Status: Finalised First registered on: 04/04/2013
Last updated on: 02/08/2017
1. Study identification
EU PAS Register NumberEUPAS3772
Official titleAssociation between anxiolytic or hypnotic drugs and total mortality
Study title acronym
Study typeObservational study
Brief description of the studyBenzodiazepines and related drugs are indicated either for the short-term treatment of moderate or severe anxiety or insomnia. They could be involved in a wide range of fatal and non-fatal outcomes. However, the ways by which these drugs can lead to an increased mortality are not entirely elucidated. This study intends to investigate the impact of benzodiazepine and related exposure on all cause and specific mortality among cohorts obtained from a representative sample of French beneficiaries of the national health insurance scheme (EGB) and through a large healthcare database (CPRD) in the United Kingdom. Patients > 18 and exposed to at least one benzodiazepine derivative or related substance will be matched to one to 10 unexposed controls , and followed up from their inclusion to either death or 90 days following the last benzodiazepine exposure. All cause and cause specific mortality will be investigated, together with patients’ sociodemographics, medicines use, medical history, and life-style (alcohol, smoking, for CPRD exclusively). Time to death will be analysed using an extended Cox regression model with time-dependent covariates
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacoepidemiology INSERM 1027
Department/Research groupPharmacoepidemiology research team
Organisation/affiliationUniversity of Toulouse 3 and INSERM 1027
Website/Homepagehttp://www.u1027.inserm.fr/
Details of (Primary) lead investigator
Title Dr
Last name Lapeyre-Mestre
First name Maryse
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/09/201217/09/2012
Start date of data collection17/04/201329/04/2013
Start date of data analysis
Date of interim report, if expected17/07/201323/08/2013
Date of final study report17/09/201307/10/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lapeyre-Mestre
First name Maryse
Address line 137 Allees Jules
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance
Phone number (incl. country code)33-561145960 
Alternative phone number33-561145606 
Fax number (incl. country code)33-561145928 
Email address maryse.lapeyre-mestre@univ-tlse3.fr
Public Enquiries
Title Dr 
Last name Lapeyre-Mestre 
First name Maryse 
Address line 137 Allees Jules 
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance 
Phone number (incl. country code)33-561145960 
Alternative phone number33-561145606 
Fax number (incl. country code)33-561145928 
Email address maryse.lapeyre-mestre@univ-tlse3.fr 
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