Treatment Side Effects
Conditions
Brief summary
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.
Detailed description
Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.
Interventions
DRUGLipid-lowering agents (Artovastatin)
Artovastatin 20 mg /day, orally, 12 consecutive weeks.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Two groups: with or without lipid-lowering agents
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient/Parent Global Activity | 12 weeks | This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale. |
| Physician Global Activity | 12 weeks | This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale. |
| Manual Muscle Testing | 12 weeks | This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies. |
| Side effects | 12 weeks | Side effects of lipid-lowering agents |
| Myositis Disease Activity Assessment Tool | 12 weeks | After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study) |
| Health Assessment Questionnaire | 12 weeks | Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00 |
| Muscle enzymes | 12 weeks | This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase. |
Countries
Brazil
Outcome results
None listed