Jorgensen P, Nambanya S, Gopinath D, Hongvanthong B, Luangphengsouk K, Bell D, Phompida S, Phetsouvanh R, 2010. High heterogeneity in Plasmodium falciparum risk illustrates the need for detailed mapping to guide resource allocation: a new malaria risk map of the Lao People's Democratic Republic. Malar J 9: 59.
Mayxay M, Khanthavong M, Lindegårdh N, Keola S, Barends M, Pongvongsa T, Yapom R, Annerberg A, Phompida S, Phetsouvanh R, White NJ, Newton PN, 2004. Randomized comparison of chloroquine plus sulphadoxine-pyrimethamine versus artesunate plus mefloquine versus artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in the Lao PDR (Laos). Clin Infect Dis 39: 1139–1147.
Stohrer JM, Dittrich S, Thongpaseuth V, Vanisaveth V, Phetsouvanh R, Phompida S, Monti F, Christophel EM, Lindegardh N, Annerberg A, Jelinek T, 2004. Therapeutic efficacy of artemether-lumefantrine and artesunate-mefloquine for treatment of uncomplicated Plasmodium falciparum malaria in LuangNamtha Province, Lao People's Democratic Republic. Trop Med Int Health 9: 1175–1183.
van Vugt M, Brockman A, Gemperli B, Luxemburger C, Gathmann I, Royce C, Slight T, Looareesuwan S, White NJ, Nosten F, 1998. Randomized comparison of artemether-benflumetol and artesunate-mefloquine in treatment of multidrug-resistant falciparum malaria. Antimicrob Agents Chemother 42: 135–139.
van Vugt M, Wilairatana P, Gemperli B, Gathmann I, Phaipun L, Brockman A, Luxemburger C, White NJ, Nosten F, Looareesuwan S, 1999. Efficacy of six doses of artemether-lumefantrine (benflumetol) in multidrug-resistant Plasmodium falciparum malaria. Am J Trop Med Hyg 60: 936–942.
Lefevre G, Looareesuwan S, Treeprasertsuk S, Krudsood S, Silachamroon U, Gathmann I, Mull R, Bakshi R, 2001. A clinical and pharmacokinetic trial of six doses of artemether-lumefantrine for multidrug-resistant Plasmodium falciparum malaria in Thailand. Am J Trop Med Hyg 64: 247–256.
Poravuth Y, Socheat D, Fandeur T, Tsuyuoka R, Hoyer S, 2002. Efficacy and safety of six dose regimen of Coartem® in the treatment of uncomplicated falciparum malaria in Cambodia. Mekong Malaria Forum 10: 54–55.
Krudsood S, Chalermrut K, Pengruksa C, Srivilairit S, Silachamroon U, Treeprasertsuk S, Kano S, Brittenham GM, Looareesuwan S, 2003. Comparative clinical trial of two-fixed combinations dihydroartemisin-napthoquine-trimethoprim (DNP) and artemether-lumefantrine (Coartem/Riamet) in the treatment of acute uncomplicated falciparum malaria in Thailand. Southeast Asian J Trop Med Public Health 34: 316–321.
Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM, 2008. Artemisinin Resistance in Cambodia 1 (ARC1) Study Consortium. Evidence of artemisinin-resistant malaria in western Cambodia. N Engl J Med 359: 2619–2620.
Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ, 2009. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med 361: 455–467.
Mayxay M, Thongpraseuth V, Khanthavong M, Lindegårdh N, Barends M, Keola S, Pongvongsa T, Phompida S, Phetsouvanh R, Stepniewska K, White NJ, Newton PN, 2006. An open, randomized comparision of artesunate plus mefloquine vs. dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in the Lao People's Democratic Republic (Laos). Trop Med Int Health 11: 1157–1165.
