Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

NCT03092154 | Terminated

• 1 other identifier: MYO-HCFMUSP-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Side Effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Side effects

  12 weeks

• Patient/Parent Global Activity

  12 weeks

• Physician Global Activity

  12 weeks

• Manual Muscle Testing

  12 weeks

• Muscle enzymes

  12 weeks

Study Arms (2)

Exposed

EXPERIMENTAL

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

Drug: Lipid-lowering agents (Artovastatin)

No intervention

NO INTERVENTION

Patients will not receive artovastatin (lipid-lowering agents)

Interventions

Lipid-lowering agents (Artovastatin) DRUG

Artovastatin 20 mg /day, orally, 12 consecutive weeks.

Also known as: Therapy

Exposed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Samuel Katsuyuki Shinjo

São Paulo, 01246903, Brazil

Location

MeSH Terms

Interventions

Hypolipidemic Agents; Therapeutics

Intervention Hierarchy (Ancestors)

Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Samuel K Shinjo, PhD

  Universidade de Sao Paulo - Rheumatology Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups: with or without lipid-lowering agents

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 27, 2017
• Study Start: January 1, 2017
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)