The comparative efficacy and tolerability of CGP 56697 (artemether plus lumefantrine) versus halofantrine in the treatment of uncomplicated falciparum malaria in travellers returning from the Tropics to The Netherlands and France

CGP 56697 (Riamet(TM)) is a new oral anti-malarial drug composed of artemet her and lumefantrine (benflumetol) which combines the fast, short-acting ar temether for rapid parasite clearance with the prolonged action of lumefant rine for intended radical cure. In this double-blind, comparative trial, th e efficacy and tolerability of CGP 56697, given as a course of 4 x 4 tablet s over 48 h, was compared to halofantrine, given as 3 x 2 tablets over 12 h with a second course 1 week later. Patients (mostly non-immune) with acute , uncomplicated Plasmodium falciparum infection were randomly assigned to e ither CGP 56697 (n = 51) or halofantrine (n = 52). CGP 56697 proved superio r with respect to parasite clearance time (median 32 vs. 48 h, P < 0.001) a nd parasite reduction at 24 h (median 99.7 vs. 89.6%, P < 0.001) with a non -significant difference in resolution of fever (median 24 vs. 32 h, P = 0.8 35). However, a 28-day cure rate of 82% was observed for CCP 56697 and 100% for halofantrine. Significant QTc prolongations (> 30 ms) were seen 6-12 h after halofantrine intake but not after CGP 56697 intake. CGP 56697 is an effective, well-tolerated treatment for uncomplicated falciparum malaria bu t for this dosing regimen the recrudescence rate is unacceptably high (18%) . For travellers contracting malaria abroad, we propose a six-dose regimen of CGP 56697 over 3 days. (C) 1999 Elsevier Science B.V. and International Society of Chemotherapy. All rights reserved.