TherapiePub Date : 2024-05-28DOI: 10.1016/j.therap.2024.05.004
Jean-Joseph Bendjilali-Sabiani, Céline Eiden, Margot Lestienne, Sabrina Cherki, David Gautre, Thomas Van den Broek, Olivier Mathieu, Hélène Peyrière
{"title":"Isotonitazene, a synthetic opioid from an emerging family: The nitazenes.","authors":"Jean-Joseph Bendjilali-Sabiani, Céline Eiden, Margot Lestienne, Sabrina Cherki, David Gautre, Thomas Van den Broek, Olivier Mathieu, Hélène Peyrière","doi":"10.1016/j.therap.2024.05.004","DOIUrl":"https://doi.org/10.1016/j.therap.2024.05.004","url":null,"abstract":"<p><p>From 2019, in the United States and Europe, the synthetic opioid market has diversified with the appearance of the 2-benzylbenzimidazole family, commonly named \"nitazenes\". In vitro studies show that these synthetic opioids have much higher affinities on μ-opioid receptors: 100 times more than morphine, and slightly higher than fentanyl for isotonitazene, increasing the risk of overdose. In south of France, isotonitazene (IZN) was identified for the first time in March 2023. In this context, there were 9 reports concerning the use of IZN in the south of France over a short period (March-April 2023), with identification of IZN in 4 cases and suspicion in others. They concerned 6 men and 3 women, with a mean age of 44.9±2 years. When available (2 cases), the product had been purchased from a dealer. IZN was identified on sample in 2 cases of overdose. Isotonitazene was also identified in biological samples in 2 cases: 1 case of overdose and coma requiring hospitalization with a favorable outcome (urinary analysis), and a death with post-mortem identification. This was the first identification of this product in France. The immediate broadcast of the alert limited the risks for users and made it possible to quickly inform regional and national health authorities. IZN is under intensive surveillance by the EMCDDA and classified as a narcotic in France since 2021. The analysis of the literature made it possible to identify cases of overdoses requiring very high doses of naloxone and deaths. The emergence of these synthetic opioids constitutes an important signal, due to their superior effects to heroin, their incomplete response to naloxone and the current difficulty in identifying them (devices for analyzing products in the reduction of risks, toxicology laboratories).</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141284813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2024-05-01DOI: 10.1016/j.therap.2023.07.002
Simon Verdez , Marc Bardou , Yannis Duffourd , Maxime Luu , Christel Thauvin-Robinet , Laurence Faivre , Nicolas Picard
{"title":"Experience and expectations of pharmacogenetic tests in France","authors":"Simon Verdez , Marc Bardou , Yannis Duffourd , Maxime Luu , Christel Thauvin-Robinet , Laurence Faivre , Nicolas Picard","doi":"10.1016/j.therap.2023.07.002","DOIUrl":"10.1016/j.therap.2023.07.002","url":null,"abstract":"<div><p>Although French genomic medicine is reaching a turning point in its history and the implementation of genome sequencing in routine is being implemented as part of the France Genomic Medicine 2025 Plan (FGMP), many questions about secondary data management remain to be addressed. In particular, the use of pharmacogenetic<span> (PGx) information that can be extracted from genome data is a concern. We sought to analyze the opinion of French health professionals on their desire to have access to this information. For this purpose, we created a 22-item questionnaire on the experiences, attitudes, expectations, and knowledge of French physicians and pharmacists about PGx. We collected the responses in different groups and determined a knowledge score with the last 3 questions of the questionnaire. Then, we built a prediction model for this score and determined which factors may influence it. Half of the responders were physicians (158/311) and the other half were pharmacists (153/311), and the majority of them worked in a hospital (265/311). Almost two third (62.7%, 195/311) of the responders thought that pharmacogenetic data should be communicated with genomic results for the primary indication within the framework of FGMP, and 89.1% (277/311) of them that PGx tests could be an interesting tool to optimize patients’ drug therapy in the future. Only 11.2% (35/311) of the responders reached the maximum knowledge score, while 25.4% (76/311) had already prescribed or recommended a PGx test. This study identified a need for training for French physicians and pharmacists in PGx, particularly given the interest of health professionals in it.</span></p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 3","pages":"Pages 341-349"},"PeriodicalIF":2.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9891999","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2024-05-01DOI: 10.1016/j.therap.2023.03.007
Yasmine Salem Mahjoubi , Imen Aouinti , Ons Charfi , Ahmed Zaiem , Widd Kaabi , Ghozlane Lakhoua , Riadh Daghfous , Sihem El Aidli
{"title":"Neurotoxicity following atezolizumab in a patient with tolerated rechallenge","authors":"Yasmine Salem Mahjoubi , Imen Aouinti , Ons Charfi , Ahmed Zaiem , Widd Kaabi , Ghozlane Lakhoua , Riadh Daghfous , Sihem El Aidli","doi":"10.1016/j.therap.2023.03.007","DOIUrl":"10.1016/j.therap.2023.03.007","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 3","pages":"Pages 393-396"},"PeriodicalIF":2.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41149417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Statins and immune-mediated necrotizing myopathy: Variability in the risk","authors":"Thierry Trenque , Jed Hadjoudj , Agathe Trenque , Federica Tralongo , Salomé Martin , Brahim Azzouz","doi":"10.1016/j.therap.2023.07.005","DOIUrl":"10.1016/j.therap.2023.07.005","url":null,"abstract":"<div><h3>Introduction</h3><p>Immune-mediated necrotizing myopathy<span> (IMNM) is a form of statin<span> myopathy characterized by the presence of antibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase (anti HMGCR).</span></span></p></div><div><h3>Objectives</h3><p>The aim of this study was to investigate the relationship between the different statins and the risk of IMNM.</p></div><div><h3>Methods</h3><p>A two-time approach was used. First, we performed a descriptive analysis of the French national pharmacovigilance database (FNPV) for the period from 1985 to december2020. To identify relevant cases, we used Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) related to IMNM. We performed a quantitative and qualitative review of individual case safety reports (ICSRs) recorded in the french vigilance spontaneous reporting system. In a second time, we performed a comparative analysis with the World Health Organization global individual case safety reports database (Vigibase). The association between IMNM and statins exposure was assessed by calculating the reporting odds ratio (ROR) and its 95% confidence interval.</p></div><div><h3>Results</h3><p><span>After analysis, a total of 25 ICSRs were related to IMNM in the FNPV. The suspected statins were atorvastatin (</span><em>n</em> <!-->=<!--> <span>21), simvastatin (</span><em>n</em> <!-->=<!--> <span>2), pravastatin (</span><em>n</em> <!-->=<!--> <span>1) and rosuvastatin (</span><em>n</em> <!-->=<!--> <span>1). In Vigibase, 567 notifications were identified. A significant ROR value was found for atorvastatin, pitavastatin, simvastatin, pravastatin and rosuvastatin.</span></p></div><div><h3>Conclusion</h3><p>Atorvastatin presents the highest risk of IMNM. Our data suggest that the occurrence of IMNM is a class effect.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 3","pages":"Pages 365-370"},"PeriodicalIF":2.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10448768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Les dispositifs de soutien à l’innovation et la structuration de l’évaluation médico-économique en France","authors":"Fanny Monmousseau , Claire Cavalin , Valéry-Pierre Riche","doi":"10.1016/j.therap.2023.09.003","DOIUrl":"10.1016/j.therap.2023.09.003","url":null,"abstract":"<div><p>La diffusion et le remboursement de stratégies ou produits de santé relèvent de la décision des pouvoirs publics et des autorités sanitaires. Dans un contexte de ressources collectives limitées et de contrainte budgétaire forte, la prise de décision quant aux produits de santé innovants et coûteux intègre non seulement des données d’efficacité, de sécurité mais aussi d’efficience. En France, plusieurs dispositifs existent et permettent la production de données médico-économiques éclairant sur l’efficience. Ils sont une opportunité de développement, de structuration et de financement de l’évaluation médico-économique. Toutefois, la multiplicité des sources de financement et les spécificités de chacune compliquent leur lisibilité. L’objectif de cet article est d’en dresser un panorama, tout en soulignant les avantages et les limites de certains d’entre eux. Il en ressort une nécessaire fluidification des interactions entre les industriels, les pouvoirs publics et les structures d’évaluation médico-économique des établissements de santé. L’enjeu est de pouvoir faire appel au dispositif le plus adapté pour produire les données pertinentes au moment le plus opportun.