Pharmacokinetics and pharmacodynamics of oral artesunate monotherapy in patients with uncomplicated plasmodium falciparum Malaria in Western Cambodia

Antimicrobial Agents and Chemotherapy

Volumn 56, Issue 11, 2012, Pages 5484-5493

  Saunders, David ^a   Khemawoot, Phisit ^a,h   Vanachayangkul, Pattaraporn ^a   Siripokasupkul, Raveewan ^a   Bethell, Delia ^a   Tyner, Stuart ^a   Se, Youry ^a   Rutvisuttinunt, Wiriya ^a   Sriwichai, Sabaithip ^a   Chanthap, Lon ^a   Lin, Jessica ^d   Timmermans, Ans ^a   Socheat, Doung ^b   Ringwald, Pascal ^c   Noedl, Harald ^e   Smith, Bryan ^f   Fukuda, Mark ^g   Teja Isavadharm, Paktiya ^a  

^a ARMED FORCES RESEARCH INSTITUTE OF MEDICAL SCIENCES   (Thailand)

^b National Center for Parasitology Entomology and Malaria Control (CNM)   (Cambodia)

^c WORLD HEALTH ORGANIZATION   (Switzerland)

^d UNIVERSITY OF NORTH CAROLINA   (United States)

^e MEDICAL UNIVERSITY OF VIENNA   (Austria)

^f US Army Medical Materiel Development Activity   (United States)

^g Armed Forces Health Surveillance Center   (United States)

^h CHULALONGKORN UNIVERSITY   (Thailand)

Author keywords

[No Author keywords available]

Indexed keywords

ARTESUNATE; DIHYDROARTEMISININ;

ADULT; ARTICLE; BLOOD LEVEL; CAMBODIA; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; ERYTHROCYTE; FEMALE; HUMAN; HUMAN CELL; IN VITRO STUDY; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MALE; MONOTHERAPY; NONHUMAN; OUTCOME ASSESSMENT; PARASITE CLEARANCE; PARASITEMIA; PHARMACODYNAMICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; ADULT; ANTIMALARIALS; ARTEMISININS; CAMBODIA; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALARIA, FALCIPARUM; MALE; PARASITEMIA; PLASMODIUM FALCIPARUM; SEVERITY OF ILLNESS INDEX;

EID: 84868028188     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.00044-12     Document Type: Article

References (40)

