Signal detection of drugs associated with obstructive and central sleep apnoea.

Autor: Jambon-Barbara C; Grenoble Alpes University Hospital, Pharmacovigilance Unit, F-38000, Grenoble, France; Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, F-38000, Grenoble, France., Revol B; Grenoble Alpes University Hospital, Pharmacovigilance Unit, F-38000, Grenoble, France; Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, F-38000, Grenoble, France., Hlavaty A; Grenoble Alpes University Hospital, Pharmacovigilance Unit, F-38000, Grenoble, France; Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, F-38000, Grenoble, France., Joyeux-Faure M; Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, F-38000, Grenoble, France., Borel JC; Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, F-38000, Grenoble, France., Cracowski JL; Grenoble Alpes University Hospital, Pharmacovigilance Unit, F-38000, Grenoble, France; Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, F-38000, Grenoble, France., Pepin JL; Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, F-38000, Grenoble, France; Grenoble Alpes University Hospital, EFCR Laboratory, Grenoble, France., Khouri C; Grenoble Alpes University Hospital, Pharmacovigilance Unit, F-38000, Grenoble, France; Univ. Grenoble Alpes, HP2 Laboratory, Inserm U1300, F-38000, Grenoble, France; Grenoble Alpes University Hospital, Clinical Pharmacology Department INSERM CIC1406, F-38000, Grenoble, France. Electronic address: ckhouri@chu-grenoble.fr.
Jazyk: angličtina
Zdroj: Sleep medicine [Sleep Med] 2024 Oct 02; Vol. 124, pp. 315-322. Date of Electronic Publication: 2024 Oct 02.
DOI: 10.1016/j.sleep.2024.09.045
Abstrakt: We aim to discover new safety signals of drug-induced sleep apnoea (SA), a global health problem affecting approximately 1 billion people worldwide. We first conducted a series of sequence symmetry analyses (SSA) in a cohort composed from all patients who received a first SA diagnosis or treatment between 2006 and 2018 in the Echantillon Généraliste des Bénéficaires (EGB), a random sample of the French healthcare database. We used two primary outcomes to estimate the sequence ratio (SR) for all drug classes available in France: a sensitive one (diagnosis or treatment of SA) and a specific one (Positive Airway Pressure (PAP) therapy). We then performed disproportionality analyses using the "Bayesian neural network method" on all cases of sleep apnoea (MedDRA high level term) reported up to November 2023 in the World Health Organisation (WHO) pharmacovigilance database. Among the 728,167 individuals, 46,193 had an incident diagnosis or treatment for SA and 17,080 had started an incident treatment by PAP therapy. Fifty-eight drug classes had a significant SR, with 7 considered highly plausible: opium alkaloids and derivatives, benzodiazepine derivatives, other centrally acting agents, other anxiolytics, carbamic acid esters, quinine and derivatives and antivertigo preparations; with consistent signals found for the first 3 drug classes in the disproportionality analysis. In this signal detection study, we found that opioids, benzodiazepines (but not Z-drugs) and myorelaxing agents are associated with the onset or aggravation of SA. Moreover, a new safety signal for antivertigo preparations such as betahistine emerged and needs to be further explored.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Jean-Christian Borel reports a relationship with Agiradom that includes: employment. Jean-Louis Pepin reports a relationship with Air Liquide Foundation that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with Agiradom that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with AstraZeneca Pharmaceuticals LP that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with Fisher & Paykel Healthcare Inc that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with Mutualia that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with Philips that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with ResMed that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with VitalAire France that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with Boehringer Ingelheim Ltd that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with Jazz Pharmaceuticals that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with Night Balance that includes: consulting or advisory and funding grants. Jean-Louis Pepin reports a relationship with Sefam that includes: consulting or advisory and funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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