title: Cohort event monitoring of patients treated for uncomplicated malaria with artemisinin-based combination therapies in selected hospitals and community pharmacies in Nigeria.
abstract: The study was designed with the broad objective of determining the safety profile of artemisinin-based combination therapies amongst Nigerian population.
  
  
  
  This was a cohort event monitoring (CEM) programme involving monitoring adverse events (AEs) in malaria patients treated with either artemether-lumefantrine (AL) or artesunate-amodiaquine (AA) in healthcare facilities in Nigeria. The study involved continuous enrolment of patients with malaria and treated with either AL or AA at the various sites until a total cohort of 600 patients were enrolled at each site. Patients were monitored from the onset of therapy, and on days 3 and 7 from the first day of treatment to identify AEs that may occur.
  
  
  
  A total of 6102 AEs were recorded in 10,259 patients monitored during the programme. Of 4896 patients who received AA, 4233 (86.5%) patients reported at least one AE while 1869 (34.8%) AEs out of 5363 patients who received AL were reported (P = 0.010). The predominant incidence of each specific AE reported in each group among the patients who received AA and AL includes body weakness 30.8%/7.5%, dizziness 10.3%/3.9%, restlessness 5.02/1.12%, vomiting 3.5/1.03% and drowsiness 3.1/1.5% for AA and AL, respectively. There were more AEs among patients with co-morbid conditions and patients in the younger age groups (9-<15 years), P = 0.000.
  
  
  
  Various types of AEs were seen and documented during the CEM programme. The findings suggested that the AA/AL monitored during this programme was generally safe and remarkably well tolerated among the Nigerian populations.
authors.affiliation: Department of Pharmacology and Therapeutics, College of Health Sciences, University of Abuja, Abuja, Nigeria.
authors.forename: P U
authors.initials: PU
authors.lastname: Bassi
authors.affiliation: National Agency for Food and Drug Administration and Control, Abuja, Nigeria.
authors.forename: A I
authors.initials: AI
authors.lastname: Osakwe
authors.affiliation: National Agency for Food and Drug Administration and Control, Abuja, Nigeria.
authors.forename: C
authors.initials: C
authors.lastname: Suku
authors.affiliation: National Agency for Food and Drug Administration and Control, Abuja, Nigeria.
authors.forename: M
authors.initials: M
authors.lastname: Kalat
authors.affiliation: National Agency for Food and Drug Administration and Control, Abuja, Nigeria.
authors.forename: C
authors.initials: C
authors.lastname: Elagbaje
authors.affiliation: Department of Medicine, Clinical Pharmacology Unit, University of Benin Teaching Hospital, Benin City, Nigeria.
authors.forename: A
authors.initials: A
authors.lastname: Isah
authors.affiliation: Department of Medicine, Clinical Pharmacology Unit, University of Benin Teaching Hospital, Benin City, Nigeria.
authors.forename: S
authors.initials: S
authors.lastname: Ayinbuomwan
authors.affiliation: Department of Paediatrics, Ahmadu Bello University Teaching Hospital, Zaria, Nigeria.
authors.forename: R D
authors.initials: RD
authors.lastname: Wammanda
authors.affiliation: Department of Paediatrics, Federal Medical Centre, Yenagoa, Nigeria.
authors.forename: I I
authors.initials: II
authors.lastname: Bob-Okon
authors.affiliation: Department of Paediatrics, University of Maiduguri Teaching Hospital, Maiduguri, Nigeria.
authors.forename: J
authors.initials: J
authors.lastname: Ambe
authors.affiliation: Department of Paediatrics, University of Maiduguri Teaching Hospital, Maiduguri, Nigeria.
authors.forename: Y
authors.initials: Y
authors.lastname: Mava
authors.affiliation: Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria.
authors.forename: A O
authors.initials: AO
authors.lastname: Adesina
authors.affiliation: Department of Paediatrics, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.
authors.forename: C G
authors.initials: CG
authors.lastname: Ugochukwu
authors.affiliation: Department of Paediatrics, University of Uyo Teaching Hospital, Akwa Ibom, Nigeria.
authors.forename: E E
authors.initials: EE
authors.lastname: Nyong
authors.affiliation: Lagos State University Teaching Hospital, Lagos, Nigeria.
authors.forename: O O
authors.initials: OO
authors.lastname: Ogunleye
authors.affiliation: Federal Medical Centre, Owerri, Nigeria.
authors.forename: F
authors.initials: F
authors.lastname: Onuoha
authors.affiliation: Department of Paediatrics, Federal Teaching Hospital, Gombe, Nigeria.
authors.forename: I
authors.initials: I
authors.lastname: Jalo
authors.affiliation: NIPRD Research Clinic, National Institute for Pharmaceutical Research and Development, Abuja, Nigeria.
authors.forename: V O
authors.initials: VO
authors.lastname: Adegoke
authors.affiliation: Department of Clinical Pharmacology and Therapeutics, University of Maiduguri, Maiduguri, Nigeria.
authors.forename: S T
authors.initials: ST
authors.lastname: Balogun
authors.affiliation: National Malaria Control Programme, FMoH, Abuja, Nigeria.
authors.forename: G
authors.initials: G
authors.lastname: Ntadom
authors.affiliation: Lafes Pharmacy Ltd, Enugu, Nigeria.
authors.forename: F N
authors.initials: FN
authors.lastname: Ejiekpe
authors.affiliation: Rata Pharmacy, Maiduguri, Nigeria.
authors.forename: R
authors.initials: R
authors.lastname: Tahir
authors.affiliation: Skylark Pharmacy, Abuja, Nigeria.
authors.forename: K
authors.initials: K
authors.lastname: Dabit
authors.affiliation: Federal Medical Center, Makurdi, Nigeria.
authors.forename: A A
authors.initials: AA
authors.lastname: Amodu
authors.affiliation: Department of Mathematics, Federal University of Technology, Makurdi, Nigeria.
authors.forename: S
authors.initials: S
authors.lastname: Nwaosu
authors.affiliation: Waziri Shehu Specialist Hospital, Kano, Nigeria.
authors.forename: A T
authors.initials: AT
authors.lastname: Habib
mesh_terms: D000962:Antimalarials / Q000009:adverse effects* / Q000627:therapeutic use; D037621:Artemisinins / Q000009:adverse effects* / Q000627:therapeutic use; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; D006801:Humans; D008288:Malaria / Q000188:drug therapy*; D009549:Nigeria; D010594:Pharmacies; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes