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[Display omitted] Concern about disease exacerbations and fear of reactions after coronavirus disease 2019 (COVID-19) vaccinations are common in chronic urticaria (CU) patients and may lead to vaccine hesitancy. We assessed the frequency and risk factors of CU exacerbation and adverse reactions in CU patients after COVID-19 vaccination. COVAC-CU is an international multicenter study of Urticaria Centers of Reference and Excellence (UCAREs) that retrospectively evaluated the effects of COVID-19 vaccination in CU patients aged ≥18 years and vaccinated with ≥1 dose of any COVID-19 vaccine. We evaluated CU exacerbations and severe allergic reactions as well as other adverse events associated with COVID-19 vaccinations and their association with various CU parameters. Across 2769 COVID-19–vaccinated CU patients, most (90%) received at least 2 COVID-19 vaccine doses, and most patients received CU treatment and had well-controlled disease. The rate of COVID-19 vaccination–induced CU exacerbation was 9%. Of 223 patients with CU exacerbation after the first dose, 53.4% experienced recurrence of CU exacerbation after the second dose. CU exacerbation most often started <48 hours after vaccination (59.2%), lasted for a few weeks or less (70%), and was treated mainly with antihistamines (70.3%). Factors that increased the risk for COVID-19 vaccination–induced CU exacerbation included female sex, disease duration shorter than 24 months, having chronic spontaneous versus inducible urticaria, receipt of adenovirus viral vector vaccine, having nonsteroidal anti-inflammatory drug/aspirin intolerance, and having concerns about getting vaccinated; receiving omalizumab treatment and Latino/Hispanic ethnicity lowered the risk. First-dose vaccine–related adverse effects, most commonly local reactions, fever, fatigue, and muscle pain, were reported by 43.5% of CU patients. Seven patients reported severe allergic reactions. COVID-19 vaccination leads to disease exacerbation in only a small number of CU patients and is generally well tolerated. [ABSTRACT FROM AUTHOR]

Devant l'augmentation du nombre de cas de COVID-19, l'Établissement Public de Santé (EPS) de Ville-Évrard a mis en place des mesures strictes pour minimiser les risques d'infection et pour assurer la continuité des soins. Dans ce contexte, il nous a paru pertinent de s'intéresser au vécu de la crise sanitaire par nos patients hospitalisés lors de la première vague. Notre équipe a élaboré un questionnaire semi-structuré, composé de 8 items, permettant au patient de s'exprimer librement sur leur vécu de la crise sanitaire, de la prise en charge durant cette crise et du confinement. Nous avons recueilli les témoignages de 12 patients en réponse aux différents items du questionnaire concernant leur vécu en abordant les différents aspects de la crise sanitaire, parmi ceux qui ont été touchés par la COVID-19 et ceux qui ne l'ont pas contractée. Les réponses apportées par les patients aux différents items du questionnaire ont permis d'évoquer leur vécu de la crise sanitaire et du confinement. Nos patients ont fait preuve d'une bonne conscience de la complexité de la situation tout en se montrant coopérant à leur prise en charge et en respectant les nouvelles mesures mises en place. Ce travail nous a permis de constater que le retentissement de la crise lors de la première vague a été globalement bien vécu par nos patients avec une prise de conscience satisfaisante des risques encourus. Since the beginning of the health crisis, health care personnel have been confronted with an influx of patients with COVID-19. Given the complexity of the situation, the reorganization of care was done on an emergency basis to ensure careful management to limit the spread of the disease among health care personnel and patients. As patients suffering from psychiatric disorders were not spared, the Ville-Évrard Public Health Establishment set up a strategy to deal with this crisis by setting up a COVID+ unit specialized in the care of patients suffering from mental disorders and infected by the Coronavirus. Patients diagnosed as positive by PCR test were transferred to this unit so that they could benefit from a global management. The aim of our work was to focus on psychiatric patients (whether they were carriers of the COVID-19 virus or not) on their experiences during the health crisis in the first wave from March to June 2020, during the first containment. We have developed a semi-structured questionnaire composed of 8 questions, allowing to explore different aspects of the experience of the health crisis. We interviewed 12 patients (six patients affected by COVID-19 and six unaffected patients) with different mental disorders. The patients expressed themselves freely and their answers to the questions were presented question by question and separated according to the two groups. The first question was intended only for patients in the first cluster infected with the Coronavirus and the second question for patients with a family member infected with the virus. For the first question, two patients among the six infected with the Coronavirus, expressed anxiety. For the second question, two patients in the Covid+ group had a family member who had contracted the virus. One patient felt guilty, and one patient was anxious. In the Covid− group, one patient whose spouse had contracted the virus was very worried. For the third question, in the Covid+ group, four of the six patients were compliant with containment, two patients were not. In the Covid− group, four patients experienced containment between home and the hospital, and two patients experienced the entire containment at home. Regarding the fourth question, all patients (in both groups) acknowledged that the health crisis had a significant impact on their lifestyle. In response to the fifth question, all patients in the Covid+ group talked about their stay in the COVID+ unit and its setting. For patients in the Covid− group, the answers were varied mentioning simple means of distraction. For the sixth question, all patients (in both groups) were globally satisfied with their care. Concerning the seventh question, all patients in the Covid+ group thought they had been sufficiently careful without expressing any fear about the risk of contamination. In the Covid− group, the answers were centered on the fear of contracting the virus in the hospital. The responses to the eighth and final question were marked by a glimmer of hope. In the light of this work, the repercussions of this crisis, during the first wave, were generally well experienced by our patients, in the psychiatric environment, with a good awareness of the stakes and the risks incurred but also with a glimmer of hope for a resolution of the situation soon. Finally, most of the psychiatric patients in this sample behaved as respectful citizens during this first wave of confinement. [ABSTRACT FROM AUTHOR]

