Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries
In: Malaria Journal, Jg. 20 (2021), Heft 1, S. 1-14
Online
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Zugriff:
Background: European travellers to endemic countries are at risk of malaria and may be affected by a different range of co-morbidities than natives of endemic regions. The safety profile, especially cardiac issues, of artenimol (previously dihydroartemisinin)–piperaquine (APQ) Eurartesim® during treatment of uncomplicated imported falciparum malaria is not adequately described due to the lack of longitudinal studies in this population. The present study was conducted to partially fill this gap. Methods: Participants were recruited through Health Care Provider’s safety registry in 15 centres across 6 European countries in the period 2013–2016. Adverse events (AE) were collected, with a special focus on cardiovascular safety by including electrocardiogram QT intervals evaluated after correction with either Bazett’s (QTcB) or Fridericia’s (QTcF) methods, at baseline and after treatment. QTcB and/or QTcF prolongation were defined by a value > 450 ms for males and children and > 470 ms for females. Results: Among 294 participants, 30.3% were women, 13.7% of Caucasian origin, 13.5% were current smoker, 13.6% current alcohol consumer and 42.2% declared at least one illness history. The mean (SD) age and body mass index were 39.8 years old (13.2) and 25.9 kg/m2 (4.7). Among them, 75 reported a total of 129 AE (27 serious), 46 being suspected to be related to APQ (11 serious) and mostly labelled as due to haematological, gastrointestinal, or infection. Women and Non-African participants had significantly (p < 0.05) more AEs. Among AEs, 21 were due to cardiotoxicity (7.1%), mostly QT prolongation, while 6 were due to neurotoxicity (2.0%), mostly dizziness. Using QTcF correction, QT prolongation was observed in 17/143 participants (11.9%), only 2 of them reporting QTcF > 500 ms (milliseconds) but no clinical symptoms. Using QTcB correction increases of > 60 ms were present in 9 participants (6.3%). A trend towards increased prolongation was observed in those over 65 years of age but only a few subjects were in this group. No new safety signal was reported. The overall efficacy rate was 255/257 (99.2%). Conclusions: APQ appears as an effective and well-tolerated drug for treatment of malaria in patients recruited in European countries. AEs and QT prolongation were in the range of those obtained in larger cohorts from endemic countries. Trial registration This study has been registered in EU Post-Authorization Studies Register as EUPAS6942
SCOPUS: ar.j
info:eu-repo/semantics/published
Titel: |
Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries
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Autor/in / Beteiligte Person: | Bacchieri, Antonella ; Tommasini, Silva ; Calleri, Guido ; Duparc, Stephan ; Nothdurft, Hans-Dieter ; Ramos, José ; Rojo-Marcos, Gerardo ; Salas-Coronas, Joaquín ; Bouchaud, Olivier ; Emilio Merlo Pich ; Bottieau, Emmanuel ; Mechain, Matthieu ; Hatz, Christoph ; Iannucelli, Maurizio ; Vignier, Nicolas ; Bardají, Azucena ; Rapp, Christophe ; Visser, Leo G. ; Bourhis, Yann ; Angheben, Andrea ; Bisoffi, Zeno ; Martin, Charlotte ; Giovan Giuseppe Mattera ; Velasco, María ; Ron H Behrens ; Jelinek, Tomas ; Laboratoire Educations et Pratiques de Santé (LEPS) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Sorbonne Paris Nord ; Centre d'investigation clinique Antilles-Guyane (CIC - Antilles Guyane) ; Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pointe-à-Pitre/Abymes [Guadeloupe] -CHU de la Martinique [Fort de France]-Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française] ; Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP) ; Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM) ; Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) ; Institute of Tropical Medicine [Antwerp] (ITM) ; Saint-Pierre, CHU ; Universidad de Alicante ; Saint-André, Hôpital ; Hôpital d'Instruction des Armées Begin ; Service de Santé des Armées ; Ludwig-Maximilians-Universität München (LMU) ; Universitat de Barcelona (UB) ; Centro de Investigação em Saúde de Manhiça [Maputo, Mozambique] (CISM) ; CIBER de Epidemiología y Salud Pública (CIBERESP) ; Leiden University Medical Center (LUMC) ; Swiss Tropical and Public Health Institute [Basel] ; University of Basel (Unibas) ; London School of Hygiene and Tropical Medicine (LSHTM) |
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Zeitschrift: | Malaria Journal, Jg. 20 (2021), Heft 1, S. 1-14 |
Veröffentlichung: | BMC, 2021 |
Medientyp: | unknown |
ISSN: | 1475-2875 (print) |
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