Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy Among Patients With SLE

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized single-blind trial. This study aimed to determine if intensive lipid-lowering therapy (simvastatin-ezetimibe combination therapy) could reduce the progression of atherosclerosis effectively and safely among SLE patients with carotid artery intima thickening. The study results were expected to be helpful for SLE patients in preventing atherosclerosis.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

Criteria

Inclusion Criteria:

1. age ≥18 years and clinical diagnosis of SLE

2. abnormal CIMT (≥0.9 mm at any site) by B-mode ultrasound

3. LDL-C≥100mg/dl

4. a signed written informed consent was able to be obtained.

Exclusion Criteria:

1. atherosclerotic cardiovascular disease

2. diabetes

3. history of intolerance or allergy to the statins or ezetimibe

4. had ever received statins or ezetimibe within 12 months of study entry

5. LDL-C≥190mg/dl

6. active infection

7. ALT was higher than 2 times of the upper normal limit or CK was higher than 1.5 times of the upper normal limit.

8. pregnant or lactating women

9. patients with severe SLE.