A randomized trial to compare the safety, tolerability and effectiveness of three antimalarial regimens for the prevention of malaria in Nigerian patients with sickle-cell disease.


Olaosebikan, R; Ernest, K; Bojang, K; Mokuolu, O; Rehman, AM; Affara, M; Nwakanma, D; Kiechel, JR; Ogunkunle, T; Olagunju, T; Murtala, R; Omefe, P; Lambe, T; Bello, S; Ibrahim, O; Olorunsola, B; Ojuawo, A; Greenwood, B; Milligan, P; (2015) A randomized trial to compare the safety, tolerability and effectiveness of three antimalarial regimens for the prevention of malaria in Nigerian patients with sickle-cell disease. The Journal of infectious diseases, 212 (4). pp. 617-25. ISSN 0022-1899 DOI: 10.1093/infdis/jiv093

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Abstract

BACKGROUND: Malaria prophylaxis is recommended for persons with sickle cell disease (SCD), but the value of this has been questioned. The aim of this study was to find out whether intermittent preventive treatment (IPT) with a fixed-dose combination of mefloquine-artesunate (MQAS) or sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) was more effective than daily proguanil for malaria prevention in subjects with SCD.<br/> METHODS: Patients with SCD were randomized to receive daily treatment with proguanil or IPT with either MQAS or SPAQ once every 2 months at routine clinic visits. Patients were followed up for 14 months.<br/> FINDINGS: A total of 270 patients with SCD were studied, with 90 in each group. Adherence to the IPT regimens was excellent, but 57% of patients took <75% of their daily doses of proguanil. IPT was well tolerated; the most common side effects were vomiting and abdominal pain. Protective efficacy against malaria, compared with daily proguanil, was 61% (95% confidence interval, 3%-84%) for MQAS and 36% (40%-70%) for SPAQ. There were fewer outpatient illness episodes in children who received IPT than those who received proguanil.<br/> CONCLUSIONS: IPT with MQAS administered to patients with SCD during routine clinic visits was well tolerated and more effective in preventing malaria than daily prophylaxis with proguanil.<br/> CLINICAL TRIALS REGISTRATION: NCT01319448 and ISRCTN46158146.<br/>

Item Type: Article
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Disease Control
Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: Malaria Centre
Tropical Epidemiology Group
PubMed ID: 25701866
Web of Science ID: 359677600014
URI: http://researchonline.lshtm.ac.uk/id/eprint/2121405

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