title: A Randomized Trial to Compare the Safety, Tolerability, and Effectiveness of 3 Antimalarial Regimens for the Prevention of Malaria in Nigerian Patients With Sickle Cell Disease.
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.
  
  
  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.
  
  
  RESULTS
  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.
  
  
  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.
  
  
  BACKGROUND
  NCT01319448 and ISRCTN46158146.
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria Medical Research Council Unit, Banjul, Gambia University of Nebraska Medical Centre, Omaha.
authors.forename: Rasaq
authors.initials: R
authors.lastname: Olaosebikan
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Kolade
authors.initials: K
authors.lastname: Ernest
authors.affiliation: Medical Research Council Unit, Banjul, Gambia.
authors.forename: Kalifa
authors.initials: K
authors.lastname: Bojang
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Olugbenga
authors.initials: O
authors.lastname: Mokuolu
authors.affiliation: London School of Hygiene and Tropical Medicine, United Kingdom.
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Rehman
authors.affiliation: Medical Research Council Unit, Banjul, Gambia.
authors.forename: Muna
authors.initials: M
authors.lastname: Affara
authors.affiliation: Medical Research Council Unit, Banjul, Gambia.
authors.forename: Davis
authors.initials: D
authors.lastname: Nwakanma
authors.affiliation: Drugs for Neglected Diseases Initiative, Geneva, Switzerland.
authors.forename: Jean-René
authors.initials: JR
authors.lastname: Kiechel
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Taofik
authors.initials: T
authors.lastname: Ogunkunle
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Tope
authors.initials: T
authors.lastname: Olagunju
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Rukayat
authors.initials: R
authors.lastname: Murtala
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Peter
authors.initials: P
authors.lastname: Omefe
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Tosin
authors.initials: T
authors.lastname: Lambe
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Surajudeen
authors.initials: S
authors.lastname: Bello
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Olayinka
authors.initials: O
authors.lastname: Ibrahim
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Benedict
authors.initials: B
authors.lastname: Olorunsola
authors.affiliation: University of Ilorin Teaching Hospital, Nigeria.
authors.forename: Ayotade
authors.initials: A
authors.lastname: Ojuawo
authors.affiliation: London School of Hygiene and Tropical Medicine, United Kingdom.
authors.forename: Brian
authors.initials: B
authors.lastname: Greenwood
authors.affiliation: London School of Hygiene and Tropical Medicine, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Milligan
mesh_terms: D000293:Adolescent; D000328:Adult; D000755:Anemia, Sickle Cell / Q000150:complications*; D000962:Antimalarials / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008288:Malaria / Q000150:complications* / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D055118:Medication Adherence; D009549:Nigeria / Q000453:epidemiology; D055815:Young Adult
chemical_list: D000962:Antimalarials
keywords: chemoprevention; intermittent preventive treatment; malaria; mefloquine-artesunate; proguanil; prophylaxis; sickle cell disease