메뉴 건너뛰기




Volumn 14, Issue 1, 2015, Pages

Prospective observational study to evaluate the clinical safety of the fixed-dose artemisinin-based combination Eurartesim® (dihydroartemisinin/piperaquine), in public health facilities in Burkina Faso, Mozambique, Ghana, and Tanzania

(21)  Baiden, Rita a   Oduro, Abraham b   Halidou, Tinto c   Gyapong, Margaret d   Sie, Ali e   Macete, Eusebio f   Abdulla, Salim g   Owusu Agyei, Seth h   Mulokozi, Abdunoor g   Adjei, Alex d   Sevene, Esperanca f   Compaoré, Guillaume e   Valea, Innocent c   Osei, Isaac b   Yawson, Abena h   Adjuik, Martin a   Akparibo, Raymond a   Ogutu, Bernhards a   Upunda, Gabriel Leonard i   Smith, Peter j   more..


Author keywords

Cohort event monitoring; Electrocardiogram; Eurartesim ; QTc prolongation; Safety monitoring

Indexed keywords

DIHYDROARTEMISININ PLUS PIPERAQUINE; ANTIMALARIAL AGENT; ARTEMISININ DERIVATIVE; DIHYDROARTEMISININ; DRUG COMBINATION; PIPERAQUINE; QUINOLINE DERIVATIVE;

EID: 84928468640     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/s12936-015-0664-9     Document Type: Article
Times cited : (36)

References (31)
  • 1
    • 31444454856 scopus 로고    scopus 로고
    • WHO World Health Organization Geneva (assessed July 2014 at http://www.who.int/malaria/docs/treatmentGuidelines.2006.pdf)
    • WHO. Guidelines for the treatment of malaria. Geneva: World Health Organization; 2006 (assessed July 2014 at http://www.who.int/malaria/docs/treatmentGuidelines.2006.pdf).
    • (2006) Guidelines for the Treatment of Malaria
  • 2
    • 84908451165 scopus 로고    scopus 로고
    • World Health Organization (Assessed June 2014
    • WHO: World Malaria Report 2013. World Health Organization (Assessed June 2014 at www.who.int/malaria/publications/world-malaria-report-2013/en/
    • WHO: World Malaria Report 2013
  • 3
    • 79952340261 scopus 로고    scopus 로고
    • Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring
    • Kuemmerle A, Dodoo AN, Olsson S, Van Erps J, Burri C, Lalvani PS. Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring. Malar J. 2011;10:57.
    • (2011) Malar J , vol.10 , pp. 57
    • Kuemmerle, A.1    Dodoo, A.N.2    Olsson, S.3    Van Erps, J.4    Burri, C.5    Lalvani, P.S.6
  • 4
    • 77955865085 scopus 로고    scopus 로고
    • Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: Lessons learned for pharmacovigilance reporting
    • Kabanywanyi AM, Mulure N, Migoha C, Malila A, Lengeler C, Schlienger R, et al. Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting. Malar J. 2010;9:205.
    • (2010) Malar J , vol.9 , pp. 205
    • Kabanywanyi, A.M.1    Mulure, N.2    Migoha, C.3    Malila, A.4    Lengeler, C.5    Schlienger, R.6
  • 5
    • 84890214492 scopus 로고    scopus 로고
    • Safety of artemisinin-based combination therapies in Nigeria: A cohort event monitoring study
    • 1:CAS:528:DC%2BC3sXhsl2nsbnN
    • Bassi PU, Osakwe AI, Isah A, Suku C, Kalat M, Jalo I, et al. Safety of artemisinin-based combination therapies in Nigeria: a cohort event monitoring study. Drug Saf. 2013;36:747-56.
    • (2013) Drug Saf , vol.36 , pp. 747-756
    • Bassi, P.U.1    Osakwe, A.I.2    Isah, A.3    Suku, C.4    Kalat, M.5    Jalo, I.6
  • 6
    • 84901940210 scopus 로고    scopus 로고
    • Profile of adverse events in patients receiving treatment for malaria in urban ghana: A cohort-event monitoring study
    • 1:CAS:528:DC%2BC2cXns1Wgu7Y%3D 24788801
    • Dodoo AN, Fogg C, Nartey ET, Ferreira GL, Adjei GO, Kudzi W, et al. Profile of adverse events in patients receiving treatment for malaria in urban ghana: a cohort-event monitoring study. Drug Saf. 2014;37:433-48.
    • (2014) Drug Saf , vol.37 , pp. 433-448
    • Dodoo, A.N.1    Fogg, C.2    Nartey, E.T.3    Ferreira, G.L.4    Adjei, G.O.5    Kudzi, W.6
  • 8
    • 33746500706 scopus 로고    scopus 로고
    • Pharmacovigilance of antimalarial treatment in Africa: Is it possible?
    • Talisuna AO, Staedke SG, D'Alessandro U. Pharmacovigilance of antimalarial treatment in Africa: is it possible? Malar J. 2006;5:50.
    • (2006) Malar J , vol.5 , pp. 50
    • Talisuna, A.O.1    Staedke, S.G.2    D'Alessandro, U.3
  • 9
    • 84873252301 scopus 로고    scopus 로고
    • Safety monitoring of artemisinin combination therapy through a national pharmacovigilance system in an endemic malaria setting
    • Thiam S, Ndiaye JL, Diallo I, Gatonga P, Fall FB, Diallo NE, et al. Safety monitoring of artemisinin combination therapy through a national pharmacovigilance system in an endemic malaria setting. Malar J. 2013;12:54.
    • (2013) Malar J , vol.12 , pp. 54
    • Thiam, S.1    Ndiaye, J.L.2    Diallo, I.3    Gatonga, P.4    Fall, F.B.5    Diallo, N.E.6
  • 10
    • 84890497904 scopus 로고    scopus 로고
    • Monitoring the efficacy and safety of three artemisinin based-combinations therapies in Senegal: Results from two years surveillance
    • Sylla K, Abiola A, Tine RC, Faye B, Sow D, Ndiaye JL, et al. Monitoring the efficacy and safety of three artemisinin based-combinations therapies in Senegal: results from two years surveillance. BMC Infect Dis. 2013;13:598.
    • (2013) BMC Infect Dis , vol.13 , pp. 598
    • Sylla, K.1    Abiola, A.2    Tine, R.C.3    Faye, B.4    Sow, D.5    Ndiaye, J.L.6
  • 11
    • 84879056888 scopus 로고    scopus 로고
    • MMV in partnership: The Eurartesim® experience
    • Ubben D, Poll EM. MMV in partnership: the Eurartesim® experience. Malar J. 2013;12:211.
    • (2013) Malar J , vol.12 , pp. 211
    • Ubben, D.1    Poll, E.M.2
  • 12
  • 14
    • 70849087812 scopus 로고    scopus 로고
    • Dihydroartemisinin-piperaquine and artemether-lumefantrine for treating uncomplicated malaria in African children: A randomised, non-inferiority trial
    • Bassat Q, Mulenga M, Tinto H, Piola P, Borrmann S, Menéndez C, et al. Dihydroartemisinin-piperaquine and artemether-lumefantrine for treating uncomplicated malaria in African children: a randomised, non-inferiority trial. PLoS One. 2009;4:e7871.
    • (2009) PLoS One , vol.4 , pp. 7871
    • Bassat, Q.1    Mulenga, M.2    Tinto, H.3    Piola, P.4    Borrmann, S.5    Menéndez, C.6
  • 15
    • 77955606614 scopus 로고    scopus 로고
    • An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for falciparum malaria in Asia
    • Valecha N, Phyo AP, Mayxay M, Newton PN, Krudsood S, Keomany S, et al. An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for falciparum malaria in Asia. PLoS One. 2010;5:e11880.
    • (2010) PLoS One , vol.5 , pp. 11880
    • Valecha, N.1    Phyo, A.P.2    Mayxay, M.3    Newton, P.N.4    Krudsood, S.5    Keomany, S.6
  • 16
    • 34447568519 scopus 로고    scopus 로고
    • Cardiotoxicity of antimalarial drugs
    • 1:CAS:528:DC%2BD2sXpsF2rsLc%3D 17646028
    • White NJ. Cardiotoxicity of antimalarial drugs. Lancet Infect Dis. 2007;7:549-58.
    • (2007) Lancet Infect Dis , vol.7 , pp. 549-558
    • White, N.J.1
