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Statin Compliance of Patients With Non-insulin-dependent Diabetes (DIOS)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Non-insulin-dependent Diabetes | Other: Girerd test |
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.
| Study Type : | Observational |
| Actual Enrollment : | 119 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Statin Compliance of Patients With Non-insulin-dependent Diabetes |
| Actual Study Start Date : | January 31, 2018 |
| Actual Primary Completion Date : | July 12, 2018 |
| Actual Study Completion Date : | July 12, 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Diabetic patients
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 [ Time Frame: Day 0 ]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.
- Compliance rate with statin according to the type of prevention [ Time Frame: Day 0 ]Type of prevention (primary/secondary) and compliance rate measured by the Girerd test
- Compliance rate with statin according to risk factors [ Time Frame: Day 0 ]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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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
| France | |
| Lille Catholic Hospitals | |
| Lomme, Nord, France, 59462 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 1, 2019 | ||||
| First Posted Date | July 5, 2019 | ||||
| Last Update Posted Date | July 17, 2019 | ||||
| Actual Study Start Date | January 31, 2018 | ||||
| Actual Primary Completion Date | July 12, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Compliance rate with statin measured by the Girerd test [ Time Frame: Day 0 ] 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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Statin Compliance of Patients With Non-insulin-dependent Diabetes | ||||
| Official Title | Evaluation of Statin Compliance of Patients With Non-insulin-dependent Diabetes | ||||
| 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. |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with non-insulin-dependent diabetes, taking statins for at least 1 month | ||||
| Condition | 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.
|
||||
| Study Groups/Cohorts | Diabetic patients
Patients with non-insulin-dependent diabetes, taking statins for at least 1 month
Intervention: Other: Girerd test
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Terminated | ||||
| Actual Enrollment |
119 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | July 12, 2018 | ||||
| Actual Primary Completion Date | July 12, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04007133 | ||||
| Other Study ID Numbers | RC-P0064 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Lille Catholic University | ||||
| Study Sponsor | Lille Catholic University | ||||
| Collaborators | University Hospital, Lille | ||||
| Investigators | Not Provided | ||||
| PRS Account | Lille Catholic University | ||||
| Verification Date | July 2019 | ||||
