Therapie最新文献

{"title":"Intravitreal vascular endothelial growth factor inhibitors and cardiovascular adverse drug reactions: Added value of the data of the French pharmacovigilance spontaneous reporting assessment.","authors":"Aurélie Bobet, Leila Chebane, Annie-Pierre Jonville-Bera, Marina Babin, Thomas Soeiro, Haleh Bagheri","doi":"10.1016/j.therap.2025.02.008","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.008","url":null,"abstract":"<p><strong>Aim: </strong>To describe cardiovascular adverse reactions reported after intravitreal injections of vascular endothelial growth factor inhibitors (I-VEGF) as registered in the French Pharmacovigilance Database (FPVDB).</p><p><strong>Methods: </strong>This retrospective study assessed spontaneous adverse drug reactions reported to the French pharmacovigilance system and registered in the FPVDB from April 2007 to June 2023. Eligible cases of thromboembolic events and arterial hypertension associated with three I-VEGFs (aflibercept, ranibizumab and bevacizumab) were selected.</p><p><strong>Results: </strong>A total of 127 cases were included (83 for ranibizumab, 37 for aflibercept, and 7 for bevacizumab), including 21 cases of arterial hypertension and 106 cases of thromboembolic events. The median onset time for thromboembolic events ranged from 1 to 119days following injection, and from 0 to 30days for arterial hypertension. The median number of injections ranged from 1 to 24 before the occurrence of an adverse drug reaction. In 23% of cases, no risk factor was found for the occurrence of a cardiovascular or thromboembolic adverse event. In two cases, a positive rechallenge was documented.</p><p><strong>Conclusion: </strong>The rational use of pharmacological data, some relevant spontaneous reports and some pharmacoepidemiological studies are a prompt to health professionals to take precautions in patients with risk factors requiring I-VEGF. However, European Summaries of Product Characteristics do not give a clear picture to healthcare professionals concerning the precautions to take for patients with risk factors.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664491","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":"Vaccines and the risk of Guillain-Barré syndrome: A French pharmacovigilance analysis.","authors":"Marie Gligorov, Bénédicte Lebrun-Vignes, Kamel Masmoudi, Thierry Vial, Helga Junot, Valérie Pourcher, Sophie Demeret, Nicolas Weiss, Kevin Bihan","doi":"10.1016/j.therap.2025.02.007","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.007","url":null,"abstract":"<p><strong>Aims: </strong>Guillain-Barré syndrome (GBS) is a rare autoimmune-mediated disease that can occur in a post-vaccination context. During the vaccination surveillance program of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, reports of GBS as a possible adverse effect (AE) of SARS-CoV-2 vaccines have been reported. Our aim was to describe post-vaccine reports of GBS whatever the vaccine used.</p><p><strong>Methods: </strong>Data were obtained from the French pharmacovigilance database from inception (1 January 1985) to 1st March 2022. Reports were analyzed according to the French causality assessment method but only reports with a time to onset from the beginning of the treatment and the first symptoms occurrence of less than 4weeks were included in our analysis, in accordance to the chronological criteria of the Brighton criteria.</p><p><strong>Results: </strong>Three hundred and seventy-five (375) reports of GBS according to these selection criteria were retained for analysis. The data indicate a higher proportion of men (59%), with a median age of 54years and a median time-to-onset after vaccination of 12days. Around 45% of the reports were recorded with SARS-CoV-2 vaccines of which 68% involved post-mRNA vaccines and more precisely 56% post-tozinameran.</p><p><strong>Conclusion: </strong>This study suggests that Guillain-Barré syndrome may be a rare but potentially severe adverse event that can occur in the first few weeks after vaccination whatever its nature. Even if a vaccine was injected in the weeks preceding the first signs of GBS, it is essential to perform a complete etiological assessment (search for bacterial or viral infection, particularly Campylobacter jejuni, etc.) in order to rule out another cause before considering its role in the onset of GBS. Continued pharmacovigilance survey of marketed vaccines is necessary to update or even harmonize its SmPCs.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639828","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":"Pharmacodynamic interaction between ginger and antiplatelet drugs: A case report.","authors":"Layal El Aridi, Hélène Jantzem, Corinne Guihard, Myriam Marteil, Greta Gourier","doi":"10.1016/j.therap.2025.02.004","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531815","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":"Validation of in-hospital diagnosis codes in one French hospital and out-hospital algorithm to identify skin ulcers in healthcare databases in France.","authors":"Clément Jambon-Barbara, N'dah Mathieu Ouattara, Claire Bernardeau, Frédéric Olive, Sophie Blaise, Jean-Luc Cracowski, Charles Khouri","doi":"10.1016/j.therap.2025.02.003","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.003","url":null,"abstract":"<p><strong>Purpose: </strong>This study has two main objectives: 1/ to validate the International Classification of Diseases, 10th revision (ICD-10) diagnostic codes of skin ulcer in one French hospital using medical charts; 2/ to validate an out-hospital algorithm against ICD-10 codes using a healthcare database.