L'expérience extraordinaire (ExE), comme son nom l'indique, est une expérience qui sort de l'ordinaire et ne correspond pas au modèle de la réalité connue en termes de qualités et de processus. Le défi des chercheurs en ce domaine repose sur la question : l'ExE est-elle un symptôme psychopathologique qu'il faut soigner ou une expansion de conscience qu'il faut accompagner et encourager ? Plusieurs études se sont intéressées à mieux définir l'un ou l'autre de ces phénomènes ou à créer des échelles pour les distinguer. Dans la recherche présente, l'objectif repose sur une mise en parallèle de toutes les expériences extraordinaires afin d'investiguer et de rassembler les aspects communs qui la caractérisent. Cette première étape permet d'accroître les connaissances à ce sujet dans le but de créer à moyen terme un instrument de screening qui aidera les intervenants en psychiatrie à adapter le suivi pour ces personnes au vécu si particulier. Vingt-sept participants concernés par cette thématique ont raconté leur récit à trois chercheurs juges qui ont analysé leur contenu de manière qualitative afin d'en déduire des caractéristiques communes. Vingt-trois catégories similaires en termes de contenu thématique ont émergé. Cinq étapes importantes sont apparues qui aident à appréhender l'ExE comme un processus dynamique avec un début, un passage, un milieu, un retour et une fin qui mène à des conséquences psychologiques et personnelles positives. L'analyse qualitative de toutes les expériences extraordinaires confondues a permis de faire émerger 23 aspects communs qui se dessinent le long d'un processus temporel dynamique. Les résultats tendent à montrer que ce type de vécu amène à des changements positifs chez les personnes concernées plutôt qu'à des symptômes psychopathologiques. An extraordinary experience (ExE), as the name suggests, is an experience that is out of the ordinary and which does not fit the model of known reality in terms of qualities and processes. The challenge for researchers in this field is to determine whether an ExE is a psychopathological symptom that must be treated or an expansion of consciousness that should be supported and encouraged. Several studies have focused on better defining one or the other of these phenomena or on creating scales of measurement to distinguish them. In the present study, the objective is to establish a correlation between all the extraordinary experiences in order to investigate and identify the common aspects that characterize them. This first step will make it possible to improve our knowledge of this subject in order to create, in the medium term, a screening instrument that will help psychiatric practitioners to adapt the follow-up of those individuals who have had particular experiences. Twenty-seven participants concerned by this theme shared their stories with three researchers who qualitatively analyzed their content in order to identify common characteristics. Twenty-three similar categories in terms of thematic content emerged. Five important steps were identified that help to understand ExE as a dynamic process with a beginning, a passage, a middle, a return, and an end phase that results in positive psychological and personal consequences. The qualitative analysis of all combined extraordinary experiences has made it possible to identify 23 common aspects that reveal themselves along a dynamic temporal process. The results tend to show that this type of experience leads to positive changes in those concerned rather than in psychopathological symptoms. [ABSTRACT FROM AUTHOR]

Introduction: Double antiplatelet therapy (DAPT) is indicated for the treatment of coronary artery diseases (CAD). The optimal duration of therapy with DAPT continues to be a subject of debate in the scientific community. To improve adherence to DAPT, the FDC (fixed dose combination) of Acetylsalicylic acid (ASA) and clopidogrel was developed into a single pill instead of two separate pills thus facilitating the dosage and administration of the therapy and increasing compliance. The aim of this study was to assess adherence and persistence over a period of two years in patients treated with DAPT composed of: ASA/clopidogrel, ASA/prasugrel, ASA/ticagrelor and FDC with ASA and clopidogrel in real life and to assess whether the use of ASA and clopidogrel FDC is associated with improved adherence.Materials and Methods: In the following retrospective pharmacological-observational non-interventional study, all patients treated with DAPT in the Hospital of Pescara from January 2010 to October 2019 were considered. Persistence to treatment is defined as the duration of time from initiation to discontinuation of treatment. Adherence was calculated as the ratio between Received Daily Dose (RDD) and Prescribed Daily Dose (PDD).Results: 277 patients treated with ASA/clopidogrel, 77 patients treated with ASA/prasugrel, 57 patients treated with ASA/ticagrelor and 108 patients treated with FDC of ASA/clopidogrel were analysed. Persistence curves at two years showed a statistically significant difference (p < 0.001). Adherence to therapy was optimal with an absolute value at two years of 0.96. Adherence was better in patients treated with ASA/prasugrel with a value of 0.98 and with 97 % of patients with an adherence value greater than or equal to 0.8, while, it was worse in patients treated with FDC ASA/clopidogrel with an absolute value of 0.94 and with 88 % of patients with an optimal adherence value. No statistically significant difference was found between the ASA/clopidogrel FDC in comparison to each component taken as a separate pill (p = 0.0752).Conclusion: DAPT along with ASA/clopidogrel showed a statistically significant better persistence than ASA/ticagrelor and ASA/prasugrel. Whereas, to our knowledge and as per the current literature no statistically significant differences were found, in terms of adherence in real life, between the use of ASA/Clopidogrel FDC and the use of two different pills. [ABSTRACT FROM AUTHOR]