Valecha N, Phyo AP, Mayxay M, Newton PN, Krudsood S, Keomany S, Khanthavong M, Pongvongsa T, Ruangveerayuth R, Uthaisil C, Ubben D, Duparc S, Bacchieri A, Corsi M, Rao BH, Bhattacharya PC, Dubhashi N, Ghosh SK, Dev V, Kunar A, Pukittayakamee S, 2010. An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for the treatment of non-complicated malaria in Thailand, Laos, and India. PLoS ONE 5: e11880.
Mayxay M, Newton PN, Khanthavong M, Tiengkham P, Phetsouvanh R, Phompida S, Brockman A, White NJ, 2003. Chloroquine versus sulphadoxine-pyrimethamine for treatment of Plasmodium falciparum malaria in Savannakhet province, Lao People's Democratic Republic: an assessment of national antimalarial drug recommendations. Clin Infect Dis 37: 1021–1028.
Mayxay M, Phetsouvanh R, Phompida S, Newton PN, Khanthavong M, Vannachone B, Brockmans A, White NJ, 2003. A randomized comparison of oral chloroquine and sulphadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in Laos. Trans R Soc Trop Med Hyg 97: 343–344.
Brockman A, Paul RE, Anderson TJC, Hackford I, Phaiphun L, Looareesuwan S, Nosten F, Day KP, 1999. Application of genetic markers to the identification of recrudescent Plasmodium falciparum infections on the northwestern border of Thailand. Am J Trop Med Hyg 60: 14–21.
World Health Organization, 2000. Severe falciparum malaria. Trans R Soc Trop Med Hyg 94 (Suppl 1): 1–90.
World Health Organization, 2003. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated falciparum Malaria. Document no. WHO/HTM/RBM 2003.50. Geneva: World Health Organization, 2003.
Stepniewska K, White NJ, 2006. Some considerations in the design and interpretation of antimalarial drug trials in uncomplicated falciparum malaria. Malar J 5: 127.
Newcombe RG, 1998. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 17: 873–890.
Day CP, James OF, Butler TJ, Campbell RW, 1993. QT prolongation and sudden cardiac death in patients with alcoholic liver disease. Lancet 341: 1423–1428.
Price RN, Nosten F, White NJ, 1998. Letter to the editor. Am J Trop Med Hyg 59: 503.
Newton PN, Chierakul W, Ruangveerayuth R, Silamut K, Teerapong P, Krudsood S, Looareesuwan S, White NJ, 2001. A comparison of artesunate alone with combined artesunate and quinine in the parenteral treatment of acute falciparum malaria. Trans R Soc Trop Med Hyg 95: 519–523.
Food and Drug Administration, 2005. Guidance for Insdustry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs. Rockville, MD: U.S. Food and Drug Administration.
White NJ, 2007. Cardiotoxicity of antimalarial drugs. Lancet Infect Dis 7: 540–558.
Kamya MR, Yeka A, Bukirwa H, Lugemwa M, Rwakimari JB, Staedke SG, Talisuna AO, Greenhouse B, Nosten F, Rosenthal PJ, Wabwire-Mangen F, Dorsey G, 2007. Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: a randomized trial. PLoS Clin Trials 2: e20.
Zongo I, Dorsey G, Rouamba N, Dokomajilar C, Sere Y, Rosenthal PJ, Ouedraogo JB, 2007. Randomized comparison of amodiaquine plus sulfadoxine-pyrimethamine, artemether-lumefantrine, and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Burkina Faso. Clin Infect Dis 45: 1453–1461.
Yeka A, Dorsey G, Kamya MR, Talisuna A, Lugemwa M, Rwakimari JB, Staedke SG, Rosenthal PJ, Wabwire-Mangen F, Bukirwa H, 2008. Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treating uncomplicated malaria: a randomized trial to guide policy in Uganda. PLoS ONE 3: e2390.
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Mytton OT, Ashley EA, Peto L, Price RN, La Y, Hae R, Singhasivanon P, White NJ, Nosten F, 2007. Short report: electrocardiographic safety evaluation of dihydroartemisinin-piperaquine in the treatment of uncomplicated falcipaurm malaria. Am J Trop Med Hyg 77: 447–450.
