CADEUS - Cox-2 and tNSAIDs: Description of users
Head :
MOORE Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
FOURRIER-REGLAT Annie, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
BLIN Patrick, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
FOURRIER-REGLAT Annie, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
BLIN Patrick, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Last update : 04/02/2012 | Version : 1 | ID : 2926
| General | |
| Identification | |
| Detailed name | Cox-2 and tNSAIDs: Description of users |
| Sign or acronym | CADEUS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTI-RS 03.135, CNIL 903102 |
| General Aspects | |
| Medical area |
General practice Rheumatology |
| Health determinants |
Iatrogenic |
| Others (details) | Use of Cox-2 and traditional NSAIDs |
| Keywords | Celebrex, NSAIDs, traditional non-steroidal anti-inflammatory drugs, gastroprotective drugs, cardiovascular events, gastrointestinal events, health authotities (Comité Economique des Produits de Santé), Cyclo-oxygenase 2, coxibs, Vioxx, use, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | MOORE |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX cedex |
| Phone | 05 57 57 46 75 |
| nicholas.moore@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Name of the director | FOURRIER-REGLAT |
| Surname | Annie |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX cedex |
| Phone | 05 57 57 46 75 |
| annie.fourrier@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Name of the director | BLIN |
| Surname | Patrick |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX cedex |
| Phone | 05 57 57 46 75 |
| patrick.blin@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Laboratoire Merck Sharp et laboratoire Pfizer (soutiens inconditionnels) - Merck Sharp and Pfizer (unconditional support) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Additional information regarding sample selection. | Patients who received between August 2003 and June 2004 dispensation of a coxib or tNSAID were randomly selected from the CNAM-TS database using the following criteria: not dead according to information in the ERASME database, living in metropolitan France with a valid address; having had a dispensation of an NSAID of interest during the month preceding selection; with at least one healthcare reimbursement within six months preceding the date of dispensation; for whom the contact details of the prescribing physician were available,; not previously selected from the source population; not being listed as a subject under guardianship or in prison. |
| Database objective | |
| Main objective | The objective of this study was to better understand the use of anti-inflammatory drugs, cyclo-oxygenase 2 (COX-2) or coxib (Vioxx®, Celebrex®) and traditional anti-inflammatory drugs (tNSAIDs, e.g. Aspirin, Ibuprofen) in France and to describe and assess the risks of adverse events possibly related to treatment. |
| Inclusion criteria | Patient randomly selected from the source population using the following criteria: not dead according to the ERASME database, living in France with a valid address, with dispensation of an NSAIDs of interest during the month preceding selection, with at least one healthcare reimbursement within six months preceding the date of dispensation, for whom the contact details of the prescribing physician were available, not previously selected from the source population, not being listed under guardianship or in prison; patient agreeing to participate in the study |
| Population type | |
| Age |
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 covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2003 |
| Date of last collection (YYYY or MM/YYYY) | 2005 |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | 45 217 patients inclus - 45 217 patients included |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire |
| Administrative data (detail) | Name, address and telephone number of the patient, the prescribing physician, the general practitioner. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | A self-administered questionnaire sent to each selected patient and prescriber of the NSAID of interest, has allowed the collection of the information requested by Comité Economique des Produits de Santé. For patients agreeing to participate in the study, healthcare reimbursement data for six months before and six months after the reference date (dispensation date of NSAID of interest) were retrieved from the CNAM-TS database. Hospitalizations for cardiovascular events or digestive having occurred between the reference date and the date of questionnaire completion have been documented (retrieval of hospital discharge summaries by a CRA from the prescribing physician or general practitioner with return to the Department of Pharmacology by post). The reason for hospitalization was subsequently validated by a committee blinded to the NSAID of interest and according to predefined diagnostic criteria. |
| Participant monitoring |
No |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Extraction from the ERASME database of the CNAM-TS |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed?term |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | The confidential study reports were submitted to the pharmaceutical companies. The study reports and scientific communications (posters, articles, ...) are validated by the study Scientific Committee. Ownership of study data was the subject of an agreement between the University Bordeaux Segalen and pharmaceutical companies. Terms for third-party access to the database are to be defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
