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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.
Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed | Experimental | Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks |
|
| No intervention | No Intervention | Patients will not receive artovastatin (lipid-lowering agents) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipid-lowering agents (Artovastatin) | Drug | Artovastatin 20 mg /day, orally, 12 consecutive weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Side effects of lipid-lowering agents | 12 weeks |
| Patient/Parent Global Activity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel K Shinjo, PhD | Universidade de Sao Paulo - Rheumatology Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samuel Katsuyuki Shinjo | São Paulo | 01246903 | Brazil |
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| ID | Term |
|---|---|
| D000960 | Hypolipidemic Agents |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Two groups: with or without lipid-lowering agents
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| 12 weeks |
| Physician Global Activity | 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. | 12 weeks |
| Manual Muscle Testing | 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. | 12 weeks |
| Muscle enzymes | 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. | 12 weeks |
| Myositis Disease Activity Assessment Tool | 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) | 12 weeks |
| Health Assessment Questionnaire | Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00 | 12 weeks |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |