Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Gilda Ferreira


Contact details

Pasteur Avenue
Belo Horizonte
+55 031 9617 4211

Additional identifiers

EudraCT number number

Protocol/serial number

FAPESP Grant No.: 2003/06738-0

Study information

Scientific title

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


Study hypothesis

1. That atorvastatin therapy improves endothelium-dependent arterial dilation in systemic lupus erythematosus (SLE) patients with and without conventional risk factors for atherosclerotic disease
2. That atorvastatin therapy reduces the plasma levels of non-traditional laboratory markers for atherosclerosis in SLE patients

Ethics approval

Local Medical Ethics Committee (Comitê de Ética em Pesquisa da Universidade Federal de Minas Gerais) approved on the 5th November 2003 (ref: ETIC 285/03)

Study design

Interventional single-centre non-randomised unblinded temporal series study with a parallel control group

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Systemic lupus erythematosus (SLE)


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 hypertension, dyslipidaemia and/or obesity, while the remaining 31 did not have any conventional risk factors for CHD.
2. The control group comprised 24 SLE patients followed in the same period without atorvastatin (no treatment)

To reinforce and check adherence to the protocol, phone calls or personal contacts were performed 30 days after the beginning the study and atorvastatin tablets were counted at the end of the study. At baseline and at the end of the 8-week period, all 88 participants underwent complete clinical examination, brachial artery ultrasound and blood sampling for laboratory analysis.

Total duration of treatment: 8 weeks
Total duration of follow-up: 8 weeks

1. Family history of CHD: presence of clinical CHD or sudden death in first-degree relatives at ages before 55 years old and 65 years old for men and women, respectively
2. Hypertension: blood pressure higher than 140 mmHg/90 mmHg or current use of antihypertensive medications
3. Obesity: body mass index (BMI) over 30 kg/m^2 and/or presence of abdominal obesity, considered as abdominal circumference above 88 cm
4. Diabetes mellitus: fasting plasma glucose higher than 126 mg/dl or use of oral hypoglycaemic agents or insulin
5. Dyslipidaemia: high density lipoprotein (HDL) cholesterol serum levels less than 40 mg/dl or low density lipoproteins (LDL) cholesterol serum levels greater than 130 mg/dl or total cholesterol serum levels greater than 200 mg/dl or triglyceride serum levels greater than 200 mg/dl
6. Menopause: amenorrhoea for more than one year or use of hormonal replacement therapy

SLE disease activity and damage were measured using SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) and SLICC (The Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for Systemic Lupus Erythematosus), respectively.

Intervention type



Phase IV

Drug names


Primary outcome measure

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.

Secondary outcome measures

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.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

88 patients with SLE

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Pasteur Avenue, 135/1403
Belo Horizonte

Sponsor information


State of São Paulo Research Foundation (FAPESP) (Brazil)

Sponsor details

R. Pio XI
1500 - Alto da Lapa
São Paulo
+55 11 3838 4000

Sponsor type

Research organisation



Funder type


Funder name

Federal University of Minas Gerais (Brazil) - Rheumatology Division; Board of Education, Research and Extension (DEPE) (ref: 078/03)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Federal University of São Paulo-Escola Paulista de Medicina (Brazil) - Rheumatology Division

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2007 results in

Publication citations

  1. Results

    Ferreira GA, Navarro TP, Telles RW, Andrade LE, Sato EI, Atorvastatin therapy improves endothelial-dependent vasodilation in patients with systemic lupus erythematosus: an 8 weeks controlled trial., Rheumatology (Oxford), 2007, 46, 10, 1560-1565, doi: 10.1093/rheumatology/kem186.

Additional files

Editorial Notes