Investigation of reproductive toxicity of piperaquine in mice

Reproductive Toxicology

Volumn 29, Issue 2, 2010, Pages 206-213

  Batty, Kevin T ^a,b   Moore, Brioni R ^a,b   Stirling, Verity ^c   Ilett, Kenneth F ^c,d   Page Sharp, Madhu ^a,b,c   Shilkin, Keith B ^d,e   Mueller, Ivo ^f   Rogerson, Stephen J ^g   Karunajeewa, Harin A ^c,h   Davis, Timothy M E ^c  

^a CURTIN UNIVERSITY   (Australia)

^b CURTIN UNIVERSITY   (Australia)

^c UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^d PATHWEST LABORATORY MEDICINE   (Australia)

^e UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^f PAPUA NEW GUINEA INSTITUTE OF MEDICAL RESEARCH   (Papua New Guinea)

^g UNIVERSITY OF MELBOURNE   (Australia)

^h WESTERN HEALTH   (Australia)

Author keywords

Biochemistry; Haematology; Malaria; Mouse; Pharmacokinetics; Piperaquine; Pregnancy; Toxicology

Indexed keywords

ALBUMIN; PIPERAQUINE;

ALBUMIN BLOOD LEVEL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BIOCHEMISTRY; BLOOD TOXICITY; CONTROLLED STUDY; DRUG BLOOD LEVEL; FEMALE; GESTATIONAL AGE; HEMATOLOGICAL PARAMETERS; HISTOPATHOLOGY; KIDNEY PARENCHYMA; LEUKOCYTE COUNT; LIVER PARENCHYMA; MALE; MOUSE; NEWBORN; NONHUMAN; PATIENT MONITORING; PREGNANCY; PROGENY; REPRODUCTIVE TOXICITY; SWISS WEBSTER MOUSE;

ANIMALS; ANIMALS, NEWBORN; ANTIMALARIALS; BODY WEIGHT; CLINICAL CHEMISTRY TESTS; DRUG-INDUCED LIVER INJURY; FEMALE; HEART; HEMATOLOGIC TESTS; KIDNEY; LEUKOCYTE COUNT; LEUKOCYTES; LIVER; MALE; MICE; ORGAN SIZE; PREGNANCY; QUINOLINES; REPRODUCTION; SERUM ALBUMIN; TOXICITY TESTS;

MUS;

EID: 77949570322     PISSN: 08906238     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.reprotox.2009.10.013     Document Type: Article

References (52)

