Document Detail


Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial.
MedLine Citation:
PMID:  20932805     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Malaria in pregnancy is associated with maternal and fetal morbidity and mortality. In 2006, WHO recommended use of artemisinin-based combination treatments during the second or third trimesters, but data on efficacy and safety in Africa were scarce. We aimed to assess whether artemether-lumefantrine was at least as efficacious as oral quinine for the treatment of uncomplicated falciparum malaria during the second and third trimesters of pregnancy in Mbarara, Uganda.
METHODS: We did an open-label, randomised, non-inferiority trial between October, 2006, and May, 2009, at the antenatal clinics of the Mbarara University of Science and Technology Hospital in Uganda. Pregnant women were randomly assigned (1:1) by computer generated sequence to receive either quinine hydrochloride or artemether-lumefantrine, and were followed up weekly until delivery. Our primary endpoint was cure rate at day 42, confirmed by PCR. The non-inferiority margin was a difference in cure rate of 5%. Analysis of efficacy was for all randomised patients without study deviations that could have affected the efficacy outcome. This study was registered with ClinicalTrials.gov, number NCT00495508.
FINDINGS: 304 women were randomly assigned, 152 to each treatment group. By day 42, 16 patients were lost to follow-up and 25 were excluded from the analysis. At day 42, 137 (99.3%) of 138 patients taking artemether-lumefantrine and 122 (97.6%) of 125 taking quinine were cured-difference 1.7% (lower limit of 95% CI -0.9). There were 290 adverse events in the quinine group and 141 in the artemether-lumefantrine group.
INTERPRETATION: Artemisinin derivatives are not inferior to oral quinine for the treatment of uncomplicated malaria in pregnancy and might be preferable on the basis of safety and efficacy.
FUNDING: Médecins Sans Frontières and the European Commission.
Authors:
Patrice Piola; Carolyn Nabasumba; Eleanor Turyakira; Mehul Dhorda; Niklas Lindegardh; Dan Nyehangane; Georges Snounou; Elizabeth A Ashley; Rose McGready; Francois Nosten; Philippe J Guerin
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Lancet. Infectious diseases     Volume:  10     ISSN:  1474-4457     ISO Abbreviation:  Lancet Infect Dis     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-10-29     Completed Date:  2010-11-15     Revised Date:  2014-08-15    
Medline Journal Info:
Nlm Unique ID:  101130150     Medline TA:  Lancet Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  762-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 Elsevier Ltd. All rights reserved.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Animals
Antimalarials / administration & dosage*
Artemisinins / administration & dosage*,  adverse effects
Drug Combinations
Ethanolamines / administration & dosage*,  adverse effects
Female
Fluorenes / administration & dosage*,  adverse effects
Humans
Malaria, Falciparum / drug therapy*
Plasmodium falciparum / drug effects,  isolation & purification
Polymerase Chain Reaction
Pregnancy
Pregnancy Complications, Infectious / drug therapy*
Quinine / administration & dosage*,  adverse effects
Treatment Outcome
Uganda
Young Adult
Grant Support
ID/Acronym/Agency:
077166/Z/05/Z//Wellcome Trust
Chemical
Reg. No./Substance:
0/Antimalarials; 0/Artemisinins; 0/Drug Combinations; 0/Ethanolamines; 0/Fluorenes; 0/artemether-lumefantrine combination; A7V27PHC7A/Quinine
Comments/Corrections
Comment In:
Lancet Infect Dis. 2010 Nov;10(11):739-40   [PMID:  21029982 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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