The clinical efficacy of artemether/lumefantrine (Coartem)

Abstract

Current World Health Organization (WHO) guidelines for the treatment of uncomplicated falciparum malaria recommend the use of artemisinin-based combination therapy (ACT). Artemether/lumefantrine is an ACT prequalified by the WHO for efficacy, safety and quality, approved by Swissmedic in December 2008 and recently approved by the USA FDA. Coartem is a fixed-dose combination of artemether and lumefantrine. Its two components have different modes of action that provide synergistic anti-malarial activity. It is indicated for the treatment of infants, children and adults with acute, uncomplicated infection due to Plasmodium falciparum or mixed infections including P. falciparum. A formulation with improved palatability has been developed especially for children (Coartem Dispersible), which rapidly disperses in a small amount of water for ease of administration. The efficacy of the six-dose regimen of artemether/lumefantrine has been confirmed in many different patient populations around the world, consistently achieving 28-day PCR (polymerase chain reaction)-corrected cure rates of >95% in the evaluable population, rapidly clearing parasitaemia and fever, and demonstrating a significant gametocidal effect, even in areas of widespread parasite resistance to other antimalarials.

Figure 1

28-day PCR-corrected cure rate for artemether/lumefantrine in Studies A025,A026 and A028 [10-12].

Figure 2

Efficacy of dispersible AL formulation across body weight groups [14].

Figure 3

Median time to (A) parasite clearance and (B) fever clearance for dispersible artemether/lumefantrine formulation and crushed tablets [14].

Figure 4

28-day PCR-corrected cure rate for AL in Study A2401 [15].