Statin Compliance of Patients With Non-insulin-dependent Diabetes

NCT ID: NCT04007133

Last Updated: 2019-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-07-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-insulin-dependent Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic patients

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

Girerd test

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role collaborator

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lille Catholic Hospitals

Lomme, Nord, France

Site Status

Countries

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France

Other Identifiers

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RC-P0064

Identifier Type: -

Identifier Source: org_study_id

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