Clinical trial NCT04007133: Statin Compliance of Patients With Non-insulin-dependent Diabetes
Official title: Evaluation of Statin Compliance of Patients With Non-insulin-dependent Diabetes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-insulin-dependent Diabetes
Keywords: Non-insulin-dependent diabetes
Statins
Compliance
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2019-07-05
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-insulin-dependent diabetes, taking statins for at least 1 month

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance rate with statin measured by the Girerd test
timeFrame: Day 0
Secondary outcomes:
measure: Compliance rate with statin according to the type of prevention
timeFrame: Day 0
measure: Compliance rate with statin according to risk factors
timeFrame: Day 0
Other outcomes:
Locations:
city: Lomme
country: France
facility: Lille Catholic Hospitals
state: Nord
Study officials:
References: