2021
Hepatic safety of repeated treatment with pyronaridine‐artesunate versus artemether–lumefantrine in patients with uncomplicated malaria: a secondary analysis of the WANECAM 1 data from Bobo-Dioulasso, Burkina Faso
Compaoré Y, Zongo I, Somé A, Barry N, Nikiéma F, Kaboré T, Ouattara A, Kabré Z, Wermi K, Zongo M, Yerbanga R, Sagara I, Djimdé A, Ouédraogo J. Hepatic safety of repeated treatment with pyronaridine‐artesunate versus artemether–lumefantrine in patients with uncomplicated malaria: a secondary analysis of the WANECAM 1 data from Bobo-Dioulasso, Burkina Faso. Malaria Journal 2021, 20: 64. PMID: 33514368, PMCID: PMC7847156, DOI: 10.1186/s12936-021-03593-6.Peer-Reviewed Original ResearchConceptsHepatic adverse eventsArtemether-lumefantrineAL armAdverse eventsElevated ALTMalaria episodesUncomplicated malariaHepatic safetyDirect bilirubinPA armFirst-line anti-malarial drugHepatic safety profileUncomplicated malaria episodesElevated total bilirubinBobo-DioulassoLogistic regression modelsAnti-malarial drugsAlkaline phosphataseSubsequent malariaUnscheduled daysStudy armsSafety profileResultsA totalClinical trialsTotal bilirubin
2018
Pyronaridine–artesunate or dihydroartemisinin–piperaquine versus current first-line therapies for repeated treatment of uncomplicated malaria: a randomised, multicentre, open-label, longitudinal, controlled, phase 3b/4 trial
Drugs T, Sagara I, Beavogui A, Zongo I, Soulama I, Borghini-Fuhrer I, Fofana B, Traore A, Diallo N, Diakite H, Togo A, Koumare S, Keita M, Camara D, Somé A, Coulibaly A, Traore O, Dama S, Goita S, Djimde M, Bamadio A, Dara N, Maiga H, Sidibe B, Dao F, Coulibaly M, Alhousseini M, Niangaly H, Sangare B, Diarra M, Coumare S, Kabore M, Ouattara S, Barry A, Kargougou D, Diarra A, Henry N, Soré H, Bougouma E, Thera I, Compaore Y, Sutherland C, Sylla M, Nikiema F, Diallo M, Dicko A, Picot S, Borrmann S, Duparc S, Miller R, Doumbo O, Shin J, Gil J, Björkman A, Ouedraogo J, Sirima S, Djimde A. Pyronaridine–artesunate or dihydroartemisinin–piperaquine versus current first-line therapies for repeated treatment of uncomplicated malaria: a randomised, multicentre, open-label, longitudinal, controlled, phase 3b/4 trial. The Lancet 2018, 391: 1378-1390. PMID: 29606364, PMCID: PMC5889791, DOI: 10.1016/s0140-6736(18)30291-5.Peer-Reviewed Original ResearchConceptsArtemisinin-based combination therapyFirst-line artemisinin-based combination therapyArtemether-lumefantrineDay 28Day 42Study drugUncomplicated malariaMalaria episodesEligible participantsIncidence ratePan African Clinical Trials RegistryUncomplicated P falciparum malariaCurrent first-line therapyAfrican Clinical Trials RegistryDeveloping Countries Clinical Trials PartnershipDihydroartemisinin-piperaquine treatmentFirst malaria episodeP falciparum malariaUncomplicated malaria episodesFirst-line therapyHistory of feverClinical Trials RegistryNon-falciparum speciesMild transient elevationUK Medical Research Council
2015
Safety and efficacy of re-treatments with pyronaridine-artesunate in African patients with malaria: a substudy of the WANECAM randomised trial
Sagara I, Beavogui A, Zongo I, Soulama I, Borghini-Fuhrer I, Fofana B, Camara D, Somé A, Coulibaly A, Traore O, Dara N, Kabore M, Thera I, Compaore Y, Sylla M, Nikiema F, Diallo M, Dicko A, Gil J, Borrmann S, Duparc S, Miller R, Doumbo O, Shin J, Bjorkman A, Ouedraogo J, Sirima S, Djimdé A. Safety and efficacy of re-treatments with pyronaridine-artesunate in African patients with malaria: a substudy of the WANECAM randomised trial. The Lancet Infectious Diseases 2015, 16: 189-198. PMID: 26601738, PMCID: PMC4726763, DOI: 10.1016/s1473-3099(15)00318-7.Peer-Reviewed Original ResearchConceptsSubstudy analysisFirst episodeFirst treatmentArtemisinin-based combination treatmentDeveloping Countries Clinical Trials PartnershipPrimary safety endpointPyronaridine-artesunate efficacyHistory of feverIncidence of hepatotoxicityAdverse event frequencyExclusion of patientsUK Medical Research CouncilMedical Research CouncilParasitological responseSafety endpointArtemether-lumefantrineMalaria episodesTreat analysisAfrican patientsMalaria treatmentClinical trialsMalaria VentureLaboratory valuesAlanine aminotransferaseHealth facilities