Psychopharmacology (Berl)

RATIONALE: While meta-analyses of clinical trials found that lurasidone and partial dopamine agonists (brexpiprazole and aripiprazole) were the antipsychotics less likely to cause QTc prolongation, and sertindole, amisulpride, and ziprasidone were the most frequently associated with this adverse drug reaction; no real-world studies have investigated this risk between the different antipsychotics. OBJECTIVES AND METHODS: Using data recorded from 1967 to 2019 in VigiBase®, the World Health Organization's Global Individual Case Safety Reports database, we performed disproportionality analysis to investigate the risk of reporting QT prolongation between 20 antipsychotics. RESULTS: Sertindole had the highest risk of reporting QT prolongation, followed by ziprasidone and amisulpride. Lurasidone was associated with the lowest risk. First-generation antipsychotics were associated with a greater QT prolongation reporting risk (ROR, 1.21; 95%CI, 1.10-1.33) than second-generation antipsychotics. A positive correlation was found between the risk of reporting QT prolongation and affinity for hERG channel (R(2) = 0.14, slope = Pearson coefficient = 0.41, p value = 0.1945). CONCLUSIONS: This large study in a real-world setting suggests that sertindole and ziprasidone were the antipsychotics drugs associated with the highest risk of QT prolongation reporting. Our results suggest that lurasidone is less associated with QT interval prolongation reports. Our study also suggests that antipsychotics with the higher hERG affinity are more associated with to QT prolongations reports

Myocarditis and Pericarditis in Adolescents after First and Second doses of mRNA COVID-19 Vaccines

International audienceNo abstract availabl

Atypical thrombosis associated with VaxZevria (R) (AstraZeneca) vaccine: Data from the French Network of Regional Pharmacovigilance Centres

International audienceNo abstract availabl

Conflicts of Interests in the Area of Healthcare Products and Technology. Current State of Affairs and Recommendations

International audienceThe handling of conflicts of interest in the area of healthcare products and technology has become a major issue for all of those involved in healthcare. Round Table N°4 at the Giens Workshops 2011 has put forward concrete proposals to clarify and optimise the handling of conflicts of interest.Conflicts of interest cannot be defined by the individuals consulted or applying for funds since each institution, whether public or private, that puts out a call for projects or that requests advice, analyses or expert testimony in the healthcare field has different degrees of what it defines as a conflict of interest, depending on the context of the proposal or specific request that it puts out. In contrast, each individual has ties of personal interest that can and must be openly disclosed. The ties are much more diverse than what is commonly found in the conflict of interest statements of large institutions operating in the healthcare field and are not limited to financial and operational ties between companies and individuals. In addition, the statements are difficult to manage because of their sheer number.The Round Table recommends that each individual should openly disclose all of his or her ties of personal interest in a Single Statement of Ties of personal Interest (SSTI). The SSTI would be updated regularly and accessible on line. Each institution could then determine whether or not the reported ties represent a conflict in the context of the mission proposed. Each institution could publish in advance the conditions that would give rise to a conflict and, in this way, an individual could refrain from applying for the mission.Other practical approaches to handling conflicts of interest were put forward

Les conflits d’intérêts dans le domaine des produits et de technologies de santé : état des lieux et recommandations

International audienceLa gestion des conflits d’intérêts dans le domaine des produits et des technologies de santé est devenue un enjeu majeur pour tous les acteurs de santé. La table ronde N°4 de Giens 2011 a fait des propositions concrètes pour clarifier et optimiser cette gestion des conflits d’intérêts.Les conflits d’intérêt ne peuvent pas être définis par les personnes consultées ou demandeuses de fonds puisque chaque institution, privée ou publique, émettant des appels à projets, ou demandeuse d’avis, d’analyses ou d’expertises en matière de santé a des niveaux variables de sa définition de ce qu’est un conflit dans le contexte particulier de la proposition ou demande particulière qu’elle émet. En revanche, chaque individu a des liens d’intérêt qui peuvent et doivent être explicitement déclarés.Ces liens sont bien plus diversifiés que ce qu’il est commun de trouver dans les déclarations d’intérêt des grands organismes liés à la santé et ne se limitent pas aux liens matériels et financiers entre entreprises et individus. Ces déclarations sont par ailleurs lourdes à gérer du fait de leur multiplication.La recommandation de la table ronde est que chaque individu liste de manière explicite dans une déclaration unique des liens d’intérêt (DULI), l’ensemble de ses liens d’intérêts. Cette déclaration serait mise à jour en continu et accessible en ligne.Chaque institution pourrait ainsi déterminer si les liens déclarés constituent, ou non, un conflit pour la mission demandée.Les conditions génératrices de conflit seraient affichées a priori par chaque institution de telle sorte qu’un individu consulté puisse se récuser pour la mission proposée.D’autres mécanismes opérationnels de gestion des conflits ont été proposés