A case-control auditory evaluation of patients treated with artemether-lumefantrine

Am J Trop Med Hyg. 2006 Feb;74(2):211-4.

Abstract

Artemether-lumefantrine is the first registered, fixed, artemisinin-based combination treatment. Artemisinin derivatives are highly effective antimalarials with a favorable safety profile. Concerns remain over their potential neurotoxicity, although there has been no clinical evidence of this in humans. In animals (rats, dogs, and monkeys) artemether, a derivative of artemisinin is associated with an unusual toxicity pattern in specific brain nuclei involving the auditory and vestibular pathways. A recent report from Mozambique described a small but significant and irreversible hearing loss in patients exposed to artemether-lumefantrine. To explore this issue, we conducted a case-control study using tympanometry, audiometry and auditory brain-stem responses. We assessed 68 subjects who had been treated with artemether-lumefantrine within the previous five years and 68 age- and sex-matched controls living in the malarious region along the Thailand-Myanmar border. There were no differences in the test results between cases and controls. There was no neurophysiologic evidence of auditory brainstem toxicity that could be attributed to artemether-lumefantrine in this study population.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acoustic Impedance Tests
  • Adolescent
  • Adult
  • Aged
  • Antimalarials / adverse effects
  • Antimalarials / therapeutic use*
  • Artemether
  • Artemisinins / adverse effects
  • Artemisinins / therapeutic use*
  • Audiometry
  • Case-Control Studies
  • Child
  • Drug Therapy, Combination
  • Ethanolamines / adverse effects
  • Ethanolamines / therapeutic use*
  • Evoked Potentials, Auditory, Brain Stem
  • Female
  • Fluorenes / adverse effects
  • Fluorenes / therapeutic use*
  • Hearing Loss / chemically induced
  • Humans
  • Lumefantrine
  • Malaria / drug therapy*
  • Male
  • Middle Aged
  • Treatment Outcome

Substances

  • Antimalarials
  • Artemisinins
  • Ethanolamines
  • Fluorenes
  • Artemether
  • Lumefantrine