Karunajeewa H, Lim C, Hung TY, Ilett KF, Denis MB, Socheat D, Davis TM, 2004. Safety evaluation of fixed combination piperaquine plus dihydroartemisinin (Artekin®) in Cambodian children and adults with malaria. Br J Clin Pharmacol 57: 93–99.
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Smithuis F, Kyaw MK, Phe O, Aye KZ, Htet L, Barends M, Lindergardh N, Singtoroj T, Ashley E, Lwin S, Stepniewska K, White NJ, 2006. Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomized comparison. Lancet 367: 2075–2085.
Rijken MJ, McGready R, Boel ME, Barends M, Proux S, Pimanpanarak M, Singhasivanon P, Nosten F, 2008. Short report: dihydroartemisinin-piperaquine rescue treatment of multidrug-resistant Plasmodium falciparum malaria in pregnancy: a preliminary report. Am J Trop Med Hyg 78: 543–545.
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Denis MB, Davis TM, Hewitt S, Incardona S, Nimol K, Fandeur T, Poravuth Y, Lim C, Socheat D, 2003. Efficacy and safety of dihydroartemisinin-piperaquine (Artekin) in Cambodian children and adults with uncomplicated falciparum malaria. Clin Infect Dis 35: 1469–1476.
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Hien TT, Dolecek C, Pham PM, Nguyen TD, Nguyen TT, Le HT, Dong TH, Tran TT, Stepniewska K, White NJ, Farrar J, 2004. Dihydroartemisinin-piperaquine against multidrug-resistant P. falciparum malaria in Vietnam: randomized clinical trial. Lancet 363: 18–22.
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Wilairatana P, Krudsood S, Chalermrut K, Pengruksa C, Srivilairit S, Silachamroon U, Treeprasertsuk S, Looareesuwan S, 2002. An open randomized clinical trial of Artecom® vs. artesunate-mefloquine in the treatment of acute uncomplicated falciparum malaria in Thailand. Southeast Asian J Trop Med Public Health 33: 519–524.
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We conducted an open, randomized clinical trial of oral dihydroartemisinin-piperaquine (DP) versus artesunate-mefloquine (AM) in 300 patients in Laos with uncomplicated Plasmodium falciparum malaria as part of a multicentre study in Asia. Survival analysis and adjustment for re-infection showed that the 63-day cure rates (95% confidence interval [CI]) were 100% for AM and 99.5% (96.4–99.8%) for DP. The 63-day cure rates per protocol were 99% (97 of 98) for AM and 99.5% (196 of 197) for DP (P = 0.55). The difference (AM minus DP) in cure rates (95% CI) was −0.5% (−5.1 to 2.0%), which is within the 5% non-inferiority margin. The median fever and parasite clearance times were also similar for AM and DP. The proportion of patients with at least one recorded potential adverse event was significantly higher in the AM group (38 of 87, 44%) than in the DP group (57 of 182, 31%) (relative risk = 0.6, 95% CI = 0.4–0.9; P = 0.04). Dihydroartemisinin-piperaquine is not inferior to AM in the treatment of uncomplicated P. falciparum malaria in Laos and is associated with fewer adverse effects. The results of this study were similar to those of the larger multicentre study.
Financial support: This study was supported by the MMV and the Wellcome Trust of Great Britain.