</p></div><div><p>Diffusion and reimbursement of healthcare strategies, drugs or medical devices are based on decisions made by public authorities and health authorities. In a situation of restricted resources and strict budget restrictions, decisions on innovative and costly health products must take into account not only efficacy and safety data, but also efficiency data. In France, generate health economics data to inform on efficiency can be obtain by different processes, resulting in an opportunity to develop, structure and finance health economic evaluation. However, the diversity of sources of funding and the specific requirements of each process make them difficult to understand. The aim of this article is to provide an overview of these sources, while highlighting their advantages and limitations. It also points the need to facilitate interaction between manufacturers, public authorities and the health economic evaluation organisations of health care institutions. The issue is to be able to mobilize the most appropriate system to produce relevant data at the most appropriate time.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 3","pages":"Pages 327-339"},"PeriodicalIF":2.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41213867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2024-05-01DOI: 10.1016/j.therap.2023.06.004
Elisabeth Frauger , Nathalie Fouilhé , Clémence Lacroix , Amélie Daveluy , Reynald Le Boisselier , Célian Bertin , Bruno Revol , Louise Carton , Cécile Chevalier , Céline Eiden , Valérie Gibaja , Aurélie Aquizerate , Leila Chaouachi , Emilie Bouquet , Anne Roussin , Michel Mallaret , Joëlle Micallef
{"title":"Augmentation des surdoses et décès en lien avec la consommation de méthadone durant la crise sanitaire liée au COVID-19 en 2020","authors":"Elisabeth Frauger , Nathalie Fouilhé , Clémence Lacroix , Amélie Daveluy , Reynald Le Boisselier , Célian Bertin , Bruno Revol , Louise Carton , Cécile Chevalier , Céline Eiden , Valérie Gibaja , Aurélie Aquizerate , Leila Chaouachi , Emilie Bouquet , Anne Roussin , Michel Mallaret , Joëlle Micallef","doi":"10.1016/j.therap.2023.06.004","DOIUrl":"10.1016/j.therap.2023.06.004","url":null,"abstract":"<div><h3>Introduction</h3><p>Une surveillance renforcée a été mise en place par le réseau français d’addictovigilance à la suite du premier confinement lié au <em>coronavirus disease 2019</em> (COVID-19), en raison du risque d’augmentation des surdoses, notamment avec la méthadone. Dans ce contexte, une étude a été mise en place pour décrire les surdoses liées à la méthadone en 2020 au regard de l’année 2019.</p></div><div><h3>Méthodes</h3><p>Les surdoses liées à la méthadone ont été analysées selon deux sources : le dispositif DRAMES (décès avec analyses toxicologiques) et la base nationale de pharmacovigilance (BNPV) pour les surdoses non fatales.</p></div><div><h3>Résultats</h3><p>D’après les données DRAMES, la méthadone est toujours la première substance impliquée dans les décès en 2020 avec une augmentation des décès : en nombre (<em>n</em> <!-->=<!--> <!-->230 en 2020 versus <em>n</em> <!-->=<!--> <!-->178 en 2019), en proportion (41 % versus 35 %) et en nombre de décès pour 1000 sujets exposés (3,4 versus 2,8). D’après la BNPV, le nombre de surdoses a augmenté en 2020 par rapport à 2019 (98 versus 79 ; soit multiplié par 1,2) en particulier durant certaines périodes cibles : premier confinement, déconfinement/période estivale et deuxième confinement. En 2020, le nombre le plus important de surdoses a été observé en avril (<em>n</em> <!-->=<!--> <!-->15) et mai (<em>n</em> <!-->=<!--> <!-->15). Les surdoses sont survenues chez des consommateurs de méthadone dans le cadre d’un protocole de soins ou en dehors (sujets naïfs/consommateurs occasionnels ayant obtenu la méthadone via le marché de rue ou l’entourage). Les surdoses résultent de différents facteurs : surconsommation, polyconsommation avec d’autres dépresseurs ou cocaïne, injection, consommation à des fins sédatives, récréatives ou intoxication médicamenteuse volontaire.