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An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis

Published online by Cambridge University Press:  16 July 2001

J. HORTON
Affiliation:
Department of Therapeutics (Tropical Medicine), SmithKline Beecham International, Brentford, Middlesex, UK TW8 9BD
C. WITT
Affiliation:
Lymphatic Filariasis Elimination (CPE/CEE/FIL), Department of Control, Prevention and Eradication, World Health Organization, 1211 Geneva 27, Switzerland
E.A. OTTESEN
Affiliation:
Lymphatic Filariasis Elimination (CPE/CEE/FIL), Department of Control, Prevention and Eradication, World Health Organization, 1211 Geneva 27, Switzerland
J.K. LAZDINS
Affiliation:
Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, 1211 Geneva 27, Switzerland
D.G. ADDISS
Affiliation:
Division of Parasitic Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA 30341 USA
K. AWADZI
Affiliation:
Onchocerciasis Chemotherapy Research Centre, Hohoe Hospital, Hohoe, Ghana
M.J. BEACH
Affiliation:
Division of Parasitic Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA 30341 USA
V.Y. BELIZARIO
Affiliation:
College of Public Health, University of the Philippines, Manila, Philippines
S.K. DUNYO
Affiliation:
Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Ghana
M. ESPINEL
Affiliation:
Instituto Juan Cesar Garcia, P.O. Box 17-11-6292, Quito, Ecuador
J.O. GYAPONG
Affiliation:
Health Research Unit, Ministry of Health, P. O. Box 184, Accra, Ghana
M. HOSSAIN
Affiliation:
Institute of Epidemiology, Disease Control and Research (IEDCR), Mohakhali, Dhaka-1212, Bangladesh
M.M. ISMAIL
Affiliation:
Faculty of Medicine, University of Colombo, Kynsey Rd., Colombo 8, Sri Lanka
R.L. JAYAKODY
Affiliation:
Faculty of Medicine, University of Colombo, Kynsey Rd., Colombo 8, Sri Lanka
P.J. LAMMIE
Affiliation:
Division of Parasitic Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, GA 30341 USA
W. MAKUNDE
Affiliation:
Bombo Research Station, Tanga, Tanzania
D. RICHARD-LENOBLE
Affiliation:
Parasitologie-Médicine Tropicale, Faculté de Médicine, Tours, France
B. SELVE
Affiliation:
Misima Mines Pty, Ltd, Bwagoia, Misima Island, Papua New Guinea
R.K. SHENOY
Affiliation:
Filariasis Chemotherapy Unit, T. D. Medical College Hospital, Alleppey 688011, Kerala, India
P.E. SIMONSEN
Affiliation:
Danish Bilharziasis Laboratory, Jaegersborg Alle 1 D, 2920 Charlottenlund, Denmark
C.N. WAMAE
Affiliation:
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya
M.V. WEERASOORIYA
Affiliation:
Filariasis Research Laboratory, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka

Abstract

This review of the safety of the co-administration regimens to be used in programmes to eliminate lymphatic filariasis (albendazole+ivermectin or albendazole+diethylcarbamazine [DEC]) is based on 17 studies conducted in Sri Lanka, India, Haiti, Ghana, Tanzania, Kenya, Ecuador, the Philippines, Gabon, Papua New Guinea, and Bangladesh. The total data set comprises 90635 subject exposures and includes individuals of all ages and both genders. Results are presented for hospital-based studies, laboratory studies, active surveillance of microfilaria-positive and microfilaria-negative individuals, and passive monitoring in both community-based studies and mass treatment programmes of individuals treated with albendazole (n=1538), ivermectin (9822), DEC (576), albendazole+ivermectin (7470), albendazole+DEC (69020), or placebo (1144). The most rigorous monitoring, which includes haematological and biochemical laboratory parameters pre- and post-treatment, provides no evidence that consistent changes are induced by any treatment; the majority of abnormalities appear to be sporadic, and the addition of albendazole to either ivermectin or DEC does not increase the frequency of abnormalities. Both DEC and ivermectin show, as expected, an adverse event profile compatible with the destruction of microfilariae. The addition of albendazole to either single-drug treatment regimen does not appear to increase the frequency or intensity of events seen with these microfilaricidal drugs when used alone. Direct observations indicated that the level of adverse events, both frequency and intensity, was correlated with the level of microfilaraemia. In non microfilaraemic individuals, who form 80–90% of the ‘at risk’ populations to be treated in most national public health programmes to eliminate lymphatic filariasis (LF), the event profile with the compounds alone or in combination does not differ significantly from that of placebo. Data on the use of ivermectin+albendazole in areas either of double infection (onchocerciasis and LF), or of loiais (with or without concurrent LF) are still inadequate and further studies are needed. Additional data are also recommended for populations infected with Brugia malayi, since most data thus far derive from populations infected with Wuchereria bancrofti.

Type
Research Article
Copyright
© 2001 Cambridge University Press

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