Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

Not Applicable

Terminated

• Conditions: Treatment Side Effects
• Interventions: Drug: Lipid-lowering agents (Artovastatin)

• Registration Number: NCT03092154
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-27
• Status Verified: 2022-05
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposed	Lipid-lowering agents (Artovastatin)	Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Health Assessment Questionnaire	12 weeks	Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
Side effects	12 weeks	Side effects of lipid-lowering agents
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.
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.
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)

Trial Locations

Locations (1)

Samuel Katsuyuki Shinjo; 🇧🇷 Sao Paulo, Brazil