Agnès Sommet

Université Toulouse III - Paul Sabatier | UPS Toulouse · Faculté de médecine Purpan

Background. Despite vaccination, patients receiving anti-CD20 monoclonal antibodies (mAbs) for multiple sclerosis (MS) or neuromyelitis optica spectrum disorders (NMOSD) have an increased risk of developing severe or protracted COVID-19. The aim of this study was to describe the effect of COVID-19 convalescent plasma (CCP) in patients with MS or NM...

Background While advances in endovascular thrombectomy (EVT) have led to high reperfusion rates, most patients treated with EVT do not avoid disability. Post‐reperfusion hemorrhagic transformation (HT) is a potential target for improving outcomes. This study examined pretreatment blood–brain barrier (BBB) disruption in tissue that would subsequentl...

Rhegmatogenous retinal detachment (RRD) is a sight-threatening condition with rising global incidence. Identifying factors contributing to seasonal variations in RRD would allow a better understanding of RRD pathophysiology. We therefore performed a retrospective case series study investigating the relationship between RRD occurrence and meteorolog...

In 2018, a significant neural tube defects (NTD) signal was reported after pre‐conceptional exposure to dolutegravir, but was not confirmed in further analysis. Since 2019, dolutegravir‐based regimen, an integrase inhibitor (INI), is recommended by WHO as the most‐effective first‐line therapy in all patients living with HIV. To explore the potentia...

Background Among the different types of pain related to Parkinson's disease (PD), parkinsonian central pain (PCP) is the most disabling. Objectives We investigated the analgesic efficacy of two therapeutic strategies (opioid with oxycodone‐ prolonged‐release (PR) and higher dose of levodopa/benserazide) compared with placebo in patients with PCP....

Background Use of psychostimulants and relative drugs has increased worldwide in treatment of attention-deficit hyperactivity disorder (ADHD) in adolescents and adults. Recent studies suggest a potential association between use of psychostimulants and psychotic symptoms. The risk may not be the same between different psychostimulants. Objective To...

To assess amantadine use and associated factors in the patients with Parkinson’s disease (PD). Immediate-release amantadine is approved for the treatment of PD and is largely used in clinical practice to treat “levodopa-induced dyskinesia (LIDs). Its use varies according to countries and PD stages. The prospective NS-Park cohort collects features o...

Background In addition to the clinical burden, asthma is responsible for a high economic burden. However, little is known about the economic burden of asthma prior to death. Objective We performed an economic analysis to describe the costs during 12 and 24 months prior to asthma death between 2013 and 2017 in France. Methods An observational coho...

Objective To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of serious adverse events in drug trials published on PubMed versus clinical trial summaries on Clinica...

Background: The association between dental problems and sublingual/buccal buprenorphine is unclear. We conducted an analysis of dental adverse drug reactions reported with sublingual/buccal buprenorphine in VigiBase®, the pharmacovigilance database of the World Health Organization. Research design and methods: We performed disproportionality ana...

Background and Purpose: The FRAME study demonstrated that even in the early time window (<6hrs) perfusion imaging profiles can influence response to mechanical thrombectomy. Perfusion imaging (PWI) can also be used to measure damage to the blood-brain barrier (BBB) which has been shown to be associated with increased risk of hemorrhagic complicatio...

Background About 1.3 million pregnant women lived with HIV and were eligible to receive antiretroviral therapy (ART) worldwide in 2021. The World Health Organization recommends protease inhibitors (PI)-based regimen as second or third-line during pregnancy. With remaining pregnant women exposed to PIs, there is still an interest to assess whether t...

Background Postoperative delirium frequently occurs in the elderly after hip fracture surgery and is associated with poor outcomes. Our aim was to identify a correlation between the atropinic burden (AB) due to drugs with clinical antimuscarinic effect and the occurrence of postoperative delirium. Methods We carried out a prospective, monocentric,...

Rationale While meta-analyses of clinical trials found that lurasidone and partial dopamine agonists (brexpiprazole and aripiprazole) were the antipsychotics less likely to cause QTc prolongation, and sertindole, amisulpride, and ziprasidone were the most frequently associated with this adverse drug reaction; no real-world studies have investigated...

Background: Although asthma mortality declined sharply until the mid-2000s, a stagnation in mortality has been observed over the past decade in different countries. Objective: The objective of this study is to describe healthcare resource consumption for patients who died from asthma in France. Method: This study was conducted using data from...

Background A target mismatch profile can identify good clinical response to recanalization after acute ischemic stroke, but does not consider region specificities. Purpose To test whether location-weighted infarction core and mismatch, determined from diffusion and perfusion MRI performed in patients with acute stroke, could improve prediction of g...

Objective: Our aim was to assess the real-world effectiveness of immune checkpoint inhibitors for treatment of patients with progressive multifocal leukoencephalopathy. Methods: We conducted a multicenter survey compiling retrospective data from 79 PML patients, including 38 published cases and 41 unpublished cases, who received immune checkpoin...

Background: About 1.3 million pregnant women lived with HIV and were eligible to receive antiretroviral therapy (ART) worldwide in 2021. The World Health Organization recommends protease inhibitors (PI)-based regimen as second or third-line during pregnancy. With remaining pregnant women exposed to PIs, there is still an interest to assess whether...

Population-based data on the epidemiology of progressive multifocal leukoencephalopathy, its predisposing conditions and mortality rate are lacking, although such data are crucial to raise awareness among clinicians and to lay foundations for future therapeutic trials in immunomodulating therapies. In our study, patients were identified by interrog...

Purpose Fosfomycin trometamol has been recommended as first-line bactericidal antibiotic for urinary tract infections in pregnant women since 2015 in France. However, studies assessing fosfomycin safety in pregnancy are sparse. This study aimed to assess the risk of major Congenital Anomaly (CA) after fosfomycin exposure during the first trimester...

OBJECTIVES:. There is only low-certainty evidence on the use of predictive models to assist COVID-19 patient’s ICU admission decision-making process. Accumulative evidence suggests that lung ultrasound (LUS) assessment of COVID-19 patients allows accurate bedside evaluation of lung integrity, with the added advantage of repeatability, absence of ra...

A fifth vaccine against Covid-19, NVX-CoV2373 Nuvavoxid® (Novavax), a protein-based adjuvanted vaccine, was recently marketed in Europe. The main clinical trial before marketing concluded to a "vaccine efficacy" of 89.7% without talking about other validated efficacy parameters. We further analysed the data of this clinical trial using the differen...

Planning pregnancy is very important for women with epilepsy (WWE), because of the potential teratogenic effects and neurodevelopmental disorders of different antiseizure medications (ASMs). Nevertheless, contraception in WWE can be challenging due to the existence of drug interactions between ASMs and hormonal contraception. The aim of this study...

Background and Objectives Neuropsychiatric disorders in childhood after prenatal drug exposure raises concerns. Most of the published studies focused on psychotropic medications. This study investigated which prenatal medication exposure was associated with neuropsychiatric disorders in childhood. Methods A case-control study, nested in the French...

This cohort study uses data from the French National Health Database to examine the risk of immune thrombocytopenia after receiving influenza vaccine among patients who were 65 years or older.

Objectives: To assess the frequency of patients in drug-free remission at 5 years in a cohort of early axial SpA, and the factors associated with this remission. Methods: Patients: Patients included in the DESIR (DEvenir des Spondyloarthropathies Indifférenciées Récentes) cohort undergoing the 5-year visit were selected for this analysis. Definitio...

Objective: Restoring anti-JC virus (JCV) immunity is the only treatment of progressive multifocal leukoencephalopathy (PML). Interleukin-7 is a cytokine that increases number and function of T cells. We analyzed a population of PML patients who received recombinant human IL-7 (rhIL-7) to estimate survival and its determinants. Methods: After exc...

Introduction: Topical sertaconazole is indicated in the treatment of vaginal or mucocutaneous fungal infections due to Candida and dermatophytosis. To our knowledge, there is no data available in the literature on the potential effects of sertaconazole during pregnancy. The aim of this study was to evaluate the potential risks of topical sertacona...

