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-
1
Denis MB, Davis TM, Hewitt S, Incardona S, Nimol K, Fandour T, Poravuth Y, Lim C, Socheat D, 2002. Efficacy and safety of dihydroartemisinin–piperaquine (Artekin) in Cambodian children and adults with uncomplicated falciparum malaria. Clin Infect Dis 35 :1467–1476.
-
2
Tran TH, 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 Plasmodium falciparum malaria in Vietnam: randomised clinical trial. Lancet 363 :18–22.
-
3
Ashley EA, Krudsood S, Phaiphun L, Srivilairit S, McGready R, Leowattana W, Hutagalung R, Wilairatana P, Brockman A, Looareesuwan S, Nosten F, White NJ, 2004. Randomized, controlled dose-optimization studies of dihydroartemisinin–piperaquine for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand. J Infect Dis 190 :1773–1782.
-
4
Ashley EA, McGready R, Hutagalung R, Phaiphun L, Slight T, Proux S, Thwai KL, Barends M, Looareesuwan S, White NJ, Nosten F, 2005. A randomised controlled study of a simple once daily regimen of dihydroartemisinin–piperaquine for the treatment of uncomplicated multi-drug resistant falciparum malaria. Clin Infect Dis 41 :425–432.
-
5
Classen W, Altmann B, Gretener P, Souppart C, Skelton-Stroud P, Krinke G, 1999. Differential effects of orally versus parenterally administered qinghaosu derivative artemether in dogs. Exp Toxicol Pathol 51 :507–516.
-
6
Brewer TG, Grate SJ, Peggins JO, Weina PJ, Petras JM, Levine BS, Heiffer MH, Schuster BG, 1994. Fatal neurotoxicity of arteether and artemether. Am J Trop Med Hyg 51 :251–259.
-
7
Van Vugt M, Ezzet E, Nosten F, Gathmann I, Wilairatana P, Looareesuwan S, White NJ, 1999. No evidence of cardiotoxicity during antimalarial treatment with artemether–lumefantrine. Am J Trop Med Hyg 61 :964–967.
-
8
Von Seidlen L, Jaffar S, Greenwood BM, 1997. Prolongation of the QTc in African children treated for falciparum malaria. Am J Trop Med Hyg 56 :494–497.
-
9
Hien TT, Day NPJ, Phu NH, Mai NT, Chau TT, Loc PP, Sinh DX, Choung LV, Vinh H, Waller D, Peto TEA, White NJ, 1996. Controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria treated with artemsinin derivatives. Am J Trop Med Hyg 60 :936–942.
-
10
Yap YG, Camm AJ, 2003. Drug induced QT prolongation and torsade de pointes. Heart 89 :1363–1372.
-
11
Karunajeewa H, Lim C, Hung T-Y, Ilett KF, Denis MB, Socheat D, Davis TME, 2003. Safety evaluation of fixed combination piperaquine plus dihydroartemisinin (Artekin) in Cambodian children and adults with malaria. Br J Clin Pharmacol 57 :93–99.
-
12
Food and Drug Administration, 2005. Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs. Rockville, MD: FDA.
-
13
Haverkamp W, Breithard G, Camm AJ, Janse MJ, Rosen MR, Antzelevitch C, Escande D, Franz M, Malik M, Moss A, Shah R, and other speakers in the sessions and chairs of the workshops, 2000. The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs: clinical and regulatory implications. Report on a policy conference of the European Society of Cardiology. Eur Heart J 21 :1216–1231.
-
14
White NJ, 2007. The cardiotoxicity of the antimalarial drugs. Lancet Infect Dis 7 :549–558.
-
15
Price RN, Nosten F, White NJ, 1998. Prolongation of the QTc interval in African children treated for falciparum malaria (letter; comment). Am J Trop Med Hyg 59 :503.
-
16
Nosten F, ter Kuile F, Luxemburger C, Woodrow C, Kyle D, Chongsuphajaisiddhi T, White NJ, 1993. Cardiac effects of antimalarial treatment with halofantrine. Lancet 341 :1054–1056.
-
17
Looareesuwan S, White NJ, Chanthavanich P, Edwards G, Nicholl DD, Bunch C, Warrell DA, 1986. Cardiovascular toxicity and distribution kinetics of intravenous chloroquine. Br J Clin Pharmacol 22 :31–36.
-
18
Gupta RK, Van Vugt M, Paiphun L, Slight T, Looareesuwan S, White NJ, Nosten F, 2005. Short report: no evidence of cardiotoxicity of atovaquone–proguanil alone or in combination with artesunate. Am J Trop Med Hyg 73 :267–278.
-
19
Karbwang J, Davis TM, Looareesuwan S, Molunto P, Bunnag D, White NJ, 1993. A comparison of the pharmacokinetic and pharmacodynamic properties of quinine and quinidine in healthy Thai males. Br J Clin Pharmacol 35 :265–271.
