Once daily isepamicin treatment in complicated urinary tract infections.

Isepamicin is a new aminoglycoside, derived from gentamicin B, which is more stable than other aminoglycosides against inactivating enzymes, and is less nephrotoxic. We evaluated the efficacy and safety of a once daily isepamicin in the treatment of complicated urinary tract infections (UTIs), as compared with amikacin. During the period May, 1997, to January, 1998, a total of 52 patients with similar demographic and baseline characteristics were enrolled into a prospective, randomized, open-label, single-center trial at the Veterans General Hospital-Kaohsiung. Eleven patients were excluded for protocol violation. The remaining 41 patients were included in the efficacy analysis. Study subjects included 16 men and 25 women, with a mean age of 57.9 (range 18-95) years. Clinical improvement was noted in 100% of patients in both the isepamicin and amikacin group. No statistically significant difference was observed between the 2 groups in regard to the rapidity of defervescence, relief of dysuria and urinary frequency, and clearance of bacteriuria and pyuria. Bacteriological cure rates were 89.4% for the isepamicin group and 100% for the amikacin group. Fifteen of 25 subjects who received isepamicin and 16 of 27 subjects who received amikacin had an adverse effect, all of which were considered to be mild except for one in the amikacin group, who had an adverse event of moderate severity (vomiting). Seven (3 isepamicin and 4 amikacin) adverse events were considered probably or possibly related to the study drug, which included eosinophilia (2 isepamicin), liver function impairment (1 isepamicin, 2 amikacin), renal function impairment (1 amikacin) and flushed face (1 amikacin). However, none of the patients had a life-threatening or severe adverse event that required discontinuation of the drug. These results show that once daily administration of isepamicin is as effective and safe as amikacin in treatment of complicated UTIs.