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Arjen M. Dondorp - One of the best experts on this subject based on the ideXlab platform.
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Artesunate versus quinine in the treatment of severe falciparum malaria in african children aquamat an open label randomised trial
The Lancet, 2010Co-Authors: Arjen M. Dondorp, Caterina I. Fanello, Ilse C E Hendriksen, Ermelinda Gomes, Amir Seni, Kajal D Chhaganlal, Kalifa Bojang, Rasaq Olaosebikan, Nkechinyere Anunobi, Kathryn MaitlandAbstract:Summary Background Severe malaria is a major cause of childhood death and often the main reason for paediatric hospital admission in sub-Saharan Africa. Quinine is still the established treatment of choice, although evidence from Asia suggests that Artesunate is associated with a lower mortality. We compared parenteral treatment with either Artesunate or quinine in African children with severe malaria. Methods This open-label, randomised trial was undertaken in 11 centres in nine African countries. Children ( Findings 5425 children were enrolled; 2712 were assigned to Artesunate and 2713 to quinine. All patients were analysed for the primary outcome. 230 (8·5%) patients assigned to Artesunate treatment died compared with 297 (10·9%) assigned to quinine treatment (odds ratio [OR] stratified for study site 0·75, 95% CI 0·63–0·90; relative reduction 22·5%, 95% CI 8·1–36·9; p=0·0022). Incidence of neurological sequelae did not differ significantly between groups, but the development of coma (65/1832 [3·5%] with Artesunate vs 91/1768 [5·1%] with quinine; OR 0·69 95% CI 0·49–0·95; p=0·0231), convulsions (224/2712 [8·3%] vs 273/2713 [10·1%]; OR 0·80, 0·66–0·97; p=0·0199), and deterioration of the coma score (166/2712 [6·1%] vs 208/2713 [7·7%]; OR 0·78, 0·64–0·97; p=0·0245) were all significantly less frequent in Artesunate recipients than in quinine recipients. Post-treatment hypoglycaemia was also less frequent in patients assigned to Artesunate than in those assigned to quinine (48/2712 [1·8%] vs 75/2713 [2·8%]; OR 0·63, 0·43–0·91; p=0·0134). Artesunate was well tolerated, with no serious drug-related adverse effects. Interpretation Artesunate substantially reduces mortality in African children with severe malaria. These data, together with a meta-analysis of all trials comparing Artesunate and quinine, strongly suggest that parenteral Artesunate should replace quinine as the treatment of choice for severe falciparum malaria worldwide. Funding The Wellcome Trust.
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Cost-effectiveness of Artesunate for the treatment of severe malaria.
Tropical medicine & international health : TM & IH, 2009Co-Authors: Yoel Lubell, Shunmay Yeung, Arjen M. Dondorp, N P Day, François Nosten, Emiliana Tjitra, M. Abul Faiz, E Bin Yunus, N M Anstey, Saroj Kanta MishraAbstract:OBJECTIVE To explore the cost-effectiveness of Artesunate against quinine based principally on the findings of a large multi-centre trial carried out in Southeast Asia. METHODS Trial data were used to compare mortality of patients with severe malaria, treated with either Artesunate or quinine. This was combined with retrospectively collected cost data to estimate the incremental cost per death averted with the use of Artesunate instead of quinine. RESULTS The incremental cost per death averted using Artesunate was approximately 140 USD. Artesunate maintained this high level of cost-effectiveness also when allowing for the uncertainty surrounding the cost and effectiveness assessments. CONCLUSION This analysis confirms the vast superiority of Artesunate for treatment of severe malaria from an economic as well as a clinical perspective.
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randomized comparison of Artesunate and quinine in the treatment of severe falciparum malaria
Clinical Infectious Diseases, 2003Co-Authors: Paul N Newton, Arjen M. Dondorp, Brian Angus, Wirongrong Chierakul, Ronatrai Ruangveerayuth, Kamolrat Silamut, Pramote TeerapongAbstract:A randomized, open-label comparison of Artesunate and quinine was conducted in 113 adults with clinically severe falciparum malaria in western Thailand. Mortality was 12% with Artesunate and 22% with quinine treatment (relative risk, 0.53; 95% confidence interval, 0.23-1.26; P=.22). Multiple logistic regression analysis found admission plasma lactate level, Glasgow Coma Scale score, and total serum bilirubin level to be independent risk factors for death. Coma recovery and times to normalize plasma lactate levels were similar, but the parasite clearance time was much shorter among Artesunate-treated patients (P=.019). Fewer patients became hypoglycemic during Artesunate therapy (10%) than during quinine therapy (28%) (P=.03). Artesunate is at least as effective as quinine in the treatment of adults with severe malaria. Larger trials are required to determine whether mortality is reduced among patients treated with Artesunate.
Paul N Newton - One of the best experts on this subject based on the ideXlab platform.
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correction manslaughter by fake Artesunate in asia will africa be next
PLOS Medicine, 2006Co-Authors: Paul N Newton, Rose Mcgready, Facundo M Fernandez, Michael R Green, Manuela Sunjio, Carinne Bruneton, Souly Phanouvong, Pascal Millet, Christopher J M Whitty, Ambrose TalisunaAbstract:In PLoS Medicine, volume 3, issue 6: DOI: 10.1371/journal.pmed.0030197 In the first paragraph of the section The Epidemic of Counterfeit Artesunate in Southeast Asia, the sentence “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 52% of “Artesunate” blister packs sampled contain no active ingredient [1–5]” should be “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 53% of “Artesunate” blister packs sampled contain no active ingredient [1–5].”
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Correction: Manslaughter by Fake Artesunate in Asia—Will Africa Be Next?
PLOS Medicine, 2006Co-Authors: Paul N Newton, Rose Mcgready, Facundo M Fernandez, Manuela Sunjio, Carinne Bruneton, Souly Phanouvong, Pascal Millet, Christopher J M Whitty, Michael Green, Ambrose TalisunaAbstract:In PLoS Medicine, volume 3, issue 6: DOI: 10.1371/journal.pmed.0030197 In the first paragraph of the section The Epidemic of Counterfeit Artesunate in Southeast Asia, the sentence “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 52% of “Artesunate” blister packs sampled contain no active ingredient [1–5]” should be “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 53% of “Artesunate” blister packs sampled contain no active ingredient [1–5].”
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randomized comparison of Artesunate and quinine in the treatment of severe falciparum malaria
Clinical Infectious Diseases, 2003Co-Authors: Paul N Newton, Arjen M. Dondorp, Brian Angus, Wirongrong Chierakul, Ronatrai Ruangveerayuth, Kamolrat Silamut, Pramote TeerapongAbstract:A randomized, open-label comparison of Artesunate and quinine was conducted in 113 adults with clinically severe falciparum malaria in western Thailand. Mortality was 12% with Artesunate and 22% with quinine treatment (relative risk, 0.53; 95% confidence interval, 0.23-1.26; P=.22). Multiple logistic regression analysis found admission plasma lactate level, Glasgow Coma Scale score, and total serum bilirubin level to be independent risk factors for death. Coma recovery and times to normalize plasma lactate levels were similar, but the parasite clearance time was much shorter among Artesunate-treated patients (P=.019). Fewer patients became hypoglycemic during Artesunate therapy (10%) than during quinine therapy (28%) (P=.03). Artesunate is at least as effective as quinine in the treatment of adults with severe malaria. Larger trials are required to determine whether mortality is reduced among patients treated with Artesunate.
Christopher J M Whitty - One of the best experts on this subject based on the ideXlab platform.
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Artesunate, artemether or quinine in severe Plasmodium falciparum malaria?
Expert review of anti-infective therapy, 2007Co-Authors: Anna M. Checkley, Christopher J M WhittyAbstract:Quinine and the artemisinin-derivative drugs Artesunate and artemether are effective treatments for severe falciparum malaria. Trials comparing artemether with quinine have not demonstrated convincing evidence of a mortality advantage for artemether. The South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT), a multicenter, randomized, open-label trial in 1461 adults with severe malaria in Asia compared Artesunate with quinine. Mortality was 15% in the Artesunate group and 22% in the quinine group, a reduction of 34.7% (95% confidence interval: 18.5-47.6%) in the Artesunate group, with almost all the benefit reported in those with high parasite counts. Artesunate should constitute first-line treatment for severe malaria in Asia. These results can probably be generalized to the treatment of severe malaria in adults from all areas, especially in those with hyperparasitemia. However, it is unclear whether these results can be generalized to children in Africa, who constitute the majority of those who die from severe malaria worldwide.
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correction manslaughter by fake Artesunate in asia will africa be next
PLOS Medicine, 2006Co-Authors: Paul N Newton, Rose Mcgready, Facundo M Fernandez, Michael R Green, Manuela Sunjio, Carinne Bruneton, Souly Phanouvong, Pascal Millet, Christopher J M Whitty, Ambrose TalisunaAbstract:In PLoS Medicine, volume 3, issue 6: DOI: 10.1371/journal.pmed.0030197 In the first paragraph of the section The Epidemic of Counterfeit Artesunate in Southeast Asia, the sentence “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 52% of “Artesunate” blister packs sampled contain no active ingredient [1–5]” should be “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 53% of “Artesunate” blister packs sampled contain no active ingredient [1–5].”
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Correction: Manslaughter by Fake Artesunate in Asia—Will Africa Be Next?
PLOS Medicine, 2006Co-Authors: Paul N Newton, Rose Mcgready, Facundo M Fernandez, Manuela Sunjio, Carinne Bruneton, Souly Phanouvong, Pascal Millet, Christopher J M Whitty, Michael Green, Ambrose TalisunaAbstract:In PLoS Medicine, volume 3, issue 6: DOI: 10.1371/journal.pmed.0030197 In the first paragraph of the section The Epidemic of Counterfeit Artesunate in Southeast Asia, the sentence “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 52% of “Artesunate” blister packs sampled contain no active ingredient [1–5]” should be “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 53% of “Artesunate” blister packs sampled contain no active ingredient [1–5].”
Peter J De Vries - One of the best experts on this subject based on the ideXlab platform.
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Treatment outcome of intravenous Artesunate in patients with severe malaria in the Netherlands and Belgium
Malaria Journal, 2012Co-Authors: Annemarie R Kreeftmeijer-vegter, Perry J Van Genderen, Leo G Visser, Wouter Fw Bierman, Jan Clerinx, Cees Kw Van Veldhuizen, Peter J De VriesAbstract:Background Intravenous (IV) Artesunate is the treatment of choice for severe malaria. In Europe, however, no GMP-manufactured product is available and treatment data in European travellers are scarce. Fortunately, Artesunate became available in the Netherlands and Belgium through a named patient programme. This is the largest case series of Artesunate treated patients with severe malaria in Europe. Methods Hospitalized patients treated with IV Artesunate between November 2007 and December 2010 in the Netherlands and Belgium were retrospectively evaluated. Patient characteristics, treatment and clinical outcome were recorded on a standardized form and mortality, parasite clearance times and the occurrence of adverse events were evaluated. Results Of the 68 treated patients, including 55 with severe malaria, two patients died (2/55 = 3.6%). The mean time to 50% parasite clearance (PCT50), 90% and 99% were 4.4 hours (3.9 - 5.2), 14.8 hours (13.0 - 17.2), and 29.5 hours (25.9 - 34.4) respectively. Artesunate was well tolerated. However, an unusual form of haemolytic anaemia was observed in seven patients. The relationship with Artesunate remains uncertain. Conclusions Data from the named patient programme demonstrate that IV Artesunate is effective and well-tolerated in European travellers lacking immunity. However, increased attention needs to be paid to the possible development of haemolytic anaemia 2-3 weeks after start of treatment. Treatment of IV Artesunate should be limited to the period that IV treatment is required and should be followed by a full oral course of an appropriate anti-malarial drug.
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treatment outcome of intravenous Artesunate in patients with severe malaria in the netherlands and belgium
Malaria Journal, 2012Co-Authors: Annemarie Rosan Kreeftmeijervegter, Leo G Visser, Wouter Fw Bierman, Jan Clerinx, Perry J J Van Genderen, Cees K W Van Veldhuizen, Peter J De VriesAbstract:Intravenous (IV) Artesunate is the treatment of choice for severe malaria. In Europe, however, no GMP-manufactured product is available and treatment data in European travellers are scarce. Fortunately, Artesunate became available in the Netherlands and Belgium through a named patient programme. This is the largest case series of Artesunate treated patients with severe malaria in Europe. Hospitalized patients treated with IV Artesunate between November 2007 and December 2010 in the Netherlands and Belgium were retrospectively evaluated. Patient characteristics, treatment and clinical outcome were recorded on a standardized form and mortality, parasite clearance times and the occurrence of adverse events were evaluated. Of the 68 treated patients, including 55 with severe malaria, two patients died (2/55 = 3.6%). The mean time to 50% parasite clearance (PCT50), 90% and 99% were 4.4 hours (3.9 - 5.2), 14.8 hours (13.0 - 17.2), and 29.5 hours (25.9 - 34.4) respectively. Artesunate was well tolerated. However, an unusual form of haemolytic anaemia was observed in seven patients. The relationship with Artesunate remains uncertain. Data from the named patient programme demonstrate that IV Artesunate is effective and well-tolerated in European travellers lacking immunity. However, increased attention needs to be paid to the possible development of haemolytic anaemia 2-3 weeks after start of treatment. Treatment of IV Artesunate should be limited to the period that IV treatment is required and should be followed by a full oral course of an appropriate anti-malarial drug.
Rose Mcgready - One of the best experts on this subject based on the ideXlab platform.