-
20
White NJ, Looareesuwan S, Warrell DA, 1983. Quinine and quinidine: a comparison of EKG effects during the treatment of malaria. J Cardiovasc Pharmacol 5 :173–175.
-
21
Sowunmi A, Falade CO, Oduola AMJ, Ogundahunsi OAT, Fehintola FA, Gbotosho GO, Larcier P, Salako S, 1998. Cardiac effects of halofantrine in children suffering from acute uncomplicated falciparum malaria. Trans R Soc Trop Med Hyg 92 :446–448.
-
22
Touze JE, Bernard J, Keundjian A, Imbert P, Vigeur A, Chaudet A, Doury JC, 1996. Electrocardiographic changes and halofantrine plasma level during acute falciparum malaria. Am J Trop Med Hyg 54 :225–228.
-
23
Sheldon R, Duff H, Koshman ML, 1995. Antiarrhythmic activity of quinine in humans. Circulation 92 :2944–2950.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 34 | 34 | 10 |
| Full Text Views | 244 | 72 | 1 |
| PDF Downloads | 58 | 17 | 0 |
Electrocardiographic Safety Evaluation of Dihydroartemisinin–Piperaquine in the Treatment of Uncomplicated falciparum Malaria
Oliver T. Mytton
Oliver T. Mytton
Shoklo Malaria Research Unit, Mae Sot, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom; Menzies School of Health Research, Charles Darwin University, Darwin, Australia, Epicentre, Paris, France
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Elizabeth A. Ashley
Elizabeth A. Ashley
Shoklo Malaria Research Unit, Mae Sot, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom; Menzies School of Health Research, Charles Darwin University, Darwin, Australia, Epicentre, Paris, France
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Leon Peto
Leon Peto
Shoklo Malaria Research Unit, Mae Sot, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom; Menzies School of Health Research, Charles Darwin University, Darwin, Australia, Epicentre, Paris, France
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Ric N. Price
Ric N. Price
Shoklo Malaria Research Unit, Mae Sot, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom; Menzies School of Health Research, Charles Darwin University, Darwin, Australia, Epicentre, Paris, France
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Yar La
Yar La
Shoklo Malaria Research Unit, Mae Sot, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom; Menzies School of Health Research, Charles Darwin University, Darwin, Australia, Epicentre, Paris, France
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Rae Hae
Rae Hae
Shoklo Malaria Research Unit, Mae Sot, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom; Menzies School of Health Research, Charles Darwin University, Darwin, Australia, Epicentre, Paris, France
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Pratap Singhasivanon
Pratap Singhasivanon
Shoklo Malaria Research Unit, Mae Sot, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom; Menzies School of Health Research, Charles Darwin University, Darwin, Australia, Epicentre, Paris, France
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Nicholas J. White
Nicholas J. White
Shoklo Malaria Research Unit, Mae Sot, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom; Menzies School of Health Research, Charles Darwin University, Darwin, Australia, Epicentre, Paris, France
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François Nosten
François Nosten
Shoklo Malaria Research Unit, Mae Sot, Thailand; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road, Headington, Oxford, United Kingdom; Menzies School of Health Research, Charles Darwin University, Darwin, Australia, Epicentre, Paris, France
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Dihydroartemisinin–piperaquine (DP) could become a leading fixed combination malaria treatment worldwide. Although there is accumulating evidence of efficacy and safety from clinical trials, data on cardiotoxicity are limited. In two randomized controlled trials in Thailand, 56 patients had ECGs performed before treatment, 4 hours after the first dose, and 4 hours after the last dose. The mean (95% CI) changes in QTc interval (Bazett’s correction) were 2 (−6 to 9) ms and 14 (7 to 21) ms, respectively. These small changes on the third day of treatment are similar to those observed elsewhere in the convalescent phase following antimalarial treatment with drugs known to have no cardiac effects and are therefore likely to result from recovery from acute malaria and not the treatment given. At therapeutic doses, DP does not have clinically significant effects on the electrocardiogram.
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-
1
Denis MB, Davis TM, Hewitt S, Incardona S, Nimol K, Fandour T, Poravuth Y, Lim C, Socheat D, 2002. Efficacy and safety of dihydroartemisinin–piperaquine (Artekin) in Cambodian children and adults with uncomplicated falciparum malaria. Clin Infect Dis 35 :1467–1476.
-
2
Tran TH, 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 Plasmodium falciparum malaria in Vietnam: randomised clinical trial. Lancet 363 :18–22.
-
3
Ashley EA, Krudsood S, Phaiphun L, Srivilairit S, McGready R, Leowattana W, Hutagalung R, Wilairatana P, Brockman A, Looareesuwan S, Nosten F, White NJ, 2004. Randomized, controlled dose-optimization studies of dihydroartemisinin–piperaquine for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand. J Infect Dis 190 :1773–1782.
-
4
Ashley EA, McGready R, Hutagalung R, Phaiphun L, Slight T, Proux S, Thwai KL, Barends M, Looareesuwan S, White NJ, Nosten F, 2005. A randomised controlled study of a simple once daily regimen of dihydroartemisinin–piperaquine for the treatment of uncomplicated multi-drug resistant falciparum malaria. Clin Infect Dis 41 :425–432.