</p></div><div><h3>Discussion/Conclusion</h3><p>L’ensemble de ces données montre une augmentation de la morbi-mortalité liée à la méthadone pendant l’épidémie de COVID-19 en 2020. Ce phénomène a été également constaté dans d’autres pays.</p></div><div><h3>Introduction</h3><p>Due to the risk of overdoses increase especially with methadone, a reinforced monitoring has been set up by the French Addictovigilance Network following the first lockdown related to coronavirus disease 2019 (COVID-19). In this context, we managed a specific study to analyze overdoses related to methadone in 2020 compared to 2019.</p></div><div><h3>Material and methods</h3><p>We analyzed methadone-related overdoses which occurred in 2019 and 2020 from two sources: DRAMES program (deaths with toxicological analysis) and the French pharmacovigilance database (BNPV) (overdoses that did not lead to death).</p></div><div><h3>Results</h3><p>Data from DRAMES program in 2020 show methadone as the first drug involved in deaths as well as an increase in deaths: in number (<em>n</em> <!-->=<!--> <!-->230 versus <em>n</em> <!-->=<!--> <!-->178), in proportion","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 3","pages":"Pages 297-306"},"PeriodicalIF":2.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10266982/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9735398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
TherapiePub Date : 2024-05-01DOI: 10.1016/j.therap.2023.07.006
Aurélie Lacroix , Victor Puybaret , Pierre Villéger , Juliette Zattoni-Leroy , Sylvain Cantaloube , Catherine Chevalier , Philippe Nubukpo
{"title":"Predictive factors for acceptance of a long-acting opiate substitution treatment studied through social representations and internalized stigma","authors":"Aurélie Lacroix , Victor Puybaret , Pierre Villéger , Juliette Zattoni-Leroy , Sylvain Cantaloube , Catherine Chevalier , Philippe Nubukpo","doi":"10.1016/j.therap.2023.07.006","DOIUrl":"10.1016/j.therap.2023.07.006","url":null,"abstract":"<div><h3>Objectives</h3><p>Opioid use disorder is a public health problem worldwide with a treatment gap partially due to sociocultural representation and stigma. Taking the opportunity of an authorization to a subcutaneous (SC) injectable solution of buprenorphine<span>, the first and only injectable treatment for opioid dependence available in France, we investigate potential obstacles to its implementation in France.</span></p></div><div><h3>Methods</h3><p>This study aimed to define the factors predicting the acceptance of a new SC form of opiate substitution treatment (OST) by comparing the social representations using an adapted version of the Explanatory Model Interview Catalogue (EMIC) and the internalized stigma of intravenous drug injection using the Internalized Stigma of Mental Illness Inventory (ISMI) between participants receiving OST likely to accept the SC form or not. We also observed whether the fear of an opiate withdrawal syndrome could influence this choice.</p></div><div><h3>Results</h3><p>Fifty OST patients were included, 54% of them accepted a new SC form of OST. Perceived causes of drug injection measured with EMIC were significantly lower among participants who would not accept the new SC form. No significant difference was found regarding the total score of the adapted ISMI or its items. The fear of opiate withdrawal syndrome did not seem to be statistically related to acceptance of a long-acting SC OST in either group. The most discriminating combination of factors in predicting patient acceptance of such treatment was related to the perceived causes of drug injection associated with a severe Diagnostic and Statistical Manual of Mental Disorders 5th version (DSM-5) diagnosis, and a lower alcohol consumption.</p></div><div><h3>Conclusions</h3><p>We observed significant differences in social representations but not in internalized stigma between the two groups. Moreover, the predictive factors linked to the acceptance of a new SC form of OST suggest a multifactorial combination of elements that will have to be tested in a larger and prospective study delivering long-acting high-dose buprenorphine.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 3","pages":"Pages 307-317"},"PeriodicalIF":2.6,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10073290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}