The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Changes in endothelial and vascular inflammatory markers
研究概览
简要总结
Behçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes of vessels. Statins display numerous effects often independent of the well-established lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and ischaemic vascular events. The aim of the present study was to determine the efficacy of rosuvastatin in improving vascular dysfunction and vascular inflammation and to assess the effect of rosuvastatin on vascular involvement in BD patients. Fifty-six BD patients (51 males and 5 females) mean age 33.4 years, mean disease duration 5.8 years), all fulfilling the classification criteria of the International Study Group for Behçet's disease were recruited.Patients were randomised into 2 groups.
The first group (n=27: 20 active and 7 inactive) were assigned to receive 40 mg of rosuvastatin and the second group(n=29: 21 active and 8 inactive) received placebo for 12 months. Inflammatory and endothelial dysregulation markers were measured at baseline and after 12 months. All patients were examined for vascular involvement. Venous or arterial system involvement was defined as present when confirmed by Doppler ultrasonography, magnetic resonance angiography, conventional angiography or CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all patients fulfilling the classification criteria of the International Study Group for Behçet's disease
排除标准
- •diabetes mellitus,
- •hypercholesterolaemia,
- •hypertension,
- •cardiac insufficiency,
- •coexisting hepatic and renal diseases
- •inflammatory diseases.
研究组 & 干预措施
Rosuvastatin Drug
Active drug-rosuvastatin 40 mg
干预措施: Rosuvastatin calcium 40mg (Drug)
Rosuvastatin Drug
Active drug-rosuvastatin 40 mg
干预措施: Placebo oral tablet (Drug)
Placebo drug
Placebo oral tablet
干预措施: Rosuvastatin calcium 40mg (Drug)
Placebo drug
Placebo oral tablet
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Changes in endothelial and vascular inflammatory markers
时间窗: 12 months
Outcome measures included alterations in endothelial injury and vascular inflammatory markers.
次要结局
- Occurrence of new-onset vascular involvement(6 months)
研究者
Anna Abou-Raya
Professor of Rheumatology
University of Alexandria
