An observational study in Non-insulin-dependent Diabetes, sponsored by Lille Catholic University. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-17.
Sponsored by Lille Catholic University · Observational
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.
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.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 119 is below the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Lille Catholic University is the lead sponsor of 112 studies on the registry; 26 are open to participants now.
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Patients with non-insulin-dependent diabetes, taking statins for at least 1 month
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: Day 0
Compliance rate with statin according to the type of prevention
Type of prevention (primary/secondary) and compliance rate measured by the Girerd test
Time frame: 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
Time frame: Day 0
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Jul 2018, 5 months.
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This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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