A case-control auditory evaluation of patients treated with artemether-lumefantrine.
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.
Hutagalung
Robert
R
Shoklo Malaria Research Unit, Mae Sot, Tak Province, Thailand. wec1@cdc.gov
Htoo
Hsar
H
Nwee
Paw
P
Arunkamomkiri
Jaruwan
J
Zwang
Julien
J
Carrara
Verena I
VI
Ashley
Elizabeth
E
Singhasivanon
Pratap
P
White
Nicholas J
NJ
Nosten
François
F
D000158:Acoustic Impedance Tests; D000293:Adolescent; D000328:Adult; D000368:Aged; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D000077549:Artemether; D037621:Artemisinins / Q000009:adverse effects / Q000627:therapeutic use*; D001299:Audiometry; D016022:Case-Control Studies; D002648:Child; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D016057:Evoked Potentials, Auditory, Brain Stem; D005260:Female; D005449:Fluorenes / Q000009:adverse effects / Q000627:therapeutic use*; D034381:Hearing Loss / Q000139:chemically induced; D006801:Humans; D000078102:Lumefantrine; D008288:Malaria / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000962:Antimalarials; D037621:Artemisinins; D004983:Ethanolamines; D005449:Fluorenes; D000077549:Artemether; D000078102:Lumefantrine