Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Endothelial function
研究概览
简要总结
The use of lipid lowering agents in patients with idiopathic inflammatory myopathies is controversial. Therefore, the aim of the present study is to assess clinically and laboratory the impact of lipid-lowering agents in this population.
详细描述
Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •fullfill all criteria of Bohan and Peter (1975)
- •dyslipidemia
- •age> 18 years
- •prednisone ≤ 0.25 mg/kg/day (or ≤ 15mg/ ay) in the last three months
- •without changing nutritional habits in the last three months, and during the study period
- •no change of lifestyle in the last three months, and during the study period
排除标准
- •Patients with:
- •disease relapsing
- •overlapping myositis
- •neoplasia associated myositis
- •diabetes mellitus
- •current and/or chronic infections
- •patients undergoing major surgery within six months prior to the study
- •pregnant patients
- •previous use of lipid-lowering agents in the last 6 months
- •in the use of cyclosporin, erythromycin, clarithromycin, fibrates, niacin, azole antifungals, cimetidine, diltiazem
- •active liver disease or persistent elevations of hepatic enzymes, with no apparent cause, exceeding three times the upper limit of normality
研究组 & 干预措施
Exposed
Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks
干预措施: Lipid-lowering agents (Artovastatin) (Drug)
结局指标
主要结局
Endothelial function
时间窗: 12 weeks
Ultrasound-based measurements of brachial reactivity were performed according to the guidelines of the International Brachial Artery Reactivity Task Force. The assessment of vascular reactivity was carried out by the same examiner. The left brachial artery was measured at a longitudinal section above the antecubital fossa, using a high-resolution ultrasound system Sequoia Echocardiography System, version 6.0, Acuson; Siemens, Vernon, CA) equipped with a multifrequency linear transducer (7-12 MHz) to produce two-dimensional images. This technique was used to evaluate the change in arterial diameter and blood flow after physical and pharmacological stimulation.
次要结局
- Physician Global Activity(12 weeks)
- Patient/Parent Global Activity(12 weeks)
- Health Assessment Questionnaire(12 weeks)
- Side effects(12 weeks)
- Manual Muscle Testing(12 weeks)
- Muscle enzymes(12 weeks)
- Myositis Disease Activity Assessment Tool(12 weeks)
研究者
Samuel Katsuyuki Shinjo, PhD
Principal Investigator
University of Sao Paulo