Abstract
BackgroundData from clinical studies show that artemether-lumefantrine (AL) is effective and well tolerated in adults and children with uncomplicated Plasmodium falciparum malaria. However, data on effectiveness and safety of AL in patients in non-endemic settings are limited.MethodsA 5-year surveillance plan included all AL-treated adult and paediatric patients with confirmed or suspected P. falciparum malaria in the USA, as reported to the National Malaria Surveillance System at the Centers for Disease Control and Prevention. Descriptive analyses included demographics, baseline characteristics, clinical effectiveness, and safety. From May 2010 to April 2015, demographics and baseline characteristics were collected for 203 patients and safety data for 108 patients. Treatment effectiveness data at day 7 were collected for 117 patients and at day 28 for 98 patients.ResultsThe majority of patients were male (58.6 %), Black (62.6 %), non-Hispanic (92.6 %), and likely malaria non-immune (80.8 %). The median age was 32 (range 1–88) years and the median body mass index was 25.5 (range 13.8–42.4) kg/m2. All patients with effectiveness data had confirmed (n = 116) or suspected (n = 1) malaria. The overall cure rate for patients treated with AL was 91.5 % (95 % CI 84.8–95.8 %) at day 7 and 96.9 % (95 % CI 91.3–99.4 %) at day 28. Adverse events were reported in four (3.7 %) patients, and there were no new or unexpected safety signals.ConclusionAL was effective and well tolerated in the treatment of likely non-immune patients with P. falciparum malaria.
Highlights
Data from clinical studies show that artemether-lumefantrine (AL) is effective and well tolerated in adults and children with uncomplicated Plasmodium falciparum malaria
This report aims to describe the demographics, baseline characteristics, clinical effectiveness, and safety outcomes for patients treated with AL in both US and foreign residents
Cases are reported by healthcare providers or laboratory staff to local and state health departments, and reports are in turn transmitted to Centers for Disease Control and Prevention (CDC) through the National Malaria Surveillance System (NMSS) [26]
Summary
Data from clinical studies show that artemether-lumefantrine (AL) is effective and well tolerated in adults and children with uncomplicated Plasmodium falciparum malaria. Artemetherlumefantrine (AL) (Coartem®, Novartis Pharma AG, Basel, Switzerland) is a fixed-dose combination of 20 mg artemether and 120 mg lumefantrine. Both components are blood schizonticides with complementary pharmacokinetic profiles and dissimilar modes of action, providing synergistic anti-malarial activity [3,4,5]. Artemether is absorbed rapidly and has an elimination half-life of around 1 h. It clears most of the parasite biomass, providing fast resolution of symptoms during the acute treatment period. With a half-life of 3 to 6 days, has a variable absorption rate
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