Background Half of the patients with large vessel occlusion (LVO)-related acute ischemic stroke (AIS) who undergo endovascular reperfusion are dead or dependent at 3 months. We hypothesize that in addition to established prognostic factors, baseline imaging profile predicts outcome among reperfusers. Methods Consecutive patients receiving endovasc...

Background and Purpose Determining the mechanism of large vessel occlusion related acute ischemic stroke is of major importance to initiate a tailored secondary prevention strategy. We investigated using the atherosclerosis, small vessel disease, cardiac source, other cause, dissection (ASCOD) classification the distribution of the causes of large...

Aims In 2018, 1.07 million pregnant women received antiretroviral drugs, raising whether this affects pregnancy outcomes. We assessed the adverse pregnancy outcomes associated with prenatal antiretroviral drug exposure, notified to the French ANRS pharmacovigilance system. Methods An exhaustive case report series has been performed using the ANRS...

We aimed to assess the risk factors of venous thrombosis (VT) and arterial thrombosis (AT) in adults with primary immune thrombocytopenia (ITP), particularly in relation to treatments. The population comprised all incident primary ITP adults in France between 2009 and 2017 (FAITH cohort; NCT03429660) built in the national health database. Outcomes...

Aim To compare different β-adrenoceptor antagonists for the risk of reporting nightmare. Methods The study involved two approaches: first, we investigated in VigiBase ® , the World Health Organization Individual Case Safety Report (ICSR) database, the disproportionality between exposure to each β-adrenoceptor antagonists and reports of nightmares...

Objective Mechanical thrombectomy (MT) is not recommended for acute stroke with large vessel occlusion (LVO) and a large volume of irreversibly injured tissue (“core”). Perfusion imaging may identify a subset of patients with large core who benefit from MT. Methods We compared two cohorts of LVO-related patients with large core (>50 ml on diffusio...

Several vaccines are being developed as part of the Covid‐19 pandemic. Results of clinical trials for these vaccines were published with efficacy values more than 90%, using mainly Relative Risk (RR). In this paper, we decided to reanalyse the data using the different validated methods of risk expression. Using main publications, Absolute Risks (AR...

IntroductionDomperidone is widely used during pregnancy, although the risks associated with pregnant women have not been adequately evaluated.Objective The objective of this study was to compare the rate of pregnancy outcomes and congenital anomalies between pregnant women exposed and unexposed to domperidone during pregnancy.Methods We conducted a...

Social Pharmacology is a branch of clinical pharmacology, which depicts relationships between society and drugs and in particular factors, reasons, social consequences of drug use as well as representations of drugs in the society. Recent development and marketing of coronavirus disease 2019 (COVID-19) vaccines raises a number of questions of Socia...

Aims Adverse drug reactions (ADRs) are important causes of death. However, the main involved drugs are relatively unknown. The present study was performed to characterise death‐related drugs recorded in a large pharmacovigilance database during the last 10 years. Methods A retrospective analysis of VigiBase, the World Health Organization pharmacov...

Background: There are no effective treatments for multiple system atrophy (MSA). Objective: The objective of this study was to assess the efficacy and safety of the serotonin reuptake inhibitor fluoxetine (40 mg/d) for the symptomatic treatment of MSA. Methods: This was a double-blind, parallel-group, placebo-controlled, randomized trial in pa...

Background The impact of prior exposure to systemic corticosteroids on COVID-19 severity in patients hospitalized for a SARS-CoV-2 pneumonia is not known. The present study was designed to answer to this question. Methods The population study was the Covid-Clinic-Toul cohort which records data about all hospitalized patients with a positive revers...

Background: Patients with Hailey-Hailey and Darier diseases present with disabling inflammatory lesions located in large skin folds, which are often exacerbated or induced by sweating. Quality of life is highly impaired because of pain and recurrent skin infections. An improvement in skin lesions after botulinum toxin A injections has previously b...

Background: The efficacy of rifaximin in the secondary prevention of overt hepatic encephalopathy (HE) is well documented, but its effectiveness in preventing a first episode in patients after transjugular intrahepatic portosystemic shunt (TIPS) has not been established. Objective: To determine whether rifaximin prevents overt HE after TIPS comp...

