Prospective observational study to evaluate the clinical and biological safety profile of pyronaridine-artesunate in a rural health district in Burkina Faso

被引:2
作者
Rouamba, Toussaint [1 ]
Sondo, Paul [1 ]
Yerbanga, Isidore W. [1 ]
Compaore, Adelaide [1 ]
Traore-Coulibaly, Maminata [1 ]
Hien, Franck S. [1 ]
Diande, Nassirou A. [1 ]
Valea, Innocent [1 ]
Tahita, Marc Christian [1 ]
Baiden, Rita [2 ]
Binka, Fred [2 ]
Tinto, Halidou [1 ]
机构
[1] Natl Ctr Sci & Technol Res, Inst Res Hlth Sci, Clin Res Unit Nanoro, Ouagadougou, Burkina Faso
[2] INDEPTH Network, Accra, Ghana
来源
PHARMACOLOGY RESEARCH & PERSPECTIVES | 2022年 / 10卷 / 04期
基金
比尔及梅琳达.盖茨基金会;
关键词
artesunate; Burkina Faso; cohort event monitoring; hepatic safety; pyronaridine; safety monitoring; PLASMODIUM-FALCIPARUM MALARIA; ARTEMETHER-LUMEFANTRINE; COMBINATION THERAPIES; NANORO HEALTH; EFFICACY; CHILDREN; PHARMACOVIGILANCE; RESISTANCE; SYSTEM;
D O I
10.1002/prp2.987
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The assessment in real-life conditions of the safety and efficacy of new antimalarial drugs is of greatest interest. This study aimed to monitor and evaluate both clinical and biological safety of pyronaridine-artesunate (PA) in real-life conditions in Burkina Faso's health system. This was a single-arm, open-label study, where patients attending Nanoro health facilities with uncomplicated malaria were consented to be part of a cohort event monitoring (CEM). At inclusion (day-0), PA was administered orally once a day for 3 days. Patients spontaneous reported any clinical adverse events (AEs) occurring within 28 days following the treatment. Additionally, the study focused on AEs of special interest (AESI), namely clinical signs related to hepatotoxicity and increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST). A nested subset of patients with blood sample collection at day-0 and day-7 were monitored to investigate the effect of PA on biochemistry parameters. From September 2017 to October 2018, 2786 patients were treated with PA. About 97.8% (2720/2786) of patients did not report any AE. The most commonly reported events were respiratory, thoracic, and mediastinal disorders (8.3 per 1000), infections and infestations (7.9 per 1000), and gastrointestinal disorders (7.2 per 1000). No clinical or biological hepatotoxicity event related to PA was reported during the follow-up. Changes in biochemistry parameters remained within laboratory reference ranges. The study showed that PA is a well-tolerated drug and should be considered as a good option by malaria control programs in countries where existing first-line antimalarial drugs are continuously threatened by the emergence of drug resistance.
引用
收藏
页数:11
相关论文
共 33 条
[1]  
[Anonymous], SAF REP PHARM
[2]   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 [J].
Baiden, Rita ;
Oduro, Abraham ;
Halidou, Tinto ;
Gyapong, Margaret ;
Sie, Ali ;
Macete, Eusebio ;
Abdulla, Salim ;
Owusu-Agyei, Seth ;
Mulokozi, Abdunoor ;
Adjei, Alex ;
Sevene, Esperanca ;
Compaore, Guillaume ;
Valea, Innocent ;
Osei, Isaac ;
Yawson, Abena ;
Adjuik, Martin ;
Akparibo, Raymond ;
Ogutu, Bernhards ;
Upunda, Gabriel Leonard ;
Smith, Peter ;
Binka, Fred .
MALARIA JOURNAL, 2015, 14
[3]   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 [J].
Compaore, Yves Daniel ;
Zongo, Issaka ;
Some, Anyirekun F. ;
Barry, Nouhoun ;
Nikiema, Frederick ;
Kabore, Talato N. ;
Ouattara, Aminata ;
Kabre, Zachari ;
Wermi, Kadidiatou ;
Zongo, Moussa ;
Yerbanga, Rakiswende S. ;
Sagara, Issaka ;
Djimde, Abdoulaye ;
Ouedraogo, Jean Bosco .
MALARIA JOURNAL, 2021, 20 (01)
[4]   Profile: Nanoro Health and Demographic Surveillance System [J].
Derra, Karim ;
Rouamba, Eli ;
Kazienga, Adama ;
Ouedraogo, Sayouba ;
Tahita, Marc C. ;
Sorgho, Hermann ;
Valea, Innocent ;
Tinto, Halidou .
INTERNATIONAL JOURNAL OF EPIDEMIOLOGY, 2012, 41 (05) :1293-1301
[5]   Safety and efficacy of pyronaridine-artesunate in uncomplicated acute malaria: an integrated analysis of individual patient data from six randomized clinical trials [J].
Duparc, Stephan ;
Borghini-Fuhrer, Isabelle ;
Craft, J. Carl ;
Arbe-Barnes, Sarah ;
Miller, Robert M. ;
Shin, Chang-Sik ;
Fleckenstein, Lawrence .
MALARIA JOURNAL, 2013, 12
[6]   Pharmacovigilance in developing countries (part I): importance and challenges [J].
Elshafie, Shaimaa ;
Zaghloul, Iman ;
Roberti, Anne Marie .
INTERNATIONAL JOURNAL OF CLINICAL PHARMACY, 2018, 40 (04) :758-763
[7]   Anti-malarial efficacy and resistance monitoring of artemether-lumefantrine and dihydroartemisinin-piperaquine shows inadequate efficacy in children in Burkina Faso, 2017-2018 [J].
Gansane, Adama ;
Moriarty, Leah F. ;
Menard, Didier ;
Yerbanga, Isidore ;
Ouedraogo, Esperance ;
Sondo, Paul ;
Kinda, Rene ;
Tarama, Casimir ;
Soulama, Edwige ;
Tapsoba, Madou ;
Kangoye, David ;
Compaore, Cheick Said ;
Badolo, Ousmane ;
Dao, Blami ;
Tchwenko, Samuel ;
Tinto, Halidou ;
Valea, Innocent .
MALARIA JOURNAL, 2021, 20 (01)
[8]  
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2003, ICH HARMONISED TRIPA
[9]   Pyronaridine-artesunate granules versus artemether-lumefantrine crushed tablets in children with Plasmodium falciparum malaria: a randomized controlled trial [J].
Kayentao, Kassoum ;
Doumbo, Ogobara K. ;
Penali, Louis K. ;
Offianan, Andre T. ;
Bhatt, Kirana M. ;
Kimani, Joshua ;
Tshefu, Antoinette K. ;
Kokolomami, Jack H. T. ;
Ramharter, Michael ;
de Salazar, Pablo Martinez ;
Tiono, Alfred B. ;
Ouedraogo, Alphonse ;
Bustos, Maria Dorina G. ;
Quicho, Frederick ;
Borghini-Fuhrer, Isabelle ;
Duparc, Stephan ;
Shin, Chang-Sik ;
Fleckenstein, Lawrence .
MALARIA JOURNAL, 2012, 11
[10]   Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring [J].
Kuemmerle, Andrea ;
Dodoo, Alex N. O. ;
Olsson, Sten ;
Van Erps, Jan ;
Burri, Christian ;
Lalvani, Paul S. .
MALARIA JOURNAL, 2011, 10