N-Acetyl Cysteine in Prevention of Amphotericin- Induced Electrolytes Imbalances: A Randomized, Double-Blinded, Placebo-Controlled, Clinical Trial Publisher Pubmed



Karimzadeh I¹ ; Khalili H¹ ; Dashtikhavidaki S¹ ; Sharifian R² ; Abdollahi A³ ; Hasibi M⁴ ; Khazaeipour Z⁵ ; Farsaei S⁶ Show Affiliations
Source: European Journal of Clinical Pharmacology Published:2014

Abstract

Purpose: The aim of this study was to evaluate the effectiveness of oral n-acetyl cysteine, as a potential nephroprotective agent, in preventing and/or attenuating amphotericin B-induced electrolytes imbalances. Methods: During a one year period, patients were to receive conventional amphotericin b for any indication for at least one week and were randomly allocated to receive either placebo or 600 mg oral n-acetyl cysteine twice daily during the treatment course of amphotericin b. Demographic and clinical data of the study population were gathered. Different aspects of amphotericin b nephrotoxicity including decrease of glomerular filtration rate, hypokalemia, hypomagnesemia, renal magnesium and potassium wasting were assessed. Each patient was monitored for any adverse reaction to n-acetyl cysteine. Sixteen and 14 patients in the n-acetyl cysteine and placebo groups completed the study, 3incidences of hypokalemia (75 % versus 70 %; P=0.724) and hypomagnesemia (30 % versus 20 %; P=0.468) did not differ significantly between placebo and NAC groups, respectively. Although the rate of AmB nephrotoxicity was higher in the placebo than in the NAC group (60 % versus 40 %), this difference was not statistically significant (P=0.209) even after adjusting for probable associated factors of amphotericin b nephrotoxicity (P=0.206). The incidence as well as time of onset of electrolyte abnormalities also did not differ significantly between placebo and n-acetyl cysteine groups. About 44 % of n-acetyl cysteine recipients experienced new onset nausea and a mild unpleasant taste during the study. Conclusion: Oral n-acetyl cysteine during the amphotericin B treatment course was not significantly effective in preventing or mitigating different features of its nephrotoxicity including decrease of glomerular filtration rate, hypokalemia, hypomagnesemia, and renal potassium as well as magnesium wasting. © 2014 Springer-Verlag.