PMID- 35855566 OWN - NLM STAT- MEDLINE DCOM- 20220721 LR - 20240901 IS - 2052-1707 (Electronic) IS - 2052-1707 (Linking) VI - 10 IP - 4 DP - 2022 Aug TI - Prospective observational study to evaluate the clinical and biological safety profile of pyronaridine-artesunate in a rural health district in Burkina Faso. PG - e00987 LID - 10.1002/prp2.987 [doi] LID - e00987 AB - 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. CI - (c) 2022 The Authors. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd. FAU - Rouamba, Toussaint AU - Rouamba T AUID- ORCID: 0000-0003-0594-3887 AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. FAU - Sondo, Paul AU - Sondo P AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. FAU - Yerbanga, Isidore W AU - Yerbanga IW AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. FAU - Compaore, Adelaide AU - Compaore A AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. FAU - Traore-Coulibaly, Maminata AU - Traore-Coulibaly M AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. FAU - Hien, Franck S AU - Hien FS AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. FAU - Diande, Nassirou A AU - Diande NA AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. FAU - Valea, Innocent AU - Valea I AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. FAU - Tahita, Marc Christian AU - Tahita MC AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. FAU - Baiden, Rita AU - Baiden R AD - INDEPTH-Network, Accra, Ghana. FAU - Binka, Fred AU - Binka F AD - INDEPTH-Network, Accra, Ghana. FAU - Tinto, Halidou AU - Tinto H AD - Clinical Research Unit of Nanoro, Institute for Research in Health Sciences, National Center for Scientific and Technological Research, Ouagadougou, Burkina Faso. LA - eng PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't PL - United States TA - Pharmacol Res Perspect JT - Pharmacology research & perspectives JID - 101626369 RN - 0 (Antimalarials) RN - 0 (Artemisinins) RN - 0 (Drug Combinations) RN - 0 (Naphthyridines) RN - 0 (pyronaridine tetraphosphate, artesunate drug combination) RN - 60W3249T9M (Artesunate) SB - IM MH - *Antimalarials/adverse effects MH - *Artemisinins/adverse effects MH - Artesunate MH - Burkina Faso/epidemiology MH - *Chemical and Drug Induced Liver Injury/epidemiology/etiology MH - Drug Combinations MH - *Drug-Related Side Effects and Adverse Reactions/drug therapy MH - Humans MH - *Malaria/chemically induced/drug therapy MH - Naphthyridines MH - Rural Health PMC - PMC9297024 OTO - NOTNLM OT - Burkina Faso OT - artesunate OT - cohort event monitoring OT - hepatic safety OT - pyronaridine OT - safety monitoring EDAT- 2022/07/21 06:00 MHDA- 2022/07/22 06:00 PMCR- 2022/07/19 CRDT- 2022/07/20 02:53 PHST- 2021/09/30 00:00 [received] PHST- 2022/06/22 00:00 [accepted] PHST- 2022/07/20 02:53 [entrez] PHST- 2022/07/21 06:00 [pubmed] PHST- 2022/07/22 06:00 [medline] PHST- 2022/07/19 00:00 [pmc-release] AID - PRP2987 [pii] AID - 10.1002/prp2.987 [doi] PST - ppublish SO - Pharmacol Res Perspect. 2022 Aug;10(4):e00987. doi: 10.1002/prp2.987.