Prospective observational study to evaluate the clinical and biological safety profile of pyronaridine-artesunate in a rural health district in Burkina Faso.
Toussaint RouambaPaul SondoIsidore W YerbangaAdelaide CompaoreMaminata Traore-CoulibalyFranck S HienNassirou A DiandeInnocent ValeaMarc Christian TahitaRita BaidenFred BinkaHalidou TintoPublished in: Pharmacology research & perspectives (2022)
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.
Keyphrases
- end stage renal disease
- ejection fraction
- newly diagnosed
- peritoneal dialysis
- public health
- randomized controlled trial
- healthcare
- clinical trial
- lymph node
- mental health
- spinal cord injury
- spinal cord
- risk assessment
- south africa
- patient reported outcomes
- drug induced
- study protocol
- double blind
- urinary tract infection
- adverse drug
- respiratory tract