg/L in the once-daily group, which is 10 x MIC for most Gram-negative bacteria, compared to 244 mg/L in the twice-daily group, which is 6 x MIC. Mean trough serum concentrations after 24 h were 1·8 mg/L in the once-daily group and 3·1 mg/L after 12 h in the twice-daily group. These serum concentrations were often close to or just below the MICs of the isolated pathogens. Drug related adverse reactions were seen in 40 (13%) of the patients. Among the adverse reactions with possible or probable relation to amikacin were 20 nephrotoxic events, nine in the once-daily group and 11 in the twice-daily group. A multivariate analysis of selective causative factors and nephrotoxic events gave a low correlation for once- vs twice-daily amikacin therapy. Five ototoxic events were observed, three in the once-daily group and two in the twice-daily group. One patient in the once-daily group experienced nausea in connection with amikacin infusions.
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