Antiparasitic drugs for paediatrics: Systematic review, formulations, pharmacokinetics, safety, efficacy and implications for control

Parasitology

Volumn 138, Issue 12, 2011, Pages 1620-1632

  Keiser, Jennifer ^a,b   Ingram, Katrin ^a,b   Utzinger, Jürg ^a,b  

^a SWISS TROPICAL AND PUBLIC HEALTH INSTITUTE   (Switzerland)

^b UNIVERSITY OF BASEL   (Switzerland)

Author keywords

adolescence; anthelminthics; antimalarials; Antiparasitic drugs; children; drug formulation; infants; paediatrics; preventive chemotherapy; systematic review

Indexed keywords

ALBENDAZOLE; ANTIPARASITIC AGENT; IVERMECTIN; LEVAMISOLE; MEBENDAZOLE; PRAZIQUANTEL; PYRANTEL EMBONATE; TRICLABENDAZOLE;

AFRICA; COCHRANE LIBRARY; DRUG BIOAVAILABILITY; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; ECONOMIC ASPECT; ETHICS; FASCIOLIASIS; FILARIASIS; GOVERNMENT REGULATION; HELMINTHIASIS; HUMAN; MEDLINE; MORBIDITY; MULTIPLE CYCLE TREATMENT; NONHUMAN; PEDIATRICS; PREVALENCE; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; SCHISTOSOMIASIS; SINGLE DRUG DOSE; STRONGYLOIDIASIS;

ADOLESCENT; ANCYLOSTOMATOIDEA; ANIMALS; ANTIPARASITIC AGENTS; CHEMISTRY, PHARMACEUTICAL; CHILD; CHILD, PRESCHOOL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; INFANT; PARASITIC DISEASES; PEDIATRICS; SCHISTOSOMA MANSONI; TREATMENT OUTCOME;

EID: 84855684716     PISSN: 00311820     EISSN: 14698161     Source Type: Journal    
DOI: 10.1017/S0031182011000023     Document Type: Review

References (81)

