TherapiePub Date : 2023-11-01DOI: 10.1016/j.therap.2022.12.009
Blandine Bertin , Marine Auffret , Paul Chabert
{"title":"Positive rechallenge of hemophagocytic lymphohistiocytosis in a patient treated with isoniazide, pembrolizumab, carboplatine and pemetrexed","authors":"Blandine Bertin , Marine Auffret , Paul Chabert","doi":"10.1016/j.therap.2022.12.009","DOIUrl":"10.1016/j.therap.2022.12.009","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10560413","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 : 2023-11-01DOI: 10.1016/j.therap.2023.01.009
Sibylle de Germay , Cécile Conte , Joëlle Micallef , Emilie Bouquet , Laurent Chouchana , Margaux Lafaurie , Antoine Pariente , on behalf of the Pharmacoepidemiological group of the French Society of Pharmacology and Therapeutics (SFPT)
{"title":"Performing pharmacoepidemiological studies using the French health insurance data warehouse (SNDS): How to translate guidelines into practice","authors":"Sibylle de Germay , Cécile Conte , Joëlle Micallef , Emilie Bouquet , Laurent Chouchana , Margaux Lafaurie , Antoine Pariente , on behalf of the Pharmacoepidemiological group of the French Society of Pharmacology and Therapeutics (SFPT)","doi":"10.1016/j.therap.2023.01.009","DOIUrl":"10.1016/j.therap.2023.01.009","url":null,"abstract":"<div><p>The French health insurance data warehouse named SNDS is one of the largest medico-administrative in the world allowing for powerful pharmacoepidemiological studies, based on real-life data collected prospectively. In addition to the absolute necessity of a strong pharmacological rationale, recommendations have been thought to improve the quality of pharmacoepidemiological studies. These guidelines emphasize the importance of an accurate definition of the study population, outcome and exposure, especially for studies performed on medico-administrative databases. Compliance with certain guidelines, particularly those concerning the identification of a specific population or an outcome and the definition of risk periods or exposure periods, may be difficult when performing studies on the SNDS because of its structure and the nature of the data recorded. The objective of this article is to provide advice for the conduct of pharmacoepidemiological studies according to the recommendations when using the SNDS, given its specificities. The performing of reliable studies from this rich but complex data warehouse requires the expertise of researchers with deep knowledge both in the SNDS and in pharmacological reasoning.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10774485","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 : 2023-11-01DOI: 10.1016/j.therap.2023.03.008
Salim Mezaache , Franck Turlure , Nathalie Fredon , Maela Le Brun Gadelius , Joëlle Micallef , Elisabeth Frauger
{"title":"Prévention des surdoses opioïdes et diffusion de naloxone (programme POP) : résultats d’un état des lieux réalisé auprès des structures d’addictologie","authors":"Salim Mezaache , Franck Turlure , Nathalie Fredon , Maela Le Brun Gadelius , Joëlle Micallef , Elisabeth Frauger","doi":"10.1016/j.therap.2023.03.008","DOIUrl":"https://doi.org/10.1016/j.therap.2023.03.008","url":null,"abstract":"<div><h3>Introduction</h3><p>En France, les opioïdes sont responsables de la majorité des décès par surdose. L’antidote naloxone est disponible en France sous forme prête à l’emploi depuis 2016. Les structures spécialisées en addictologie sont en première ligne pour sa diffusion. L’objectif était de dresser un état des lieux des pratiques professionnelles, difficultés et besoins concernant la prévention des surdoses d’opioïdes et la diffusion de la naloxone au sein de ces structures de la région Provence-Alpes-Côte d’Azur (PACA).</p></div><div><h3>Méthodes</h3><p>Le programme POP « Prévention et réduction des risques des surdoses liées aux opioïdes en région PACA » vise à améliorer la prise en charge des patients à risque de surdose et faciliter la diffusion de naloxone. Les 75 structures spécialisées en addictologie de la région ont été sollicitées de juin à novembre 2021 pour répondre à un entretien semi-directif ou un questionnaire téléphonique. Les données collectées concernaient l’activité des structures en 2020 ainsi que les perceptions des professionnels vis-à-vis du risque de surdose dans leur file active, leurs pratiques, difficultés et besoins.