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Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

Sponsor
University of Sao Paulo (Other)
Overall Status
Terminated
CT.gov ID
NCT03092154
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
64.9
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lipid-lowering agents (Artovastatin)
 N/A

Detailed Description

Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups: with or without lipid-lowering agentsTwo groups: with or without lipid-lowering agents
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exposed

Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks

Drug: Lipid-lowering agents (Artovastatin)
Artovastatin 20 mg /day, orally, 12 consecutive weeks.
Other Names:
  • Therapy

    		•
    No Intervention: No intervention

    Patients will not receive artovastatin (lipid-lowering agents)

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Side effects [12 weeks]

      Side effects of lipid-lowering agents

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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)

    7. Health Assessment Questionnaire [12 weeks]

      Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samuel Katsuyuki Shinjo Sao Paulo Brazil 01246903

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    • Principal Investigator: Samuel K Shinjo, PhD, Universidade de Sao Paulo - Rheumatology Division

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samuel Katsuyuki Shinjo, PhD, Principal Investigator, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT03092154
    Other Study ID Numbers:
    • MYO-HCFMUSP-03
    First Posted:
    Mar 27, 2017
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dermatomyositis
    Polymyositis
    Hypolipidemic Agents

    Study Results

    No Results Posted as of Jun 3, 2022