Evaluation of Statin Compliance of Patients With Non-insulin-dependent Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Compliance rate with statin measured by the Girerd test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient's refusal to participate in the study
- •Patient under guardianship or curatorship
结局指标
主要结局
Compliance rate with statin measured by the Girerd test
时间窗: 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.
次要结局
- Compliance rate with statin according to risk factors(Day 0)
- Compliance rate with statin according to the type of prevention(Day 0)