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Table 3 Published studies with the six-dose artemether/lumefantrine regimen in Asia

From: The clinical efficacy of artemether/lumefantrine (Coartem®)

Authors Country Design and patient population Comparator(s) No. of patients Results
South-East Asia     
Krudsood et al 2003 [45] Thailand Randomized, open-label, single centre in adults AL (n = 41)
DNP (n = 89)
The 28-day parasitological cure rates (not PCR corrected) were 99% for DNP and 97% for AL.
Rojanawatsirivej et al 2003 [46] Thailand Open-label, multicentre, adults & children (10-74 years), treatment by area (all treatment groups also received primaquine) AL (n = 33)
MAS (n = 199)
Mefloquine (n = 318)
All 33 (100%) patients treated with AL plus primaquine had adequate clinical response (i.e. parasitological cure at Day 28), compared with 86.3% of the 80 patients who received mefloquine plus primaquine.
Stohrer et al 2004 [47] Laos Randomized, open-label, single centre, in adults & children (≥ 10 kg) AL (n = 53)
MAS (n = 55)
PCR-corrected cure rates at Day 42 were 93.6% for AL and 100% for MAS. The difference between treatment groups was not statistically significant. Day 28 cure rates were identical to those at Day 42.
Mayxay et al 2004 [48] Laos Randomized, open-label, single centre, in adolescents and adults (12-19 years) AL (n = 110)
MAS (n = 110)
CQSP (n = 110)
42-day PCR-corrected parasitological cure rates were 97% for AL, 100% for MAS and 93% for CQSP. The difference in cure rates between MAS and CQSP was statistically significant.
Ratcliff et al 2007 [49] Indonesia Randomized, open-label, 2-centre in children (body weight ≥ 10 kg) and adults with P. falciparum, P. vivax, or mixed infections AL (n = 387)
DP (n = 387)
For P. falciparum infections, rates of recrudescence at 42 days (PCR-corrected) were 4.7% with AL and 4.1% with DP.
Hutagalung 2005 [50] Thailand Randomized, open-label, 2-centre, in children (>10 kg) and adults AL (n = 245)
MAS (n = 245)
Both treatments were associated with rapid clearance of fever and parasitaemia. 42-day parasitological cure rates were 98.8% for AL and 96.3% for MAS.
South Asia     
van den Broek et al 2005 [51] Bangladesh Randomized, open-label, single centre, in adults & children (≥ 1 year) AL (n = 121)
MAS (n = 121)
CQSP (n = 122)
Day 42 PCR-corrected cure rates were 62.4% for CQSP, 100% for MAS and 97.1% for AL. The cure rate in the CQSP group was statistically significantly lower than that in the other treatment groups.
Haque et al 2007 [52] Bangladesh Open-label, non-comparative, 2-centre in adults (≥ 18 years) AL (n = 67) Rapid fever and parasite clearance, and PCR-corrected 28- and 42-day parasitological cure rates of 98.3% and 94.3%, respectively.
Thapa et al 2007 [53] Nepal Randomized, open-label, single centre, in adults & children (>5 years) AL (n = 66)
SP (n = 33)
The 28-day PCR-corrected parasitological cure rate for AL was 100%, compared with 87.9% in the SP group (p = 0.011).
  1. 1Includes 2 MAS regimens (mefloquine at 25 mg/kg, n = 153, and 15 mg/kg, n = 46);AL: artemether/lumefantrine; SP: sulphadoxine plus pyrimethamine; CQSP: Chloroquine plus sulphadoxine pyrimethamine; DP: Dihydroartemisinin plus piperaquine; DNP: dihydroartemisinin, napthoquine and trimethoprim; MAS: mefloquine plus artesunate