EFICACY, SAFETY AND TOLERABILITY OF ARTESUNATE –MEFLOQUINE (ARTEQUIN) IN TREATMENT OF UNCOMPLICATED FALCIPARUM MALARIA IN 4 GEOGRAPHIC ZONES IN NIGERIA

Abstract

BACKGROUND: Artequin™, a combination of Artesunate and Mefloquine has been reported to be effective against multi-drug resistant Plasmodium falciparum malaria in other countries but not in Nigeria where we now report the results of multi-centre studies in four high malaria transmission areas. The objective was to evaluate the efficacy, safety and tolerability of the co-packaged drug in the treatment of malaria in children and adults weighing 15 -< 30kg and ≥30kg respectively. Methods: Rural communities in the North East (Maiduguri), North Central (Jos), South West (Lagos) and South-South (Calabar) were used for the trial. The WHO protocol was followed. Outpatients having amongst other criteria, a pre-treatment parasite density of > 1000µl of blood were enrolled. Ethical approval and Informed Consent were obtained by each site and the drugs were given on days 0, 1 and 2. Each patient was followed up to day 28 with the assessment of the parasitological, biochemical and haematological parameters on days 0, 1, 2, 3, 7, 14 and 28. Data generated from the four sites were entered into EPI- INFO Version 6.04, Microsoft Excel was used to plot simple graphs and various aspects of the data were subsequently analysed using SPSS statistical Package Version 11. Results: of the 4,139 patients screened in the four sites, 446 met the enrollment criteria but 431 (203 Adults and 228 children) completed the trial. The rates in adults on D1, D2, D3, D7, D14 and D28 were 40.6%, 92.1%, 99.5% 100%, 100%, 99.5%, respectively. The rates in children were 31.3%, 91.6%, 100%, 100%, 100%, and 97.8% respectively. The mean parasite clearance times in adults and children were 40.1 h and 42.4 hrs respectively while the mean fever clearance times were 11.25 h and 13.25 h respectively. Artequin™ exhibited marked antigametocyte activity, with mean gametocyte clearance time of 42.0 h in adults and 45.6 h in children. There were no serious adverse events in all centres. The most common adverse events were headache, dizziness, vomiting and abdominal discomfort. There was also no significant derangement in the haematological and biochemical parameters in the treated patients. Conclusion: We conclude that co-packaged artesunate + amodiquine (Artequin™) is highly efficacious, safe and well tolerated. Its use in the treatment of malaria is therefore recommended. .