Therapie最新文献

{"title":"Adverse drug reactions on male fertility","authors":"Isabelle Lacroix","doi":"10.1016/j.therap.2023.10.009","DOIUrl":"10.1016/j.therap.2023.10.009","url":null,"abstract":"<div><p><span><span>For several years, fertility disorders have been on the increase worldwide. These disorders affect both sexes, but are more pronounced in men; and in half of cases the etiology is unknown. The role of drugs in </span>male infertility has been little studied to date. Most of the available data comes from experimental animal studies, with all their limitations. With the exception of a few drugs, such as certain </span>anticancer agents<span>, human data are rare. This article describes the mainly drugs known to have deleterious effects on male fertility, the mechanisms leading to these effects and methods used to assess the risk of drug-induced male infertility. It underlines the need for further work in experimental research, clinical trials<span> and post-marketing surveillance to improve our knowledge of drugs that induce male infertility. Although these adverse effects are not life-threatening, they can have a significant impact on patients’ lives.</span></span></p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 2","pages":"Pages 199-203"},"PeriodicalIF":2.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136128640","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":"Drug-induced glomerular diseases","authors":"Anne-Sophie Garnier ,&nbsp;Hélène Laubacher ,&nbsp;Marie Briet","doi":"10.1016/j.therap.2023.10.010","DOIUrl":"10.1016/j.therap.2023.10.010","url":null,"abstract":"<div><p><span><span><span><span>Drug-induced kidney diseases represent a wide range of diseases that are responsible for a significant proportion of all acute kidney injuries and </span>chronic kidney diseases. In the present review, we focused on drug-induced </span>glomerular diseases<span>, more precisely podocytopathies – minimal change diseases (MCD), focal segmental glomerulosclerosis (FSGS) – and membranous nephropathies (MN), from a physiological and a pharmacological point of view. The glomerular filtration barrier is composed of podocytes that form foot processes tightly connected and directly in contact with the basal membrane and surrounding capillaries. The common </span></span>clinical feature of these diseases is represented by the loss of the ability of the filtration barrier to retain large proteins, leading to massive </span>proteinuria<span><span><span><span> and nephrotic syndrome. Drugs such as non-steroidal anti-inflammatory drugs (NSAIDs), D-penicillamine, </span>tiopronin<span><span>, trace elements, </span>bisphosphonate, and </span></span>interferons<span> have been historically associated with the occurrence of MCD, FSGS, and MN. In the last ten years, the development of new anti-cancer agents, including tyrosine kinase inhibitors<span> and immune checkpoint inhibitors, and research into their renal </span></span></span>adverse effects highlighted these issues and have improved our comprehension of these diseases.</span></p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 2","pages":"Pages 271-281"},"PeriodicalIF":2.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136129910","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":"Drug-induced hearing loss: Listening to the latest advances","authors":"Pierre Reynard ,&nbsp;Hung Thai-Van","doi":"10.1016/j.therap.2023.10.011","DOIUrl":"10.1016/j.therap.2023.10.011","url":null,"abstract":"<div><p>Sensorineural hearing loss (SNHL) is the most common type of hearing loss. Causes include degenerative changes in the sensory hair cells, their synapses and/or the cochlear nerve. As human inner ear hair cells have no capacity for regeneration, their destruction is irreversible and leads to permanent hearing loss. SNHL can be genetically inherited or acquired through ageing, exposure to noise or ototoxic drugs. Ototoxicity generally refers to damage to the structures and functions of the inner ear following exposure to specific drugs. Ototoxicity can be multifactorial, causing damage to cochlear hair cells or cells with homeostatic functions that modulate cochlear hair cell function. Clinical strategies to limit ototoxicity include identifying patients at risk, monitoring drug concentrations, performing serial hearing assessments and switching to less ototoxic therapy. This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, using the PubMed® database. The search terms “ototoxicity”, “hearing loss” and “drugs” were combined. We included studies published between September 2013 and June 2023, and focused on medicines and drugs used in hospitals. The review highlighted a number of articles reporting the main drug classes potentially involved: namely, immunosuppressants, antimalarials, vaccines, antibiotics, antineoplastic agents, diuretics, nonsteroidal anti-inflammatory drugs and analgesics. The presumed ototoxic mechanisms were described, together with the therapeutic and preventive options developed over the last ten years.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 2","pages":"Pages 283-295"},"PeriodicalIF":2.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0040595723001774/pdfft?md5=3192a869af6c91387ec3009ee96b168a&pid=1-s2.0-S0040595723001774-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92156837","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}

