Pyronaridine-artesunate versus mefloquine plus artesunate for malaria

New England Journal of Medicine

Volumn 366, Issue 14, 2012, Pages 1298-1309

  Rueangweerayut, Ronnatrai ^a   Phyo, Aung Pyae ^b   Uthaisin, Chirapong ^c   Poravuth, Yi ^d   Binh, Tran Quang ^e   Tinto, Halidou ^g   Pénali, Louis K ^h   Valecha, Neena ⁱ   Tien, Nong Thi ^f   Abdulla, Salim ^j   Borghini Fuhrer, Isabelle ^k   Duparc, Stephan ^k   Shin, Chang Sik ^l   Fleckenstein, Lawrence ^m  

^a MAE SOT GENERAL HOSPITAL   (Thailand)

^b SHOKLO MALARIA RESEARCH UNIT   (Thailand)

^c Mae Ramat Hospital   (Thailand)

^d National Malaria Center   (Cambodia)

^e Choray Hospital   (Viet Nam)

^f National Institute of Malariology Parasitology and Entomology Hanoi   (Viet Nam)

^g CENTRE MURAZ   (Burkina Faso)

^h INSTITUT PASTEUR DE CÔTE D'IVOIRE   (Côte d’Ivoire)

ⁱ NATIONAL INSTITUTE OF MALARIA RESEARCH   (India)

^j IFAKARA HEALTH INSTITUTE   (Tanzania)

^k International Center Cointrin   (Switzerland)

^l Shin Poong Pharmaceutical Company   (South Korea)

^m UNIVERSITY OF IOWA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIMALARIAL AGENT; ARTESUNATE PLUS MEFLOQUINE; ARTESUNATE PLUS PYRONARIDINE; UNCLASSIFIED DRUG;

ABORTION; ACUTE PYELONEPHRITIS; ADULT; AFRICA; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASIA; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; AUTOIMMUNE HEMOLYTIC ANEMIA; BASOPHILIA; BRAIN MALARIA; CHILD; CHOLERA; CONTROLLED STUDY; COUGHING; DEPRESSION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; EOSINOPHILIA; FEMALE; GENOTYPE; GRAND MAL SEIZURE; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; IN VIVO STUDY; INFECTION RISK; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; OUTCOME ASSESSMENT; PARASITE CLEARANCE; PHASE 3 CLINICAL TRIAL; PNEUMONIA; POLYMERASE CHAIN REACTION; PRESCHOOL CHILD; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SEIZURE; SIDE EFFECT; SURVIVAL RATE; VOMITING; WOUND INFECTION;

EID: 84859413629     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1007125     Document Type: Article

References (31)

1. Guidelines for the treatment of malaria. 2nd ed. Geneva: World Health Organization, 2010 (http://whqlibdoc.who.int/publications/2010/9789241547925- eng.pdf).
2. Maude RJ, Pontavornpinyo W, Saralamba S, et al. The last man standing is the most resistant: eliminating artemisinin-resistant malaria in Cambodia. Malar J 2009;8:31.
3. Containment of malaria multi-drug resistance on the Cambodia-Thailand border: report of an informal consultation, Phnom Penh, 29-30 January 2007. Geneva: World Health Organization, 2007 (http:// www.who.int/malaria/ publications/ multi-drug-resistance-en.pdf).
4. Global malaria control and elimination: report of a meeting on containment of artemisinin tolerance. Geneva: World Health Organization, 2008 (http:// whqlibdoc.who.int/publications/2008/ 9789241596817-eng.pdf).
5. Guerin PJ, Bates SJ, Sibley CH. Global resistance surveillance: ensuring antimalarial efficacy in the future. Curr Opin Infect Dis 2009;22:593-600.
6. Dondorp AM, Nosten F, Yi P, et al. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med 2009;361:455-67. [Erratum, N Engl J Med 2009;361:1714.]
7. Delacollette C, D'Souza C, Christophel E, et al. Malaria trends and challenges in the Greater Mekong Subregion. Southeast Asian J Trop Med Public Health 2009;40: 674-91.
8. Wongsrichanalai C, Meshnick SR. Declining artesunate-mefloquine efficacy against falciparum malaria on the Cambodia-Thailand border. Emerg Infect Dis 2008;14:716-9. (Pubitemid 351838633)
9. Ramharter M, Kurth F, Schreier AC, et al. Fixed-dose pyronaridine- artesunate combination for treatment of uncomplicated falciparum malaria in pediatric patients in Gabon. J Infect Dis 2008;198:911-9.
10. Tshefu AK, Gaye O, Kayentao K, et al. Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether- lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial. Lancet 2010; 375:1457-67.
11. Poravuth Y, Socheat D, Rueangweerayut R, et al. Pyronaridine-artesunate versus chloroquine in patients with acute Plasmodium vivax malaria: a randomized, doubleblind, non-inferiority trial. PLoS One 2011; 6(1):e14501.
12. Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria. Geneva: World Health Organization, 2003 (http://whqlibdoc.who.int/hq/2003/ WHO-HTM-RBM-2003.50.pdf).
13. Severe falciparum malaria. Trans R Soc Trop Med Hyg 2000;94:Suppl 1:S1-S90.
14. Felger I, Beck HP. Genotyping of Plasmodium falciparum: PCR-RFLP analysis. Methods Mol Med 2002;72:117-29.
15. Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations. Geneva: World Health Organization, 2008 (http://whqlibdoc.who.int/publications/ 2008/9789241596305-eng.pdf).
16. Wongsrichanalai C, Wimonwattrawatee T, Sookto P, et al. In vitro sensitivity of Plasmodium falciparum to artesunate in Thailand. Bull World Health Organ 1999; 77:392-8. (Pubitemid 29269528)
17. Jambou R, Legrand E, Niang M, et al. Resistance of Plasmodium falciparum field isolates to in-vitro artemether and point mutations of the SERCA-type PfATPase6. Lancet 2005;366:1960-3. (Pubitemid 41713986)
18. Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM. Evidence of artemisinin- resistant malaria in western Cambodia. N Engl J Med 2008;359:2619-20.
19. Douglas NM, Nosten F, Ashley EA, et al. Plasmodium vivax recurrence following falciparum and mixed species malaria: risk factors and effect of antimalarial kinetics. Clin Infect Dis 2011;52:612-20.
20. Simpson JA, Watkins ER, Price RN, Aarons L, Kyle DE, White NJ. Mefloquine pharmacokinetic-pharmacodynamic models: implications for dosing and resistance. Antimicrob Agents Chemother 2000;44: 3414-24. (Pubitemid 33009503)
21. White NJ. Antimalarial pharmacokinetics and treatment regimens. Br J Clin Pharmacol 1992;34:1-10.
22. Douglas NM, Anstey NM, Angus BJ, Nosten F, Price RN. Artemisinin combination therapy for vivax malaria. Lancet Infect Dis 2010;10:405-16.
23. Stepniewska K, White NJ. Pharmacokinetic determinants of the window of selection for antimalarial drug resistance. Antimicrob Agents Chemother 2008;52: 1589-96. (Pubitemid 351614647)
24. Sinclair D, Zani B, Donegan S, Olliaro P, Garner P. Artemisinin-based combination therapy for treating uncomplicated malaria. Cochrane Database Syst Rev 2009;3:CD007483.
25. Price R, van Vugt M, Phaipun L, et al. Adverse effects in patients with acute falciparum malaria treated with artemisinin derivatives. Am J Trop Med Hyg 1999; 60:547-55. (Pubitemid 29233109)
26. Ribeiro IR, Olliaro P. Safety of artemisinin and its derivatives: a review of published and unpublished clinical trials. Med Trop (Mars) 1998;58:Suppl:50-3. (Pubitemid 128707818)
27. Ringwald P, Bickii J, Basco L. Randomised trial of pyronaridine versus chloroquine for acute uncomplicated falciparum malaria in Africa. Lancet 1996;347:24-8. (Pubitemid 26012413)
28. Ringwald P, Bickii J, Basco LK. Efficacy of oral pyronaridine for the treatment of acute uncomplicated falciparum malaria in African children. Clin Infect Dis 1998;26:946-53. (Pubitemid 28180335)
29. Nevin RL. Epileptogenic potential of mefloquine chemoprophylaxis: a pathogenic hypothesis. Malar J 2009;8:188.
30. Bem JL, Kerr L, Stuerchler D. Mefloquine prophylaxis: an overview of spontaneous reports of severe psychiatric reactions and convulsions. J Trop Med Hyg 1992;95:167-79.
31. Guidance for industry [on] drug-induced liver injury: premarketing clinical evaluation. Washington, DC: Food and Drug Administration, July 2009 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM174090.pdf).