Statin Compliance of Patients With Non-insulin-dependent Diabetes

Non-insulin-dependent Diabetes Clinical Trial

— DIOS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04007133
• Other study ID #: RC-P0064
• Status: Terminated
• Start date: January 31, 2018
• Est. completion date: July 12, 2018

Study information

• Verified date: July 2019
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 119
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Non-insulin-dependent Diabetes

Intervention

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.

Locations

Country	Name	City	State
France	Lille Catholic Hospitals	Lomme	Nord

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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