Safety, tolerability, efficacy and plasma concentrations of diethylcarbamazine and albendazole co-administration in a field study in an area endemic for lymphatic filariasis in India

• Published in: Transactions of the Royal Society of Tropical Medicine and Hygiene 2004-04, Vol.98 (4), p.205-217
• Main Authors: Kshirsagar, N.A, Gogtay, N.J, Garg, B.S, Deshmukh, P.R, Rajgor, D.D, Kadam, V.S, Kirodian, B.G, Ingole, N.S, Mehendale, A.M, Fleckenstein, L, Karbwang, J, Lazdins-Helds, J.K
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Albendazole - administration & dosage; Albendazole - adverse effects; Albendazole - blood; Biological and medical sciences; Child; Child, Preschool; Diethylcarbamazine - administration & dosage; Diethylcarbamazine - adverse effects; Diethylcarbamazine - blood; Diseases caused by nematodes; Double-Blind Method; Drug Therapy, Combination; Elephantiasis, Filarial - blood; Elephantiasis, Filarial - drug therapy; Elephantiasis, Filarial - epidemiology; Endemic Diseases; Female; Filariases; Filaricides - administration & dosage; Filaricides - adverse effects; Filaricides - blood; Helminthic diseases; Humans; India - epidemiology; Infectious diseases; Lymphatic filariases; Male; Medical sciences; Middle Aged; Parasitic diseases; Treatment Outcome
• ISSN: 0035-9203; 1878-3503
• DOI: 10.1016/S0035-9203(03)00044-0

Filariasis control programmes are moving towards a strategy of repeated single-dose mass treatment of endemic populations. Using a combination, such as albendazole (ALB) to diethylcarbamazine (DEC) gives both macrofilaricidal and antihelmintic activity. However, the safety of the combination versus DEC alone should be established in field studies in large populations prior to incorporation into national programmes. The present study compared the safety, tolerability, and efficacy of single doses of DEC 6 mg/kg + ALB placebo with DEC 6 mg/kg + ALB 400 mg in populations living in two filariasis endemic villages in the district of Wardha in western India. The study was double blind, parallel group, and randomized. Safety and tolerability study were studied in males and females older than 5 years. Safety was assessed by monitoring if adverse events (AEs) over 5 days affected daily acivities. Subjects in the 2 treatment groups experienced insignificantly different effects on daily activities and the combination was shown to be safe. Efficacy was evaluated by microfilaraemia (Mf), immunochromatographic test (ICT) and ultrasonography (USG) at 0, 3, 6, and 12 months of follow up. The efficacy study enrolled 103 male patients (aged 18–50 years) in microfilariae positive, clinical disease and asymptomatic, amicrofilaremic groups. There was no significant difference in efficacy between groups at 12 months. Within the Mf positive group, significant differences were seen in microfilaraemia ( P