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Université Bordeaux 2 CHU de Bordeaux INSERM
Département Hospitalo-Universitaire de Pharmacologie de Bordeaux
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Pharmacoepidemiology Unit studies

The Pharmacoepidemiology unit carries out numerous public health studies in collaborations with the research unit INSERM U657 and the ministry of Health...

 

EREBUS study

EREBUS is a French observational cohort study. The main objective is to evaluate the resection rate of metastases at 12 months in real-life setting for patients with metastatic colorectal cancer and treated by cetuximab in 1st-line tratment. Cetuximab, a targeted-therapy, is a monoclonal antibody that specially blocks the EGFR (Epidermal Growth Factor Receptor). Furthermore, others research works wrer developed with identification of new biologic predictive factors as KRAS oncogene mutation. Presently, cetuximab is indicated in first-line treatment for patients with metastatic colorectal cancer and wild-type KRAS.

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SANTORIN study

The treatment of metastatic renal cancer has seen a major evolution with the arrival of target therapies such as antiangiogenics that have become gold-standard therapies for this disease. As part of a pharmacoepidemiology platform following targeted therapies in oncology, the Department of Pharmacology of Bordeaux is performing a study on the Survey of ANTI-angiOgenic use in Renal cancer IN a real-life setting (SANTORIN). This observational national (French) cohort performed in collaboration with hospital practitioners plans to include a total of 350 patients and to follow these for a period of 24 months. The principal objective of which is to estimate the overall survival at 24 months of patients suffering from metastatic renal cancer and treated in a real-life setting and by antiangiogenics as a first-line treatment and to determine whether or not this differs from that reported by pivotal clinical trials which contributed to market authorisation.

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PriSMe study

The PriSMe study (Prise en charge multidisciplinaire du Syndrome Métabolique lors d'une cure thermale) is a pharmaco-epidemiological, observational, prospective population-based study. The aim of this study is to assess the maximum effect of multidisciplinary care (dietetic, physical and psychological) to the one-year improvement of metabolic syndrome and the quality of life of patients undertaking spa therapy. This study will begin in July 2008 to include 150 patients with a metabolic syndrome undertaking spa therapy at Eugénie Les Bains, Western France. Patients are to be evaluated at initiation of spa therapy as well as 6 and 12 months after its completion.

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ETNA study

Observational inter-regional (France) cohort study of 330 patients with metastatic colorectal cancer treated by Avastin® and followed for a minimum of 12 months. The principal objective is to estimate the overall 12-month survival of patients treated with Avastin® in a real-life setting and to determine whether or not this differs from that reported by the pivotal clinical trial which contributed to market authorisation.

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COLCHIC study

Observational study evaluating chemotherapy practices in 200 patients, presenting with colorectal cancer at the Bordeaux teaching hospitals and followed for 18 months in the context of the evaluation of professional practices. The objectives are to survey and describe the modalities of use of chemotherapies used in the Bordeaux teaching hospitals and to determine whether prescription practices are in accordance with current official recommendations.

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THEATRE study

Observational study on the evaluation of the therapeutical strategies during the acute exacerbation of chronic bronchitis in real-life medical practise.

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VESUVE study

Observational study of 700 patients followed over 3 years at the request of the French Transparency Commission in the context of rating the Improved Medical Benefit (Amélioration du Service Médical Rendu) of Velcade®.
In agreement with the Janssen-Cilag laboratories, the Department of Pharmacology is in charge of the coordination of the study that aims to: evaluate the survival and treatment response of patients taking Velcade® for multiple myeloma, describe the population of patients initiating this treatment and the conditions of use.

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EOLE study

The EOLE study (Etude Observationnelle de suivi Long terme du post-infarctus du MyocardE) was initiated at the request of the health authorities and is sponsored by the French Society of Cardiology and the National College of French Cardiologists. The main objective of this study is to evaluate the impact on mortality of cardiovascular drugs recommended for secondary prevention of myocardial infarction as well as dietetics in a real-life setting. This study began in May 2006 and will end in December 2015. A cohort of 5000 patients will be included and these followed for 6 years.

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EULEV study

The EULEV study (Efficacité et Utilisation du Lévétiracétam En Vie réelle) was requested from UCB Pharma by the health authorities. The objective of this epidemiological study is to describe the prescription modalities and to assess real-life efficiency of levetiracetam over one year in patients initiating this treatment. This study is the first observational study of levetiracetam performed in France. This study has started in September 2005 and its results will be communicated in November 2008.

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ABSINTHE study

Observational study of therapeutical strategies in acute sinusitis during real-life medical practise.

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CADEUS study

The CADEUS study (COX-2 and tNSAIDs: Description of users) is an observational cohort study performed at the request of the French health authorities. The objective of which was to describe the use of selective (coxibs) and traditional non-steroidal anti-inlfammatory drugs (NSAIDs) in a real-life setting. This study included over 45 thousand patients and the principal results have now been published.

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