Atorvastatin and endothelial function in systemic lupus erythematosus (SLE) patients

Completed

Conditions: Systemic lupus erythematosus (SLE)
Musculoskeletal Diseases
Systemic lupus erythematosus

Registration Number: ISRCTN19073445

Lead Sponsor: State of São Paulo Research Foundation (FAPESP) (Brazil)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 88

Inclusion Criteria

1. Female
2. SLE according to the American College of Rheumatology revised classification criteria
3. Disease diagnosis equal or greater than 1 year
4. Aged above 18 years old
5. Regular menstruation

Exclusion Criteria

1. Current or past use of hypolipidemic drugs in the last six months
2. Menopausal women
3. Diabetes mellitus
4. Serum creatinine above 1.2 mg/dl
5. Pregnancy
6. Smoking status (last 12 months)
7. Family history of coronary heart disease (CHD)
8. Skeletal myopathic disease and/or elevated creatinine phosphokinase
9. Hepatic disease
10. Ciclosporin use

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Resting diameter (mm)<br>2. Resting flow (ml/min)<br>3. Hyperaemia flow (mL/min)<br>4. Flow-mediated dilation (%)<br>5. Glyceryl-trinitrate induced dilation (%)<br><br>Measured at baseline and 8 weeks.<br><br>Vascular studies were performed at room temperature (25 - 28°C) using high-resolution ultrasound equipment, vascular colour echo-Doppler with flow mapping (ACUSON, Mountain View - California, USA) and multiple-frequency linear 7 MHz transducer. All patients were evaluated between 8:00 and 10:00 am after 12 hours overnight fast. Antihypertensive medication was stopped 24 hours before the study. All exams were performed by the same examiner and with the guidelines for ultrasound assessment of endothelial-dependent flow-mediated dilation of the brachial artery. Recorded images were later analysed by the examiner without any information on the patient's identification.

Secondary Outcome Measures