Increased systemic exposures of artemether and dihydroartemisinin in infants under 5 kg with uncomplicated Plasmodium falciparum malaria treated with artemether-lumefantrine (Coartem®)

Table 5 Pharmacokinetic exposure of artemether, dihydroartemisinin, and lumefantrine: comparison with historical data from older infants and children

Time point post-first dose	Current study		Historical data
Time point post-first dose	Mean ± SD (CV %) [n]	Range	Mean ± SD (CV %) [n]	Range
	Artemether concentration (ng/mL)
1 h	446 ± 321 (72%) [15]	19.7-1210	139 ± 160 (116%) [173]	0-932
2 h	380 ± 262 (68%) [18]	0-933	140 ± 122 (87%) [170]	0-776
	Dihydroartemisinin concentration (ng/mL)
1 h	87.6 ± 58.9 (67%) [15]	7.2-202	46.0 ± 54.2 (118%) [177]	0-345
2 h	93.4 ± 67.0 (72%) [18]	0-252	57.4 ± 57.5 (100%) [178]	0-429
2 h	Lumefantrine concentration (μg/mL)
30 h	No sample taken		5.29 ± 4.28 (81%) [63]	0-23.7
54 h	6.50 ± 3.37 (52%) [17]	0.819-12.5	5.84 ± 4.28 (73%) [62]	0.524-21.4
66 h	6.04 ± 2.77 (45%) [17]	2.27-12.8	6.98 ± 5.29 (76%) [323]	0.069-42.0
84 h	3.40 ± 2.28 (67%) [17]	1.16-8.72	3.02 ± 2.08 (69%) [49]	0.010-7.80
168 h (Day 7)	0.815 ± 0.567 (70%) [16]	0.200-2.39	0.386 ± 0.326 (84%) [63]	0-1.71
336 h	No sample taken		0.541 ± 2.13 (394%) [65]	0-12.2

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