Objectives In recent clinical trials some cardiac arrhythmias were reported with use of remdesivir for COVID-19. To address this safety concern, we investigated whether use of remdesivir for COVID-19 is associated with an increased risk of bradycardia. Methods Using VigiBase®, the World Health Organization Global Individual Case Safety Reports dat...

Several papers have reported that tramadol can induce hypoglycemia. However, in some reports, confounding factors can be found, like coadministration of hypoglycemic drugs. We used the WHO pharmacovigilance database (VigiBase®) to investigate if tramadol alone could be associated with hyponatremia. All 2010‐2019 ICSRs (Individual Case Safety Report...

Background and Purpose Mechanical thrombectomy (MT) is the recommended treatment for acute ischemic stroke caused by anterior circulation large vessel occlusion. However, despite a high rate of reperfusion, the clinical response to successful MT remains highly variable in the early time window where optimal imaging selection criteria have not been...

Introduction Autoimmune hemolytic anemia (AIHA) is a rare disease characterized by the destruction of red blood cells by warm or cold autoantibodies. Epidemiological data are lacking about AIHA incidence, the prevalence of associated disorders and the risk of death, thrombosis and infection as compared with the general population. This study was de...

Data are lacking on the impact of ACEI/ARB exposure on unfavorable outcome in the population of patients hospitalized for COVID‐19 with hypertension/cardiovascular disease, particularly in Europe. The ACE‐CoV study was designed to assess this question. The study was conducted in the Covid‐Clinic‐Toul cohort, which contains data about all patients h...

Background: Patients with Hailey-Hailey and Darier diseases present with disabling inflammatory lesions located in large skin folds, which are often exacerbated or induced by sweating. Quality of life is highly impaired because of pain and recurrent skin infections. An improvement in skin lesions after botulinum toxin A injections has previously be...

Thrombocytopenia (defined by platelet count <150 x 10⁹/L) has been observed in up to 36% of patients with the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), the virus responsible for Coronavirus disease 2019 (COVID‐19; Guan et al , 2020). In this setting, thrombocytopenia is usually mild, caused by platelet activation and consumption...

Purpose To describe drug prescriptions in pregnant women in France and to identify teratogenic and fetotoxic drug prescriptions. Methods This study was carried out using data from EGB (Echantillon Généraliste des Bénéficiaires), a French national health database which includes 1/97th of the French population. Our study population included all pregn...

IntroductionFluoroquinolones are widely used to treat bacterial infections. Many in vitro and in vivo studies have established a chemical relationship between fluoroquinolones’ particular chemical structure and photosensitivity. The aim of this study was to establish a relationship between the chemical structure of fluoroquinolones and the risk of...

PurposeThe aim of this study was to compare tracheal intubation conditions after induction of anesthesia with a bolus of propofol-sufentanil or propofol-remifentanil and a rapid induction technique.Material and methodsA total of 70 patients (American Society of Anesthesiologists (ASA) classification I‑II) undergoing outpatient surgery under general...

Introduction: Target mismatch (TMM) identifies salvageable penumbra independent of time from stroke onset. Current guidelines do not recommend advanced imaging to select patients for mechanical thrombectomy (MT) within 6 hours after onset but indicate that more research is needed. To address this question, we designed a prospective multicenter coho...

Introduction: Epidemiological studies suggest a risk of immune thrombocytopenia (ITP) following viral infections, particularly influenza. Conversely, an increased risk of ITP following vaccination has been proven for some vaccines like Measles-Mumps-Rubella vaccine. However, the risk of ITP induced by influenza vaccine is debated. Two case-controls...

Background: In preclinical studies, eltrombopag has been associated to an increased incidence of cataract in mice and rats. No increased risk has been observed in randomized controlled trials in immune thrombocytopenia (ITP) patients. During the eltrombopag extension study EXTEND, 28/302 patients developed or worsened cataract, i.e. 9.3% of the pat...

