STUDY ON THE EFFICACY AND SAFETY OF ARTEMETHER/LUMEFANTRINE IN THE TREATMENT OF UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA AMONGST CHILDREN IN KANO

STUDY ON THE EFFICACY AND SAFETY OF ARTEMETHER/LUMEFANTRINE IN THE TREATMENT OF UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA AMONGST CHILDREN IN KANO

ABSTRACT

Globally, malaria is a major health concern because it causes high morbidity and mortality particularly in children under 5 years because of their low immunity. The development of resistance to chloroquine and sulphodoxine/pyrimethamine in many parts of the world has further worsened the disease. In 2001, WHO recommended the use of artemisinin combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria in countries experiencing resistance to chloroquine and other antimalarial monotherapies. In 2005, Nigeria made a shift in the policy of treatment and adopted WHO Artemisinin Combination Therapy policy for the treatment of uncomplicated Plasmodium falciparum malaria. The aim of the study was to assess the therapeutic efficacy and safety of the artemether/lumefantrine supplied by the Kano State Government for the treatment of uncomplicated Plasmodium falciparum malaria following an observed increase in patients requiring retreatment. It was a prospective evaluation of clinical and parasitological responses to directly observed treatment of uncomplicated Plasmodium falciparum malaria using artemether/lumefantrine. Patients of ages 6-59 months numbering 73 who met the inclusion criteria were enrolled into the study after a written informed consent by their parents or guardians. The drug was administered at 0, 8, 12, 24, 48, and 60 hr according to the ages of the patients. They were followed-up on days 0, 1, 2,3,7,14,21, and 28 in which they were assessed clinically and parasitologically. Data obtained were analyzed using the WHO malaria drugs therapeutic efficacy Excel Data Sheet and Graphpad instat software. The test drug was also subjected to qualitative tests such disintegration test, weight uniformity test, hardness test and friability test to determine the quality of the drug. The result of the study showed that 63 patients completed the 28 days follow-up period while10 patients were lost to follow-up. There was no early treatment failure observed. However, there was 1 late clinical failure, 8 late parasitological failures and 54 adequate clinical and parasitological response. The cure rate was 85.7% (PCR uncorrected) and failure rate was 14.3% on day 28. The fever clearance time was found to be 40.22 hrs while the parasite clearance time was 52.14 hrs. There was no serious adverse drug reactions observed or reported during the course of the study. The results of the qualitative tests using B.P. 2009 standards were all within the normal limit with a disintegration time of 4.5min, average weight of 244.5 mg ± 1.1 hardness of 9.05 Kg F and the friability was 0.4%. When the above efficacy results are compared with previous efficacy studies conducted in 2002, 2004 and more recently in 2009 it could be seen that the efficacy of artemether/lumefantrine is gradually diminishing with time though it is still within the acceptable limit. The study showed that the standard six dose regime in malaria treatment with the brand of artemether/lumefantrine was efficacious, safe and qualitative in the treatment of uncomplicated Plasmodium falciparum malaria in children less than 5 years of age with an efficacy of 85.7% PCR uncorrected in the 28 days per protocol analysis

STUDY ON THE EFFICACY AND SAFETY OF ARTEMETHER/LUMEFANTRINE IN THE TREATMENT OF UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA AMONGST CHILDREN IN KANO