{"title":"Cutaneous adverse drug reactions","authors":"Thomas Bettuzzi ,&nbsp;Paola Sanchez-Pena ,&nbsp;Bénédicte Lebrun-Vignes","doi":"10.1016/j.therap.2023.09.011","DOIUrl":"10.1016/j.therap.2023.09.011","url":null,"abstract":"<div><p><span>Cutaneous adverse drug reactions (ADRs) represent a heterogeneous field including various clinical patterns without specific features suggesting drug causality. </span>Maculopapular exanthema<span><span> and urticaria are the most common types of cutaneous ADR. Serious cutaneous ADRs, which may cause permanent sequelae or have fatal outcome, may represent 2% of all cutaneous ADR and must be quickly identified to guide their management. These serious reactions include bullous manifestations (epidermal necrolysis i.e. Stevens-Johnson syndrome and toxic epidermal necrolysis), drug reaction with </span>eosinophilia<span><span><span><span><span> and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Some risk factors for developing cutaneous ADRs have been identified, including immunosuppression, autoimmunity or genetic variants. All drugs can cause cutaneous ADRs, the most commonly implicated being antibiotics (especially </span>aminopenicillins<span> and sulfonamides), anticonvulsants, </span></span>allopurinol, </span>antineoplastic drugs, non-steroidal anti-inflammatory drugs and </span>iodinated contrast media<span>. Pathophysiology<span> is related to immediate or delayed “idiosyncratic” immunologic mechanisms, i.e., usually not related to dose, and pharmacologic/toxic mechanisms, commonly dose-dependent and/or time-dependent. If an immuno-allergic mechanism is suspected, allergological explorations (including epicutaneous patch testing and/or intradermal test) are often possible to clarify drug causality, however these have a variable sensitivity according to the drug and to the ADR type. No in vivo or in vitro test can consistently confirm the drug causality. To determine the origin of a rash, a logical approach based on clinical characteristics, chronologic factors and elimination of differential diagnosis (especially infectious etiologies) is required, completed with a literature search. Reporting to pharmacovigilance system is therefore essential both to analyze drug causality at individual level, and to contribute to knowledge of the drug at population level, especially for serious cutaneous ADRs or in cases involving newly marketed drugs.</span></span></span></span></p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 2","pages":"Pages 239-270"},"PeriodicalIF":2.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136129166","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":"Drug-induced tumoral disease: A global pharmacovigilance database analysis","authors":"Yoann Zelmat,&nbsp;Fabien Despas","doi":"10.1016/j.therap.2023.11.003","DOIUrl":"10.1016/j.therap.2023.11.003","url":null,"abstract":"<div><h3>Introduction</h3><p>Cancer remains a worldwide threat, having caused almost 10 million deaths in 2020. The American Cancer Society has identified both known and probable carcinogens, including commonly used drugs. The aim of this study is to describe the drugs most frequently reported in the occurrence of cancer.</p></div><div><h3>Methods</h3><p><span>Among all individual case safety reports (ICSRs) in the global pharmacovigilance database VigiBase, we searched for the 50 most reported drugs with an </span>adverse drug reaction term belonging to the query “Malignant or unspecified tumors” until June 30, 2023. Then, we extracted the disproportionality measurement data, information component (IC), and reporting odds ratio (ROR) in order to assess a disproportionality signal.</p></div><div><h3>Results</h3><p><span><span>Among all ICSRs in VigiBase, 871,925 contained an ADR belonging to the SMQ “Malignant or unspecified tumors”. </span>Ranitidine was the drug with the most reported ADRs related to cancer (</span><em>n</em> <!-->=<!--> <span>106,484), followed by lenalidomide (</span><em>n</em> <!-->=<!