Background and Purpose: Whether patients with both lobar and deep cerebral microbleeds (mixed CMB) have advanced cerebral amyloid angiopathy (CAA), hypertensive angiopathy (HA) or both is uncertain. To get insight into the underlying small vessel disease (SVD) associated with mixed CMB, we explored its association with cortical superficial siderosi...

Objective: Central venous catheter insertion is a common practice for anesthetists, but this invasive procedure generates anxiety and pain in patients that are often underestimated. We compared target controlled infusion of remifentanil and local lidocaine infiltration to placebo and local lidocaine infiltration to decrease pain scores during cent...

Background The aim of this study was to compare tracheal intubation conditions after anesthetic induction bolus of propofol-sufentanil or propofol-remifentanil. Methods A total of 70 patients, ASA I-II undergoing ambulatory surgery under general anesthesia with intubation for tooth extraction were randomly assigned in this double-blind study. They...

Taking a medication is usually a challenge for a pregnant woman as the beneficial drug effect on the mother has to be considered regarding its potential adverse effects, not only for her but also for her unborn child. As medication use is common in pregnant women, by chance or necessity, it gives the opportunity to evaluate the consequences of pren...

Relations between hypolipidemic drugs and diabetes are discussed. The aim of our study was to assess the association between diabetes and use of statins or fibrates or their association using the World Health Organization (WHO) global individual case safety reports database, VigiBase®, which records reports from over 130 countries worldwide. We per...

A recent cohort study described a 66% increased rate of aortic aneurysms in patients receiving fluoroquinolones (Pasternak et al. BMJ 2018; 360:k678). The authors did not study the different fluoroquinolones. The present study was performed to investigate the fluoroquinolones more at risk of aortic aneurysms. We used Vigibase®, the World Health Org...

Background and purpose Diffusion‐weighted imaging (DWI) commonly detects acute ischaemic lesions in patients with acute intracerebral hemorrhage (ICH), especially with cerebral amyloid angiopathy (CAA). We investigated the relationship between cortical superficial siderosis (cSS), a neuroimaging marker of CAA, and DWI lesions in patients with acute...

Introduction: The association of measles, mumps and rubella (MMR) vaccination with immune thrombocytopenia (ITP) occurrence has been shown. The risk of ITP with other vaccines is still not known. This study was aimed at assessing the association of recommended vaccinations in children with ITP occurrence. Methods: We conducted a population-based st...

In contrast to statins, the risk of diabetes with fibrates was not clearly studied. The present study investigates a putative signal of diabetes associated with the use of fibrates using the World Health Organization (WHO) global individual case safety reports database, VigiBase®. We included all reports registered until the 31st December 2017 in V...

Adherence to antiretroviral (ARV) is crucial to achieve viral load suppression in HIV-infected patients. This study aimed to compare adherence to generic multi-tablet regimens (MTR) ver-sus brand MTR likely to incorporate ARV drugs without breaking fixed-dose combinations (FDC) and brand single-tablet regimens (STR) likely to incorporate generics b...

The aim of this study was to compare the infectious risk between a group of psoriasis patients treated by Biological Drugs (BD) and a group treated by Traditional Systemic Treatments (TST). We built a retrospective observational cohort study from the French health insurance database in the Midi-Pyrénées area (2.9 million inhabitants, South West of...

The French healthcare insurance databases have proven to be valuable tools for the conduct of pharmaco-epidemiological studies with regards to the size of the population covered and that of the available information. Their wider use in the field of pediatric pharmacoepidemiology is of paramount importance given the existing gap of knowledge in the...

Background: Transient ischemic attacks and minor stroke are vascular emergencies associated with a high risk of brain infarction within the first hours after onset. When available those patients may be evaluated and managed in a TIA clinic. Several therapeutic strategies are currently tested within 12 hrs after TIA/minor stroke onset. We aim to inv...

Introduction Simulation studies showed that generic antiretroviral (ARV) drug utilization could lead to significant cost reduction of HIV treatment in developed world. This study aimed to quantify ARV utilization and costs in European countries between 2006 and 2015. We also assessed the impact of generic ARV drug utilization on cost reduction in r...