</p><p><strong>Methods: </strong>We first validated in-hospital ICD-10 codes for pressure, diabetic and vascular skin ulcers using the Grenoble University Hospital medical charts. Secondly, we assessed the validity of an out-hospital algorithm using dressing reimbursements, medical exams and comorbidities to identify skin ulcers using the French \"échantillon généraliste des benéficiaires\" database. We then compared the type of skin ulcers in patients hospitalized 1 year around the out-hospital skin ulcer identification date. We calculated specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV).</p><p><strong>Results: </strong>The performances of ICD-10 codes for identifying patients with vascular, diabetic and pressure ulcers were all superior to 70%. The out-hospital identification of skin ulcers selected very different patients, younger and with less comorbidities than those hospitalized for skin ulcers. In patients hospitalized 1 year before or after the first dispensation of wound dressings, the concordance with ICD-10 codes was modest. Indeed, patients are wrongly classified as pressure ulcers, vascular ulcers and diabetic foot ulcers in respectively 27.7%, 52.0% and 48.8% of skin ulcers.</p><p><strong>Conclusion: </strong>We found that performances of the in-hospital identification of pressure, vascular and diabetic foot ulcers were high allowing to use them to conduct observational studies in healthcare databases. However, outpatient identification retrieved heterogeneous performance, we therefore advise researchers using the latter to perform a sensitivity analysis restricted to hospitalized patients.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504328","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":"[HOPIPRAC: Pharmacovigilance interface for detecting cases of adverse events in a hospital data warehouse].","authors":"Layal El Aridi, Hélène Jantzem, André Happe, Jean Michel Cauvin, Dominique Carlhant-Kowalski, Greta Gourier","doi":"10.1016/j.therap.2025.02.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.002","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Spontaneous reporting is the reference method for collecting data on adverse drug reactions (ADRs). However, it remains insufficient. Text search in the electronic medical record has opened up a new way of collecting ADRs. However, these methods have certain limitations. Data warehouses constitute a rich digital environment bringing together all the informations in an electronic medical record. The Clinical Data Centre (CDC) at Brest University Hospital has developed a pharmacovigilance tool, the HOPIPRAC interface, which provides autonomy in querying the entire hospital database to detect cases of suspected ADRs from computerised patient records.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Method: &lt;/strong&gt;The data source used was the CHU de Brest data warehouse. The IT tool was developed and tested between 2015 and 2018. A validation test of the tool was proposed, based on the choice of a positive signal from Brest's previous experience (valvulopathy with Benfluorex). The hospital data warehouse query tool can also be used to carry out other forms of interrogation to identify new risks, particularly with new drugs on the market, such as Nivolumab. The tool was tested to identify and analyse bullous toxidermia, described as the most severe and very often of a drug origin.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The validation test identified 98% of the historical cases recorded in the national pharmacovigilance database, as well as potential new cases not reported to the Brest CRPV. The nivolumab cohort identified 34 ADR cases. Of these cases, 82% were serious and some were unexpected at the time of extraction. The toxidermia query identified 137 cases, 56% of which had not been reported to the Brest CRPV. With regard to Stevens Johnson Syndrome (SJS), 28% of cases were associated with antineoplastics (7 cases), in particular tyrosine kinase inhibitors (sorafenib, vemurafenib, regorafenib) derived from advanced therapies, although this risk is described as rare in the summaries of product characteristics for these 3 drugs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;The HOPIPRAC interface is an innovative IT tool for assessing drug safety. It gives pharmacovigilants independent access to electronic hospital medical data. Its applications are: 1- amplification of a pharmacovigilance signal obtained by spontaneous notification; 2- monitoring of adverse reactions in cohorts of patients exposed to a specific drug; and 3- mapping of certain drug toxicities within hospital data. However, a number of limitations has been identified: the difficulty of identifying rare adverse events due to the low population representativeness of the surveyed warehouse, and the absence of certain data relevant to the exploration of adverse drug reactions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The HOPIPRAC interface gives pharmacovigilants autonomy in monitoring drug risk in healthcare institutions, in addition to spontaneous notification. Querying a more advanced warehouse that collect","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516866","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":"Dealing with large packaging in algorithms using the French health reimbursement data system (SNDS) database.","authors":"Sylvain Couderc, Sabrina Crépin, Marc Labriffe, Caroline Monchaud, Hélène Roussel, Alexandre Garnier, Aurélie Prémaud, Claire Villeneuve, Clément Benoist, Jean-Baptiste Woillard, Pierre Marquet","doi":"10.1016/j.therap.2025.02.001","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143504326","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":"Association between antidepressant drugs and falls in older adults: A mediation analysis in the World Health Organization's pharmacovigilance database.","authors":"Elise-Marie Minoc, Cédric Villain, Basile Chrétien, Soumia Benbrika, Marie Heraudeau, Claire Lafont, Clémence Béchade, Thierry Lobbedez, Véronique Lelong-Boulouard, Charles Dolladille","doi":"10.1016/j.therap.2025.01.004","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.004","url":null,"abstract":"<p><strong>Objectives: </strong>The objective is to investigate the association between antidepressant drugs intake and falls reporting, as well as the potential mediators in-between, in older adults.