--> <span>13,466), and etanercept (</span><em>n</em> <!-->=<!--> <!-->8014). The drugs with the highest IC were ranitidine (IC<!--> <!-->=<!--> <!-->5.2, 95% confidence interval [95% CI]<!--> <!-->=<!--> <span>5.2–5.2), pioglitazone (1353 ICSRs, IC</span> <!-->=<!--> <!-->4.2, 95% CI<!--> <!-->=<!--> <span>4.2–4.2), and regorafenib (1272 ICSRs, IC</span> <!-->=<!--> <!-->2.8, 95% CI<!--> <!-->=<!--> <!-->2.8–2.8).</p></div><div><h3>Discussion</h3><p><span>Our results show that the main pharmacological mechanisms are associated with ranitidine (link with levels of N-nitrosodimethylamine in ranitidine-based drugs), gene-activating drugs (pioglitazone: link with agonist effects on PPAR-γ gene activation), various pharmacological families with immunosuppressive<span><span> effects (protein kinase inhibitors, immunomodulators<span>, azathioprine, etc.), certain types of </span></span>protein kinase inhibitors<span> whose oncogenic mechanisms remain unclear (regorafenib, sorafenib, </span></span></span>imatinib<span>, ibrutinib<span>, etc.), and hormone antagonists (tamoxifen, letrozole). Special monitoring of patients exposed to these drugs may be required. Further studies are needed to assess the risk with certain drugs in this ranking.</span></span></p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 2","pages":"Pages 189-197"},"PeriodicalIF":2.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138478624","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":"Drug-induced cardiac toxicity and adverse drug reactions, a narrative review","authors":"Alexandre Destere ,&nbsp;Diane Merino ,&nbsp;Thibaud Lavrut ,&nbsp;Fanny Rocher ,&nbsp;Delphine Viard ,&nbsp;Milou-Daniel Drici ,&nbsp;Alexandre O. Gérard","doi":"10.1016/j.therap.2023.10.008","DOIUrl":"10.1016/j.therap.2023.10.008","url":null,"abstract":"<div><p><span><span><span>Drug-induced cardiotoxicity is a primary concern in both drug development and clinical practice. Although the heart is not a common target for </span>adverse drug reactions<span><span>, some drugs still cause various adverse cardiac events, with sometimes severe consequences. Direct cardiac toxicity encompasses functional and structural changes of the cardiovascular system due to possible exposure to medicines. This phenomenon extends beyond cardiovascular drugs to include non-cardiovascular drugs including </span>anticancer drugs<span><span> such as tyrosine kinase inhibitors<span><span>, anthracyclines and </span>immune checkpoint inhibitors<span> (ICIs), as well as various antipsychotics, </span></span></span>venlafaxine, and even some antibiotics (such as macrolides). Cardiac ADRs comprise an array of effects, ranging from heart failure and </span></span></span>myocardial ischemia<span><span> to valvular disease, thrombosis, myocarditis<span>, pericarditis<span>, arrhythmias, and conduction abnormalities. The underlying mechanisms may include disturbances of ionic processes, induction of cellular damage via impaired mitochondrial function, and even </span></span></span>hypercoagulability. To mitigate the impact of drug-induced cardiotoxicity, multi-stage evaluation guidelines have been established, following the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for </span></span><em>in vitro</em> and <em>in vivo</em><span><span> testing. Despite preclinical safeguards, post-marketing surveillance remains critical, as certain cardiotoxic drugs may escape initial scrutiny. Indeed, historical data show that cardiovascular ADRs contribute to almost 10% of market withdrawals. The impact of drug-induced cardiotoxicity on cardiac issues, particularly heart failure, is often underestimated, with incidence rates ranging from 11.0% to over 20.0%. We here comprehensively examine different patterns of drug-induced cardiotoxicity, highlighting current concerns and emerging pharmacovigilance signals. Understanding the underlying mechanisms and the associated risk factors is critical in order to promptly identify, effectively manage, and proactively prevent drug-induced cardiac </span>adverse events. Collaborative efforts between physicians and cardiologists, coupled with thorough assessment and close monitoring, are essential to ensuring patient safety in the face of potential drug-induced cardiotoxicity.</span></p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 2","pages":"Pages 161-172"},"PeriodicalIF":2.