International, cross-sectional, non-interventional, disease observational study to describe the management and the LDL-Cholesterol control versus ESC/EAS guidelines of patients receiving lipid-modifying treatments in non-US non-European countries in real-life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,159
- 试验地点
- 49
- 主要终点
- Percentage of patients reaching LDL-C targets as defined by the ESC/EAS guidelines for the management of dyslipidemia (2011), in patients at very high, high and moderate CV risk.
研究概览
简要总结
- Participants:
The study was implemented in 18 countries. Of the 454 centres who accepted to participate in the study, 453 included atleast one patient. The largest numbers of patients came from India, South Korea and Turkey.
- Participant Characteristics and Primary Analyses:
a) Descriptive Data:
Characteristics of participating Physicians
The median age of the physicians was 49 yrs-old and the majority were male (71.5%).Their practice locations were mainly urban (85.2%). The physicians specialty breakdown was Cardiologists (40.5%), Internal Medicine (25.4%), GPs (13.5%), Endocrinologists(11.7%), Lipdologists (1.8%), other specialty (4.4 %) or multiple specialities (2.7%).
96% of physicians declared that they followed specific guidelines or recommendations for management of lipid disorders.
Cardiovascular Risk Factors:
Most frequent cardiovascular risk factors were hypertension (71.5% of patients) and diabetes (54.3%, mostly type II). 36% of patients were current or former smokers, 9.5% had a regular consumption of alcohol and 24.6% had a familial history of cardiovascular disease. 50.8% of patients were declared physically active.
Medical History:
3320 (36.7%) of patients presented with a documented coronary artery disease, of which the most frequent pathologies were a previous acute coronary syndrome or myocardial infarction and a previous percutaneous coronary intervention . Documented cerebrovascular disease (stroke) were found in 6.3% of patients and documented peripheral artery diseases were found in 4.8%of patients.
Disease Characteristics:
87.2% of patients had a diagnosis or history of dyslipidemia, since a mean (SD) of 6.0 (5.7) years. The etiology was secondary for 57.5 % patients
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient receiving a lipid-modifying therapy for atleast 3 months with a LDL-C value performed less than 12 months AND under the same lipid-modifying treatment (same drugs, same doses) received for at least 3 months at the time of sample
- •Patient agrees to participate in the study by giving written informed consent.
排除标准
- •1.Patient currently participating in a clinical trial 2.Past use of a PCSK9 inhibitor within 6 months prior to study entry.
结局指标
主要结局
Percentage of patients reaching LDL-C targets as defined by the ESC/EAS guidelines for the management of dyslipidemia (2011), in patients at very high, high and moderate CV risk.
时间窗: Visit 1 | As this is a cross sectional study with no follow-ups.
次要结局
- 1.Percentage of patients reaching LDL-C targets as defined by the ESC/EAS guidelines for the management of dyslipidemia (2011), by physicians’ specialty(2.Description of Patient’s profiles)