Statin Compliance of Patients With Non-insulin-dependent Diabetes (DIOS)

Evaluation of Statin Compliance of Patients With Non-insulin-dependent Diabetes

The diabetic population has an increased cardiovascular risk compared to the general population.

Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia.

Many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and as secondary prevention, to avoid recurrence.

However, compliance to these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness.

The purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.

Study Overview

• Status: Terminated
• Conditions: Non-insulin-dependent Diabetes
• Intervention / Treatment: Other: Girerd test

Detailed Description

The diabetic population has an increased cardiovascular risk compared to the general population. The mortality of people with diabetes due to ischemic heart disease is multiplied by 2.2, and when is due to cerebrovascular disease by 1.8 compared to those patients without diabetes. Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia.

Statins have been shown to be effective in reducing the risk of cardiovascular events, each 1 mmol decrease in LDL cholesterol reduces the risk of cardiovascular events by 21% at 5 years.

Many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and for secondary prevention, to avoid recurrence.

However, compliance with these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness. Indeed, the persistence of statin use, one year after its prescription, is estimated at 70% in the general population. However, there are no data in the French population, and in particular on French diabetic patients for whom the cardiovascular risk is increased compared to the general population.

The purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• France
  • Nord
    • Lomme, Nord, France, 59462
      • Lille Catholic Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-insulin-dependent diabetes, taking statins for at least 1 month

Description

Inclusion Criteria:

• Major patients
• With non-insulin-dependent diabetes, taking statins for at least 1 month (to assess compliance)
• Hospitalized in the Diabetology Day Hospital of the Saint Philibert Hospital
• In capacity to answer the Girerd test
• Patient who has been informed and not opposed to the study

Exclusion Criteria:

• Patient's refusal to participate in the study
• Patient under guardianship or curatorship

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic patients; Patients with non-insulin-dependent diabetes, taking statins for at least 1 month	Other: Girerd test; This is a simple and quick questionnaire, composed of 6 questions with a binary yes/no answer. It allows to assess the degree of compliance with the prescribed treatment to better identify the constraints related to the treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance rate with statin measured by the Girerd test	This is a simple and quick questionnaire, composed of 6 questions with a binary yes/no answer. It allows to assess the degree of compliance with the prescribed treatment and thus to better identify the constraints related to the treatment. The score varies from 0 to 6 depending on the presence of "yes". 0 "yes": Good compliance, more than 3 "yes": non compliance.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance rate with statin according to the type of prevention	Type of prevention (primary/secondary) and compliance rate measured by the Girerd test	Day 0
Compliance rate with statin according to risk factors	Link between compliance rate measured by Girerd test and potential factors analyzed: age, sex, polypharmacy, duration of diabetes, no previous cardiovascular history, no prior dyslipidemia, blood LDL level, duration of statin intake, modalities of treatment preparation, understanding of the benefits of treatment	Day 0

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Actual): July 12, 2018
• Study Completion (Actual): July 12, 2018

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Compliance; Statins; Non-insulin-dependent diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RC-P0064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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