title: Monitoring the efficacy and safety of three artemisinin based-combinations therapies in Senegal: results from two years surveillance.
abstract: BACKGROUND
  Malaria remains a major public health problem in developing countries. Then in these countries prompt access to effective antimalarial treatment such as Artemisinin based-Combination Therapies (ACT) proves to be an essential tool for controlling the disease. In Senegal, since 2006 a nationwide scaling up program of ACT is being implemented. In this context it has become relevant to monitor ACT efficacy and provide recommendations for the Senegalese national malaria control program.
  
  
  METHODS
  An open randomized trial was conducted during two malaria transmission seasons (2011 and 2012) to assess the efficacy and safety of three combinations: dihydro-artemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ). The primary end point of the study was represented by a PCR adjusted adequate clinical and parasitological response (ACPR) at day 28. Secondary end points included: (i) a ACPR at days 35 and 42, (ii) a parasite and fever clearance time, (iii) ACTs safety and tolerability. The 2003 WHO's protocol for antimalarial drug evaluation was used to assess each outcome.
  
  
  RESULTS
  Overall, 534 patients were randomized selected to receive, either ASAQ (n = 180), AL (n = 178) or DHAPQ (n = 176). The PCR adjusted ACPR at day 28 was 99.41% for the group ASAQ, while that was 100% in the AL and DHAPQ groups (p = 0.37). The therapeutic efficacy was evaluated at 99.37% in the ASAQ arm versus 100% in AL and DHAPQ arm at day 35 (p = 0.37). At day 42, the ACPR was 99.27% in the ASAQ group versus 100% for both AL and DHAPQ groups, (p = 0.36). No serious adverse event was noted during the study period. Also a similar safety profile was noted in the 3 study groups.
  
  
  CONCLUSIONS
  In the context of scaling up of ACTs in Senegal, ASAQ, AL and DHAPQ are highly effective and safe antimalarial drugs. However, it's remains important to continue to monitor their efficacy.
  
  
  BACKGROUND
  PACTR 201305000552290.
authors.affiliation: Département de Parasitologie-Mycologie, Faculté de Médecine, Université Cheikh Anta DIOP de Dakar, Dakar, Senegal. khadimesylla@yahoo.fr.
authors.forename: Khadime
authors.initials: K
authors.lastname: Sylla
authors.forename: Annie
authors.initials: A
authors.lastname: Abiola
authors.forename: Roger Clément Kouly
authors.initials: RC
authors.lastname: Tine
authors.forename: Babacar
authors.initials: B
authors.lastname: Faye
authors.forename: Doudou
authors.initials: D
authors.lastname: Sow
authors.forename: Jean Louis
authors.initials: JL
authors.lastname: Ndiaye
authors.forename: Magatte
authors.initials: M
authors.lastname: Ndiaye
authors.forename: Aminata Colé
authors.initials: AC
authors.lastname: Lo
authors.forename: Kuaku
authors.initials: K
authors.lastname: Folly
authors.forename: Léon Amath
authors.initials: LA
authors.lastname: Ndiaye
authors.forename: Oumar
authors.initials: O
authors.lastname: Gaye
mesh_terms: D000293:Adolescent; D000328:Adult; D000655:Amodiaquine / Q000008:administration & dosage / Q000009:adverse effects; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D005260:Female; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D010963:Plasmodium falciparum / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D011159:Population Surveillance; D011804:Quinolines / Q000008:administration & dosage; D012675:Senegal; D055815:Young Adult; D010879:Piperazines
chemical_list: D000655:Amodiaquine; D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D011804:Quinolines; C515299:amodiaquine, artesunate drug combination; C039060:artenimol; C031327:artemisinin; C034759:piperaquine; D010879:Piperazines