Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

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.

Study Overview

• Status: Terminated
• Conditions: Treatment Side Effects
• Intervention / Treatment: Drug: Lipid-lowering agents (Artovastatin)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01246903
    • Samuel Katsuyuki Shinjo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Myositis; Dermatomyositis; Polymyositis; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Lipid Regulating Agents; Hypolipidemic Agents
• Other Study ID Numbers: MYO-HCFMUSP-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No