AN OPEN RANDOMIZED CLINICAL TRIAL OF ARTEKIN ® VS ARTESUNATE-MEFLOQUINE IN THE TREATMENT OF ACUTE UNCOMPLICATED FALCIPARUM MALARIA

Malaria remains a major cause of morbidity and mortality in tropical countries and sub- tropical regions in the world. Southeast Asia has the most resistant malaria parasites in the world, which has limited treatment options in this region. In response to this situation, short-course artemisinin-based combination therapies (ACTs) have been developed. The combination of dihydroartemisinin (DHA) and piperaquine (PQP) in the form of Artekin® has been developed as an alternative to established combinations, such as artesunate-mefloquine, primarily to reduce treat- ment costs and toxicity. We conducted a study comparing a standard treatment for acute uncompli- cated falciparum malaria (artesunate 4 mg/kg/day together with mefloquine 8 mg/kg/day oral route once a day for 3 days) (Group A) and a combination of dihydroartemisinin 40 mg and piperaquine 320 mg in the form of Artekin® given once a day for 3 days (Group B) to determine safety, efficacy, and tolerability. One hundred and eighty patients were randomly enrolled at the ratio of 1:2 into groups A:B. All patients had rapid initial clinical and parasitological responses. There were no signifi- cant differences in fever clearance time or parasite clearance time between both groups. The 28- day cure rates were high, at 100% and 99%, in groups A and B, respectively. We conclude that Artekin® was as effective and well-tolerated as artesunate-mefloquine, and can be used alterna-