-
5
Classen W, Altmann B, Gretener P, Souppart C, Skelton-Stroud P, Krinke G, 1999. Differential effects of orally versus parenterally administered qinghaosu derivative artemether in dogs. Exp Toxicol Pathol 51 :507–516.
-
6
Brewer TG, Grate SJ, Peggins JO, Weina PJ, Petras JM, Levine BS, Heiffer MH, Schuster BG, 1994. Fatal neurotoxicity of arteether and artemether. Am J Trop Med Hyg 51 :251–259.
-
7
Van Vugt M, Ezzet E, Nosten F, Gathmann I, Wilairatana P, Looareesuwan S, White NJ, 1999. No evidence of cardiotoxicity during antimalarial treatment with artemether–lumefantrine. Am J Trop Med Hyg 61 :964–967.
-
8
Von Seidlen L, Jaffar S, Greenwood BM, 1997. Prolongation of the QTc in African children treated for falciparum malaria. Am J Trop Med Hyg 56 :494–497.
-
9
Hien TT, Day NPJ, Phu NH, Mai NT, Chau TT, Loc PP, Sinh DX, Choung LV, Vinh H, Waller D, Peto TEA, White NJ, 1996. Controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria treated with artemsinin derivatives. Am J Trop Med Hyg 60 :936–942.
-
10
Yap YG, Camm AJ, 2003. Drug induced QT prolongation and torsade de pointes. Heart 89 :1363–1372.
-
11
Karunajeewa H, Lim C, Hung T-Y, Ilett KF, Denis MB, Socheat D, Davis TME, 2003. Safety evaluation of fixed combination piperaquine plus dihydroartemisinin (Artekin) in Cambodian children and adults with malaria. Br J Clin Pharmacol 57 :93–99.
-
12
Food and Drug Administration, 2005. Guidance for Industry: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs. Rockville, MD: FDA.
-
13
Haverkamp W, Breithard G, Camm AJ, Janse MJ, Rosen MR, Antzelevitch C, Escande D, Franz M, Malik M, Moss A, Shah R, and other speakers in the sessions and chairs of the workshops, 2000. The potential for QT prolongation and proarrhythmia by non-antiarrhythmic drugs: clinical and regulatory implications. Report on a policy conference of the European Society of Cardiology. Eur Heart J 21 :1216–1231.
-
14
White NJ, 2007. The cardiotoxicity of the antimalarial drugs. Lancet Infect Dis 7 :549–558.
-
15
Price RN, Nosten F, White NJ, 1998. Prolongation of the QTc interval in African children treated for falciparum malaria (letter; comment). Am J Trop Med Hyg 59 :503.
-
16
Nosten F, ter Kuile F, Luxemburger C, Woodrow C, Kyle D, Chongsuphajaisiddhi T, White NJ, 1993. Cardiac effects of antimalarial treatment with halofantrine. Lancet 341 :1054–1056.
-
17
Looareesuwan S, White NJ, Chanthavanich P, Edwards G, Nicholl DD, Bunch C, Warrell DA, 1986. Cardiovascular toxicity and distribution kinetics of intravenous chloroquine. Br J Clin Pharmacol 22 :31–36.
-
18
Gupta RK, Van Vugt M, Paiphun L, Slight T, Looareesuwan S, White NJ, Nosten F, 2005. Short report: no evidence of cardiotoxicity of atovaquone–proguanil alone or in combination with artesunate. Am J Trop Med Hyg 73 :267–278.
-
19
Karbwang J, Davis TM, Looareesuwan S, Molunto P, Bunnag D, White NJ, 1993. A comparison of the pharmacokinetic and pharmacodynamic properties of quinine and quinidine in healthy Thai males. Br J Clin Pharmacol 35 :265–271.
-
20
White NJ, Looareesuwan S, Warrell DA, 1983. Quinine and quinidine: a comparison of EKG effects during the treatment of malaria. J Cardiovasc Pharmacol 5 :173–175.
-
21
Sowunmi A, Falade CO, Oduola AMJ, Ogundahunsi OAT, Fehintola FA, Gbotosho GO, Larcier P, Salako S, 1998. Cardiac effects of halofantrine in children suffering from acute uncomplicated falciparum malaria. Trans R Soc Trop Med Hyg 92 :446–448.
-
22
Touze JE, Bernard J, Keundjian A, Imbert P, Vigeur A, Chaudet A, Doury JC, 1996. Electrocardiographic changes and halofantrine plasma level during acute falciparum malaria. Am J Trop Med Hyg 54 :225–228.
-
23
Sheldon R, Duff H, Koshman ML, 1995. Antiarrhythmic activity of quinine in humans. Circulation 92 :2944–2950.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 34 | 34 | 10 |
| Full Text Views | 244 | 72 | 1 |
| PDF Downloads | 58 | 17 | 0 |