1. World Health Organization Guidelines for the treatment of malaria 2006, World Health Organization, Geneva.
2. Rogerson S.J., Mwapasa V., Meshnick S.R. Malaria in pregnancy: linking immunity and pathogenesis to prevention. Am J Trop Med Hyg 2007, 77(Suppl 6):14-22.
3. Desai M., ter Kuile F.O., Nosten F., McGready R., Asamoa K., Brabin B., et al. Epidemiology and burden of malaria in pregnancy. Lancet Infect Dis 2007, 7:93-104.
4. Nyunt M.M., Plowe C.V. Pharmacologic advances in the global control and treatment of malaria: combination therapy and resistance. Clin Pharmacol Ther 2007, 82:601-605.
5. Menendez C., d'Alessandro U., ter Kuile F.O. Reducing the burden of malaria in pregnancy by preventive strategies. Lancet Infect Dis 2007, 7:126-135.
6. Greenwood B., Alonso P., ter Kuile F.O., Hill J., Steketee R.W. Malaria in pregnancy: priorities for research. Lancet Infect Dis 2007, 7:169-174.
7. Ward S.A., Sevene E.J., Hastings I.M., Nosten F., McGready R. Antimalarial drugs and pregnancy: safety, pharmacokinetics, and pharmacovigilance. Lancet Infect Dis 2007, 7:136-144.
8. World Health Organization Assessment of the safety of artemisinin compounds in pregnancy 2007, World Health Organization, Geneva.
9. Nosten F., McGready R., Mutabingwa T. Case management of malaria in pregnancy. Lancet Infect Dis 2007, 7:118-125.
10. World Health Organization World malaria report 2008 2008, World Health Organization, Geneva.
11. White T.E., Bushdid P.B., Ritter S., Laffan S.B., Clark R.L. Artesunate-induced depletion of embryonic erythroblasts precedes embryolethality and teratogenicity in vivo. Birth Defects Res (Part B) 2006, 77:413-429.
12. Boareto A.C., Muller J.C., Bufalo A.C., Botelho G.G., de Araujo S.L., Foglio M.A., et al. Toxicity of artemisinin [Artemisia annua L.] in two different periods of pregnancy in Wistar rats. Reprod Toxicol 2008, 25:239-246.
13. Longo M., Zanoncelli S., Manera D., Brughera M., Colombo P., Lansen J., et al. Effects of the antimalarial drug dihydroartemisinin (DHA) on rat embryos in vitro. Reprod Toxicol 2006, 21:83-93.
14. Davis T.M., Hung T.Y., Sim I.K., Karunajeewa H.A., Ilett K.F. Piperaquine: a resurgent antimalarial drug. Drugs 2005, 65:75-87.
15. Myint H.Y., Ashley E.A., Day N.P., Nosten F., White N.J. Efficacy and safety of dihydroartemisinin-piperaquine. Trans R Soc Trop Med Hyg 2007, 101:858-866.
16. Denis M.B., Davis T.M., Hewitt S., Incardona S., Nimol K., Fandeur T., et al. Efficacy and safety of dihydroartemisinin-piperaquine (Artekin) in Cambodian children and adults with uncomplicated falciparum malaria. Clin Infect Dis 2002, 35:1469-1476.
17. Ashley E.A., Krudsood S., Phaiphun L., Srivilairit S., McGready R., Leowattana W., et al. Randomized, controlled dose-optimization studies of dihydroartemisinin-piperaquine for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand. J Infect Dis 2004, 190:1773-1782.
18. Ashley E.A., McGready R., Hutagalung R., Phaiphun L., Slight T., Proux S., et al. A randomized, controlled study of a simple, once-daily regimen of dihydroartemisinin-piperaquine for the treatment of uncomplicated, multidrug-resistant falciparum malaria. Clin Infect Dis 2005, 41:425-432.
19. Smithuis F., Kyaw M.K., Phe O., Aye K.Z., Htet L., Barends M., et al. Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison. Lancet 2006, 367:2075-2085.
20. Ratcliff A., Siswantoro H., Kenangalem E., Maristela R., Wuwung R.M., Laihad F., et al. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open label randomised comparison. Lancet 2007, 369:757-765.
21. Karunajeewa H.A., Lim C., Hung T.Y., Ilett K.F., Denis M.B., Socheat D., et al. Safety evaluation of fixed combination piperaquine plus dihydroartemisinin (Artekin) in Cambodian children and adults with malaria. Br J Clin Pharmacol 2004, 57:93-99.
22. Mytton O.T., Ashley E.A., Peto L., Price R.N., La Y., Hae R., et al. Electrocardiographic safety evaluation of dihydroartemisinin-piperaquine in the treatment of uncomplicated falciparum malaria. Am J Trop Med Hyg 2007, 77:447-450.
23. Ahmed T., Sharma P., Gautam A., Varshney B., Kothari M., Ganguly S., et al. Safety, tolerability, and single and multiple-dose pharmacokinetics of piperaquine phosphate in healthy subjects. J Clin Pharmacol 2008, 48:166-175.
24. Batty K.T., Moore B.R., Stirling V., Ilett K.F., Page-Sharp M., Shilkin K.B., et al. Toxicology and pharmacokinetics of piperaquine in mice. Toxicology 2008, 249:55-61.
25. International Conference on Harmonisation. Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals M3 (R1); 2000.
26. Moore B.R., Batty K.T., Andrzejewski C., Jago J.D., Page-Sharp M., Ilett K.F. Pharmacokinetics and pharmacodynamics of piperaquine in a murine malaria model. Antimicrob Agents Chemother 2008, 52:306-311.