1. Alin MH, et al. 1995. Efficacy of oral and intravenous artesunate in male Tanzanian adults with Plasmodium falciparum malaria and in vitro susceptibility to artemisinin, chloroquine, and mefloquine. Am. J. Trop. Med. Hyg. 53:639-645.
2. Angus BJ, Thaiaporn I, Chanthapadith K, Suputtamongkol Y, White NJ. 2002. Oral artesunate dose-response relationship in acute falciparum malaria. Antimicrob. Agents Chemother. 46:778-782.
3. Asawamahasakda W, Benakis A, Meshnick SR. 1994. The interaction of artemisinin with red cell membranes. J. Lab. Clin. Med. 123:757-762.
4. Batty KT, et al. 1998. A pharmacokinetic and pharmacodynamic study of intravenous vsoral artesunatein uncomplicated falciparum malaria. Br. J. Clin. Pharmacol. 45:123-129.
5. Benakis A, Paris M, Loutan L, Plessas CT, Plessas ST. 1997. Pharmacokinetics of artemisinin and artesunate after oral administration in healthy volunteers. Am. J. Trop. Med. Hyg. 56:17-23.
6. Bethell D, et al. 2010. Dose-dependent risk of neutropenia after 7-day courses of artesunate monotherapy in Cambodian patients with acute Plasmodium falciparum malaria. Clin. Infect. Dis. 51:e105-e114. doi: 10.1086/657402.
7. Bethell D, et al. 2011. Artesunate dose escalation for the treatment of uncomplicated malaria in a region of reported artemisinin resistance: a randomized clinical trial. PLoS One 6:e19283. doi:10.1371/journal.pone.0019283.
8. Bunnag D, Viravan C, Looareesuwan S, Karbwang J, Harinasuta T. 1991. Clinical trial of artesunate and artemether on multidrug resistant falciparum malaria in Thailand. A preliminary report. Southeast Asian J. Trop. Med. Public Health 22:380-385.
9. Bunnag D, Viravan C, Looareesuwan S, Karbwang J, Harinasuta T. 1991. Double blind randomised clinical trial of oral artesunate at once or twice daily dose in falciparum malaria. Southeast Asian J. Trop. Med. Public Health. 22:539-543.
10. de Vries PJ, Dien TK. 1996. Clinical pharmacology and therapeutic potential of artemisinin and its derivatives in the treatment of malaria. Drugs 52:818-836.
11. Diem Thuy LT, Ngoc Hung L, Danh PT, Na-Bangchang K. 2008. Absence of time-dependent artesunate pharmacokinetics in healthy subjects during 5-day oral administration. Eur. J. Clin. Pharmacol. 64:993-998.
12. Dondorp AM, et al. 2009. Artemisinin resistance in Plasmodium falciparum malaria. N. Engl. J. Med. 361:455-467.
13. Flegg JA, Guerin PJ, White NJ, Stepniewska K. 2011. Standardizing the measurement of parasite clearance in falciparum malaria: the parasite clearance estimator. Malar. J. 10:339. doi:10.1186/1475-2875-10-339.
14. Fujioka H, Aikawa M. 1993. Morphological changes of clefts in Plasmodium-infected erythrocytes under adverse conditions. Exp. Parasitol. 76: 302-307.
15. Ginsburg H, Kutner S, Zangwil M, Cabantchik ZI. 1986. Selectivity properties of pores induced in host erythrocyte membrane by Plasmodium falciparum. Effect of parasite maturation. Biochim. Biophys. Acta 861:194-196.
16. Gordi T, et al. 2005. A semiphysiological pharmacokinetic model for artemisinin in healthy subjects incorporating autoinduction of metabolism and saturable first-pass hepatic extraction. Br. J. Clin. Pharmacol. 59:189-198.
17. Hassan Alin M, Ashton M, Kihamia CM, Mtey GJ, Bjorkman A. 1996. Multiple dose pharmacokinetics of oral artemisinin and comparison of its efficacy with that of oral artesunate in falciparum malaria patients. Trans. R. Soc. Trop. Med. Hyg. 90:61-65.
18. Hietala SF, et al. 2010. Population pharmacokinetics and pharmacodynamics of artemether and lumefantrine during combination treatment in children with uncomplicated falciparum malaria in Tanzania. Antimicrob. Agents Chemother. 54:4780-4788.
19. Hong YL, Yang YZ, Meshnick SR. 1994. The interaction of artemisinin with malarial hemozoin. Mol. Biochem. Parasitol. 63:121-128.
20. Ittarat W, et al. 2003. Recrudescence in artesunate-treated patients with falciparum malaria is dependent on parasite burden not on parasite factors. Am. J. Trop. Med. Hyg. 68:147-152.