1. Aponte, J. J., Schellenberg, D., Egan, A., Breckenridge, A., Carneiro, I., Critchley, J., Danquah, I., Dodoo, A., Kobbe, R., Lell, B., May, J., Premji, Z., Sanz, S., Sevene, E., Soulaymani-Becheikh, R., Winstanley, P., Adjei, S., Anemana, S., Chandramohan, D., Issifou, S., Mockenhaupt, F., Owusu-Agyei, S., Greenwood, B., Grobusch, M. P., Kremsner, P. G., Macete, E., Mshinda, H., Newman, R. D., Slutsker, L., Tanner, M., Alonso, P. and Menendez, C. (2009). Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials. Lancet 374, 1533-1542.
2. Barsch, M. and Otte, A. (2010). The legal standards for the radioactive or non radioactive drugs research and approval in the European Community and in Germany after the thalidomide catastrophe. Hellenic Journal of Nuclear Medicine 13, 45-51.
3. Bethony, J., Brooker, S., Albonico, M., Geiger, S. M., Loukas, A., Diemert, D. and Hotez, P. J. (2006). Soil-transmitted helminth infections: ascariasis, trichuriasis, and hookworm. Lancet 367, 1521-1532.
4. Betson, M., Sousa-Figueiredo, J. C., Rowell, C., Kabatereine, N. B. and Stothard, J. R. (2010). Intestinal schistosomiasis in mothers and young children in Uganda: investigation of field-applicable markers of bowel morbidity. American Journal of Tropical Medicine and Hygiene 83, 1048-1055.
5. Black, R. E., Cousens, S., Johnson, H. L., Lawn, J. E., Rudan, I., Bassani, D. G., Jha, P., Campbell, H., Fischer Walker, C., Cibulskis, R., Eisele, T., Liu, L., Mathers, C., Child Health Epidemiology Reference Group of WHO and UNICEF (2010). Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet 375, 1969-1987.
6. Boots, I., Sukhai, R. N., Klein, R. H., Holl, R. A., Wit, J. M., Cohen, A. F. and Burggraaf, J. (2007). Stimulation programs for pediatric drug research-do children really benefit? European Journal of Pediatrics 166, 849-855.
7. Bosompem, K. M., Bentum, I. A., Otchere, J., Anyan, W. K., Brown, C. A., Osada, Y., Takeo, S., Kojima, S. and Ohta, N. (2004). Infant schistosomiasis in Ghana: a survey in an irrigation community. Tropical Medicine and International Health 9, 917-922.
8. Breitkreutz, J. (2009). Dosage forms for children. After the EU Reform. Pharmazie unserer Zeit 38, 30-37.
9. Breitkreutz, J. and Boos, J. (2007). Paediatric and geriatric drug delivery. Expert Opinion on Drug Delivery 4, 37-45.
10. Breitkreutz, J., Tuleu, C. and Solomonidou, D. (2007). Paediatric formulations. In: Guide to Paediatric Clinical Research (ed. Rose, K. and van den Anker, J. N.), pp. 65-77. Karger, Basel.
11. Choonara, I. (2009). Ethical and safety aspects of clinical trials in neonates. Early Human Development 85, S19-20.
12. Cohen, J., Dibner, M. S. and Wilson, A. (2010). Development of and access to products for neglected diseases. PLoS One 5, e10610.
13. Conroy, S.,McIntyre, J., Choonara, I. and Stephenson, T. (2000). Drug trials in children: problems and the way forward. British Journal Clinical Pharmacology 49, 93-97.
14. Doenhoff, M. J., Hagan, P., Cioli, D., Southgate, V., Pica-Mattoccia, L., Botros, S., Coles, G., Tchuem Tchuenté, L. A., Mbaye, A. and Engels, D. (2009). Praziquantel: its use in control of schistosomiasis in sub-Saharan Africa and current research needs. Parasitology 136, 1825-1835.
15. European Medicines Agency (2006). Reflection paper: formulations of choice for the paediatric population. European Medicines Agency, London.
16. Fairweather, I. (2009). Triclabendazole progress report, 2005-2009: an advancement of learning? Journal of Helminthology 83, 139-150.
17. Fenwick, A., Webster, J. P., Bosque-Oliva, E., Blair, L., Fleming, F. M., Zhang, Y., Garba, A., Stothard, J. R., Gabrielli, A. F., Clements, A. C. A., Kabatereine, N. B., Toure, S., Dembele, R., Nyandindi, U., Mwansa, J. and Koukounari, A. (2009). The Schistosomiasis Control Initiative (SCI): rationale, development and implementation from 2002-2008. Parasitology 136, 1719-1730.
18. Fox, L. M. (2006). Ivermectin: uses and impact 20 years on. Current Opinion in Infectious Diseases 19, 588-593.