Real-world data inform the outcome comparisons and help the development of new therapeutic strategies. To this end, we aimed to describe the full characteristics and outcomes in the Epidemiological Strategy and Medical Economics (ESME) cohort, a large national contemporary observational database of patients with metastatic breast cancer (MBC). Women aged ≥18 years with newly diagnosed MBC and who initiated MBC treatment between January 2008 and December 2016 in one of the 18 French Comprehensive Cancer Centers (N = 22,109) were included. We assessed the full patients' characteristics, first-line treatments, overall survival (OS) and first-line progression-free survival, as well as updated prognostic factors in the whole cohort and among the 3 major subtypes: hormone receptor positive and HER2-negative (HR+/HER2−, n = 13,656), HER2-positive (HER2+, n = 4017) and triple-negative (n = 2963) tumours. The median OS of the whole cohort was 39.5 months (95% confidence interval [CI], 38.7–40.3). Five-year OS was 33.8%. OS differed significantly between the 3 subtypes (p < 0.0001) with a median OS of 43.3 (95% CI, 42.5–44.5) in HR+/HER2−; 50.1 (95% CI, 47.6–53.1) in HER2+; and 14.8 months (95% CI, 14.1–15.5) in triple-negative subgroups, respectively. Beyond performance status, the following variables had a constant significant negative prognostic impact on OS in the whole cohort and among subtypes: older age at diagnosis of metastases (except for the triple-negative subtype), metastasis-free interval between 6 and 24 months, presence of visceral metastases and number of metastatic sites ≥ 3. The ESME program represents a unique large-scale real-life cohort on MBC. This study highlights important situations of high medical need within MBC patients. clinicaltrials.gov Identifier NCT032753. • ESME provides a full picture of the real-life overall survival (OS) of women diagnosed with metastatic breast cancer from 2008 till 2016. • The median OS of the whole population over this 9-year period was 39.5 months (95% confidence interval, 38.7–40.3). • Prognostic factors on OS were age, tumour subtype, metastasis-free interval, presence of visceral metastases and number of metastatic sites. [ABSTRACT FROM AUTHOR]

• Each stage of cataract surgery requires a certain learning curve, and it is necessary to pay attention to every detail. • In light of the nature of human error, according to the general error modeling system, there are three types of errors, namely skill-based, rule-based, and knowledge-based. • This is the first study to report the outcomes of dominant and non-dominant hand phacoemulsification performed by an experienced cataract surgeon in a real operating room setting. To compare dominant and non-dominant hand phacoemulsification surgery outcomes. This retrospective, single-center study included 300 patients who underwent phacoemulsification surgery by a single, right-handed surgeon. The patients were divided into two groups according to whether the surgeon used his dominant or non-dominant hand during surgery. Right eye operations were performed with the right hand, and left eye operations were performed with the left hand. Detailed ophthalmological examinations were performed on all patients preoperatively and postoperatively. Intraoperative phacoemulsification parameters, the presence of intraoperative and postoperative complications, postoperative refractive errors, visual acuity, and surgically induced astigmatism values were compared between the groups. There were 171 patients in the dominant hand phacoemulsification group and 129 patients in the non-dominant hand phacoemulsification group. The distributions of age, gender, systemic diseases, and lens opacification were similar between the groups (p >0.05, for all). No statistically significant difference was observed between the two groups in terms of total operation time, phaco power, ellips fx, or ultrasonic time (p >0.05, for all). There was also no significant difference in relation to intraoperative and postoperative complication distributions, postoperative third-month refractive errors, visual acuity, or surgically induced astigmatism values (p >0.05, for all). This study demonstrated that cataract surgery performed by a single surgeon can be effectively and safely performed using both hands on patients in a real operating theater environment. More objective results can be obtained with surgeries performed by a larger number of experienced surgeons. [ABSTRACT FROM AUTHOR]

Lenvatinib is a multi-kinase inhibitor approved for patients with radioactive iodine (RAI)–resistant differentiated thyroid cancer (DTC). Before the drug approval from the Italian National Regulatory Agency, a compassionate use programme has been run in Italy. This retrospective study aimed to analyse data from the first series of patients treated with lenvatinib in Italy. The primary aim was to assess the response rate (RR) and progression-free survival (PFS). Secondary end-points include overall survival (OS) and toxicity data. From November 2014 to September 2016, 94 patients were treated in 16 Italian sites. Seventeen percent of patients had one or more comorbidities, hypertension being the most common (60%). Ninety-eight percent of patients were treated by surgery, followed by RAI in 98% of cases. Sixty-four percent of patients received a previous systemic treatment. Lenvatinib was started at 24 mg in 64 subjects. Partial response and stable disease were observed in 36% and in 41% of subjects, respectively; progression was recorded in 14% of patients. Drug-related side-effects were common; the most common were fatigue (13.6%) and hypertension (11.6%). Overall, median PFS and OS were 10.8 months (95% confidence interval [CI], 7.7–12.6) and 23.8 months (95% CI, 19.7–25.0) respectively. Lenvatinib is active and safe in unselected, RAI-refractory, progressive DTC patients in real-life setting. RR and PFS seem to be less favourable than those observed in the SELECT trial, likely due to a negative selection that included heavily pretreated patients or with poor performance status. • Patients with metastatic differentiated thyroid cancer (DTC) have poor survival rate. • Lenvatinib improved clinical outcomes in patient with metastatic radioactive iodine-refractory DTC. • Lenvatinib is active and safe, even in a real-life patient population. • Older patients show survival benefit from lenvatinib, without safety concern. [ABSTRACT FROM AUTHOR]