21. LaCrue AN, Scheel M, Kennedy K, Kumar N, Kyle DE. 2011. Effects of artesunate on parasite recrudescence and dormancy in the rodent malaria model Plasmodium vinckei. PLoS One 6:e26689. doi:10.1371/journal.pone.0026689.
22. Li Q, et al. 2009. Pharmacokinetic profiles of artesunate after single intravenous doses at0.5, 1, 2, 4, and 8 mg/kg in healthy volunteers: aphase I study. Am. J. Trop. Med. Hyg. 81:615-621.
23. Li Q, Milhous WK, Weina PJ. 2007. Artemisinins in malaria therapy, p 91-92. Nova Science, New York, NY.
24. Li Q, Xie LH, Haeberle A, Zhang J, Weina P. 2006. The evaluation of radiolabeled artesunate on tissue distribution in rats and protein binding in humans. Am. J. Trop. Med. Hyg. 75:817-826.
25. Li QG, et al. 1998. Pharmacology and toxicology of artelinic acid: preclinical investigations on pharmacokinetics, metabolism, protein and red blood cell binding, and acute and anorectic toxicities. Trans. R. Soc. Trop. Med. Hyg. 92:332-340.
26. Looareesuwan S, et al. 1997. Monotherapy with sodium artesunate for uncomplicated falciparum malaria in Thailand: a comparison of 5- and 7-day regimens. Acta Trop. 67:197-205.
27. Maguire PA, Sherman IW. 1990. Phospholipid composition, cholesterol content and cholesterol exchange in Plasmodium falciparum-infected red cells. Mol. Biochem. Parasitol. 38:105-112.
28. Meshnick SR, Thomas A, Ranz A, Xu CM, Pan HZ. 1991. Artemisinin (qinghaosu): the role of intracellular hemin in its mechanism of antimalarial action. Mol. Biochem. Parasitol. 49:181-189.
29. Noedl H, Attlmayr B, Wernsdorfer WH, Kollaritsch H, Miller RS. 2004. A histidine-rich protein 2-based malaria drug sensitivity assay for field use. Am. J. Trop. Med. Hyg. 71:711-714.
30. Noedl H, et al. 2010. Artemisinin resistance in Cambodia: a clinical trial designed to address an emerging problem in Southeast Asia. Clin. Infect. Dis. 51:e82-e89. doi:10.1086/657120.
31. Noedl H, Schaecher YSK, Smith BL, Socheat D, Fukuda MM. 2008. Evidence of artemisinin-resistant malaria in western Cambodia. Artemisinin Resistance in Cambodia 1 (ARC1) Study Consortium. N. Engl. J. Med. 359:2619-2620.
32. Onyamboko MA, et al. 2011. Pharmacokinetics and pharmacodynamics of artesunate and dihydroartemisinin following oral treatment in pregnant women with asymptomatic Plasmodium falciparum infections in Kinshasa DRC. Malar. J. 10:49. doi:10.1186/1475-2875-10-49.
33. Orrell C, et al. 2008. Pharmacokinetics and tolerability of artesunate and amodiaquine alone and incombination in healthy volunteers. Eur. J. Clin. Pharmacol. 64:683-690.
34. Price R, et al. 1998. Artesunate versus artemether for the treatment of recrudescent multidrug-resistant falciparum malaria. Am. J. Trop. Med. Hyg. 59:883-888.
35. Roffey SJ, Obach RS, Gedge JI, Smith DA. 2007. What is the objective of the mass balance study? A retrospective analysis of data in animal and human excretion studies employing radiolabeled drugs. Drug Metab. Rev. 39:17-43.
36. Saralamba S, et al. 2011. Intrahost modeling of artemisinin resistance in Plasmodium falciparum. Proc. Natl. Acad. Sci. U. S. A. 108:397-402.
37. Tan B, et al. 2009. Population pharmacokinetics of artesunate and dihydroartemisinin following single- and multiple-dosing oforal artesunate in healthy subjects. Malar. J. 8:304. doi:10.1186/1475-2875-8-304.
38. Teja-Isavadharm P, et al. 2010. A simplified liquid chromatographymass spectrometry assay for artesunate and dihydroartemisinin, its metabolite, in human plasma. Molecules 15:8747-8768.
39. Teja-Isavadharm P, et al. 2001. Comparative pharmacokinetics and effect kinetics of orally administered artesunate in healthy volunteers and patients with uncomplicated falciparum malaria. Am. J. Trop. Med. Hyg. 65:717-721.
40. Viriyakosol S, et al. 1995. Genotyping of Plasmodium falciparum isolates by the polymerase chain reaction and potential uses in epidemiological studies. Bull. World Health Organ. 73:85-95.