19. Garba, A., Barkire, N., Djibo, A., Lamine, M. S., Sofo, B., Gouvras, A. N., Bosque-Oliva, E., Webster, J. P., Stothard, J. R., Utzinger, J. and Fenwick, A. (2010). Schistosomiasis in infants and preschool-aged children: infection in a single Schistosoma haematobium and a mixed S. haematobium-S. mansoni foci of Niger. Acta Tropica 115, 212-219.
20. Geary, T. G., Woo, K., McCarthy, J. S., Mackenzie, C. D., Horton, J., Prichard, R. K., de Silva, N. R., Olliaro, P. L., Lazdins-Helds, J. K., Engels, D. A. and Bundy, D. A. (2010). Unresolved issues in anthelmintic pharmacology for helminthiases of humans. International Journal for Parasitology 40, 1-13.
21. Gosling, R. D., Cairns, M. E., Chico, R. M. and Chandramohan, D. (2010). Intermittent preventive treatment against malaria: an update. Expert Reviews of Anti-Infective Therapy 8, 589-606.
22. Hotez, P. J., Engels, D., Fenwick, A. and Savioli, L. (2010). Africa is desperate for praziquantel. Lancet 376, 496-498.
23. Hotez, P. J., Molyneux, D. H., Fenwick, A., Kumaresan, J., Ehrlich Sachs, S., Sachs, J. D. and Savioli, L. (2007). Control of neglected tropical diseases. New England Journal of Medicine 357, 1018-1027.
24. Howie, R. C. (2011). Blood sample volumes in child health research: review of safe limits. Bulletin of the World Health Organization 89, 46-53.
25. Jordan, P. and Webbe, G. (1969). Human Schistosomiasis. William Heinemann Medical Books Ltd, London.
26. Kastner, M., Wilczynski, N. L., Walker-Dilks, C., McKibbon, K. A. and Haynes, B. (2006). Age-specific search strategies for Medline. Journal of Medical Internet Research 8, e25.
27. Kayser, O., Olbrich, C., Croft, S. L. and Kiderlen, A. F. (2003). Formulation and biopharmaceutical issues in the development of drug delivery systems for antiparasitic drugs. Parasitology Research 90 (Suppl. 2), S63-S70.
28. Kearns, G. L., Abdel-Rahman, S. M., Alander, S.W., Blowey, D. L., Leeder, J. S. and Kauffman, R. E. (2003). Developmental pharmacology-drug disposition, action, and therapy in infants and children. New England Journal of Medicine 349, 1157-1167.
29. Keiser, J., Engels, D., Büscher, G. and Utzinger, J. (2005). Triclabendazole for the treatment of fascioliasis and paragonimiasis. Expert Opinion on Investigational Drugs 14, 1513-1526.
30. Keiser, J. and Utzinger, J. (2007). Advances in the discovery and development of trematocidal drugs. Expert Opinion on Drug Discovery 2 (Suppl. 1), S9-S23.
31. Keiser, J. and Utzinger, J. (2008). Efficacy of current drugs against soiltransmitted helminth infections: systematic review and meta-analysis. JAMA 299, 1937-1948.
32. Keiser, J. and Utzinger, J. (2010). The drugs we have and the drugs we need against major helminth infections. Advances in Parasitology 73, 197-230.
33. Kuepfer, I. and Burri, C. (2009). Reflections on clinical research in sub-Saharan Africa. International Journal for Parasitology 39, 947-954.
34. Lippert, C., Gbenado, S., Qiu, C., Lavin, B. and Kovacs, S. J. (2005). The bioequivalence of telithromycin administered orally as crushed tablets versus tablets swallowed whole. Journal of Clinical Pharmacology 45, 1025-1031.
35. Lunn, P. G. and Northrop-Clewes, C. A. (1993). The impact of gastrointestinal parasites on protein-energy malnutrition in man. Proceedings of the Nutrition Society 52, 101-111.
36. Macleod, S. (2010). Therapeutic drug monitoring in paediatrics: how do children differ? Therapeutic Drug Monitoring 32, 253-256.
37. Mafiana, C. F., Ekpo, U. F. and Ojo, D. A. (2003). Urinary schistosomiasis in preschool children in settlements around Oyan Reservoir in Ogun State, Nigeria: implications for control. Tropical Medicine and International Health 8, 78-82.
38. Mellin, G.W. and Katzenstein, M. (1962). The saga of thalidomide. Neuropathy to embryopathy, with case reports of congenital anomalies. New England Journal of Medicine 267, 1238-1244.
39. Mennella, J. A. and Beauchamp, G. K. (2008). Optimizing oral medications for children. Clinical Therapy 30, 2120-2132.