The purpose of the current study was to compare the efficacy and safety of edoxaban versus vitamin K antagonist (VKA) therapy among a cohort of elderly patients (ie, those aged ≥75 years) with atrial fibrillation (AF) in a real-life setting. A propensity score–matched cohort observational study was performed comparing the safety and efficacy of edoxaban versus VKA therapy among a cohort of elderly (aged ≥75 years) patients with AF in a real-life setting. Follow-up data were obtained through outpatient visits at 1, 3, and every 6 months. The primary safety outcome was major bleeding. The primary efficacy outcome was the composite of stroke, transient ischemic attack, and systemic embolism. A total of 130 patients receiving edoxaban 60 mg (EDO) treatment were compared with the same number of VKA recipients. The mean follow-up was 16 (2.6) months. The cumulative incidence of thromboembolic events in the EDO and VKA groups was 1.5% (2 of 130) and 2.3% (3 of 130), respectively (P < 0.6). The cumulative incidence of major bleeding events was 1.5% (2 of 130) in the EDO group and 3.1% (4 of 130) in the VKA group (P < 0.4). The total anticoagulant therapy discontinuation rate was 2.3% (3 of 130) in the EDO group and 4.6% (6 of 130) in the VKA group (P < 0.3). A nonsignificant trend in improved adherence was observed between the EDO and VKA groups (81% vs 78%; P = 0.6). Edoxaban therapy showed a good real-life performance among elderly patients (aged ≥75 years) with AF. [ABSTRACT FROM AUTHOR]

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Abstract Purpose We aimed to assess the implementation and effectiveness of exemestane plus everolimus treatment per hospital type in real-life, shortly after approval of everolimus. Methods Advanced breast cancer patients treated with exemestane plus everolimus in 2012–2014 were included from the SONABRE registry. Progression-free survival (PFS) and a 12-week conditional PFS (post-hoc) were estimated by Kaplan-Meier method. The multivariable Cox proportional hazards model was performed by type of hospital and adjusted for patient, tumour and treatment characteristics. Results We included 122 patients, comprising 48 patients treated in academic (N = 1), 56 in teaching (N = 4), and 18 in non-teaching (N = 2) hospitals. The median PFS was 6.3 months (95% Confidence Interval (CI) 4.0–8.6) overall, and 8.5 months (95% CI 7.7–9.3), 4.2 months (95% CI 2.0–6.3), and 5.5 months (95% CI 4.2–6.7) for the patients treated in academic, teaching and non-teaching hospitals, respectively. The adjusted Hazard Ratio (HR) for PFS-events was 1.5 (95% CI 1.0–2.2) and 1.0 (95% CI 0.5–1.9) respectively for patients treated at teaching and non-teaching hospitals versus the academic hospital. The adjusted HR for 12-week conditional PFS-events was not different between hospital types. In the first 12-week treatment period, treatment was discontinued due to early progression in one out of 48 patients in the academic versus nine out of 74 patients in the non-academic hospitals, confirmed by imaging in one and two patients, respectively. Conclusions In our study, the median PFS was borderline significantly different between hospital types, possibly the result of a different assessment approach in the first 12-week treatment period. Highlights • The real-life overall median progression-free survival (PFS) was 6.3 months. • The median PFS was borderline significantly different between hospital types. • The assessment of progression seemed different in the first 12-week treatment period. • We recommend physicians to broadly share protocols and treatment experience. [ABSTRACT FROM AUTHOR]

Highlights • This series illustrates treatment outcomes with nivolumab in a real life setting. • The only variable which significantly correlated with OS was ECOG PS. • mOS was 2.7 times shorter for ECOG PS ≥2 patients compared to ECOG PS 0/1 patients. Abstract Objectives Nivolumab has recently received regulatory approval as a 2nd-line treatment of non-small cell lung cancer (NSCLC). The data regarding its effectiveness and safety in real life setting is lacking. Materials and methods 260 consecutive patients with advanced NSCLC treated with nivolumab at five Israeli cancer centers between January 2015 and March 2016 were evaluated for overall survival (OS) and toxicity. OS was analyzed by the Cox proportional-hazards regression model. Overall response rate (ORR) and progression-free survival (PFS) were assessed in 49 patients using RECIST, v.1.1. Results Median age was 67y (41–99); males 68%; smokers 76%; ECOG PS ≥2 46%; non-squamous/squamous/other/NR 70%/23%/6%/1%; brain metastases 21%; liver metastases 21%; treatment line: 1st/2nd/3rd+-line/NR 6%/64%/26%/4%. With median survival follow-up of 18.5 months (range, 12.0–26.9), 155 (60%) patients died; median OS comprised 5.9 months (95% CI 4.7–7.4). In univariate and multivariate analysis, the only variable which significantly correlated with OS was ECOG PS. Median OS of patients with ECOG PS 0/1 and ECOG PS ≥2 comprised 9.5 months (95% CI, 6.7-NR) and 3.5 months (95% CI, 2.6–4.5), respectively. For 49 patients evaluable for response (median follow-up of 8.4 months (range, 2–16.8), ORR was 35%, median PFS was 2.8 months (95% CI, 1.8–7.7), incidence of pseudo-progression was 9%. The nivolumab safety profile was in accordance with the literature data, except for febrile neutropenia and pericarditis (observed in 1 case each). Conclusion In real life setting, the effectiveness of nivolumab is reasonable yet less prominent than it has been demonstrated in clinical trials. ECOG PS ≥2 is associated with poor prognosis. [ABSTRACT FROM AUTHOR]

