Efficacy, safety and tolerability of artesunate-mefloquine in the treatment of uncomplicated Plasmodium falciparum malaria in four geographic zones of Nigeria

<p>Abstract</p> <p>Background</p> <p>The combination of artesunate and mefloquine has been reported to be effective against multi-drug resistant <it>Plasmodium falciparum </it>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.</p> <p>Methods</p> <p>The 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.</p> <p>Results</p> <p>Four 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.</p> <p>Conclusion</p> <p>This co-packaged formulation of artesunate + mefloquine (Artequin™) is highly efficacious, safe and well-tolerated. It is recommended for the treatment of uncomplicated <it>P. falciparum </it>malaria in Nigeria.</p

Responses of Plasmodium falciparum infections to antimalarial drugs in north eastern Nigeria – Part 1: 1988 - 1995.

The responses of Plasmodium falciparum strains to different antimalarial drugs were assessed in the north east of Nigeria, using a modified version of the World Health Organization (WHO) extended in vivo field test protocol from 1988 to 1995. The sensitivity of the strains to chloroquine phosphate varied from a delayed clearance of parasitaemia, through Type-RI resistance or recrudescence to asymptomatic Type-RII resistance. Chloroquine was still clinically efficacious against P. falciparum malaria and continued to play a major role in reducing malaria-related morbidity. However, parasitological failure rates were on the increase as demonstrated in Damboa, where a 1.3-fold increase occurred in D7 failure rate over a 7-year period, from 18.7% in 1988 to 24.5% in 1995. This highlighted the need for continued monitoring of the performance of the drug against the parasites, in addition to evaluating the efficacy and tolerability of new products. Second-line drugs, particularly the combinations of pyrimethamine and sulphadoxine (SD-Pyr, Fansidar®), and pyrimethamine and sulfalene (SL-Pyr, Metakelfin®) were clinically and parasitologically efficacious, producing 100% and 97.1% cure rates, respectively. Self-medication, non-compliance with treatment regimens (particularly for multiple dose therapy), sub-standard or even fake drugs/products, in addition to parasite resistance were identified as factors compounding the treatment of P. falciparum malaria. Key Words: Antimalarial drugs; Plasmodium falciparum; North Eastern Nigeria; 1988 – 1995. Journal of Pharmacy and Bioresources Vol.1(1) 2004: 51-6