PMID- 28000637
OWN - NLM
STAT- MEDLINE
DCOM- 20180824
LR  - 20181202
IS  - 1117-1936 (Print)
VI  - 23
IP  - 4
DP  - 2016 Oct-Dec
TI  - Cohort event monitoring of patients treated for uncomplicated malaria with 
      artemisinin-based combination therapies in selected hospitals and community 
      pharmacies in Nigeria.
PG  - 172-181
LID - 10.4103/1117-1936.196246 [doi]
AB  - AIMS AND OBJECTIVES: The study was designed with the broad objective of 
      determining the safety profile of artemisinin-based combination therapies amongst 
      Nigerian population. PATIENTS AND METHODS: 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. RESULTS: 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. 
      CONCLUSIONS: 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.
FAU - Bassi, P U
AU  - Bassi PU
AD  - Department of Pharmacology and Therapeutics, College of Health Sciences, 
      University of Abuja, Abuja, Nigeria.
FAU - Osakwe, A I
AU  - Osakwe AI
AD  - National Agency for Food and Drug Administration and Control, Abuja, Nigeria.
FAU - Suku, C
AU  - Suku C
AD  - National Agency for Food and Drug Administration and Control, Abuja, Nigeria.
FAU - Kalat, M
AU  - Kalat M
AD  - National Agency for Food and Drug Administration and Control, Abuja, Nigeria.
FAU - Elagbaje, C
AU  - Elagbaje C
AD  - National Agency for Food and Drug Administration and Control, Abuja, Nigeria.
FAU - Isah, A
AU  - Isah A
AD  - Department of Medicine, Clinical Pharmacology Unit, University of Benin Teaching 
      Hospital, Benin City, Nigeria.
FAU - Ayinbuomwan, S
AU  - Ayinbuomwan S
AD  - Department of Medicine, Clinical Pharmacology Unit, University of Benin Teaching 
      Hospital, Benin City, Nigeria.
FAU - Wammanda, R D
AU  - Wammanda RD
AD  - Department of Paediatrics, Ahmadu Bello University Teaching Hospital, Zaria, 
      Nigeria.
FAU - Bob-Okon, I I
AU  - Bob-Okon II
AD  - Department of Paediatrics, Federal Medical Centre, Yenagoa, Nigeria.
FAU - Ambe, J
AU  - Ambe J
AD  - Department of Paediatrics, University of Maiduguri Teaching Hospital, Maiduguri, 
      Nigeria.
FAU - Mava, Y
AU  - Mava Y
AD  - Department of Paediatrics, University of Maiduguri Teaching Hospital, Maiduguri, 
      Nigeria.
FAU - Adesina, A O
AU  - Adesina AO
AD  - Department of Obstetrics and Gynecology, University College Hospital, Ibadan, 
      Nigeria.
FAU - Ugochukwu, C G
AU  - Ugochukwu CG
AD  - Department of Paediatrics, Nnamdi Azikiwe University Teaching Hospital, Nnewi, 
      Nigeria.
FAU - Nyong, E E
AU  - Nyong EE
AD  - Department of Paediatrics, University of Uyo Teaching Hospital, Akwa Ibom, 
      Nigeria.
FAU - Ogunleye, O O
AU  - Ogunleye OO
AD  - Lagos State University Teaching Hospital, Lagos, Nigeria.
FAU - Onuoha, F
AU  - Onuoha F
AD  - Federal Medical Centre, Owerri, Nigeria.
FAU - Jalo, I
AU  - Jalo I
AD  - Department of Paediatrics, Federal Teaching Hospital, Gombe, Nigeria.
FAU - Adegoke, V O
AU  - Adegoke VO
AD  - NIPRD Research Clinic, National Institute for Pharmaceutical Research and 
      Development, Abuja, Nigeria.
FAU - Balogun, S T
AU  - Balogun ST
AD  - Department of Clinical Pharmacology and Therapeutics, University of Maiduguri, 
      Maiduguri, Nigeria.
FAU - Ntadom, G
AU  - Ntadom G
AD  - National Malaria Control Programme, FMoH, Abuja, Nigeria.
FAU - Ejiekpe, F N
AU  - Ejiekpe FN
AD  - Lafes Pharmacy Ltd, Enugu, Nigeria.
FAU - Tahir, R
AU  - Tahir R
AD  - Rata Pharmacy, Maiduguri, Nigeria.
FAU - Dabit, K
AU  - Dabit K
AD  - Skylark Pharmacy, Abuja, Nigeria.
FAU - Amodu, A A
AU  - Amodu AA
AD  - Federal Medical Center, Makurdi, Nigeria.
FAU - Nwaosu, S
AU  - Nwaosu S
AD  - Department of Mathematics, Federal University of Technology, Makurdi, Nigeria.
FAU - Habib, A T
AU  - Habib AT
AD  - Waziri Shehu Specialist Hospital, Kano, Nigeria.
LA  - eng
PT  - Journal Article
PL  - Nigeria
TA  - Niger Postgrad Med J
JT  - The Nigerian postgraduate medical journal
JID - 9613595
RN  - 0 (Antimalarials)
RN  - 0 (Artemisinins)
RN  - 0 (Drug Combinations)
RN  - 0 (Ethanolamines)
RN  - 0 (Fluorenes)
SB  - IM
MH  - Antimalarials/*adverse effects/therapeutic use
MH  - Artemisinins/*adverse effects/therapeutic use
MH  - Drug Combinations
MH  - Ethanolamines
MH  - Fluorenes
MH  - Humans
MH  - Malaria/*drug therapy
MH  - Nigeria
MH  - *Pharmacies
MH  - Treatment Outcome
EDAT- 2016/12/22 06:00
MHDA- 2018/08/25 06:00
CRDT- 2016/12/22 06:00
PHST- 2016/12/22 06:00 [entrez]
PHST- 2016/12/22 06:00 [pubmed]
PHST- 2018/08/25 06:00 [medline]
AID - NigerPostgradMedJ_2016_23_4_172_196246 [pii]
AID - 10.4103/1117-1936.196246 [doi]
PST - ppublish
SO  - Niger Postgrad Med J. 2016 Oct-Dec;23(4):172-181. doi: 10.4103/1117-1936.196246.