Supervised versus unsupervised intake of six-dose artemether-lumefantrine for treatment of acute, uncomplicated Plasmodium falciparum malaria in Mbarara, Uganda: a randomised trial

Abstract

CitationSupervised versus unsupervised intake of six-dose artemether-lumefantrine for treatment of acute, uncomplicated Plasmodium falciparum malaria in Mbarara, Uganda: a randomised trial., 365 (9469 Articles IntroductionWith an estimated 500 million individuals affected every year, malaria is a leading cause of morbidity and mortality in sub-Saharan Africa along with HIV/AIDS. 1Of the 1 million deaths caused by malaria worldwide, about 90% occur in African children, a situation compounded by the emergence of drug resistance. 2In Uganda, which had a population of 24·7 million in 2003, an estimated 9·8 million individuals are infected with malaria every year (John Bosco Rwakimari, Ugandan Ministry of Health, Uganda, personal communication; http://www.health.go.ug). To tackle malaria-related mortality and morbidity, the Ugandan Ministry of Health (MoH) is concentrating on early diagnosis and effective treatment of the disease. In the 1970s and the 1980s, high malaria awareness in the population and easy access to cheap and effective antimalarials such as chloroquine and sulfadoxinepyrimethamine ensured the disease was reasonably well controlled. However, resistance to these drugs is now widespread in Uganda and in other parts of east Africa, with adverse consequences for malaria control. 3-7The MoH-recommended first-line antimalarial drug in Uganda is chloroquine combined with sulfadoxinepyrimethamine, 6 though introduction of artemisininbased combination treatments (ACTs) is planned for 2005.8 Day-28 cure rates of 52%, 9 65%, 7 and 77% 10 have been reported for this combination in different parts of Uganda. ACTs are judged effective in Africa, where they improve cure rates and reduce gametocyte carriage compared with presently used monotherapies.11,12 To combat drug-resistant malaria in Africa, WHO advocates the adoption of ACTs as first-line treatment.2 The use of the non-ACT combination of amodiaquine and sulfadoxine-pyrimethamine is considered by some as an interim measure while waiting for ACTs to become widely available. Day-28 efficacy rates of this combination were 84% and 90% in two studies in Uganda. 7,9 Artemether-lumefantrine (Coartem, Novartis Pharma, Basel, Switzerland) is the only fixed-dose formulation ACT on the WHO essential drug list. However, the combination is not registered for use in pregnant women, and was not registered for children under 10 kg in weight when we did our trial. Results of studies [13][14][15] from southeast Asia show that the six-dose regimen of artemether-lumefantrine has cure rates of more than 96%, is well tolerated, and has a good safety profile when Supervised versus unsupervised intake of six-dose artemether-lumefantrine for treatment of acute, uncomplicated Plasmodium falciparum malaria in Mbarara, Uganda: a randomised trial Patrice Piola, Carole Fogg, Francis Bajunirwe, Samuel Biraro, Francesco Grandesso, Eugene Ruzagira, Joseph Babigumira, Isaac Kigozi, James Kiguli, Juliet Kyomuhendo, Laurent Ferradini, Walter Taylor, Francesco Checchi, Jean-Paul Guthmann S...

Adherence to artemether/lumefantrine treatment in children under real-life situations in rural Tanzania

“…The high reported adherence found in this study can be explained by the availability of ALu in pre-packaged packets with pictorial instructions, which have been reported to improve caretakers' understanding of the schedule administration of the drug 30 and hence they are more likely to follow the provider's advice. 12,22,31 Studies conducted when CQ resistance was high reported low adherence levels, 10,11 thus the highly efficacious ALu used in the present study might also explain the high reported level of adherence to treatment.…”

Confirmed Vivax Resistance to Chloroquine and Effectiveness of Artemether-Lumefantrine for the Treatment of Vivax Malaria in Ethiopia

“…As a follow-up to confirm compliance to the evening doses, patients were asked on each follow-up day to confirm that the correct doses were taken at the right time and that vomiting did not occur after drug intake. Although the issue of non-compliance is a real concern, a similar study conducted in Ethiopia in 2004 to assess the efficacy of AL for the treatment of uncomplicated falciparum malaria, where the evening doses of AL were not supervised, reported a 99% rate of treatment success 19 Another study conducted in Uganda 20 Contrary to the high level of efficacy of AL for the treatment of P. falciparum, its efficacy for the treatment of P. vivax does not seem as high. In a study conducted in Thailand 21 comparing the efficacy of CQ and AL combined with a 14-day course of primaquine, full treatment success was achieved in the CQ treatment group, whereas the treatment success with AL was slightly lower at 97.4%.…”

Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial

“…10 In African children, effi cacy of artemether-lumefantrine at day 28 after treatment is consistently more than 90%, [11][12][13][14][15][16] even with unsupervised administration. 17,18 However, many young children cannot swallow whole tablets, and the bitter taste of the crushed commercial tablet added to water could compromise tolerability. Also, crushing tablets is an ineffi cient procedure, which could result in loss of drug and reduced dose ingested.…”