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Impact of Tafamidis on survival in elderly patients: Insights from the Healthcare European Amyloidosis Registry
No full textInternational audienceBackground: Cardiac transthyretin amyloidosis (ATTR-CM) is a life-threatening cardiomyopathy. Tafamidis has been demonstrated to be an effective treatment. Our aim was to analyze clinical characteristics and survival of patients with ATTR-CM aged ≥80 years diagnosed after November 2018, treated with tafamidis 80/61 mg, and compare them with a non-treated group diagnosed before that date.Methods: Data from the two groups were extracted from the Healthcare European Amyloidosis Registry (HEAR). Propensity score matching was used to adjust for baseline differences between the groups. Kaplan-Meier survival curves and Cox regression analyses were applied to assess survival outcomes.Results: Out of 1380 patients, 1194 were treated with tafamidis 80/61 mg. Treated patients were significantly less severe at baseline, with a lower occurrence of NYHA class III-IV compared to the untreated group (24 vs. 46 %, p < 0.001). The median NT-proBNP at baseline was lower in the treated group (2330 vs. 4854 pg/ml, p < 0.001), as was the average level of high-sensitivity troponin T (55 vs. 74 ng/ml, p < 0.001), and the interventricular septal thickness (16 vs. 18 mm, p < 0.001). The 3-year survival rate for treated patients was 57 %, and 40 % for untreated patients. In the treated group, the 3-year survival rate was 68 % for patients aged 80-85 years and 58 % for those over 85 years. Survival rates were confirmed after propensity score analyses.Conclusions: This study demonstrates that tafamidis provides significant survival benefits for elderly patients with ATTR-CM, even in those over 85 years old. The findings emphasize the importance of early diagnosis and treatment
Sex-Related Gap in the Use of Disease-Modifying Therapies in Multiple Sclerosis
No full textInternational audienceBackground and objectives: In women with multiple sclerosis (MS), the therapeutic strategy may be influenced by the anticipation of future pregnancies, leading to underexposure to disease-modifying therapies (DMTs) and highly effective DMTs (HEDMTs) compared with men. We aimed to evaluate potential therapeutic inertia in women with MS and explore its causes.Methods: We performed a retrospective cohort study based on data extracted on June 2023 from the Observatoire Français de la Sclérose en Plaques for all patients with a relapsing-remitting MS onset between 18 and 40 years. The primary outcome was the annual probability of receiving a DMT, accounting for sex, disease severity, and pregnancy/postpartum periods. Secondary outcomes were the annual probability of receiving a HEDMT, each DMT separately, and interaction of the effect of sex with calendar year, patient age, and disease duration. We used a longitudinal logistic model with generalized estimating equations and an inverse-probability-of-censoring weighting.Results: We included 22,657 patients with MS; 16,857 (74.4%) were female, mean (SD) age at onset was 29.0 (6.0) years, and median (interquartile range) follow-up duration was 11.6 (6.6-17.3) years. Women were significantly less likely to receive a DMT (odds ratio [OR] 0.92, 95% CI 0.87-0.97) or a HEDMT (OR 0.80, 95% CI 0.74-0.86). This difference appeared 2 years after disease onset for DMTs and 1 year for HEDMTs, and did not differ significantly according to patient's age. Teriflunomide, sphingosine-1-phosphate receptor modulators, and anti-CD20s were significantly underused in women throughout their entire period of availability; interferons β (IFN-β) and natalizumab were initially less used and then equally after some time; glatiramer acetate and fumarates were first used equally, then more frequently in women. The proportion of treated women, analyzed from the first childbirth of 5,268 women, began to decline 18 months before childbirth, from 42.6% to 27.9% at the estimated time of conception.Discussion: Women with MS were significantly less exposed to DMTs compared with men. Anticipation of pregnancy was probably an important factor underlying this difference, but also sex-specific therapeutic inertia. Neurologists and patients should be educated on the most recent recommendations on the use of DMTs in the context of pregnancy to avoid deleterious therapeutic inertia
Impact of urine drug screening on opioid agonist treatment maintenance with buprenorphine in primary care in France: A cluster-randomized trial
No full textInternational audienceIntroductionTo assess the impact of onsite urine drug screening tests (OS-UDTs) in general practice compared with that of routine medical care on opioid agonist treatment (OAT) retention at six months in opioid-dependent patients initiating buprenorphine.MethodsIn this cluster-randomized controlled trial, general practitioners (GPs) working in primary care and regularly managing patients treated with buprenorphine were invited to participate and were randomly assigned to the intervention or routine care group. GPs (cluster level) were asked to include 1–10 patients starting buprenorphine (individual level). The intervention included: (1) a training session on OS-UDTs; (2) the supply of OS-UDTs at GPs’ offices; and (3) performing an OS-UDT before the first prescription of buprenorphine. The primary outcome was OAT retention at 6 months.ResultsAmong the 97 GPs included (intervention group: 49; control group: 48), 17 GPs included at least one patient, totaling 39 patients: 23 in the intervention group and 16 in the control group. Retention at 6 months was similar: 8 patients (34.7%) in the intervention group and 7 (43.8%) in the control group (OR = 0.69 [95% CI: 0.18–2.56], P value = 0.57). The patients were mainly men (69.2%), aged 39.3 ± 11.6 years. All 13 patients in the intervention group who returned the acceptability questionnaire rated as “normal medical practice” the GP asking for OS-UDT for the management of OAT.ConclusionIn the context of a recent decline in the number of patients receiving OAT, and while all participating GPs reported regularly caring for patients for OUD, this inconclusive trial faced recruitment difficulties due to the low level of buprenorphine initiation in current daily practice. Nevertheless, this trial determined the characteristics of patients starting buprenorphine in primary care and revealed that OS-UDT was acceptable
Brain metastases from Merkel cell carcinoma: A nationwide retrospective study
No full textInternational audienceBackground: Merkel cell carcinoma (MCC) is an aggressive skin cancer causing distant metastases in 30 % of cases but rarely involving the brain. PD-1/PD-L1 inhibitors constitute the standard treatment of advanced MCC but their impact on brain metastases is unknown.Methods: This retrospective study included MCC patients with central nervous system (CNS) metastases from the French CARADERM registry and the Groupe de Cancérologie Cutanée network. Primary objective was to assess CNS metastases incidence. Secondary objectives included response and survival.Results: Among 1056 MCC patients, CNS metastases incidence was 0.3 % at baseline and 2.6 % throughout the disease course, reaching 7.0 % in stage IV patients. In 37 patients with CNS metastases, median time from diagnosis to CNS metastases was 15.7 months. Extra-CNS metastases preceded CNS involvement (n = 23) with a median delay of 7.3 months. PD-1/PD-L1 inhibitors were administered before (n = 20) and/or after (n = 23) CNS metastases onset. Intra-cranial responses (n = 15) occurred regardless of prior treatment before CNS metastases. Most (9/15) occurred following stereotactic radiosurgery (SRS) plus immunotherapy, with longer median response duration (15.3 months) versus other treatments (5.1 months). Of prior PD-1/PD-L1 complete responders, 4/6 achieved intracranial response. Median OS and PFS after CNS metastases were 6.6 months and 4.7 months, respectively. PD-1/PD-L1 inhibitors and SRS were associated with improved survival in univariate analysis.Conclusion: CNS metastases are rare, late, and often fatal. PD-1/PD-L1 inhibitors with SRS are likely to constitute the optimal treatment. The quality of response to PD-1/PD-L1 inhibitors prior to CNS metastases predicts intracranial disease control
Health-related quality of life and cognitive functioning in survivors of oligodendroglioma: an international cross-sectional investigation
