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NCT Number: NCT03449784

Assessment of Compliance With European and French Guidelines for the Management of Dyslipidaemias

Cardiovascular disease (CVD) due to atherosclerosis of the arterial vessel wall and to thrombosis is the foremost cause of premature mortality and of disability-adjusted life years in Europe, and is also increasingly common in developing countries. In the European Union, the economic cost of CVD represents annually €192 billion in direct and indirect healthcare costs. The main clinical entities are coronary artery disease (CAD), ischaemic stroke, and peripheral arterial disease (PAD). The causes of these CVDs are multifactorial. Some of these factors relate to lifestyles, such as tobacco smoking, lack of physical activity, and dietary habits, and are thus modifiable. Other risk factors are also modifiable, such as elevated blood pressure, type 2 diabetes, and dyslipidaemias, or non-modifiable, such as age and male gender. LDL-cholesterol (LDL-C) is one of the major risk factors for CVD, through its role in the development of atherosclerosis. The efficacy of statins has been demonstrated by a considerable amount of literature not only in lowering LDL cholesterol levels but also in reducing cardiovascular events, both in diabetes and non-diabetes patients. Guidelines for the management of dyslipidemia have emerged from different countries. Thereby, in 2016 the French Society of Endocrinology (SFE) and the New French Society of Atherosclerosis (NSFA) published a consensus statement on the management of dyslipidemias integrating features from European recommendations and in 2017 the Haute Autorité de Santé updated the French guidelines. However, LDL-C goal attainment has rarely been assessed specifically in diabetes population, in which CVD is of particular importance. This study aimed to assess the rate of dyslipidaemias in a population of patient hospitalized in Endocrinology-Diabetology-Nutrition unit.

This observational study was carried in the Diabetes-Nutrition unit of the University Hospital of Montpellier - France. All consecutive patients admitted to that unit during the study period were assessed for eligibility. Data on age, sex, tobacco smoking, body mass index, hypertension (treatment of previously diagnosed hypertension or blood values > 140/90 mmHg), presence and type of CVD (coronary artery disease, stroke and transient ischemic attack, peripheral arterial disease), were collected at admission. LDL-C, HDL-C and triglycerides levels calculated with the Friedewald formula, and glomerular filtration rate calculated according to the CKD-EPI formula were obtained from blood samples taken within 24 hours of hospitalization admission. Information on the name and daily dose of lipid lowering drugs (statins, fibrate, ezetimibe …) at admission was documented. Cardiovascular risk level and LDL-C target values were defined according to 2011 and 2016 ESC guidelines and 2017 French guidelines.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Location status: Recruiting

Location contact

A Avignon

PRINCIPAL_INVESTIGATOR

A Sultan

PRINCIPAL_INVESTIGATOR

B Sallerin

PRINCIPAL_INVESTIGATOR

P Cestac

PRINCIPAL_INVESTIGATOR

P Goudry

PRINCIPAL_INVESTIGATOR

cyril BREUKER

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged above 18 years old, admitted to the department during the study period and hospitalized for at least 24 hours, blood samples taken within 24 hours of hospitalization admission (LDL-C, triglycerides)

Exclusion criteria

  • Patients with elevated triglycerides (>4.5 mmol/L or >400 mg/dL)

Treatment and study plan

Detection of patients with dyslipidemia

Other

Detection of patients with dyslipidemia

Primary outcomes

  1. number with dyslipidemia

    Time frame: 1 day

    number of patient with dyslipidemia

Secondary outcomes

  1. number of patient not achieving LDL-C target according to cardiovascular risk

    Time frame: 1 day

    number of patient not achieving LDL-C target according to cardiovascular risk

Study contacts

Contact information is provided by the study sponsor or research team.

Cyril BREUKER, PharmD,Phd

CONTACT

[email protected]

467337121 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • University Hospital, Toulouse

Registry information

Official study title

Observatory of Patients With Dyslipidemia Hospitalized in Endocrinology-Diabetology-Nutrition Unit: Observational Study

Acronym: OBDYSLIP

Important dates

Study start
2012
Primary completion
2040
Study completion
2041
First posted
Feb 28, 2018
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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