40. Meyer, T., Sekljic, H., Fuchs, S., Bothe, H., Schollmeyer, D. and Miculka, C. (2009). Taste, a new incentive to switch to (R)-praziquantel in schistosomiasis treatment. PLoS Neglected Tropical Diseases 3, e357.
41. Michele, T. M., Knorr, B., Vadas, E. B. and Reiss, T. F. (2002). Safety of chewable tablets for children. Journal of Asthma 39, 391-403.
42. Milne, C. P. (2009). Pharmaceutical economics and applications to pediatrics: business case development. In Pediatric Drug Development Concepts and Applications (ed. Mulberg, A. E., Silber, S. A. and van den Anker, J. N.) pp. 39-57. John Wiley & Sons, Hoboken.
43. Milne, C. P. and Bruss, J. B. (2008). The economics of paediatric formulation development for off-patent drugs. Clinical Therapy 30, 2133-2145.
44. Montresor, A., Awasthi, S. and Crompton, D.W. T. (2003). Use of benzimidazoles in children younger than 24 months for the treatment of soil-transmitted helminthiasis. Acta Tropica 86, 223-232.
45. Moran, M. (2005). A breakthrough in R&D for neglected diseases: new ways to get the drugs we need. PLoS Medicine 2, e302.
46. Moran, M., Guzman, J., Ropars, A. L., McDonald, A., Jameson, N., Omune, B., Ryan, S. and Wu, L. (2009). Neglected disease research and development: how much are we really spending? PLoS Medicine 6, e30.
47. Na Bangchang, K., Karbwang, J., Pungpak, S., Radomyos, B. and Bunnag, D. (1993). Pharmacokinetics of praziquantel in patients with opisthorchiasis. Southeast Asian Journal of Tropical Medicine and Public Health 24, 717-723.
48. Nor Aripin, K. N. B., Choonara, I. and Sammons, H. M. (2010b). A systematic review of paediatric randomised controlled drug trials published in 2007. Archives of Disease in Childhood 95, 469-473.
49. Nor Aripin, K. N. B., Sammons, H. M. and Choonara, I. (2010a). Published paediatric randomized drug trials in developing countries, 1996-2002. Paediatric Drugs 12, 99-103.
50. Nwaka, S., and Hudson, A. (2006). Innovative lead discovery strategies for tropical diseases. Nature Reviews Drug Discovery 5, 941-955.
51. Odogwu, S. E., Ramamurthy, N. K., Kabatereine, N. B., Kazibwe, F., Tukahebwa, E., Webster, J. P., Fenwick, A. and Stothard, J. R. (2006). Schistosoma mansoni in infants (aged <3 years along the ugandan shoreline of lake Victoria, Annals of Tropical Medicine and Parasitology 100, 315-326
52. Pandolfini, C. and Bonati, M. (2005). A literature review on off-label drug use in children. European Journal of Pediatrics 164, 552-558.
53. Pifferi, G. and Restani, P. (2003). The safety of pharmaceutical excipients. Farmaco 58, 541-550.
54. Rakhmanina, N. Y. and van den Anker, J. N. (2009). Developmental pharmacology issues: neonates, infants and children. In Pediatric Drug Development Concepts and Applications (ed. Mulberg, A. E., Silber, S. A. and van den Anker, J. N.), pp. 231-242. John Wiley & Sons, Hoboken.
55. Rose, K. (2009). European perspective. In Pediatric Drug Development Concepts and Applications (ed. Mulberg, A. E., Silber, S. A. and van den Anker, J. N.), pp. 137-152. John Wiley & Sons, Hoboken.
56. Sammons, H.M. and Choonara, I. (2005). Clinical trials of medication in children, 1996-2002. European Journal of Clinical Pharmacology 61, 165-167.
57. Savioli, L., Gabrielli, A. F., Montresor, A., Chitsulo, L. and Engels, D. (2009). Schistosomiasis control in Africa: 8 years after World Health Assembly Resolution 54-19. Parasitology 136, 1677-1681.
58. Schachter, A. D. and Ramoni, M. F. (2007). Paediatric drug development. Nature Reviews Drug Discovery 6, 429-430.
59. Schwartz, C., Issanchou, S. and Nicklaus, S. (2009). Developmental changes in the acceptance of the five basic tastes in the first year of life. British Journal of Nutrition 102, 1375-1385.
60. Sousa-Figueiredo, J. C., Day, M., Betson, M., Kabatereine, N. B. and Stothard, J. R. (2010a). An inclusive dose pole for treatment of schistosomiasis in infants and preschool children with praziquantel. Transaction of the Royal Society of Tropical Medicine and Hygiene 104, 740-742.