Highlights • Treatment of NSCLC with nivolumab in real life leads to an ORR of 20.2% and mOS of 10 months • Significantly better OS for patients with ECOG-PS <2 • Significantly better OS and PFS for patients with prior response to chemotherapy • Immunotherapy related toxicities in 18.1% (any grade), or 6.0% (grade 3–5) of patients [ABSTRACT FROM AUTHOR]

Recent research suggests that non-attentively perceived odours may significantly influence people’s food choices. This study’s aim was to examine the effects of different types of non-attentively perceived food odours, namely, bread odour and cucumber odour, on subsequent lunch choices in a real-life setting. The study was conducted using a within-participant design (n = 37, age 21–55 years). Participants took part in three sessions: two priming conditions (bread and cucumber odour) and one control condition (no odour). During each session, participants started by answering a questionnaire for20 min, in a room in which they were exposed to one of the odour conditions. The questionnaire functioned as a ‘lure’ task. Subsequently, participants were guided to the restaurant where they could choose lunch from a buffet. Besides lunch choice, sociodemographic factors, personality traits, and eating behaviour factors were assessed. Odour priming and control conditions did not affect lunch selections (χ 2 (2, N = 37) = 28.1, p = 0.46). Self-reported positive mood was significantly affected by odour condition ( F (2, 72) = 3.26, p  = 0.044). In conclusion, odour condition did affect mood but not lunch choice. It is therefore questionable whether an odour prime can be used as a nudge to contribute to healthy food choice behaviour. [ABSTRACT FROM AUTHOR]

Objectives Given their inclusion and exclusion criteria, randomized clinical trials (RCT) might not include a population that truly mirrors real life (RL). This raises concerns about the applicability of RCT results in clinical practice. We evaluated the efficacy of anti-HER2 treatment with pertuzumab combined with trastuzumab and a taxane as first-line treatment for HER2-positive metastatic breast cancer in a RL setting, and compared the safety results obtained in our population versus the experimental cohort of the CLEOPATRA RCT, which led to the approval of this therapy. Materials and methods Patients treated with trastuzumab, pertuzumab and a taxane were enrolled in this retrospective study. We compared the tumor features and the patients' characteristics of the RL cohort to those of the CLEOPATRA cohort. We also compared the median progression-free survival (PFS) in the RL population versus specific patients' subgroups. Results RL patients were more frequently HR-positive, less likely to have visceral metastases (P < .001 for both) and had more frequently received (neo)adjuvant hormone therapy or trastuzumab than CLEOPATRA patients (P = .004 and P < .001, respectively). The median number of anti-HER2 cycles was 8 vs 24 and the median number of cycles was 7 vs 8 for docetaxel in the RL versus CLEOPATRA population, respectively. Adverse reactions of all grades were less frequent in RL. Median PFS was 27.8 months in the RL population and the treatment was equally effective in all patients' subgroups. Conclusion This study provides compelling evidence that pertuzumab, trastuzumab and a taxane are effective and safe also in a clinical scenario. [ABSTRACT FROM AUTHOR]