No full textInternational audienceBackground: Patients with oligodendroglioma have a relatively favourable prognosis. The long-term impacts of the tumour itself and its treatment on health-related quality of life (HRQOL) and cognition remain largely unclear. We investigated associations between treatment and functioning of survivors of oligodendroglioma.Methods: In this cross-sectional observational study, patients with oligodendroglioma, isocitrate dehydrogenase-mutant and 1p/19q-codeleted, diagnosed ≥5 years ago, were recruited. Patients completed patient-reported outcome measures (EORTC QLQ-C30; BN20; MOS Cognitive Complaints Scale) and cognitive tests (HVLT-R, TMT, COWAT). Associations between HRQOL and cognition outcomes, and clinical variables (time since diagnosis; age at diagnosis; progression; tumour location; treatments delivered; time since treatment; current medication;) were explored with regression analyses.Results: In total, 237 patients M=9.9 years post-diagnosis (sd=4.2, range 5.0-25.8) took part from 33 sites across 9 countries. Clinically relevant levels of impairment were noted in >40% of patients on EORTC QLQ-C30 scales for cognitive functioning (56.1%), emotional functioning (49.8%), fatigue (45.1%), and physical functioning (40.5%). In individuals, cognitive impairment ranged from 17.7% for processing speed to 46.0% for episodic verbal memory (delayed recall). Among other clinical factors such as current use of antiseizure medication or antidepressants, age, disease progression, time since diagnosis and time since treatment, and radiotherapy treatment (ever received) was linked to HRQOL and cognitive functioning outcomes (post-hoc analyses for cumulative radiotherapy dose: not significant).Conclusions: In oligodendroglioma survivors, HRQOL and cognitive impairment are prevalent even years into follow-up. Supportive care and rehabilitation should be prioritized to mitigate these challenges and improve daily functioning.Trial registration: NCT04708548
Anticoagulant management in emergency settings: 2024 guidelines from the French Society of Emergency Medicine (SFMU), the French Society of Anaesthesia and Intensive Care Medicine (SFAR), the French Society of Thrombosis and Haemostasis (SFTH) and the French Working Group on Perioperative Haemostasis (GIHP)*
No full textInternational audienceObjective: The Soci & eacute;t & eacute; Fran & ccedil;aise de M & eacute;decine d'Urgence (SFMU), the Soci & eacute;t & eacute; Fran & ccedil;aise d'Anesth & eacute;sie et de R & eacute;animation (SFAR), the Groupe d'Int & eacute;r & ecirc;t en H & eacute;mostase P & eacute;ri-op & eacute;ratoire (GIHP) and the Soci & eacute;t & eacute; Fran & ccedil;aise de Thrombose et d'H & eacute;mostase (SFHT) have collaborated to propose a set of guidelines on the management of anticoagulants in an emergency setting.Design: A group of French and Belgian experts from the French Societies of Emergency Medicine (SFMU), Anaesthesia and Intensive Care (SFAR), the working group on Perioperative Haemostasis (GIHP) and the French Society of Thrombosis and Haemostasis (SFHT) was convened. Any potential conflicts of interest were officially declared at the start of the recommendation development process, which was conducted independently of any industry funding. The authors used the GRADE ("Grading of Recommendations Assessment, Development and Evaluation") methodology to assess the level of evidence in the literature.Methods: Five areas were defined: (1) The role of laboratory testing in determining anticoagulant use and the level of anticoagulation; (2) Management of anticoagulant-associated bleeding; (3) Management of asymptomatic overdoses; (4) Management of non-elective invasive procedures on anticoagulants; and (5) Thrombolysis for acute ischaemic stroke on anticoagulants. For each field, the aim of the recommendations was to answer a certain number of questions formulated by the experts according to the PICO model ("Population, Intervention, Comparison, Outcome"). Based on these questions, an extensive bibliographic search from 1990 onwards was carried out using predefined key words according to the PRISMA recommendations. Data quality was analysed using the GRADE method. Recommendations were formulated using the GRADE method and then voted on by all the experts using the GRADE grid method.Results: The experts' summary work and application of the GRADE method resulted in 103 recommen-dations concerning 21 questions. After two rounds of voting and several amendments, strong agreement was reached on 97 recommendations. Out of these recommendations, 19 have a high level of evidence (19 GRADE 1), 35 have a low level of evidence (35 GRADE 2), and 48 are expert opinions. Finally, for one question, no recommendation could be made.Conclusions: There was strong agreement among the experts to provide recommendations for clinicians to provide up-to-date management of patients on anticoagulants in an emergency setting. 2025 Published by Elsevier Masson SAS on behalf of Soci & eacute;t & eacute; Fran & ccedil;aise d'Anesth & eacute;sie et de R & eacute;animation(SFAR)
