Da Vinci
Research type
Research Study
Full title
EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care DA VINCI
IRAS ID
228208
Contact name
Kausik Ray
Contact email
Sponsor organisation
Amgen Ltd
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
It is estimated that up to 50% of the European population aged 35-64 years has a total cholesterol > 6.5 mmol/L, (equivalent to > 254 mg/dL). This high occurrence of dyslipidemia translates into significant cardiovascular morbidity and mortality, through development of atherosclerotic cardiovascular disease. The Cholesterol Treatment Trialist’s Collaboration (2005, 2010, 2012) have shown that for every 1 mmol/L (equivalent to 39 mg/dL) reduction of LDL cholesterol (i.e. ‘bad cholesterol’), there is an approximate 20% reduction in the risk of heart attacks, heart surgery, or stroke, and this is similar in patients with and without a history of cardiovascular disease. Despite this, there is a lack of appreciation of the benefits of cholesterol-lowering therapies.
This study will provide new information on how patients with dyslipidemia are managed in primary care and secondary care settings across Europe. The main objective of the study is to estimate the proportion of patients with or without atherosclerotic cardiovascular disease who have a LDL cholesterol above the recommended guidelines level despite being prescribed cholesterol-lowering treatment.
The study is observational and will include 6,000 patients across 18 European countries who attend their GP or hospital doctor for routine appointments. A short questionnaire is completed by the patient and recent medical history will be recorded from the patient’s clinical notes by the research team. No further follow up is required. To be eligible, patients are required to be over 18 years old, have a LDL cholesterol measure within the previous 14 months, are prescribed cholesterol-lowering treatment within the previous 12 months and are expected to survive for at least 1 year after enrolment. The study is funded by a pharmaceutical company.REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0863
Date of REC Opinion
30 May 2017
REC opinion
Further Information Favourable Opinion