Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

Treatment Side Effects Clinical Trial

Official title:

Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03092154
• Other study ID #: MYO-HCFMUSP-03
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2022
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis
• Polymyositis
• Treatment Side Effects

Intervention

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

Locations

Country	Name	City	State
Brazil	Samuel Katsuyuki Shinjo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side effects	Side effects of lipid-lowering agents	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health Assessment Questionnaire	Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00	12 weeks