Enhancing individual glomerular filtration rate assessment: can we trust the equation? Development and validation of machine learning models to assess the trustworthiness of estimated GFR compared to measured GFR
No full textInternational audienceBackground: Creatinine-based estimated glomerular filtration rate (eGFR) equations are widely used in clinical practice but exhibit inherent limitations. On the other side, measuring GFR is time consuming and not available in routine clinical practice. We developed and validated machine learning models to assess the trustworthiness (i.e. the ability of equations to estimate measured GFR (mGFR) within 10%, 20% or 30%) of the European Kidney Function Consortium (EKFC) equation at the individual level.Methods: This observational study used data from European and US cohorts, comprising 22,343 participants of all ages with available mGFR results. Four machine learning and two traditional logistic regression models were trained on a cohort of 9,202 participants to predict the likelihood of the EKFC creatinine-derived eGFR falling within 30% (p30), 20% (p20) or 10% (p10) of the mGFR value. The algorithms were internally and then externally validated on cohorts of respectively 3,034 and 10,107 participants. The predictors included in the models were creatinine, age, sex, height, weight, and EKFC.Results: The random forest model was the most robust model. In the external validation cohort, the model achieved an area under the curve of 0.675 (95%CI 0.660;0.690) and an accuracy of 0.716 (95%CI 0.707;0.725) for the P30 criterion. Sensitivity was 0.756 (95%CI 0.747;0.765) and specificity was 0.485 (95%CI 0.460; 0.511) at the 80% probability level that EKFC falls within 30% of mGFR. At the population level, the PPV of this machine learning model was 89.5%, higher than the EKFC P30 of 85.2%. A free web-application was developed to allow the physician to assess the trustworthiness of EKFC at the individual level.Conclusions: A strategy using machine learning model marginally improves the trustworthiness of GFR estimation at the population level. An additional value of this approach lies in its ability to provide assessments at the individual level
Clinical profile, short and long-term outcomes of non-ischaemic cardiogenic shock: A FRENSHOCK sub-analysis
No full textInternational audienceAims: Although predominant in routine practice, non-ischaemic cardiogenic shock (NICS) remains underrepresented in past studies, mainly focused on ischaemic cardiogenic shock (CS). This study aims to describe the current NICS picture and define its independent correlates of short- and long-term outcomes.Methods and results: FRENSHOCK is a prospective registry including 772 CS patients from 49 centers. One-year mortality was the primary outcome. One-month mortality and the composite of 1-year mortality, heart transplantation (HTx), or ventricular assistance device (VAD) were secondary outcomes. Within 772 patients included, 492 (63.7%) were NICS. One-month and 1-year mortality rates were 25.6% and 45.7%, with a combined endpoint of 1-year mortality, HTx, or VAD of 53.9%. Multivariate analysis showed five independent factors for 1-year mortality: age (per year: aHR 1.03 [1.01-1.05], P < 0.01), chronic kidney disease (CKD) (aHR 1.87 [1.25-2.80], P < 0.01), norepinephrine use (aHR 1.52 [1.02-2.26], P = 0.04), active cancer (aHR 1.91 [1.07-3.42], P = 0.03) and acute renal replacement therapy (aHR 1.57 [1.01-2.46], P = 0.049). Age, CKD and norepinephrine were also predictive of 1-month mortality and 1-year mortality and/or HTx and/or VAD. Additionally, 1-month mortality was associated with septic triggers, and 1-year mortality and/or HTx and/or VAD with acute mechanical circulatory support, NYHA stage ≥ 3 and fluid administration.Conclusions: In this large study, NICS accounted for almost two-thirds of all CS cases, with substantial rates of short- and long-term mortality. Future studies should evaluate interventions to improve early stratification and management. NCT02703038