Résumé Propos Les traitements anticoagulants oraux concernent plus de 1 million de patients en France et constituent la première cause de iatrogénie médicamenteuse. L’apparition récente des anticoagulants oraux directs (AOD) dans la fibrillation atriale (FA) et la maladie thromboembolique veineuse (MTEV) offre une alternative thérapeutique. Devant l’augmentation croissante de la prescription de ces molécules, comportant de nombreux avantages mais également des inconvénients, il nous a paru intéressant d’évaluer, en pratique médicale hospitalière quotidienne, la proportion de patients pour laquelle l’initiation d’un AOD pourrait se faire en toute sécurité. Méthodes Il s’agit d’une étude prospective observationnelle menée dans un service de médecine interne sur une période d’un an. Tous les patients hospitalisés sous traitement anticoagulant oral ont été inclus consécutivement. Outre les données démographiques usuelles, l’indication du traitement anticoagulant, l’existence de contre-indications et d’interactions médicamenteuses connues pour les AOD ont été colligées, afin de déterminer le pourcentage de patients pouvant bénéficier d’un AOD en toute sécurité. Résultats Au total, 290 patients ont été inclus avec une moyenne d’âge de 76,3 ± 15,2 ans. La FA et la MTEV représentaient respectivement 67,2 % et 22,4 % des indications du traitement anticoagulant. L’indication des anticoagulants répondait à l’AMM des AOD pour 260 patients (89,7 %). Parmi eux, 79,1 % ne présentaient pas de contre-indication à ces nouvelles molécules et seuls 53,1 % n’avaient pas d’interaction médicamenteuse. La principale contre-indication à la prescription des AOD était une insuffisance rénale sévère (clairance < 30 mL/min) dans 10,7 % des cas. Les antiagrégants plaquettaires et l’amiodarone constituaient, dans notre cohorte, les deux principales interactions médicamenteuses avec les AOD (respectivement 14,5 % et 11,6 %). Presque deux tiers des patients (65,1 %) avaient au moins une interaction médicamenteuse avec les AVK. Conclusion Ces résultats, concernant la prescription d’AOD dans la « vraie vie », mettent en garde contre un engouement trop rapide envers ces molécules que sont les AOD. En effet, seuls 53,1 % des patients anticoagulés seraient susceptibles de bénéficier de la prescription d’AOD de façon totalement sécuritaire. La prudence reste donc de mise et les AVK gardent une place importante au sein de l’arsenal thérapeutique des anticoagulants. Purpose More than one million patients received an oral anticoagulant treatment in France. This medication is the first aetiology of iatrogenic events. Recently, direct oral anticogulant (DOA) provided efficacy and safety in the treatment of atrial fibrillation and venous thromboembolic events. Given the growing increase in the prescription of these molecules, with many advantages but also disadvantages, it seemed interesting to assess in routine hospital medical practice, the proportion of patients for which the initiation of AOD could be safe. Methods This prospective, observational study was conducted in the department of internal medicine from October 2012 and September 2013. All inpatients receiving oral anticoagulant treatment have been included. Demographic data, indication of anticoagulant treatment, contraindications and interactions have been reported. From these information, we have established the percentage of patients who could benefit from DOA safely and securely. Results Two hundred and ninety inpatients were included with a mean age of 76.3 ± 15.2 years old. Atrial fibrillation and thromboembolic venous disease were the most prevalent indications of anticoagulant treatments (67.2% and 22.4% of cases respectively). Among all patients, 260 had an indication of DOA (89.7%), authorized by the French National health agency. Eighty percent had both indication and no contraindication for DOA. However, only 53.1% of patients neither had drug–drug interaction. Main contraindications were severe renal failure (clearance < 30 mL/min) in 10.7% of cases, and recent history of gastric ulcer in 15.3% of cases. The most frequent interactions with DOA were antiplatelet agent (14.5%) and amiodarone (11.6%). Almost two thirds of inpatients (65.1%) had at least one drug-drug interaction with VKA. Conclusion These results, coming from “real life”, provide that only 53.1% of inpatients under anticoagulants could receive DOA safely. Caution is warranted, and VKA still have a preponderant role among anticoagulant drugs. [ABSTRACT FROM AUTHOR]

Objectives To examine if a preventive 20-week aerobic exercise intervention (AET) can improve emotional stress reactivity during real-life stress. Design Randomised controlled trial; within-subject design. Method Sixty-one inactive students were randomly assigned to a waiting control and an AET group. To capture the situation-specific, intra-individual data in real life, electronic diaries were used. Participants reported their moods and perceived stress (PS) repeatedly over two days during their daily routines pre- and post-intervention. The pre-intervention baseline assessment was scheduled at the beginning of the semester, and the post-intervention assessment was scheduled at a real-life stressful episode, an academic examination. For the aerobic fitness assessment, both groups completed a cardiopulmonary exercise test on the treadmill before and after the intervention. Multilevel models (MLMs) were conducted to compare within- and between-subject associations. Results Significant emotional stress reactivity was evident in both groups during all assessment periods. However, participants in the AET group showed lower emotional stress reactivity compared with their control counterparts after the 20-week training programme during the real-life stress episode (the academic examination). Conclusions AET conferred beneficial effects on emotional stress reactivity during an academic examination, which is likely an extremely stressful real-life situation for students. AET appears to be a promising strategy against the negative health effects of accumulated emotional stress reactivity. [ABSTRACT FROM AUTHOR]

Abstract: Background: Evidence on the real effectiveness of statins on acute coronary syndrome (ACS) incidence is scarce. We assessed the effectiveness of real-life statins on the risk of first non-fatal ACS in a low-cardiovascular-risk country. Methods: Systematic case–control study was conducted in 60 cardiology centres and 371 general practices from across France. A total of 2238 cases with first ACS within 1month from recruitment and 2238 controls without history of ACS were included; controls were matched to ACS cases on sex, age, frequency of visits to GPs, date of recruitment and personal history of chronic diseases. Statin exposure and risk factors were documented through patient telephone interviews and validated against medical records. The index date was the date of ACS for cases. Adjusted odds ratios (OR) of first ACS and statin use were estimated by multiple conditional logistic regression models controlled for risk factors and propensity score for statin exposure. Results: Statin use was associated with lower ACS risk, with an adjusted matched OR of 0.67; 95% confidence interval (CI): 0.56 to 0.79 for current use (within 2months) and 0.73; 95% CI: 0.62 to 0.86 for any use within 24months [atorvastatin: 0.83 (0.63–1.10), fluvastatin: 0.75 (0.43–1.30), pravastatin: 0.98 (0.72–1.34), rosuvastatin: 0.49 (0.35–0.68) and simvastatin: 0.62 (0.46–0.84)]. The preventive effect of statins on non-fatal ACS reached its maximum after one to four years of use. Conclusion: A similar magnitude of effect for statin use was observed in real life, as compared to randomised clinical trials in France. [Copyright &y& Elsevier]