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92156836","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":"Drug-induced fetal and offspring disorders, beyond birth defects","authors":"Margaux Louchet ,&nbsp;Mylène Tisseyre ,&nbsp;Florentia Kaguelidou ,&nbsp;Jean-Marc Treluyer ,&nbsp;Laure-Hélène Préta ,&nbsp;Laurent Chouchana","doi":"10.1016/j.therap.2023.11.002","DOIUrl":"10.1016/j.therap.2023.11.002","url":null,"abstract":"<div><p><span>Studies on drug utilization in western countries disclosed that about nine over ten women use at least one or more drugs during pregnancy. Determining whether a drug is safe or not in pregnant women is a challenge of all times. As a developing organism, the fetus is particularly vulnerable to effects of drugs used by the mother. Historically, research has predominantly focused on birth defects, which represent the most studied adverse pregnancy outcomes. However, drugs can also alter the ongoing process of pregnancy and impede the general growth of the fetus. Finally, </span>adverse drug reactions can theoretically damage all developing systems, organs or tissues, such as the central nervous system or the immune system. This extensive review focuses on different aspects of drug-induced damages affecting the fetus or the newborn/infant, beyond birth defects, which are not addressed here.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 2","pages":"Pages 205-219"},"PeriodicalIF":2.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135764353","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":"Patient's reporting of adverse drug reactions: Which added value in 2023?","authors":"Haleh Bagheri","doi":"10.1016/j.therap.2023.09.009","DOIUrl":"10.1016/j.therap.2023.09.009","url":null,"abstract":"<div><p><span>Several studies were focused on the qualitative and quantitative analysis of serious adverse drug reactions<span> (ADRs) leading to hospitalisation or death. These figures do not take into account ADRs in ambulatory patients affecting their quality of life. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with health care professional (HCP) reporting. A certain amount of information is crucial in order to determine the drug-reaction relationship. European regulation and patient support programs have contributed widely to increased patient reporting but the quality of ADR reports is still unequal from one country to another. Patient reports of ADRs have contributed enormously to pharmacovigilance signal detection in a number of ways. Over the last decades, countries have developed dedicated websites for direct patient reporting. The increasing involvement of patients in ADR reporting activities facilitated by a web portal was confirmed by some studies. Patients are now recognised as having a legitimate part to play in the decision-making process. The contribution of patient reports to drug safety was acknowledged and consolidated by European Union (EU) PV legislation in 2012 aiming to involve patients more actively, nowadays called “patient centricity in pharmacovigilance”. Patient organisations are involved in regulatory issues and collaborate with health institutions on the development of guidelines. However, some studies suggested that a substantial number of patient organisations have potential financial conflicts of interest but limited disclosure practices. Pharmaceutical companies integrate into patient associations, particularly for </span></span>chronic diseases by different strategies: educational therapeutic or observance support programs. The question of conflict of interest of patient associations is important requiring better transparency.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 2","pages":"Pages 155-159"},"PeriodicalIF":2.6,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136129416","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":"Comité de surveillance indépendant dans les essais cliniques : de la justification scientifique à l’organisation","authors":"Clara Locher ,&nbsp;Silvy Laporte ,&nbsp;Peggy Derambure ,&nbsp;Olivier Chassany ,&nbsp;Cécile Girault ,&nbsp;Alix Avakiantz ,&nbsp;Claire Bahans ,&nbsp;Dominique Deplanque ,&nbsp;Pierre Fustier ,&nbsp;Anne-Françoise Germe ,&nbsp;Behrouz Kassaï ,&nbsp;Louis Lacoste ,&nbsp;Nadine Petitpain ,&nbsp;Matthieu Roustit ,&nbsp;Tabassome Simon ,&nbsp;Cécile Train ,&nbsp;Michel Cucherat","doi":"10.1016/j.therap.2023.10.013","DOIUrl":"10.1016/j.therap.2023.10.013","url":null,"abstract":"<div><p>Les essais cliniques durent souvent plusieurs mois voire plusieurs années. Au fur et à mesure de l’avancée de l’essai, il peut être tentant de s’assurer que les données accumulées ne permettent pas déjà de répondre à la question posée par l’essai et ainsi arrêter précocement les inclusions ou le suivi. Mais de façon contre-productive, la connaissance et la prise en compte de résultats intermédiaires peuvent, dans certaines conditions, compromettre l’intégrité des résultats. C’est pour limiter ce risque – et assurer ainsi une fiable évaluation des thérapeutiques – que cette surveillance