title: Safety of a fixed-dose combination of artesunate and amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in real-life conditions of use in Côte d'Ivoire.
abstract: In many malaria-endemic, sub-Saharan African countries, existing pharmacovigilance systems are not sufficiently operational to document reliably the safety profile of anti-malarial drugs. This study describes the implantation of a community-based pharmacovigilance system in Côte d'Ivoire and its use to document the safety of ASAQ Winthrop®(artesunate-amodiaquine).
  
  
  
  This prospective, longitudinal, descriptive, non-comparative, non-interventional study on the use of artesunate-amodiaquine in real-life conditions of use was conducted in seven Community Health Centres of the Agboville district in Côte d'Ivoire. Twenty trained Health Centre employees and 70 trained community health workers were involved in data collection in the field. All patients with suspected uncomplicated falciparum malaria, seeking treatment at one of the participating Health Centres, and treated with artesunate-amodiaquine could be enrolled. Two visits were planned, one for inclusion at the Health Centre and a second at home, performed by a community health worker 3-10 days after the inclusion visit. Administration of artesunate-amodiaquine was unsupervised. Adverse events (AEs) were documented at the home visit or during any unexpected visit to the Health Centre or to the hospital and coded and adjudicated by a local pharmacovigilance committee. Symptoms suggestive of hepatic failure, severe neutropaenia, extrapyramidal disorders and retinopathy were considered a priori as AEs of special interest.
  
  
  
  Some 15,228 malaria episodes in 12,198 patients were evaluated; 2545 AEs were documented during 1978 malaria episodes (13.0%). The most frequently observed events were asthenia (682 cases), vomiting (482 cases) and somnolence (174 cases). Most reported AEs were of mild or moderate intensity and resolved without corrective treatment. One-hundred and five (105) AEs reported during 100 episodes (0.7%) were considered as serious. Three serious cases of transient extrapyramidal disorders, identified as AEs of special interest were reported in three patients.
  
  
  
  The fixed dose artesunate-amodiaquine combination ASAQ Winthrop®for the unsupervised treatment of uncomplicated falciparum malaria under real-life conditions of care in Côte d'Ivoire is well tolerated. The study emphasizes the interest of involving properly trained community health workers to collect pharmacovigilance data in the field in order to document rare AEs.
authors.affiliation: Institut Pierre Richet (IPR)/Institut National de Santé Publique (INSP), Bouaké, Ivory Coast. assisergi@yahoo.fr.|National Malaria Control Programme, Abidjan, Ivory Coast. assisergi@yahoo.fr.
authors.forename: Serge-Brice
authors.identifier: 0000-0001-7055-5405
authors.initials: SB
authors.lastname: Assi
authors.affiliation: Infectious and Tropical Diseases Department, Bouaké University Hospital, Bouaké, Ivory Coast.
authors.forename: Yapo Thomas
authors.initials: YT
authors.lastname: Aba
authors.affiliation: Pharmacovigilance Unit, Medical Sciences, Felix Houphouët-Boigny, Abidjan, Ivory Coast.
authors.forename: Jean Claude
authors.initials: JC
authors.lastname: Yavo
authors.affiliation: Infectious and Tropical Diseases Unit, Treichville University Hospital, Abidjan, Ivory Coast.
authors.forename: Abouo Franklin
authors.initials: AF
authors.lastname: Nguessan
authors.affiliation: Institut Pierre Richet (IPR)/Institut National de Santé Publique (INSP), Bouaké, Ivory Coast.
authors.forename: N'cho Bertin
authors.initials: NB
authors.lastname: Tchiekoi
authors.affiliation: National Malaria Control Programme, Abidjan, Ivory Coast.
authors.forename: Koffi Moïse
authors.initials: KM
authors.lastname: San
authors.affiliation: Infectious and Tropical Diseases Unit, Treichville University Hospital, Abidjan, Ivory Coast.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Bissagnéné
authors.affiliation: Medicines for Malaria Venture, Geneva, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Duparc
authors.affiliation: Sanofi Access to Medicines, Gentilly, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Lameyre
authors.affiliation: National Malaria Control Programme, Abidjan, Ivory Coast.
authors.forename: Mea Antoine
authors.initials: MA
authors.lastname: Tanoh
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000655:Amodiaquine / Q000008:administration & dosage / Q000009:adverse effects*; D000962:Antimalarials / Q000008:administration & dosage / Q000009:adverse effects*; D037621:Artemisinins / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D007560:Cote d'Ivoire; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008137:Longitudinal Studies; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; C515299:amodiaquine, artesunate drug combination; D000655:Amodiaquine
keywords: Artesunate–amodiaquine; Côte d’Ivoire; Malaria; Pharmacovigilance