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

Evaluation of the atorvastatin effect on endothelial-dependent vasodilation in patients with systemic lupus erythematosus: an 8-week controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19073445

Enrollment

Registered

2009-07-21

Start date

2004-07-21

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus (SLE) Musculoskeletal Diseases Systemic lupus erythematosus

Interventions

Patients were divided in two groups: 1. The intervention group consisted of 64 patients who received atorvastatin 20 mg/day during 8 weeks. Thirty-three patients in the intervention group had hyperten

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Resting diameter (mm) 2. Resting flow (ml/min) 3. Hyperaemia flow (mL/min) 4. Flow-mediated dilation (%) 5. Glyceryl-trinitrate induced dilation (%) Measured at baseline and 8 weeks. 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.	—

Measure

Time frame

1. Resting diameter (mm) 2. Resting flow (ml/min) 3. Hyperaemia flow (mL/min) 4. Flow-mediated dilation (%) 5. Glyceryl-trinitrate induced dilation (%) Measured at baseline and 8 weeks. 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.

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Secondary

Measure	Time frame
1. Total cholesterol (mg/dl) 2. LDL-cholesterol (mg/dl) 3. HDL-cholesterol (mg/dl) 4. Triglycerides (mg/dl) 5. Creatine phosphokinase (CPK) 6. Homocysteine (µmol/L) 7. Lipoprotein-a (mg/dL) 8. Endothelin-1 (pg/ml) 9. Cytokines and receptors (tumour necrosis factor-alpha, sTNFR1 and sTNFR2) 10. Chemokines (CL2, CCL3 and CXCL9) serum levels 11. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score 12. Anti-DNA antibodies (0 = absent, 1 = present) 13. Anti-oxidised LDL antibodies (0 = absent, 1 = present) and anti-lipoprotein lipase antibodies(0 = absent, 1 = present) 14. Anticardiolipin antibodies (GPL or MPL) Measured at baseline and 8 weeks. Laboratory exams were performed according to standard routine techniques. Anti-dsDNA antibodies were detected by indirect immunofluorescence in Crithidia luciliae. Homocysteine and lipoprotein-a serum levels were measured by liquid chromatography (reference range less than 15 µmol/L) and immunonephelometry (Dade Behring, reference range less than 30 mg/dl), respectively. The concentration of cytokines, chemokines, endotelin-1, anti-DNA antibodies, anti-oxidised LDL antibodies, and anti-lipoprotein lipase antibodies, anticardiolipin antibodies were determined by enzyme immunoassay. Anticardiolipin antibodies were considered positive when higher than 20 GPL or 11 MPL.	—

Measure

Time frame

1. Total cholesterol (mg/dl) 2. LDL-cholesterol (mg/dl) 3. HDL-cholesterol (mg/dl) 4. Triglycerides (mg/dl) 5. Creatine phosphokinase (CPK) 6. Homocysteine (µmol/L) 7. Lipoprotein-a (mg/dL) 8. Endothelin-1 (pg/ml) 9. Cytokines and receptors (tumour necrosis factor-alpha, sTNFR1 and sTNFR2) 10. Chemokines (CL2, CCL3 and CXCL9) serum levels 11. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score 12. Anti-DNA antibodies (0 = absent, 1 = present) 13. Anti-oxidised LDL antibodies (0 = absent, 1 = present) and anti-lipoprotein lipase antibodies(0 = absent, 1 = present) 14. Anticardiolipin antibodies (GPL or MPL) Measured at baseline and 8 weeks. Laboratory exams were performed according to standard routine techniques. Anti-dsDNA antibodies were detected by indirect immunofluorescence in Crithidia luciliae. Homocysteine and lipoprotein-a serum levels were measured by liquid chromatography (reference range less than 15 µmol/L) and immunonephelometry (Dade Behring, reference range less than 30 mg/dl), respectively. The concentration of cytokines, chemokines, endotelin-1, anti-DNA antibodies, anti-oxidised LDL antibodies, and anti-lipoprotein lipase antibodies, anticardiolipin antibodies were determined by enzyme immunoassay. Anticardiolipin antibodies were considered positive when higher than 20 GPL or 11 MPL.

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Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026