</p></div><div><h3>Résultats</h3><p>Au total, 33 structures ont répondu dont 22 délivraient la naloxone avec en moyenne 20 kits délivrés en 2020 (min–max : 1–100). Deux stratégies ont été relevées : la proposition de naloxone à tous les utilisateurs d’opioïdes ou le ciblage des personnes considérées à risque. Plusieurs difficultés ont été exprimées : un manque de connaissance par les utilisateurs d’opioïdes, des refus de personnes ne se sentant pas concernées ou refusant la forme injectable, un manque de formation de certains professionnels pour être à l’aise avec la naloxone ou des contraintes réglementaires et de temps.</p></div><div><h3>Conclusion</h3><p>La diffusion de naloxone entre progressivement dans les pratiques courantes, néanmoins, des barrières persistent. À partir des difficultés et besoins exprimés, des supports d’information et de formation ont été co-construits et diffusés.</p></div><div><h3>Introduction</h3><p>In France, opioids are responsible for the majority of overdose deaths in France. The antidote naloxone is available in France in take home formulations since 2016. Addiction specialized centres are in front-line for naloxone diffusion. The objective was to provide an overview of professional practices, difficulties and needs regarding overdose prevention and naloxone diffusion in these centres of the Provence-Alpes-Côte d’Azur (PACA) region.</p></div><div><h3>Methods</h3><p>The POP programme “Prevention and harm reduction of opioid overdoses in PACA region” aims to improve the care of patients at risk of overdose and facilitate naloxone diffusion. The 75 addiction specialized centres of the PACA region were invited to respond to a semi-structured interview or a telephone questionnaire. Data collected included 2020 centres’ activity and professionals’ perceptions of overdos","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92139139","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":"Le cannabidiol (CBD) : aspects analytiques et toxicologiques","authors":"Jean-Claude Alvarez , Anne-Laure Pelissier , Patrick Mura , Jean-Pierre Goullé","doi":"10.1016/j.therap.2023.02.006","DOIUrl":"https://doi.org/10.1016/j.therap.2023.02.006","url":null,"abstract":"<div><p>Cannabidiol (CBD) is a phytocannabinoid present in cannabis, obtained either by extraction from the plant or by synthesis. The latter has the advantage of being pure and contains few impurities, unlike CBD of plant origin. It is used by inhalation, ingestion or skin application. In France, the law stipulates that specialties containing CBD may contain up to 0.3% of tetrahydrocannabinol (THC), the psychoactive principle of cannabis. From an analytical point of view, it is therefore important to be able to quantify the two compounds as well as their metabolites in the various matrices that can be used clinically or forensically, in particular saliva and blood. The transformation of CBD into THC, which has long been suggested, appears to be an analytical artifact under certain conditions. CBD is not without toxicity, whether acute or chronic, as seems to attest to the serious adverse effects recorded by pharmacovigilance during the experiment currently being conducted in France by the <em>Agence Nationale de Sécurité du Médicament et des Produits de Santé</em>. Although CBD does not seem to modify driving abilities, driving a vehicle after consuming CBD containing up to 0.3% THC, and sometimes much more in products bought on the internet, can lead to a positive result in screening and confirmation tests by law enforcement agencies, whether salivary or blood tests, and therefore lead to a legal sanction.