Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

University of Sao Paulo24 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Treatment Side Effects

Interventions

Lipid-lowering agents (Artovastatin)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Samuel Katsuyuki Shinjo

São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

Side effects

Side effects of lipid-lowering agents

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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