Abstract
BackgroundThe combination of artesunate and mefloquine has been reported to be effective against multi-drug resistant Plasmodium falciparum malaria, which has been reported in Nigeria. The objective of this multi-centre study was to evaluate the efficacy, safety and tolerability of the co-packaged formulation of artesunate and mefloquine in the treatment of uncomplicated malaria in two weight groups: those between 15 – 29 kg and ≥ 30 kg respectively.MethodsThe trial was conducted in rural communities in the north-east, north-central, south-west and south-eastern parts of Nigeria. The WHO protocol for testing antimalarial drugs was followed. Outpatients having amongst other criteria, parasite density of ≥1,000 μl were enrolled. The co-packaged drugs were administered for 3 days at a dosage of artesunate, 4 mg/kg body wt/day and mefloquine, 25 mg/kg/body wt total) on days 0, 1 and 2. Patients were followed up for 28 days with the assessment of the parasitological parameters on days 1, 2, 3, 7, and 28.ResultsFour hundred and forty-six (446) patients were enrolled and 431 completed the study. Cure rates in both treatment groups was >90% at day 28. The mean parasite clearance times in treatment groups I and II were 40.1 and 42.4 hours respectively. The combination of artesunate and mefloquine showed good gametocidal activity, (gametocyte clearance time of 42.0 & 45.6 hours in treatment groups I and II respectively). There were no serious adverse events. Other adverse events observed were headache, dizziness, vomiting and abdominal discomfort. There was no significant derangement in the haematological and biochemical parameters.ConclusionThis co-packaged formulation of artesunate + mefloquine (Artequin™) is highly efficacious, safe and well-tolerated. It is recommended for the treatment of uncomplicated P. falciparum malaria in Nigeria.
Highlights
The combination of artesunate and mefloquine has been reported to be effective against multidrug resistant Plasmodium falciparum malaria, which has been reported in Nigeria
Treatment group I consisted of those weighing between 15–29 kg, while treatment group II consisted of participants whose weight was ≥ 30 kg
General A total of 4,139 patients who had not taken any antimalarial medication in the previous seven days were screened in the four sites
Summary
The combination of artesunate and mefloquine has been reported to be effective against multidrug resistant Plasmodium falciparum malaria, which has been reported in Nigeria. There are between 300–500 million cases of clinical malaria every year, with 85% of these from Africa [1]. In Nigeria, malaria is holoendemic clinical cases of the disease are seen throughout the year. It is the commonest cause of outpatient hospital attendance in all age-groups in the country [2]. The global malaria control strategy advocates prompt and adequate treatment with an effective antimalarial drug as an essential measure to reduce the morbidity and mortality arising from the disease [3]. The rationale for the use of ACTs is to reduce the probability of resistance developing simultaneously to two drugs with independent mechanisms of action [5,6]
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