Evaluation of the Comparative Safety and Efficacy of Artemisinin-Piperaquine and Artemether-Lumefantrine for the treatment of acute uncomplicated Malaria among Children in Ibadan, South-West Nigeria.

Abstract

Background- Artemisinin-based-combination

therapies (ACT), are the drugs of choice in the

treatment of malaria globally because of their good

tolerability and efficacy. Although Artemether

lumefantrine (AL) and Artesunate-amodiaquine are

the ACTs of choice in Nigeria, there are other ACTs

in the market of which artemisinin-piperaquine (AP)

is one. There is paucity of information about the

safety and efficacy of AP in Nigeria. In this study,

we evaluated the safety and efficacy of AP against

AL, the preferred ACT in Nigeria.

Methods- Children (114) aged 2-10 years with acute

uncomplicated malaria were enrolled and followed

up using the WHO antimalarial efficacy testing

protocol. Enrollees were randomized to receive AP

(56) or AL (58) at standard doses for three days.

Laboratory evaluations for hematological, liver and

renal functions were done at D0, D7 (and D28 if

necessary) as part of safety evaluation.

Results - Geometric mean parasite densities were

17,406/µL and 11,571/µL for AP and AL treated

children respectively. Response of infection to

treatment was prompt. Uncorrected adequate clinical

and parasitological response (ACPR) rate for AP was

96.1% and for 90.4% AL. while polymerase chain

reaction (PCR) corrected ACPR was 100% for both.

Parasite clearance time was significantly shorter for

AL (1.81±0.63 days) versus 2.34±0.70 days for AP

(ρ <0.001). Fever clearance times were 1.13±0.34

and 1.33±0.66 days (ρ=0.181) for AP and AL

respectively. Gametocyte clearance time was shorter

for AL than AP (3 versus 7 days). Both drugs were

well tolerated.

Conclusion- AP and AL was found to be safe and

efficacious for the treatment of uncomplicated

malaria in children in the study area.