Statin Compliance of Patients With Non-insulin-dependent Diabetes

Study Overview
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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.

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

Conditions
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Non-insulin-dependent Diabetes

Intervention / Treatment
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* Other: Girerd test


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic patients<br>Patients with non-insulin-dependent diabetes, taking statins for at least 1 month | Other: Girerd test<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-insulin-dependent diabetes, Statins, Compliance