  • 17
    • 84861121469 scopus 로고    scopus 로고
    • In vitrocardiovasculareffects of dihydroartemisin-piperaquine combination compared with other antimalarials
    • 1:CAS:528:DC%2BC38XnslWrtbk%3D 22391528
    • Borsini F, Crumb W, Pace S, Ubben D, Wible B, Yan GX, et al. In vitrocardiovasculareffects of dihydroartemisin-piperaquine combination compared with other antimalarials. Antimicrob Agents Chemother. 2012;56:3261-70.
    • (2012) Antimicrob Agents Chemother , vol.56 , pp. 3261-3270
    • Borsini, F.1    Crumb, W.2    Pace, S.3    Ubben, D.4    Wible, B.5    Yan, G.X.6
  • 19
    • 85081871175 scopus 로고    scopus 로고
    • (accessed on July 2014)
    • INDEPTH: INDEPTH Network. http://www.indepth-network.org (accessed on July 2014)
    • INDEPTH: INDEPTH Network
  • 20
    • 0027981660 scopus 로고
    • Patterns of malaria morbidity and mortality in children in northern Ghana
    • 1:STN:280:DyaK28%2FjtFantA%3D%3D 7570811
    • Binka FN, Morris SS, Ross DA, Arthur P, Aryeetey ME. Patterns of malaria morbidity and mortality in children in northern Ghana. Trans R Soc Trop Med Hyg. 1994;88:381-5.
    • (1994) Trans R Soc Trop Med Hyg , vol.88 , pp. 381-385
    • Binka, F.N.1    Morris, S.S.2    Ross, D.A.3    Arthur, P.4    Aryeetey, M.E.5
  • 21
    • 0042235761 scopus 로고    scopus 로고
    • Seasonal profiles of malaria infection, anaemia, and bednet use among age groups and communities in northern Ghana
    • Koram KA, Owusu-Agyei S, Fryauff DJ, Anto F, Atuguba F, Hodgson A, et al. Seasonal profiles of malaria infection, anaemia, and bednet use among age groups and communities in northern Ghana. Trop Med Int Health. 2003;8:793-802.
    • (2003) Trop Med Int Health , vol.8 , pp. 793-802
    • Koram, K.A.1    Owusu-Agyei, S.2    Fryauff, D.J.3    Anto, F.4    Atuguba, F.5    Hodgson, A.6
  • 24
    • 84874566103 scopus 로고    scopus 로고
    • Moving towards universal coverage with malaria control interventions: Achievements and challenges in rural Burkina Faso
    • De Allegri M, Louis VR, Tiendrébeogo J, Souares A, Yé M, Tozan Y, et al. Moving towards universal coverage with malaria control interventions: achievements and challenges in rural Burkina Faso. Int J Health Plann Manage. 2013;28:102-21.
    • (2013) Int J Health Plann Manage , vol.28 , pp. 102-121
    • De Allegri, M.1    Louis, V.R.2    Tiendrébeogo, J.3    Souares, A.4    Yé, M.5    Tozan, Y.6
  • 25
    • 33845739662 scopus 로고    scopus 로고
    • Levels and trends of demographic indices in southern rural Mozambique: Evidence from demographic surveillance in Manhiça district
    • Nhacolo AQ, Nhalungo DA, Sacoor CN, Aponte JJ, Thompson R, Alonso P. Levels and trends of demographic indices in southern rural Mozambique: evidence from demographic surveillance in Manhiça district. BMC Public Health. 2006;6:291.
    • (2006) BMC Public Health , vol.6 , pp. 291
    • Nhacolo, A.Q.1    Nhalungo, D.A.2    Sacoor, C.N.3    Aponte, J.J.4    Thompson, R.5    Alonso, P.6
  • 26
    • 78049365824 scopus 로고    scopus 로고
    • Patterns and seasonality of malaria transmission in the forest-savannah transitional zones of Ghana
    • Dery DB, Brown C, Asante KP, Adams M, Dosoo D, Amenga-Etego S, et al. Patterns and seasonality of malaria transmission in the forest-savannah transitional zones of Ghana. Malar J. 2010;9:314.
    • (2010) Malar J , vol.9 , pp. 314
    • Dery, D.B.1    Brown, C.2    Asante, K.P.3    Adams, M.4    Dosoo, D.5    Amenga-Etego, S.6
  • 27
  • 28
    • 85081871129 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): ICH Harmonised Tripartite Guideline
    • Version dated 12 May 2005
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice. Version dated 12 May 2005. http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E6-R1/Step4/E6-R1-Guideline.pdf wesite
    • Guideline for Good Clinical Practice
  • 29
    • 79952051804 scopus 로고    scopus 로고
    • Safety and efficacy of dihydroartemisinin-piperaquine versus artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Zambian children
    • Nambozi M, Van Geertruyden JP, Hachizovu S, Chaponda M, Mukwamataba D, Mulenga M, et al. Safety and efficacy of dihydroartemisinin-piperaquine versus artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Zambian children. Malar J. 2011;10:50.
    • (2011) Malar J , vol.10 , pp. 50
    • Nambozi, M.1    Van Geertruyden, J.P.2    Hachizovu, S.3    Chaponda, M.4    Mukwamataba, D.5    Mulenga, M.6
  • 30
    • 81255185508 scopus 로고    scopus 로고
    • Antimalarial efficacy of piperaquine-based antimalarial combination therapies: Facts and uncertainties
    • 1:CAS:528:DC%2BC38Xjs1alsw%3D%3D 21914092
    • Gargano N, Cenci F, Bassat Q. Antimalarial efficacy of piperaquine-based antimalarial combination therapies: facts and uncertainties. Trop Med Int Health. 2011;16:1466-73.
    • (2011) Trop Med Int Health , vol.16 , pp. 1466-1473
    • Gargano, N.1    Cenci, F.2    Bassat, Q.3
  • 31
    • 84907907884 scopus 로고    scopus 로고
    • Effect of coadministered fat on the tolerability, safety, and pharmacokinetic properties of dihydroartemisinin-piperaquine in Papua New Guinean children with uncomplicated malaria
    • 1:CAS:528:DC%2BC2cXhslSit7zE 25049242
    • Moore BR, Benjamin JM, Salman S, Griffin S, Ginny E, Page-Sharp M, et al. Effect of coadministered fat on the tolerability, safety, and pharmacokinetic properties of dihydroartemisinin-piperaquine in Papua New Guinean children with uncomplicated malaria. Antimicrob Agents Chemother. 2014;58:5784-94.
    • (2014) Antimicrob Agents Chemother , vol.58 , pp. 5784-5794
    • Moore, B.R.1    Benjamin, J.M.2    Salman, S.3    Griffin, S.4    Ginny, E.5    Page-Sharp, M.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.