Authors' addresses: Mayfong Mayxay, Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Mahosot Hospital, Mahosot Road, Vientiane, Laos, Faculty of Postgraduate Studies, University of Health Sciences, Vientiane, Laos, and Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford OX3 7LJ, United Kingdom, E-mail: mayfong@tropmedres.ac. Sommay Keomany and Phoutthalavanh Souvannasing, Salavan Provincial Hospital, Salavan Province, Laos. Maniphone Khanthavong and Samlane Phompida, Centre of Malariology, Parasitology and Entomology, Vientiane, Laos, E-mail: cmpe@laotel.com. Kasia Stepniewska, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford OX3 7LJ, United Kingdom and Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. Tiengthong Khomthilath, Faculty of Postgraduate Studies, University of Health Sciences, Vientiane, Laos. Siamphay Keola, Phalanxay District Clinic, Savannakhet Province, Laos. Tiengkham Pongvongsa, Savannakhet Provincial Malaria Station, Savannakhet Province, Laos, E-mail: tpongvongsa@hotmail.com. David Ubben, Medicine for Malaria Venture, Geneva, Switzerland, E-mail: ubbend@mmv.org. Neena Valecha, National Institute of Malaria Research, 22-Sham NathMarg, Delhi-110 054, India, E-mail: neenavalecha@gmail.com. Nicholas J. White, Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Mahosot Hospital, Mahosot Road, Vientiane, Laos, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford OX3 7LJ, United Kingdom, and Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand, 420/6 Rajvithi Road, Bangkok, 10400, Thailand, E-mail: nickw@tropmedres.ac. Paul N. Newton, Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Mahosot Hospital, Mahosot Road, Vientiane, Laos and Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford OX3 7LJ, United Kingdom, E-mail: paul@tropmedres.ac.
Jorgensen P, Nambanya S, Gopinath D, Hongvanthong B, Luangphengsouk K, Bell D, Phompida S, Phetsouvanh R, 2010. High heterogeneity in Plasmodium falciparum risk illustrates the need for detailed mapping to guide resource allocation: a new malaria risk map of the Lao People's Democratic Republic. Malar J 9: 59.
Mayxay M, Khanthavong M, Lindegårdh N, Keola S, Barends M, Pongvongsa T, Yapom R, Annerberg A, Phompida S, Phetsouvanh R, White NJ, Newton PN, 2004. Randomized comparison of chloroquine plus sulphadoxine-pyrimethamine versus artesunate plus mefloquine versus artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in the Lao PDR (Laos). Clin Infect Dis 39: 1139–1147.
Stohrer JM, Dittrich S, Thongpaseuth V, Vanisaveth V, Phetsouvanh R, Phompida S, Monti F, Christophel EM, Lindegardh N, Annerberg A, Jelinek T, 2004. Therapeutic efficacy of artemether-lumefantrine and artesunate-mefloquine for treatment of uncomplicated Plasmodium falciparum malaria in LuangNamtha Province, Lao People's Democratic Republic. Trop Med Int Health 9: 1175–1183.
van Vugt M, Brockman A, Gemperli B, Luxemburger C, Gathmann I, Royce C, Slight T, Looareesuwan S, White NJ, Nosten F, 1998. Randomized comparison of artemether-benflumetol and artesunate-mefloquine in treatment of multidrug-resistant falciparum malaria. Antimicrob Agents Chemother 42: 135–139.
van Vugt M, Wilairatana P, Gemperli B, Gathmann I, Phaipun L, Brockman A, Luxemburger C, White NJ, Nosten F, Looareesuwan S, 1999. Efficacy of six doses of artemether-lumefantrine (benflumetol) in multidrug-resistant Plasmodium falciparum malaria. Am J Trop Med Hyg 60: 936–942.
Lefevre G, Looareesuwan S, Treeprasertsuk S, Krudsood S, Silachamroon U, Gathmann I, Mull R, Bakshi R, 2001. A clinical and pharmacokinetic trial of six doses of artemether-lumefantrine for multidrug-resistant Plasmodium falciparum malaria in Thailand. Am J Trop Med Hyg 64: 247–256.
Poravuth Y, Socheat D, Fandeur T, Tsuyuoka R, Hoyer S, 2002. Efficacy and safety of six dose regimen of Coartem® in the treatment of uncomplicated falciparum malaria in Cambodia. Mekong Malaria Forum 10: 54–55.
Krudsood S, Chalermrut K, Pengruksa C, Srivilairit S, Silachamroon U, Treeprasertsuk S, Kano S, Brittenham GM, Looareesuwan S, 2003. Comparative clinical trial of two-fixed combinations dihydroartemisin-napthoquine-trimethoprim (DNP) and artemether-lumefantrine (Coartem/Riamet) in the treatment of acute uncomplicated falciparum malaria in Thailand. Southeast Asian J Trop Med Public Health 34: 316–321.
Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM, 2008. Artemisinin Resistance in Cambodia 1 (ARC1) Study Consortium. Evidence of artemisinin-resistant malaria in western Cambodia. N Engl J Med 359: 2619–2620.
Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ, 2009. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med 361: 455–467.
Mayxay M, Thongpraseuth V, Khanthavong M, Lindegårdh N, Barends M, Keola S, Pongvongsa T, Phompida S, Phetsouvanh R, Stepniewska K, White NJ, Newton PN, 2006. An open, randomized comparision of artesunate plus mefloquine vs. dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in the Lao People's Democratic Republic (Laos). Trop Med Int Health 11: 1157–1165.
Valecha N, Phyo AP, Mayxay M, Newton PN, Krudsood S, Keomany S, Khanthavong M, Pongvongsa T, Ruangveerayuth R, Uthaisil C, Ubben D, Duparc S, Bacchieri A, Corsi M, Rao BH, Bhattacharya PC, Dubhashi N, Ghosh SK, Dev V, Kunar A, Pukittayakamee S, 2010. An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for the treatment of non-complicated malaria in Thailand, Laos, and India. PLoS ONE 5: e11880.
Mayxay M, Newton PN, Khanthavong M, Tiengkham P, Phetsouvanh R, Phompida S, Brockman A, White NJ, 2003. Chloroquine versus sulphadoxine-pyrimethamine for treatment of Plasmodium falciparum malaria in Savannakhet province, Lao People's Democratic Republic: an assessment of national antimalarial drug recommendations. Clin Infect Dis 37: 1021–1028.
Mayxay M, Phetsouvanh R, Phompida S, Newton PN, Khanthavong M, Vannachone B, Brockmans A, White NJ, 2003. A randomized comparison of oral chloroquine and sulphadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in Laos. Trans R Soc Trop Med Hyg 97: 343–344.
Brockman A, Paul RE, Anderson TJC, Hackford I, Phaiphun L, Looareesuwan S, Nosten F, Day KP, 1999. Application of genetic markers to the identification of recrudescent Plasmodium falciparum infections on the northwestern border of Thailand. Am J Trop Med Hyg 60: 14–21.
World Health Organization, 2000. Severe falciparum malaria. Trans R Soc Trop Med Hyg 94 (Suppl 1): 1–90.
World Health Organization, 2003. Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated falciparum Malaria. Document no. WHO/HTM/RBM 2003.50. Geneva: World Health Organization, 2003.
Stepniewska K, White NJ, 2006. Some considerations in the design and interpretation of antimalarial drug trials in uncomplicated falciparum malaria. Malar J 5: 127.
Newcombe RG, 1998. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 17: 873–890.
Day CP, James OF, Butler TJ, Campbell RW, 1993. QT prolongation and sudden cardiac death in patients with alcoholic liver disease. Lancet 341: 1423–1428.
Price RN, Nosten F, White NJ, 1998. Letter to the editor. Am J Trop Med Hyg 59: 503.
Newton PN, Chierakul W, Ruangveerayuth R, Silamut K, Teerapong P, Krudsood S, Looareesuwan S, White NJ, 2001. A comparison of artesunate alone with combined artesunate and quinine in the parenteral treatment of acute falciparum malaria. Trans R Soc Trop Med Hyg 95: 519–523.
Food and Drug Administration, 2005. Guidance for Insdustry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs. Rockville, MD: U.S. Food and Drug Administration.
White NJ, 2007. Cardiotoxicity of antimalarial drugs. Lancet Infect Dis 7: 540–558.
Kamya MR, Yeka A, Bukirwa H, Lugemwa M, Rwakimari JB, Staedke SG, Talisuna AO, Greenhouse B, Nosten F, Rosenthal PJ, Wabwire-Mangen F, Dorsey G, 2007. Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: a randomized trial. PLoS Clin Trials 2: e20.
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