de critères de sécurité et|ou d’efficacité en cours d’étude est confiée à un comité de surveillance indépendant. À partir des résultats qui leur sont transmis de façon confidentielle, le comité de surveillance indépendant évalue la balance bénéfice-risque du traitement à l’étude et établit une recommandation quant à la poursuite, la modification ou l’arrêt de l’étude. Au travers de ces recommandations, les membres des comités de surveillance indépendants ont une responsabilité importante : une décision d’arrêt trop hâtive peut rendre l’essai non concluant et infructueux pour répondre à la question initiale et au contraire, une décision d’arrêt trop tardive peut exposer les participants à des interventions potentiellement inefficaces voire nocives. La mission confiée aux membres des comités de surveillance indépendants est donc particulièrement complexe. Dans ce contexte, la table ronde des ateliers de Giens a été l’occasion de revenir sur la justification scientifique vis-à-vis de l’organisation des comités de surveillance indépendants et de rappeler la nécessite pour les membres des comités de surveillance indépendants d’être parfaitement formés aux problématiques inerrantes aux analyses multiples, à l’obligation de confidentialité vis-à-vis des résultats et au fait que les recommandations d’arrêt doivent reposer sur des données suffisamment convaincantes pour évaluer la balance bénéfice-risque du traitement étudié.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 1","pages":"Pages 99-110"},"PeriodicalIF":2.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135411084","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":"Evaluation of digital medical devices: How to take into account the specificities of these solutions?","authors":"Anouk Trancart ,&nbsp;Valery-Pierre Riche ,&nbsp;Antoine Disset ,&nbsp;Dorothée Camus ,&nbsp;Anne Josseran ,&nbsp;Pascal Bécache ,&nbsp;Cécile Charle-Maachi ,&nbsp;Laure De Place ,&nbsp;Arthur Denninger ,&nbsp;Jérôme Fabiano ,&nbsp;Charlotte Gourio ,&nbsp;Vincent Vercamer","doi":"10.1016/j.therap.2024.01.001","DOIUrl":"10.1016/j.therap.2024.01.001","url":null,"abstract":"<div><p>The beginning of the 21st century has seen an increasing number of digital medical devices (DMDs) arrive on the European market, bringing major benefits and changes for society. DMDs are unique in that they bring intelligence to the organisation of care, and generate and collect a wealth of real-life data with ultra-fast life cycles. They have specific requirements, particularly in terms of data security and interoperability. In France and Europe, the construction of evidence, the assessment process and evaluation methodologies with a view to purchase or reimbursement must adjust to these changes, given the specific features of these technologies. This digital leap has opened up new perspectives for healthcare, along with economic, ethical and regulatory issues. The challenge is to assess the clinical and organisational impact, reliability, safety, interoperability, efficiency and budgetary impact of DMDs in line with the requirements of new standards, guidelines and regulations. This should result in a coherent, pragmatic and proportionate evaluation, so that public decision-makers and buyers can take advantage of the potential opportunities that these digital devices offer to improve healthcare delivery. Thus, a fair and informed evaluation of DMDs would emerge, providing a solid basis to steer their inclusion into contemporary medical practices. This fundamental issue of evaluation, linked to the digital nature of these MDs, is what the round table, comprising experts from academia and/or hospitals, institutions and industry, sought to resolve. Discussions led to proposals on how DMDs should be evaluated, bearing in mind their complexity. The round table set out to identify the bottlenecks in the entire evaluation process, from the CE marking phase, compliance with French safety and interoperability requirements, through to national or local evaluation, in order to inform a purchasing policy and draw up proposals covering the entire spectrum. Ten concrete recommendations were put forward by the round table, aimed at improving the evaluation process by making it clearer and more adaptable, thus offering greater flexibility in the evaluation and decision-making stages. This well-thought-out approach is designed to facilitate a comprehensive and flexible evaluation of DMDs given the constantly evolving technological context.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 1","pages":"Pages 137-150"},"PeriodicalIF":2.6,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139538897","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}