Status: Finalised First registered on: 25/11/2013
Last updated on: 21/09/2016
1. Study identification
EU PAS Register NumberEUPAS5275
Official titleComparison of care use between cohorts differentiated by the patients adherence to statins in France between 2005 and 2008
Study title acronymC2STAT
Study typeObservational study
Brief description of the studyCardiovascular disease is the leading cause of death worldwide, with about 30 % of deaths. Statins (or HMG -CoA reductase inhibitors) form a class of lipid-lowering drugs, drugs used to lower cholesterol levels in people at risk for cardiovascular disease. Statins are now considered as the most effective therapeutic class for the treatment of hypercholesterolemia. They also demonstrated their beneficial effect on all-cause mortality decrease and on the occurrence of cardiovascular events. Statins are one of the main expenditure for the French health insurance since the early 2000s (1.28 billion euros in 2008). The financial burden associated with statins should remain a major concern in the coming years, particularly because of the aging population and the increased prevalence of risk factors such as diabetes or obesity, often associated with abnormal lipids. The objective of this study is to compare the use of health care, and the costs associated, with each patient cohorts differentiated by adherence to statin therapy, between 2005 and 2008, based on the French health national insurance database (EGB) which contains healthcare reimbursement data of 1/97 of the French population. The study mainly describes the annualized costs of care use in patients who have had an introduction to statin therapy and compares these costs between three cohorts defined by the level of adherence to statin therapy. It also describes the study population (socio-demographic characteristics, therapeutic profile of patients, characteristics associated with the initiation of statin therapy, level of adherence), identifies factors associated with annualized costs and poor adherence to statins and compare cardiovascular events between the three cohorts defined by level of adherence to statins.
Was this study requested by a regulator?No
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 belongsPELyon
Department/Research groupUnité de Pharmacoépidémiologie
Organisation/affiliationUniversité Claude Bernard Lyon 1
Website/Homepagehttp://eia.univ-lyon1.fr
Details of (Primary) lead investigator
Title Dr
Last name VAN GANSE
First name Eric
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
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/07/200901/07/2009
Start date of data collection15/07/200915/07/2009
Start date of data analysis15/07/201002/08/2010
Date of interim report, if expected
Date of final study report16/09/201116/09/2011
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name VAN GANSE
First name Eric
Address line 1Unité de Pharmacoépidémiologie
Address line 2Faculte d'Odontologie Universite Lyon 1 
Address line 311 rue Guillaume Paradin 
CityLyon cedex 08 
PostcodeF-69372 
CountryFrance
Phone number (incl. country code)33-478778610 
Alternative phone number 
Fax number (incl. country code)33-478778660 
Email address eric.van-ganse@univ-lyon1.fr
Public Enquiries
Title Dr 
Last name VAN GANSE 
First name Eric 
Address line 1Unité de Pharmacoépidémiologie 
Address line 2Faculte d'Odontologie Universite Lyon 1 
Address line 311 rue Guillaume Paradin 
CityLyon cedex 08 
PostcodeF-69372 
CountryFrance 
Phone number (incl. country code)33-478778610 
Alternative phone number 
Fax number (incl. country code)33-478778660 
Email address eric.van-ganse@univ-lyon1.fr 
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