ITMO Santé Publique
ITMO Santé Publique
Date de modification : 26/10/2017 | Version : 3 | ID : 2824
| Général | |
| Identification | |
| Nom détaillé | Effectiveness and Use of Levetiracetam in Real Life |
| Sigle ou acronyme | EULEV |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CCTIRS 04.198, CNIL 904498 |
| Thématiques générales | |
| Domaine médical |
Neurology Psychology and psychiatry |
| Déterminants de santé |
Iatrogenic Medicine |
| Mots-clés | Levetiracetam, prescribing patterns, effectiveness, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Fourrier-Reglat |
| Prénom | Annie |
| Adresse | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Téléphone | + 33 (0)5 57 57 46 75 |
| annie.fourrier@pharmaco.u-bordeaux2.fr | |
| Laboratoire | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisme | Université Bordeaux |
| Nom du responsable | Moore |
| Prénom | Nicholas |
| Adresse | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Téléphone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@pharmaco.u-bordeaux2.fr | |
| Laboratoire | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisme | Université Bordeaux |
| Collaborations | |
| Financements | |
| Financements |
Mixed |
| Précisions | Laboratoire UCB Pharma (soutien inconditionnel) - UCB Pharma (unconditional support) - Inserm |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | INSERM |
| Statut de l’organisation |
Secteur Public |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Longitudinal study (except cohorts) |
| Origine du recrutement des participants |
A selection of health institutions and services |
| Critère de sélection des participants |
Medication(s) taken |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon | Two parallel and complementary studies have been implemented. An observational study was conducted among a sample of hospital and non-hospital neurologists who were to retrospectively include over two periods 1000 patients who had received a first prescription of levetiracetam (between 1 January and 31 August 2005, or between January 1 and August 31, 2006 for the second period). For each inclusion period, all neurologists registered in the "Cegedim" database were invited by post to participate in the study.In parallel, a study based on the EPIB sample from the SNIIRAM database was performed using two extractions of anonymised data of patients who had at least one reimbursement of levetiracetam between 1 July 2004 and 31 August 2005 for the first extraction and between 1 July 2005 and 31 August 2006 for the second.The study based on the EPIB sample allowed the verification of the field study sample validity and to collect information independently of the field study. |
| Objectif de la base de données | |
| Objectif principal | The objectives of this study were to describe patients initiating treatment with levetiracetam, the prescribing patterns, and to evaluate the effectiveness of levetiracetam in a real-life situation in terms of treatment retention over one year. |
| Critères d'inclusion | Patients who initiated treatment with levetiracetam between 01/01/2005 and 31/08/2005 or between 01/01/2006 and 31/08/2006 (irrespective of whether or not treatment was continued), and having never previously been treated with levetiracetam; patient agreeing to participate; patient can be followed over the next 12 months; Patient not participating in a clinical trial (Huriet-Sérusclat). |
| Type de population | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | Hospital and non-hospital neurologists in metropolitan France |
| Collecte | |
| Dates | |
| Année du premier recueil | 2006 |
| Année du dernier recueil | 2008 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
[500-1000[ individuals |
| Détail du nombre d'individus | 858 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data |
| Données cliniques, précisions |
Direct physical measures |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Health event/mortality Health care consumption and services |
| Consommation de soins, précisions |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Modalités | |
| Mode de recueil des données | Included patients were the subject of collection of indirectly personal medical data (patient questionnaire completed by the neurologist) at inclusion, at each follow-up visit, and at one year of follow-up or in case of discontinuation of levetiracetam data will be collected for all patients. |
| Suivi des participants |
Yes |
| Détail du suivi | Levetiracetam-treated patients were followed for a period of one year (from date of levetiracetam initiation). |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Lien vers le document | http://www.ncbi.nlm.nih.gov/pubmed?term=eulev%20NOT%20eulevp&cmd=correctspelling |
| Description | List of publications in Pubmed |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | A final study report was submitted to the funder. The final study report and scientific communications (posters, articles, ...) are validated by the study Scientific Committee. Ownership of study data is the subject of an agreement between the University of Bordeaux Segalen and the funder. Terms for third-party access to the database are to be defined. |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
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