27. International Conference on Harmonisation. Detection of toxicity to reproduction for medicinal products and toxicity to male fertility S5 (R2); 2005.
28. Sansom L. Australian pharmaceutical formulary and handbook 2006, Pharmaceutical Society of Australia, Australian Capital Territory. 20th ed.
29. Karunajeewa H.A., Ilett K.F., Mueller I., Siba P., Law I., Page-Sharp M., et al. Pharmacokinetics and efficacy of piperaquine and chloroquine in Melanesian children with uncomplicated malaria. Antimicrob Agents Chemother 2008, 52:237-243.
30. German P.I., Aweeka F.T. Clinical pharmacology of artemisinin-based combination therapies. Clin Pharmacokinet 2008, 47:91-102.
31. Phillips-Howard P.A., Wood D. The safety of antimalarial drugs in pregnancy. Drug Safety 1996, 14:131-145.
32. Tagbor H.K., Chandramohan D., Greenwood B. The safety of amodiaquine use in pregnant women. Expert Opin Drug Saf 2007, 6:631-635.
33. Ings R.M. Interspecies scaling and comparisons in drug development and toxicokinetics. Xenobiotica 1990, 20:1201-1231.
34. Riviere J.E., Martin-Jimenez T., Sundlof S.F., Craigmill A.L. Interspecies allometric analysis of the comparative pharmacokinetics of 44 drugs across veterinary and laboratory animal species. J Vet Pharmacol Therap 1997, 20:453-463.
35. Mahmood I. Application of allometric principles for the prediction of pharmacokinetics in human and veterinary drug development. Adv Drug Deliv Rev 2007, 59:1177-1192.
36. Hasugian A.R., Purba H.L., Wuwung R.M., Ebsworth E.P., Maristela R., Penttinen P., et al. Dihydroartemisinin-piperaquine versus artesunate-amodiaquine: superior efficacy and posttreatment prophylaxis against multidrug-resistant Plasmodium falciparum and Plasmodium vivax malaria. Clin Infect Dis 2007, 44:1067-1074.
37. Price R.N., Hasugian A.R., Ratcliff A., Siswantoro H., Purba H.L., Kenangalem E., et al. Clinical and pharmacological determinants of the therapeutic response to dihydroartemisinin-piperaquine for drug-resistant malaria. Antimicrob Agents Chemother 2007, 51:4090-4097.
38. Peters P.J., Thigpen M.C., Parise M.E., Newman R.D. Safety and toxicity of sulfadoxine/pyrimethamine: implications for malaria prevention in pregnancy using intermittent preventive treatment. Drug Safety 2007, 30:481-501.
39. Clark R.L., White T.E., Clode S.A., Gaunt I., Winstanley P., Ward S.A. Developmental toxicity of artesunate and an artesunate combination in the rat and rabbit. Birth Defects Res (Part B) 2004, 71:380-394.
40. Tarning J., Lindegardh N., Sandberg S., Day N.P., White N.J., Ashton M. Pharmacokinetics and metabolism of the antimalarial piperaquine after intravenous and oral single doses to the rat. J Pharm Sci 2008, 97:3400-3410.
41. Tarning J., Bergqvist Y., Day N.P., Bergquist J., Arvidsson B., White N.J., et al. Characterization of human urinary metabolites of the antimalarial piperaquine. Drug Metab Dispos 2006, 34:2011-2019.
42. White N.J. Antimalarial drug resistance. J Clin Invest 2004, 113:1084-1092.
43. Rijken M.J., McGready R., Boel M.E., Barends M., Proux S., Pimanpanarak M., et al. Dihydroartemisinin-piperaquine rescue treatment of multidrug-resistant Plasmodium falciparum malaria in pregnancy: a preliminary report. Am J Trop Med Hyg 2008, 78:543-545.
44. Suckow M.A., Danneman P., Brayton C. The laboratory mouse 2001, CRC Press, Boca Raton.
45. Hedrich H., Bullock G. The laboratory mouse 2004, Elsevier Academic Press, London.
46. Aleman C.L., Noa M., Mas R., Rodeiro I., Mesa R., Menendez R., et al. Reference data for the principal physiological indicators in three species of laboratory animals. Lab Anim 2000, 34:379-385.
47. Lindstedt S.L., Schaeffer P.J. Use of allometry in predicting anatomical and physiological parameters of mammals. Lab Anim 2002, 36:1-19.
48. Wolford S.T., Schroer R.A., Gohs F.X., Gallo P.P., Brodeck M., Falk H.B., et al. Reference range data base for serum chemistry and hematology values in laboratory animals. J Toxicol Environ Health 1986, 18:161-188.
49. Schnell M.A., Hardy C., Hawley M., Propert K.J., Wilson J.M. Effect of blood collection technique in mice on clinical pathology parameters. Hum Gene Ther 2002, 13:155-162.
50. Hanson R.L., Ho R.S., Wiseberg J.J., Simpson R., Younathan E.S., Blair J.B. Inhibition of gluconeogenesis and glycogenolysis by 2,5-anhydro-D-mannitol. J Biol Chem 1984, 259:218-223.
51. Rajkumar K., Murphy L.J. Enhanced gluconeogenesis and hepatic insulin resistance in insulin-like growth factor binding protein-1 transgenic mice. Biochim Biophys Acta 1999, 1426:491-497.
52. Suzuki Y., Lanner C., Kim J.H., Vilardo P.G., Zhang H., Yang J., et al. Insulin control of glycogen metabolism in knockout mice lacking the muscle-specific protein phosphatase PP1G/RGL. Mol Cell Biol 2001, 21:2683-2694.