Ototoxicity of Gentamicin in Man: A Survey and Controlled Analysis of Clinical Experience in the United States

Abstract

Ototoxicity from gentamicin was recognized early as a potential risk. From clinical trials in the U.S. between 1962 and 1969, a total of 72 courses of treatment resulted in ototoxicity of which 70 courses in 69 patients were reviewed. Gentamicin-induced ototoxicity was doubtful in 26 cases, and probable in 44. The recent clinical incidence was 2.8%, the true incidence about 2%. Among 1,484 courses from 1966 to 1969 in which there was no ototoxicity, 843 were compared to those with ototoxicity. In matched subgroups, 14 variables were analyzed by stepwise discriminant function and for the statistical significance of differences in incidence or mean values. Impaired renal function was the dominant characteristic of patients. The dose (in mg/kg per day) was the major factor in treatment and the only significant one in patients with normal renal function. With renal impairment, previous courses with ototoxic antibiotics and the total dose/kg were important. The duration of treatment was not significant. Age had a variable effect. The risk of ototoxicity should not prevent proper treatment with gentamicin.