Randomized controlled trial of artesunate or artemether in Vietnamese adults with severe falciparum malaria.
BACKGROUND
Both artemether and artesunate have been shown to be superior to quinine for the treatment of severe falciparum malaria in Southeast Asian adults, although the magnitude of the superiority has been greater for artesunate than artemether. These two artemisinin derivatives had not been compared in a randomized trial.


METHODS
A randomized double blind trial in 370 adults with severe falciparum malaria; 186 received intramuscular artesunate (2.4 mg/kg immediately followed by 1.2 mg/kg at 12 hours then 24 hours then daily) and 184 received intramuscular artemether (3.6 mg per kilogram immediately followed by 1.8 mg per kilogram daily) was conducted in Viet Nam. Both drugs were given for a minimum of 72 hours.


RESULTS
There were 13 deaths in the artesunate group (7 percent) and 24 in the artemether group (13 percent); P = 0.052; relative risk of death in the patients given artesunate, 0.54; (95 percent confidence interval 0.28-1.02). Parasitaemia declined more rapidly in the artesunate group. Both drugs were very well tolerated.


CONCLUSIONS
Intramuscular artesunate may be superior to intramuscular artemether for the treatment of severe malaria in adults.
Phu
Nguyen H
NH
Hospital for Tropical Diseases, 190 Ham Tu, Quan 5, Ho Chi Minh City, Vietnam. hientt@oucru.org.
Tuan
Phung Q
PQ
Day
Nicholas
N
Mai
Nguyen T H
NT
Chau
Tran T H
TT
Chuong
Ly V
LV
Sinh
Dinh X
DX
White
Nicholas J
NJ
Farrar
Jeremy
J
Hien
Tran T
TT
D000293:Adolescent; D000328:Adult; D000368:Aged; D000962:Antimalarials / Q000627:therapeutic use*; D000077549:Artemether; D037621:Artemisinins / Q000627:therapeutic use*; D000077332:Artesunate; D002423:Cause of Death; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000187:drug effects* / Q000302:isolation & purification; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014744:Vietnam; D055815:Young Adult
D000962:Antimalarials; D037621:Artemisinins; D000077332:Artesunate; D000077549:Artemether
Trans R Soc Trop Med Hyg. 2000 Sep-Oct;94(5):537-44
11132385
N Engl J Med. 1996 Jul 11;335(2):76-83
8649493
Trans R Soc Trop Med Hyg. 1997 May-Jun;91(3):331-4
9231211
Trans R Soc Trop Med Hyg. 2001 Nov-Dec;95(6):637-50
11816438
Antimicrob Agents Chemother. 2004 Nov;48(11):4234-9
15504846
Antimicrob Agents Chemother. 2002 Dec;46(12):3933-9
12435698
Lancet. 2005 Aug 27-Sep 2;366(9487):717-25
16125588
Br J Clin Pharmacol. 2002 Jan;53(1):23-30
11849191