title: Results of a safety trial on single-dose treatments with 400 mcg/kg of ivermectin in bancroftian filariasis.
abstract: Two groups of Polynesian Wuchereria bancrofti carriers, 17 females aged 21 to 84 years and 20 males aged 26 to 57 years, in whom microfilaraemia ranged from 1 to 10,121 mf/ml and from 1 to 6,484 mf/ml, respectively, were given a supervised singledose treatment with 400 mcg/kg of ivermectin. Carriers were examined and questioned regarding their experience of adverse reactions, which were graded 0 to 3 according to severity, at 6, 12 and 24 hours and at 4 days after treatment. Biological examinations which included determination of microfilaraemia, complete blood count, liver function tests and assessment of creatinine and urea levels were performed at 4 days before and 4 days after treatment. Adverse reactions were observed in 65% of female and in 70% of male carriers; they were of grade > or = 2 in 35% of carriers in both groups. None as considered serious; they all disappeared in 24-48 hours. The main symptoms were headache, fever > or = 37.5 degrees C and myalgia in females. One male vomited 3 hours after treatment; as a result the drug was not ingested and no decrease of microfilaraemia was noted. Twelve days afterwards, he was given a second 400 mcg/kg dose, he experienced again a grade 1 reaction and his microfilaraemia fell to zero. The 37 carriers in the present study were matched with 37 other Polynesian carriers treated with a 100 mcg/kg single dose of ivermectin in previous trials for pretreatment mf density and sex: no significant difference could be found in adverse reactions between the 2 treatment groups.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Institut Territorial de Recherches Medicales Louis Malardé, Papeete, Tahiti, Polynésie Francaise.
authors.forename: J L
authors.initials: JL
authors.lastname: Cartel
authors.forename: J P
authors.initials: JP
authors.lastname: Moulia-Pelat
authors.forename: P
authors.initials: P
authors.lastname: Glaziou
authors.forename: L N
authors.initials: LN
authors.lastname: Nguyen
authors.forename: S
authors.initials: S
authors.lastname: Chanteau
authors.forename: J F
authors.initials: JF
authors.lastname: Roux
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D002353:Carrier State / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004361:Drug Tolerance; D004605:Elephantiasis, Filarial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007559:Ivermectin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008842:Microfilariae; D008875:Middle Aged; D012737:Sex Factors; D014958:Wuchereria bancrofti
chemical_list: D007559:Ivermectin