An open label randomized comparison of mefloquine-artesunate as separate tablets vs. a new co-formulated combination for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand.
BACKGROUND
Delivering drugs in a fixed combination is essential to the success of the strategy of artemisinin-based combination therapy. This prevents one drug being taken without the protection of the other, reducing the chance of emergence and spread of drug resistant strains of Plasmodium falciparum. A lower tablet burden should also facilitate adherence to treatment. A new fixed combination of mefloquine plus artesunate has been developed. This was compared with the conventional regimen of separate tablets for the treatment of uncomplicated multidrug-resistant falciparum malaria.


METHODS
On the north-western border of Thailand 500 adults and children with uncomplicated falciparum malaria were randomized to receive either the new fixed combination or separate tablets. They were followed up weekly for 63 days.


RESULTS
The day 63 polymerase chain reaction-adjusted cure rates were 91.9% (95% CI 88.2-95.6) in the fixed combination group and 89.2% (85.0-93.4) in the loose tablets group (P=0.3). There was a lower incidence of early vomiting in the group receiving the fixed combination.


CONCLUSIONS
This new fixed combination of mefloquine and artesunate was efficacious, well tolerated and convenient to administer.
Ashley
Elizabeth A
EA
Shoklo Malaria Research Unit, Tak, Thailand.
Lwin
Khin Maung
KM
McGready
Rose
R
Simon
Win Htay
WH
Phaiphun
Lucy
L
Proux
Stephane
S
Wangseang
Nantawan
N
Taylor
Walter
W
Stepniewska
Kasia
K
Nawamaneerat
Wimon
W
Thwai
Kyaw Lay
KL
Barends
Marion
M
Leowattana
Wattana
W
Olliaro
Piero
P
Singhasivanon
Pratap
P
White
Nicholas J
NJ
Nosten
François
F
D000293:Adolescent; D000328:Adult; D000368:Aged; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects; D000077332:Artesunate; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D018432:Drug Resistance, Multiple; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000453:epidemiology; D016780:Malaria, Vivax / Q000188:drug therapy / Q000453:epidemiology; D008297:Male; D015767:Mefloquine / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011786:Quality Control; D012717:Sesquiterpenes / Q000008:administration & dosage* / Q000009:adverse effects; D013607:Tablets; D013785:Thailand / Q000453:epidemiology; D016896:Treatment Outcome
D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D012717:Sesquiterpenes; D013607:Tablets; D000077332:Artesunate; D015767:Mefloquine