Safety and efficacy of artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in Ethiopia

Objective: To document baseline data on the efficacy and safety of artemetherlumefantrine for the treatment of uncomplicated falciparum malaria in Ethiopia. Design: Patients diagnosed for P. falciparum, who were treated with six doses of artemether-lumefantrine over three days, were followed for 28 days and treatment outcomes classified based on the WHO (2003) protocol. Setting: Four health facilities located in malarious areas in two regions: Alamata and Humera hospitals in Tigray region and Assendabo and Nazareth in Oromia region. Subjects: Patients with body weight of more than 10 kgs, excluding pregnant women, who or their guardians consented to participate in the study after fulfilling the inclusion criteria were enrolled in the study for a follow-up period of 28 days. Main outcome measures: Proportion of treatment success and adverse drug effects that required discontinuation of treatment and/or follow-up. Results: A total of 213 patients who fulfilled the enrolment criteria completed the 28 days follow-up after treatment with artemether-lumefantrine. A treatment success rate of 99.1% (95% confidence interval [CI] 96.9, 99.8) and no adverse effects or complaints related to the drug that required discontinuation of treatment or withdrawal from follow-up was reported. Treatment success was not achieved in 213 (0.9%) subjects for whom fever and peripheral parasitaemia was demonstrated on day 21 and 28. The day 21 and day 28 blood samples of the treatment failure cases were not PCR corrected. Conclusion: The artemisinin based combination drug artemether-lumefantrine has shown very high (99.1%) clinical and parasitological cure for the treatment of uncomplicated falciparum malaria with no reports of adverse reaction that required withdrawal of treatment or discontinuation of follow-up. In the presence of the low efficacy of sulfadoxinepyrimethamine, chloroquine and amodiaquine, the use of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria is the best choice for Ethiopia. East African Medical Journal Vol. 82(8) 2005: 387-39