Summary: Objectives: To estimate the prevalence of partly controlled and uncontrolled asthmatic patients, to evaluate quality of life and healthcare resource consumption. Methods: Cross-sectional phase followed by a 12-month prospective phase. Asthma Control Test and the EQ-5D were used. Results: 2853 adult patients recruited in 56 Hospital Respiratory Units in Italy were evaluated: 64.4% had controlled asthma, 15.8% partly controlled asthma and 19.8% were uncontrolled. The mean (SD) EQ-5D score was 0.86 (0.17) in controlled, 0.75 (0.20) in partly controlled and 0.69 (0.23) in uncontrolled patients (p <0.001 between groups). The number of patients requiring hospitalization or emergency room visits was lower in controlled (1.8% and 1.6%, respectively) than in partly controlled (5.1% and 11.5%) and uncontrolled (6.4% and 18.6%). A combination of an inhaled corticosteroid and a long-acting beta-2 agonist was the reported therapy by 56.0% of patients, with the rate of controlled asthma and improved quality of life being higher in patients on extrafine beclomethasone/formoterol compared to budesonide/formoterol (p <0.05) and fluticasone/salmeterol (p <0.05 for quality of life). Conclusions: Asthma control is achieved in a good proportion of Italian patients. Differences may be detected in a real-life setting in favor of extrafine beclomethasone/formoterol combination. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To investigate the effectiveness and safety of TNFα antagonists in patients with rheumatoid arthritis (RA) or spondyloarthropathies (SpA) treated by a single physician, according to the presence of the inclusion and non-inclusion criteria used to select patients for pivotal clinical trials. Methods: Effectiveness was evaluated based on four categories defined by the DAS28-ESR and BASDAI values, from a very good response (mean DAS-28-ESR less than 3.2 and mean BASDAI less than 2.0) to failure (DAS28-ESR unchanged or greater than 5.1 and BASDAI unchanged). Serious adverse events were defined as events that required permanent TNFα antagonist discontinuation or that led to sequelae, hospital admission, or death. Results: The study included 475 patients, 230 with RA, 226 with SpA, 10 with juvenile-onset arthritis, and nine with unclassifiable arthritis. Mean number of TNFα antagonists used per patient was 1.3 and mean duration of TNFα antagonist treatment was 28±23 months. Overall, 41% of patients met the inclusion and non-inclusion criteria used in pivotal trials; the proportion was 43% in the RA group and 40% in the SpA group. These patients had a 3-fold higher rate of very good responses (54 versus 19%) and a 5-fold lower rate of failures (5 versus 25%) compared to the other patients. Of the 15 (3%) patients who died, none met pivotal trial criteria. The group that met pivotal trial criteria had a significantly lower rate of serious adverse events (11 versus 16%; Chi2, p =0.0001), although age was similar in the two groups (53±16 years versus 57±14 years). Conclusion: Patients meeting the selection criteria used in pivotal trials had a higher response rate and significantly fewer serious adverse events. [ABSTRACT FROM AUTHOR]

Summary: Objective: To evaluate direct asthma-related costs in Swedish primary care in a real-life setting. Design: 12-month open-label study. Setting: Swedish primary care in a real-life setting. Participants: 1776 patients with persistent asthma. Interventions: Patients with persistent asthma were randomised to one of three treatments: a free adjustable combination of budesonide (100–400μg/inhalation) and formoterol (4.5 or 9μg/inhalation) via separate inhalers plus terbutaline as needed; budesonide/formoterol (160/4.5μg or 80/4.5μg, two inhalations twice daily) plus terbutaline as needed; budesonide/formoterol (160/4.5μg or 80/4.5μg, one inhalation twice daily or two inhalations once daily), for maintenance plus additional inhalations as needed. Doses depended on previous inhaled corticosteroid dose. Patients attended the clinic at 0, 1.5, and 12months. Telephone interviews were conducted at 4, 6, 8, and 10months. Main outcome measures: The primary endpoint was direct asthma-related healthcare costs. Results: Statistically significant reductions in annual direct costs per patient were observed with budesonide/formoterol maintenance and reliever therapy compared with the free adjustable combination of budesonide and formoterol (−13%, P<0.001) and fixed-dose budesonide/formoterol plus terbutaline (−20%, P<0.001). Time to first severe exacerbation did not differ significantly across treatment groups, with a mean reduction of 28% versus the free adjustable combination of budesonide and formoterol (P=0.076). Patients receiving budesonide/formoterol maintenance and reliever therapy used a significantly lower daily dose of budesonide compared with the conventional (P<0.001). Conclusions: This study reports direct cost savings with budesonide/formoterol maintenance and reliever therapy compared with conventional treatment regimens with at least equivalent efficacy. [Copyright &y& Elsevier]

Summary: Objective: To describe omalizumab (Xolair®) effectiveness in the first patients treated on compassionate grounds before its commercialisation in France. Methods: In a historic-prospective study, data were obtained by questionnaire from the physicians whose patients had received a nominative temporary use authorisation (ATU) for omalizumab from July 2003 to January 2006. Anonymised patient data regarding demographics, asthma-related treatments and events in the year previous to the start of omalizumab treatment as well as the details of omalizumab treatment itself were obtained at inclusion. Follow-up data at more than 3 months following inclusion were also obtained and regarded asthma-related treatment (including omalizumab), events and undesirable effects suspected to be linked to omalizumab treatment. Results: Data were obtained for 147 of the 154 patients treated via ATU. 31.3% received inappropriate monthly doses of omalizumab. Of the 28 patients (19%) who discontinued for unsatisfactory therapeutic effect, 7 were treated for less than the 16 weeks recommended to evaluate efficacy and 9 who were treated for a longer period of time were underdosed. During the treatment period and compared to the previous year, patients with follow-up data at 5 months or more had experienced 62% fewer exacerbations requiring oral corticosteroids, 65% fewer emergency department visits and 29% fewer hospitalisations per year. The nature of adverse effects reported was similar to that reported in omalizumab clinical trials. Conclusion: Results strongly suggest that omalizumab in the first patients treated in real-life setting provided a similar benefit to that observed in clinical trials. Underdosing of patients may limit this therapeutic effect. [Copyright &y& Elsevier]