</p><p><strong>Methods: </strong>In VigiBase®, the World Health Organization's pharmacovigilance database, we performed a disproportionality analysis to probe the putative associations between each antidepressant drugs class (non-selective monoamine reuptake inhibitors [NSMRIs], selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], alpha-2-adrenergic receptor antagonists, and \"other antidepressants\") and reports of falls in people aged 65 and over (NCT05628467). The reporting odds ratios and their 95% confidence interval were derived from logistic regression models with adjustment for confounders. We studied the falls-inducing mechanisms (delirium, hyponatremia, hypotension) by using causal mediation analyses and by using a disproportionality analysis for the co-occurrence of falls and these events.</p><p><strong>Results: </strong>Our main analysis included 86,200 cases of falls reporting in older adults (of which 57% were 75 and over). A significant association was found between falls and every antidepressant drugs class, except for NSMRIs. According to causal mediation analysis, a direct effect on the falls reports was shown for alpha-2-adrenergic receptor antagonists and for \"other antidepressants\". According to the co-reports analyses, all antidepressant drugs classes except SNRIs were associated with the co-event fall-delirium; SSRIs, alpha-2-adrenergic receptor antagonists, and \"other antidepressants\" with fall-hypotension; all antidepressant drugs classes except NSMRIs with fall-hyponatremia.</p><p><strong>Conclusions: </strong>In multivariate disproportionality analyses, all antidepressant drugs classes were associated with signals of disproportionate reporting of falls in older adults, except for NSMRIs. In mediation analyses, a direct effect on the falls reports was only found for alpha-2-adrenergic receptor antagonists. Single-mediators based models seem insufficient to explain the diversity of clinical settings resulting in falls. These findings underline the necessity of a comprehensive analysis of all clinical and pharmacological features in older falling adults treated with antidepressant drugs.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-02-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143558138","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":"Photodistributed cutaneous vasculitis: An uncommon side effect for topical ketoprofen.","authors":"Nadia Fetoui Ghariani, Nour El Imene Ouni, Sawssen Layouni, Marwa Thabouti, Haifa Mkhinini, Maha Lahouel, Badreddine Sriha, Chaker Ben Salem, Najet Ghariani, Mohamed Denguezli","doi":"10.1016/j.therap.2025.01.003","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143410854","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":"[Infusion-related reactions with human polyclonal immunoglobulins: Analysis from the French National Pharmacovigilance Database].","authors":"Aurélie Bobet, Justine Bravo, Eyrian Aubin-Beale, Blandine Bertin, François Montastruc, Romain Barus","doi":"10.1016/j.therap.2025.01.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.002","url":null,"abstract":"<p><strong>Objectives: </strong>Infusion-related reactions to immunoglobulins are well documented. The objective of this study was to characterize these reactions using real-world data to provide clinically relevant information.</p><p><strong>Methods: </strong>This descriptive study analyzed cases of infusion-related reactions reported in the French National Pharmacovigilance Database for immunoglobulins administered via intravenous or subcutaneous routes up to December 27, 2023.</p><p><strong>Results: </strong>During the study period, 239 cases of infusion-related reactions were reported, primarily associated with intravenous immunoglobulins (97.4%). In over half of the cases (51%), the reactions presented as flu-like syndromes. These reactions typically occurred during the first cycle for IV immunoglobulins and the fourth cycle for SC immunoglobulins. Following the onset of an infusion-related reaction, the infusion was most commonly discontinued (87.7%) or the infusion rate reduced (9.1%). In 64 cases, resolution of the reaction allowed the continuation of treatment with reduced infusion rates (65%), premedication (28%), or both (7%). Resumption of the infusion did not lead to recurrence in 60% of cases. For subsequent cycles, administration of the same formulation (n=100) resulted in recurrence in 40% of cases, while switching to a different formulation (n=16) was associated with recurrence in 75% of cases.</p><p><strong>Conclusion: </strong>Infusion-related reactions to immunoglobulins most frequently present as flu-like syndromes or cardiovascular disturbances, which are typically resolved by reducing the infusion rate or discontinuing the infusion. Resumption of the infusion is feasible following resolution, using a reduced rate or premedication. The findings suggest that switching to a different formulation of the same administration route does not confer a practical advantage.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143383365","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":"Addictovigilance: The Edge of reason?","authors":"Maryse Lapeyre-Mestre, Joelle Micallef","doi":"10.1016/j.therap.2025.01.001","DOIUrl":"https://doi.org/10.1016/j.therap.2025.01.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081097","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}