Study identification

PURI

https://redirect.ema.europa.eu/resource/46554

EU PAS number

EUPAS37569

Study ID

46554

Official title and acronym

Cardiovascular-Renal-Metabolism comorbidity epidemiology and healthcare utilisation – Observational studies across Europe – French part of the study program (CaReMe Europe)

DARWIN EU® study

No

Study countries

France

Study description

Commonalities between cardiovascular, renal and metabolic (CaReMe) diseases with clinical overlap between these diseases and their associated complications are increasingly recognized. AstraZeneca conducts a European study program in 10 countries according to a common protocol to address specific unanswered questions on the epidemiology of CaReMe disorders and the impact of these on healthcare utilization, using the French claims database (SNDS) for the French part of the program. The French cohort will include all adult type 2 diabetes (T2D) patients in 2014 with a follow-up of 5 years and having 4-year history period before the index date (01/01/2014) in the database. The cardiovascular and renal disease-free T2D population will include all T2D patients without angina, unstable angina, atrial fibrillation, myocardial infarction (MI), heart failure (HF), coronary revascularisation, stroke, transient ischemic attack, peripheral artery disease (PAD), peripheral artery revascularisation, chronic kidney disease (CKD) or dispensing of nitrates within the 4-year period before the index date. Several co-morbid T2D populations will be defined as cardiorenal syndrome (HF and CKD) population, HF population, CKD population, stroke population, MI population and PAD population. It is expected for the study approximately 3 million of T2D population in 2015. The events of interest (cardiorenal disease HF or CKD, HF, CKD, PAD, MI, stroke, and all-cause death) during the study period will be described in terms of crude incidence rate (person-year), cumulative incidence/probability (in %, Kaplan-Meier estimator or Cumulative Incidence Function), and risk comparison for each event between disease-free and co-morbid populations (Cox proportional hazards model or Fine and Grey Model). Specific cost (all payer perspective) of HF, CKD, cardiorenal diseases (HF or CKD), PAD, MI, or stroke will be estimated during the follow-up in T2D patients free from cardiovascular and renal diseases.

Study status

Ongoing
Research institutions and networks

Institutions

University of Bordeaux
France
First published:
01/02/2024
InstitutionEducational Institution

Contact details

Patrick Blin

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable