Study identification

EU PAS number

EUPAS3772

Study ID

20236

Official title and acronym

Association between anxiolytic or hypnotic drugs and total mortality

DARWIN EU® study

No

Study countries

France
United Kingdom

Study description

Benzodiazepines 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

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Maryse Lapeyre-Mestre

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable