Document Detail


The comparative efficacy and tolerability of CGP 56697 (artemether + lumefantrine) versus halofantrine in the treatment of uncomplicated falciparum malaria in travellers returning from the Tropics to The Netherlands and France.
MedLine Citation:
PMID:  10418762     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
CGP 56697 (Riamet) is a new oral anti-malarial drug composed of artemether and lumefantrine (benflumetol) which combines the fast, short-acting artemether for rapid parasite clearance with the prolonged action of lumefantrine for intended radical cure. In this double-blind, comparative trial, the efficacy and tolerability of CGP 56697, given as a course of 4 x 4 tablets over 48 h, was compared to halofantrine, given as 3 x 2 tablets over 12 h with a second course 1 week later. Patients (mostly non-immune) with acute, uncomplicated Plasmodium falciparum infection were randomly assigned to either CGP 56697 (n = 51) or halofantrine (n = 52). CGP 56697 proved superior with respect to parasite clearance time (median 32 vs. 48 h, P < 0.001) and parasite reduction at 24 h (median 99.7 vs. 89.6%, P < 0.001) with a non-significant difference in resolution of fever (median 24 vs. 32 h, P = 0.835). However, a 28-day cure rate of 82% was observed for CGP 56697 and 100% for halofantrine. Significant QTc prolongations (> 30 ms) were seen 6-12 h after halofantrine intake but not after CGP 56697 intake. CGP 56697 is an effective, well-tolerated treatment for uncomplicated falciparum malaria but for this dosing regimen the recrudescence rate is unacceptablyhigh (18%). For travellers contracting malaria abroad, we propose a six-dose regimen of CGP 56697 over 3 days.
Authors:
M van Agtmael; O Bouchaud; D Malvy; J Delmont; M Danis; S Barette; C Gras; J Bernard; J E Touze; I Gathmann; R Mull
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  International journal of antimicrobial agents     Volume:  12     ISSN:  0924-8579     ISO Abbreviation:  Int. J. Antimicrob. Agents     Publication Date:  1999 Jul 
Date Detail:
Created Date:  1999-09-02     Completed Date:  1999-09-02     Revised Date:  2012-04-24    
Medline Journal Info:
Nlm Unique ID:  9111860     Medline TA:  Int J Antimicrob Agents     Country:  NETHERLANDS    
Other Details:
Languages:  eng     Pagination:  159-69     Citation Subset:  IM    
Affiliation:
Department of Infectious Diseases, Tropical Medicine and AIDS, Academic Medical Centre, Amsterdam, The Netherlands. agtmael@bacl.azr.nl
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Africa / ethnology
Animals
Antimalarials / therapeutic use*
Artemisinins*
Double-Blind Method
Drug Combinations
Female
Fluorenes / therapeutic use*
France
Humans
Malaria, Falciparum / drug therapy*,  ethnology,  parasitology
Male
Middle Aged
Netherlands
Parasite Egg Count
Phenanthrenes / therapeutic use*
Plasmodium falciparum / isolation & purification
Sesquiterpenes / therapeutic use*
Time Factors
Travel
Tropical Climate
Chemical
Reg. No./Substance:
0/Antimalarials; 0/Artemisinins; 0/Drug Combinations; 0/Fluorenes; 0/Phenanthrenes; 0/Sesquiterpenes; 0/artemether-lumefantrine combination; 36167-63-2/halofantrine

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


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