title: Safety trial of single-dose treatments with a combination of ivermectin and diethylcarbamazine in bancroftian filariasis.
abstract: A supervised safety trial of the treatment with a combination of ivermectin 400 micrograms.kg-1 (IVER 400) plus increasing doses of diethylcarbamazine (DEC), given simultaneously in single dose, was performed on five groups of Polynesian Wuchereria bancrofti carriers, 49 males aged 25 to 73 years, in whom microfilaremia ranged from 1 to 6,137 mf/ml. The trial was hospital-based, open, dose-escalating (1 group per week). Safety of an unchanging dose of IVER 400 and ascending doses of DEC were studied in the 5 following groups: group 1- IVER 400 plus DEC 1 mg.kg-1, 12 patients; group 2- IVER 400 plus DEC 3 mg.kg-1, 17 patients; group 3- IVER 400 plus DEC 6 mg.kg-1, 10 patients. Two control groups were included in the study, group 4- DEC 6 mg.kg-1 alone, 5 patients; group 5-: IVER 400 alone, 5 patients. 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 examination was performed 4 days before and 4 days after treatment and included determination of microfilaremia, complete blood count, liver function tests and assessment of creatinine and urea levels. Adverse reactions were observed in 51% of 49 carriers (15 of grade 1, 8 of grade 2, 2 of grade 3). None was considered serious and they all disappeared in 2 days. The main symptoms were fever > or = 37.5 degrees C, myalgia, arthralgia, headache, asthenia, anorexia, vertigo and chills. Adverse reactions of patients were not significantly different between the five groups.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Institut Territorial de Recherches Medicales Louis Malarde, Papeete, Tahiti, Polynesie Francaise.
authors.forename: J P
authors.initials: JP
authors.lastname: Moulia-Pelat
authors.forename: L N
authors.initials: LN
authors.lastname: Nguyen
authors.forename: P
authors.initials: P
authors.lastname: Glaziou
authors.forename: S
authors.initials: S
authors.lastname: Chanteau
authors.forename: V M
authors.initials: VM
authors.lastname: Gay
authors.forename: P M
authors.initials: PM
authors.lastname: Martin
authors.forename: J L
authors.initials: JL
authors.lastname: Cartel
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D002353:Carrier State / Q000097:blood / Q000188:drug therapy*; D004049:Diethylcarbamazine / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004605:Elephantiasis, Filarial / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007559:Ivermectin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008842:Microfilariae / Q000187:drug effects; D008875:Middle Aged; D013997:Time Factors; D014958:Wuchereria bancrofti / Q000187:drug effects
chemical_list: D004338:Drug Combinations; D007559:Ivermectin; D004049:Diethylcarbamazine