• In real life, DMF reduced the annualized relapse rate (ARR) by 75% respect to the pre-treatment ARR. • Age of onset of MS was related with rate or relapses, with younger age being protective. • De-escalating from second-line therapies was associated to higher risk of relapsing. • Disease duration was associated with higher rate of NEDA-3 failure. • Higher pre-treatment EDSS was associated with DMF discontinuation. Dimethyl-fumarate (DMF) was effective and safe in relapsing–remitting multiple sclerosis (MS) in randomized clinical trials. We aimed to evaluate the efficacy and safety of DMF and factors related to drug response in real-life setting. We analysed prospectively collected demographic and clinical data for patients treated with DMF in six multiple sclerosis (MS) centers from 2015 to 2017 in Campania region, Italy. We performed univariate and multivariate analyses to assess relationships between baseline parameters and DMF efficacy outcomes, Annualized Relapse Rate (ARR), Expanded Disability Status Scale (EDSS) progression and No Evidence of Disease Activity (NEDA-3) status. we analyzed data of 456 patients (67% female subjects, mean age 40 ± 12 years, mean disease duration 9 ± 9 years, mean treatment duration 18 ± 11 months, median EDSS 2.5, 0–8). Proportion of Naïve versus pretreated with other DMTs patients was 149/307 (32.7%), with 122 patients switching to DMF for disease activity (26.7%) and 185 for safety and tolerability issues (40.6%). During treatment with DMF, the annualized relapse rate was reduced by 75% respect to the pre-treatment ARR [incidence-rate-ratio (IRR) = 0.25, p < 0.001, CI 0.18–0.33]. Factors influencing ARR rate while on DMF were relapsing remitting (RR) MS course (IRR = 2.0, p = <0.001, CI 1.51–2.73) and previous DMTs status: de-escalating from second-line therapies was associated to higher risk of relapsing (IRR = 1.8, p < 0.001, CI 1.39–2.31). At multivariable Cox proportional hazard model, only age of onset was related with rate or relapses, with younger age being protective (HR 0.96, p = 0,02). EDSS remained stable in 88% of patients. Disease duration was associated with higher rate of NEDA-3 failure, that was instead maintained in 65% of patients at 24 months. 109 patients (22%) discontinued therapy after a mean of 1.1 ±+ 0.7 years. Reasons for DMF discontinuation over time were lack of efficacy (50%), safety issues (30%), tolerability (7%), poor compliance (7%), and pregnancy (4%). Higher pre-treatment EDSS was associated with DMF discontinuation (p = 0.009). Only 33 patients dropped out due to safety reasons (7%), the most frequent safety issues driving to drop out being lymphopenia, liver/pancreatic enzymes increase, gatrointestinal severe tolerability issues. We recorded 95 cases (24%) of lymphopenia: 60 grade I (13%), 31 grade II (7%) and 4 grade III (1%). We confirm that DMF shows a good efficacy in both naïve patients and patients switching from other first-line DMTs, especially in patients with early onset of disease. Higher baseline EDSS was a risk factor for discontinuing DMF therapy, while shorter disease duration was protective for both EDSS progression and NEDA-3 status maintenance. [ABSTRACT FROM AUTHOR]

Objective: Dulaglutide is an agonist of "glucagon-like peptide type 1″ receptors (arGLP1). The clinical efficacy of this molecule is based on reductions in glycosylated hemoglobin (HbA1c) and weight, data shown in the pivotal AWARD studies.Methods: We propose a retrospective and multicenter study that allows evaluating the effectiveness of dulaglutide at 24 months after treatment began, under conditions of usual clinical practice, and comparing the results obtained with those that are reflected in the controlled trials.Results: The results show a reduction in the HbA1c levels -1.4% at 6 M and this reduction were maintained throughout 12 M and 24 M (p < 0.001). Plasma glucose showed significant reductions around -30 mg / dL at 6 months (p < 0.001) that remained until the end of the follow-up at 12 and 24 M, respectively. The weight decreased significantly at 6 M (p < 0.001) but continued decreasing at 12 and 24 M, showing statistically significant differences (p: 0.001).Conclusions: Our results are similar to those obtained in pivotal clinical trials and confirm these benefits in real life. [ABSTRACT FROM AUTHOR]

Abstract: Epidemiological data concerning acute coronary syndromes in Europe are based on national registries, studies by the European Society of Cardiology within the framework of the EuroHeart Survey and on the study of European population sub-groups in large international cohorts. In this article, recently published studies will be reviewed, and the principal developments in different countries as well as the characteristics and particularities of the most recent epidemiological data will be highlighted. In Europe, the presentation of acute coronary syndromes (ACS) has evolved considerably over the last ten years. This evolution is characterized by a reduction in the proportion of acute coronary syndromes with ST-segment elevation (STEMI) and by ageing populations. [Copyright &y& Elsevier]