title: Good efficacy of artemether-lumefantrine for uncomplicated falciparum malaria in eastern Sumba, East Nusatenggara, Indonesia.
abstract: OBJECTIVE
  to evaluate the safety and efficacy of a fixed combination of artemether-lumefantrine for likely use against failures of the artesunate-amodiaquine first line therapy.
  
  
  METHODS
  the study was an open label single arm uncontrolled trial. we evaluated the safety and efficacy of standard artemether-lumefantrine therapy in 59 subjects with uncomplicated malaria caused by Plasmodium falciparum on the island of Sumba in eastern Indonesia. No treatment failures occurred up to day 35. One subject had recurrent parasitemia on day 42 that showed a genotype consistent with recrudescence. The efficacy of this therapy was thus estimated to be 98.3% (95% confidence interval=95%-100%). Descriptive analysis was done using the SPSS 12 computer software.
  
  
  RESULTS
  two hundred and thirteen P. falciparum patients met the inclusion criteria for in vivo efficacy study, 79 were given artemether-lumefantrine and 134 were treated under another protocol with artesunate-amodiaquine or sulfadoxine-pyrimethamine. Among 79 eligible subjects, 59 successfully completed the 42-day test. As expected, the mean PCT was longer than the mean FCT, i.e. 1.34 ± 0.67 (95% CI 1.21-1.47) and 1.05 ± 0.05 (95% CI 0.95-1.15) days, respectively. On day 3 of treatment, both fever and asexual stage of P. falciparum disappeared in all subjects. Observation until Day 35 showed that all of the 59 subjects treated with artemether-lumefantrine were cured.
  
  
  CONCLUSIONS
  the findings of this uncontrolled study suggest good safety and efficacy of artemether-lumefantrine for treatment of uncomplicated falciparum malaria on Sumba Island in the Lesser Sundas archipelago of eastern Indonesia.
authors.affiliation: Department of Parasitology, Faculty of Medicine, University of Indonesia, Jakarta Pusat, Indonesia. sutanto.inge@yahoo.com
authors.forename: Inge
authors.initials: I
authors.lastname: Sutanto
authors.forename: Sri
authors.initials: S
authors.lastname: Suprianto
authors.forename: Anri
authors.initials: A
authors.lastname: Widiaty
authors.lastname: Rukmiyati
authors.forename: Paul
authors.initials: P
authors.lastname: Ruckert
authors.forename: Alexander
authors.initials: A
authors.lastname: von Bethmann
authors.forename: Frederique
authors.initials: F
authors.lastname: de Monbrison
authors.forename: Stephane
authors.initials: S
authors.lastname: Picot
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Laihad
authors.forename: J Kevin
authors.initials: JK
authors.lastname: Baird
mesh_terms: D000655:Amodiaquine / Q000627:therapeutic use; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D005449:Fluorenes / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007214:Indonesia; D016778:Malaria, Falciparum / Q000097:blood / Q000188:drug therapy*; D010963:Plasmodium falciparum / Q000235:genetics; D011739:Pyrimethamine / Q000627:therapeutic use; D012008:Recurrence; D013413:Sulfadoxine / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; C515299:amodiaquine, artesunate drug combination; D000655:Amodiaquine; C001205:fanasil, pyrimethamine drug combination; D013413:Sulfadoxine; D011739:Pyrimethamine