Abstract
We conducted an open, randomized clinical trial of oral dihydroartemisinin-piperaquine (DP) versus artesunate-mefloquine (AM) in 300 patients in Laos with uncomplicated Plasmodium falciparum malaria as part of a multicentre study in Asia. Survival analysis and adjustment for re-infection showed that the 63-day cure rates (95% confidence interval [CI]) were 100% for AM and 99.5% (96.4–99.8%) for DP. The 63-day cure rates per protocol were 99% (97 of 98) for AM and 99.5% (196 of 197) for DP (P = 0.55). The difference (AM minus DP) in cure rates (95% CI) was −0.5% (−5.1 to 2.0%), which is within the 5% non-inferiority margin. The median fever and parasite clearance times were also similar for AM and DP. The proportion of patients with at least one recorded potential adverse event was significantly higher in the AM group (38 of 87, 44%) than in the DP group (57 of 182, 31%) (relative risk = 0.6, 95% CI = 0.4–0.9; P = 0.04). Dihydroartemisinin-piperaquine is not inferior to AM in the treatment of uncomplicated P. falciparum malaria in Laos and is associated with fewer adverse effects. The results of this study were similar to those of the larger multicentre study.
Highlights
Malaria remains an important public health challenge in southern Laos with a median incidence of Plasmodium falciparum infection of 4.7–23.5/1,000 population.[1]
Dihydroartemisinin-piperaquine is not inferior to AM in the treatment of uncomplicated P. falciparum malaria in Laos and is associated with fewer adverse effects
This study confirms that the fixed-dose, co-formulated artemisinin-combination treatment (ACT) dihydroartemisinin-piperaquine is not inferior to the more expensive, not co-formulated AM in the treatment of uncomplicated P. falciparum malaria in southern Laos and showed a 63-day follow-up cure rate of almost 100% for both drugs
Summary
Malaria remains an important public health challenge in southern Laos with a median incidence of Plasmodium falciparum infection of 4.7–23.5/1,000 population.[1]. The Lao Government changed national policy for first-line antimalarial drug treatment of uncomplicated P. falciparum malaria to artemetherlumefantrine (AL) in 2005. This artemisinin-combination treatment (ACT) and artesunate-mefloquine both have high efficacies and good tolerability with 42-day failure rates of ≤ 6% in Laos.[2,3] there is uncertainty as to the clinical importance of reduced bioavailability of lumefantrine when taken without fatty food,[4,5,6,7,8] especially with evidence of resistance to artemisinin derivatives in adjacent Cambodia increasing the required contribution to efficacy by the partner drug.[9,10] Artemether-lumefantrine has to be taken twice a day, which reduces adherence
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