Optimizing Statin Tratment in People Living With Diabetes (MEDPHARM-RCV)

Medico-pharmaceutical Collaboration in Optimizing Statin Tratment in People Living With Diabetes

Hypercholesterolemia is frequent (prevalence of 30% in general population) and constitue with diabetes, obesity and arterial hypertension a major risk factor of atherosclerosis that leads to cardiovascular diseases (CVD). 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. 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 patients which requiered an management in cardiovascular risk treatment according to european recommendations.

This observationnal study was carried in Diabetes-Nutrition unit of the University Hospital of Montpellier - France. Data of age, sex, tobacco smoking, body mass index, hypertension, presence and type of CVD (coronary artery disease, stroke, peripheral arterial disease), treatment by statins (intensity, molecule, dosage), diabetes complicaion (nephropathy, retinopathy) were collected at admission. Management of cardiovasculare risk treatment (initiation, modificiation of dosage, molecule or others …) were collected during hospitalization and at discharge of hospitalization. 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. Cardiovascular risk level and LDL-c target values were definied according to ESC guidelines.

Study Overview

• Status: Completed
• Conditions: Diabetes

• Study Type: Observational
• Enrollment (Actual): 387

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population was composed of people living with diabetes hospitalized in Diabetes-Nutrition unit of Montpellier University hospital

Description

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with treatment	rate of patient which requiered an management in cardiovascular risk treatment according to european recommendations	about 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical characteristics of patients	clinical characteristics of patients requiered an management in cardiovascular risk treatment at hospital admission.	1 day
biological characteristics of patients	biological characteristics of patients requiered an management in cardiovascular risk treatment at hospital admission.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Cyril BREUKER, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: March 21, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: cardiovascular risk; dyslipidemia; low-density lipoprotein cholesterol; lipid-lowering therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: RECHMPL19_0541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No