</p></div><div><p>Le cannabidiol (CBD) est un phytocannabinoïde présent dans le cannabis, obtenu soit par extraction à partir de la plante soit par synthèse. Ce dernier a l’avantage d’être pur et ne renferme que peu d’impuretés, contrairement au CBD d’origine végétale. Il est utilisé par inhalation, ingestion ou application cutanée. En France, la loi stipule que les spécialités contenant du CBD peuvent contenir jusqu’à 0,3 % de tétrahydrocannabinol (THC), principe psychoactif du cannabis. D’un point de vue analytique, il est donc important de pouvoir quantifier les deux composés ainsi que leurs métabolites dans les diverses matrices utilisables en clinique ou en médicolégal, en particulier la salive et le sang. La transformation du CBD en THC, longtemps évoquée, semble n’être qu’un artéfact analytique dans certaines conditions. Le CBD n’est pas dénué de toxicité, qu’elle soit aigue ou chronique, comme semble l’attester les effets indésirables graves recensés par la pharmacovigilance lors de l’expérimentation conduite actuellement en France par l’Agence nationale de sécurité du médicament et des produits de santé (ANSM). Bien que le CBD ne semble pas modifier les capacités à la conduite, la conduite d’un véhicule après consommation de CBD contenant jusqu’à 0,3 % de THC, et parfois beaucoup plus dans des produits achetés sur internet, peut entrainer une positivité des tests de dépistage et de confirmation des forces de l’ordre, qu’ils soient salivaires ou sanguins, et donc entrainer une sanction judiciaire.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92059882","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":"Osteonecrosis of the jaw with axitinib: A case report","authors":"Salomé Martin , Thierry Trenque , Angélique Bergeret , Federica Tralongo , Brahim Azzouz","doi":"10.1016/j.therap.2022.12.010","DOIUrl":"10.1016/j.therap.2022.12.010","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10839282","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 : 2023-11-01DOI: 10.1016/j.therap.2023.01.011
Mor Fall , Guillaume Grenet , Hai-Ha Le , Behrouz Kassaï , Jean-Christophe Lega , Rémy Boussageon , Sabine Mainbourg , Ivanny Marchant , Johanne Gafsi , Amadou Moctar Dieye , François Gueyffier
{"title":"L’aspirine a-t-elle une place dans la prévention cardiovasculaire primaire par la polypill ? Étude de simulation sur une population virtuelle réaliste","authors":"Mor Fall , Guillaume Grenet , Hai-Ha Le , Behrouz Kassaï , Jean-Christophe Lega , Rémy Boussageon , Sabine Mainbourg , Ivanny Marchant , Johanne Gafsi , Amadou Moctar Dieye , François Gueyffier","doi":"10.1016/j.therap.2023.01.011","DOIUrl":"https://doi.org/10.1016/j.therap.2023.01.011","url":null,"abstract":"<div><h3>Background</h3><p>The polypill strategy could become widely accepted in cardiovascular prevention due to reduced costs and its simplicity, which promote compliance. Aspirin is often included as a component of the polypill for primary prevention, but three powerful recent trials failed to show any favorable net benefit even in high-risk subgroups. Our objective is to estimate the net benefit associated with aspirin in primary cardiovascular prevention.</p></div><div><h3>Methods</h3><p>We simulated the impact of different polypill compositions combining pravastatin, ramipril, hydrochlorothiazide, with or without aspirin, on a realistic French virtual population between 35 and 65 years old. We assessed how this impact on myocardial infarction and stroke varied according to gender, diabetes, and arterial hypertension. We identified the subgroup of individuals whose specific benefit from aspirin was greater than twice the risk of serious bleeding it induced.</p></div><div><h3>Results</h3><p>The absolute benefit associated with aspirin was reduced by co-prescriptions. No subgroup of women benefited from aspirin, and the subgroup of women with a clear net benefit represented 128 women out of 529,421. Men at high risk of cardiovascular death, or with diabetes and hypertension, had a benefit from aspirin exceeding the risk of bleeding induced, but this risk represented more than half of the benefit. No subgroup analyzed did show a benefit greater than twice the risk of bleeding. The proportion of men whose expected benefit from aspirin was greater than twice the risk of bleeding represented 3% of all men. An optimal polypill strategy in primary prevention between the ages of 35 and 65, combining three drugs but not aspirin, can hope to save two out of three strokes and more than one out of two myocardial infarctions. It would prevent a major cardiovascular accident every 16 to 193 individuals treated according to the subgroups considered.