Comparison of care use between cohorts differentiated by the patients adherence to statins in France between 2005 and 2008 (C2STAT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15439
• EU PAS number:
  EUPAS5275
• Study ID:
  15439
• Official title and acronym:
  Comparison of care use between cohorts differentiated by the patients adherence to statins in France between 2005 and 2008 (C2STAT)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Cardiovascular 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Université Claude Bernard Lyon 1

Study timelines

Date when funding contract was signed

Planned: 01/07/2009

Actual: 01/07/2009

Study start date

Planned: 15/07/2009

Actual: 15/07/2009

Data analysis start date

Planned: 15/07/2010

Actual: 02/08/2010

Date of final study report

Planned: 16/09/2011

Actual: 16/09/2011

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable