Comparative evaluation of efficacy and safety of artesunate-lumefantrine vs. artemether-lumefantrine fixed-dose combination in the treatment of uncomplicated Plasmodium falciparum malaria

Objective To establish efficacy and safety of artesunate/lumefantrine fixed-dose combination (FDC) in comparison with artemether/lumefantrine FDC in treatment of uncomplicated Plasmodium falciparum malaria. Methods Confirmed cases of uncomplicated P.falciparum malaria were randomly assigned to receive artesunate (100mg)/lumefantrine (480mg) (ASLF FDC) or artemether (80mg)/lumefantrine (480mg) (AMLF FDC) tablets for 3days. Patients were followed up on Day 7, 14, 21 and 28. Results Of the 158 enrolled patients, 144 completed the study. Seventy-three patients (94.8%) from the ASLF group and 71 patients (94.7%) from the AMLF group showed parasite clearance within 48h. The mean parasite clearance time was 25.40 +/- 14.82h in the ASLF group and 24 +/- 13.32h in the AMLF group (P=0.542). All patients showed gametocyte clearance by Day 7 and remained gametocyte free till Day 28. Sixty-five patients (84.4%) from the ASLF group and 56 patients (74.7%) from the AMLF group were afebrile within 24h. The mean fever clearance time was 17.38 +/- 12.33h in the ASLF group and 17.2 +/- 12.01h in the AMLF group (P=0.929). There was one early treatment failure in the AMLF group as per WHO criteria. Improvement in haemoglobin and haematocrit was comparable in both the treatment groups. In the ASLF group, of the 25 (32.47%) patients anaemic at baseline, only seven (9.09%) reported anaemia on Day28, while in the AMLF group, of the 14 (18.67%) patients anaemic at baseline, only four (5.33%) reported anaemia on Day 28. Both study medications were well tolerated. Conclusion Artesunate (100mg)/lumefantrine (480mg) fixed-dose combination could add one more option to currently available artemisinin combinations in treatment of uncomplicated P.falciparum malaria.