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

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).