First insights into the utilisation of the M.BLUE ® device for post-haemorrhagic hydrocephalus treatment
No full textInternational audienc
Avis de l'Anses relatif à la caractérisation et évaluation des impacts sur la santé de la consommation d’aliments dits ultratransformés
No full textAnses. (2024). Avis relatif à la caractérisation et à l'évaluation des impacts sur la santé de la consommation d’aliments dits ultratransformés. (saisine 2022-SA-0155). Maisons-Alfort : Anses, 104 p.L’Anses a été saisie le 27 août 2022 par la Direction générale de l’alimentation (DGAL) et par la Direction générale de la santé (DGS) pour caractériser et évaluer les impacts sur la santé de la consommation d'aliments dits ultratransformés.CONTEXTE ET OBJET DE LA SAISINE : Les résultats de l’étude Inca 3 (2014-2015) de l’Anses, publiée en 2017, ont documenté une augmentation de la consommation de produits transformés par les Français, en particulier ,chez les jeunes, par rapport à ce qui était observé dans l’étude Inca 2 (2006-2007). Cela contribue à « créer une distance entre les individus et leur alimentation, notamment en termes de connaissance de la composition des aliments » (Anses 2017).L’effet des aliments dits ultratransformés sur la santé est une thématique de recherche émergente, qui a conduit certaines agences sanitaires à s’emparer du sujet (AESAN 2020; FAO/OMS 2019; NNR 2023; SACN 2023). Un nombre croissant de publications scientifiques a en effet rapporté une association entre la consommation de produits dits ultratransformés et le risque de maladies chroniques.Si la préoccupation est aujourd’hui internationale et partagée tant au niveau scientifique qu’au niveau sociétal, il n’existe pas à ce jour de définition consensuelle des aliments transformés.La classification Nova, qui est la classification la plus utilisée par la recherche en épidémiologie, différencie les aliments en quatre classes en fonction notamment de leur degré de transformation et la classe Nova 4 correspond aux aliments considérés comme les plus transformés. En France, bien qu’il n’existe pas de définition réglementaire pour les aliments qualifiés d’ultratransformés, plusieurs recommandations officielles y font référence. Ainsi, les objectifs du Haut Conseil de la santé publique pour le Programme national nutrition santé (PNNS) sont « d’interrompre la croissance de la consommation des produits ultratransformés » et Santé publique France recommande « de limiter les boissons sucrées, les aliments gras, sucrés, salés et ultratransformés ». Le Programme national de l’alimentation et de la nutrition (PNAN) prévoit la caractérisation des aliments ultratransformés, l’étude de l’impact pour la santé de leur consommation et la priorisation des actions à mener. De plus, de nombreuses propositions, issues de rapports parlementaires, de la Convention citoyenne pour le climat ou d’initiatives citoyennes, portent sur les aliments ultratransformés, en lien avec l’étiquetage, la taxation, l’interdiction de la publicité ou la limitation en restauration collective.En réponse à la demande de la DGAL et de la DGS, l’Anses a mené une expertise sous les cinq angles suivants, procédant à :1 – la caractérisation des produits dits ultratransformés par une identification des procédés de transformation susceptibles d’induire sur la composition des aliments des modifications présentant un danger pour la santé ;2 – le recensement des classements existants des aliments selon leur degré de transformation et évaluation de leur pertinence au regard des caractéristiques identifiées précédemment ; 3 – l’étude des relations épidémiologiques entre la consommation d’aliments dits ultratransformés et les risques de maladies chroniques non transmissibles (MCNT) ;4 – la détermination, le cas échéant, en fonction des risques identifiés, à l’issue de l’analyse des études épidémiologiques, des facteurs responsables de la nocivité des aliments dits ultratransformés en vue d’identifier des leviers permettant de limiter les risques associés à leur consommation ;5 – l’identification des travaux scientifiques devant être conduits pour mieux caractériser les impacts sanitaires des aliments dits ultratransformés