</p></div><div><h3>Conclusion</h3><p>Until proven otherwise, aspirin has only a limited place in individuals between 35 and 65 years without a cardiovascular history. We showed how simulating therapeutic strategies on a realistic virtual population could be used for best applying available evidence.</p></div><div><h3>Argumentaire</h3><p>La stratégie polypill pourrait s’imposer largement en prévention cardiovasculaire en raison de coûts réduits et de sa simplicité favorisant l’observance. L’aspirine est souvent proposée comme composant de la polypill en prévention primaire, mais trois essais récents puissants n’ont pas réussi à montrer un bénéfice net favorable même dans des sous-groupes à haut risque. Notre objectif est d’estimer le bénéfice net associé à l’aspirine en prévention cardiovasculaire primaire.</p></div><div><h3>Méthode</h3><p>Nous avons simulé l’impact de différentes compositions de polypill associant pravastatine, ramipril, hydrochlorothiazide, avec ou sans aspirine, sur une population virtuelle réa","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91639316","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":"Reality of drug-induced erythema multiforme: A French pharmacovigilance study","authors":"Sarah Demouche , Thomas Bettuzzi , Emilie Sbidian , Delphine Laugier Castellan , Marie-Noelle Osmont , Saskia Ingen-Housz-Oro , Bénédicte Lebrun-Vignes","doi":"10.1016/j.therap.2023.03.004","DOIUrl":"10.1016/j.therap.2023.03.004","url":null,"abstract":"<div><h3>Background</h3><p>Since the 2002 SCAR study, erythema multiforme<span> (EM), a post-infectious disease, has been distinguished from Stevens-Johnson syndrome (SJS), drug-induced. Nevertheless, EM cases are still reported in the French pharmacovigilance database (FPDB).</span></p></div><div><h3>Objectives</h3><p>To describe EM reported in the FPDB and to compare the quality and the characteristics of the reports.</p></div><div><h3>Methods</h3><p>This retrospective observational study selected all EM cases reported in the FPDB over two periods: period 1 (P1, 2008–2009) and period 2 (P2, 2018–2019). Inclusion criteria were 1) a diagnosis of clinically typical EM and/or validated by a dermatologist; 2) a reported date of onset of the reaction; and 3) a precise chronology of drug exposure. Cases were classified confirmed EM (typical acral target lesions and/or validation by a dermatologist) and possible EM (not-otherwise-specified target lesions, isolated mucosal involvement, doubtful with SJS). We concluded possible drug-induced EM when EM was confirmed, with onset ranging from 5 to 28 days without an alternative cause.</p></div><div><h3>Results</h3><p>Among 182 selected reports, 140 (77%) were analyzed. Of these, 67 (48%) presented a more likely alternative diagnosis than EM. Of the 73 reports of EM cases finally included (P1, <em>n</em> <!-->=<!--> <!-->41; P2, <em>n</em> <!-->=<!--> <!-->32), 36 (49%) had a probable non-drug cause and 28 (38%) were associated with only drugs with an onset time ≤<!--> <!-->4 days and/or ≥<!--> <!-->29 days. Possible drug-induced EM was retained in 9 cases (6% of evaluable reports). Etiological work-up was more often performed in period 2 than 1 (53.1% vs 29.3%, <em>P</em> <!-->=<!--> <!-->0.04), and the time to onset from 5 to 28 days was more frequent in period 2 (59.2% vs 40%, <em>P</em> <!-->=<!--> <!-->0.04).</p></div><div><h3>Conclusions</h3><p>This study suggests that possible drug-induced EM is rare. Many reports describe “polymorphic” rashes inappropriately concluded as EM or post-infectious EM with unsuitable drug accountability subject to protopathic bias.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9257027","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}