61. Sousa-Figueiredo, J. C., Pleasant, J., Day, M., Betson, M., Rollinson, D., Montresor, A., Kazibwe, F., Kabatereine, N. B. and Stothard, J. R. (2010b). Treatment of intestinal schistosomiasis in Ugandan preschool children: best diagnosis, treatment efficacy and side-effects, and an extended praziquantel dosing pole. International Health 2, 103-113.
62. Standing, J. F. and Tuleu, C. (2005). Paediatric formulations-getting to the heart of the problem. International Journal of Pharmacy 300, 56-66.
63. Stothard, J. R. and Gabrielli, A. F. (2007). Schistosomiasis in African infants and preschool children: to treat or not to treat? Trends in Parasitology 23, 83-86.
64. Stothard, J. R., Sousa-Figuereido, J. C., Betson, M., Adriko, M., Arinaitwe, M., Rowell, C., Besiyge, F. and Kabatereine, N. B. (2011). Schistosoma mansoni infections in young children: when are schistosome antigens in urine, eggs in stool and antibodies to eggs first detectable? PLoS Neglected Tropical Diseases 5, e938.
65. Stötter, H. (2007). Paediatric drug development-historical background of regulatory initiatives. In Guide to Paediatric Clinical Research (ed. Rose, K. and van den Anker, J. N.), pp. 25-32. Karger, Basel.
66. Strolin Benedetti, M., Whomsley, R. and Baltes, E. L. (2005). Differences in absorption, distribution, metabolism and excretion of xenobiotics between the paediatric and adult populations. Expert Opinion on Drug Metabolism and Toxicology 1, 447-471.
67. Taylor, M. J., Hoerauf, A. and Bockarie, M. (2010). Lymphatic filariasis and onchocerciasis. Lancet 376, 1175-1185.
68. United Nations (2009). World Population Prospects: The 2008 Revision. United Nations, Department of Economic and Social Affairs Population Division, New York.
69. Utzinger, J., Raso, G., Brooker, S., de Savigny, D., Tanner, M., ørnbjerg, N., Singer, B. H. and N'Goran, E. K. (2009). Schistosomiasis and neglected tropical diseases: towards integrated and sustainable control and a word of caution. Parasitology 136, 1859-1874.
70. WHO (1985). The control of schistosomiasis: report of a WHO expert committee. WHO Technical Report Series 728, 1-113.
71. WHO (2002a). Report of the WHO Informal Consultation on the Use of Praziquantel during Pregnancy/Lactation and Albendazole/Mebendazole in Children under 24 Months. World Health Organization, Geneva.
72. WHO (2002b). Prevention and control of schistosomiasis and soiltransmitted helminthiasis: report of a WHO expert committee. WHO Technical Report Series 912, 1-57.
73. WHO (2006). Preventive Chemotherapy in Human Helminthiasis: Coordinated Use of Anthelminthic Drugs in Control Interventions: A Manual for Health Professionals and Programme Managers. World Health Organization, Geneva.
74. WHO (2007a). Promoting Safety of Medicines for Children. World Health Organization, Geneva.
75. WHO (2007b). The Selection and Use of Essential Medicines. World Health Institution, Geneva.
76. WHO (2008a). The Global Burden of Disease: 2004 Update. World Health Organization, Geneva.
77. WHO (2008b). Soil-transmitted helminthiasis. Progress report on number of children treated with anthelminthic drugs: an update towards the 2010 global target. Weekly Epidemiological Records 82, 237-252.
78. WHO (2010a). Working to Overcome the Global Impact of Neglected Tropical Diseases. First WHO Report on Neglected Tropical Diseases. World Health Organization, Geneva.
79. WHO (2010b). Schistosomiasis.Weekly Epidemiological Records 85, 158-164.
80. WHO (2010c). Soil-transmitted helminthiasis. Weekly Epidemiological Records 85, 141-147.
81. Wu, M. H., Wei, C. C., Xu, Z. Y., Yuan, H. C., Lian, W. N., Yang, Q. J., Chen, M., Jiang,Q.W., Wang, C. Z., Zhang, S. J., Liu, Z. D., Wei, R. M., Yuan, S. J., Hu, L. S. and Wu, Z. S. (1991). Comparison of the therapeutic efficacy and side effects of a single dose of levo-praziquantel with mixed isomer praziquantel in 278 cases of schistosomiasis japonica. American Journal Tropical Medicine and Hygiene 45, 345-349.