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opposite malaria and pregnancy effect on oral bioavailability of Artesunate a population pharmacokinetic evaluation
British Journal of Clinical Pharmacology, 2015Co-Authors: Rose Mcgready, Aung Pyae Phyo, Frank Kloprogge, Marcus J Rijken, Warunee Hanpithakpon, Hla Hla Than, Nathar Hlaing, Naw Thida ZinAbstract:Aim The aim was to compare the pharmacokinetic properties of Artesunate and dihydroartemisinin in the same women: i) pregnant with acute uncomplicated malaria on day 1 and 2, ii) pregnant with convalescent malaria on day 7 and iii) in a healthy state 3 months post-partum on day 1, 2 and 7. Methods Non-linear mixed-effects modelling was used to compare plasma concentration–time profiles of Artesunate and dihydroartemisinin over 7 days of treatment following oral and intravenous Artesunate administration to pregnant women with uncomplicated Plasmodium falciparum malaria during their second or third trimesters of pregnancy. The same women were restudied 3 months after delivery when fully recovered. Non-compartmental results of the same study have been published previously. Results Twenty pregnant patients on the Thailand-Myanmar border were studied and 15 volunteered to be restudied 3 months post-partum. Malaria and pregnancy had no effect on the pharmacokinetic properties of Artesunate or dihydroartemisinin after intravenous Artesunate administration. However, malaria and pregnancy had opposite effects on the absorption of orally administered Artesunate. Malaria increased the absolute oral bioavailability of Artesunate by 87%, presumably by inhibiting first pass effect, whereas pregnancy decreased oral bioavailability by 23%. Conclusions The population pharmacokinetic analysis demonstrated opposite effects of malaria and pregnancy on the bioavailability of orally administered Artesunate. Lower drug exposures during the second and third trimesters of pregnancy may contribute to lower cure rates and thus the development of drug resistance. Dose optimization studies are required for Artesunate containing artemisinin-based combination therapies (ACTs) in later pregnancy.
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Correction: Manslaughter by Fake Artesunate in Asia—Will Africa Be Next?
PLOS Medicine, 2006Co-Authors: Paul N Newton, Rose Mcgready, Facundo M Fernandez, Manuela Sunjio, Carinne Bruneton, Souly Phanouvong, Pascal Millet, Christopher J M Whitty, Michael Green, Ambrose TalisunaAbstract:In PLoS Medicine, volume 3, issue 6: DOI: 10.1371/journal.pmed.0030197 In the first paragraph of the section The Epidemic of Counterfeit Artesunate in Southeast Asia, the sentence “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 52% of “Artesunate” blister packs sampled contain no active ingredient [1–5]” should be “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 53% of “Artesunate” blister packs sampled contain no active ingredient [1–5].”
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correction manslaughter by fake Artesunate in asia will africa be next
PLOS Medicine, 2006Co-Authors: Paul N Newton, Rose Mcgready, Facundo M Fernandez, Michael R Green, Manuela Sunjio, Carinne Bruneton, Souly Phanouvong, Pascal Millet, Christopher J M Whitty, Ambrose TalisunaAbstract:In PLoS Medicine, volume 3, issue 6: DOI: 10.1371/journal.pmed.0030197 In the first paragraph of the section The Epidemic of Counterfeit Artesunate in Southeast Asia, the sentence “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 52% of “Artesunate” blister packs sampled contain no active ingredient [1–5]” should be “Counterfeit Artesunate continues to circulate on a vast scale in mainland Southeast Asia, where between 38% and 53% of “Artesunate” blister packs sampled contain no active ingredient [1–5].”
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treatment of uncomplicated multidrug resistant falciparum malaria with Artesunate atovaquone proguanil
Clinical Infectious Diseases, 2002Co-Authors: Michele Van Vugt, Elisabetta Leonardi, L Phaipun, Thra Slight, Kyaw Lay Thway, Rose Mcgready, Alan Brockman, Leopoldo VillegasAbstract:In an open-label trial carried out on the northwest border of Thailand, 1596 patients with uncomplicated multidrug-resistant falciparum malaria were randomly assigned to receive atovaquone-proguanil, atovaquone-proguanil-Artesunate, or Artesunate-mefloquine and were followed up for 42 days. All 3 regimens were highly effective and well tolerated. Fever duration and parasite clearance times were significantly shorter among patients who received Artesunate (P <.001). Polymerase chain reaction genotyping confirmed that recrudescence occurred in 13 patients who received Artesunate-mefloquine (2.4%), 5 who received atovaquone-proguanil-Artesunate (0.9%), and 15 who received atovaquone-proguanil (2.8%). Adding Artesunate to atovaquone-proguanil reduced the risk of failure 3-fold (95% confidence interval [CI], 1.1-8.2) and subsequent gametocyte carriage 21-fold (95% CI, 14-30). Gastrointestinal complaints in the first 48 h after initiation of treatment were more common among Artesunate recipients, but after day 2, dizziness, sleep disturbance, nausea, vomiting, and anorexia were more common among mefloquine recipients (P
Artesunate-atovaquone-proguanil is a highly effective and well-tolerated treatment for multidrug-resistant falciparum malaria
