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Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

U

University of Sao Paulo

Status

Terminated

Conditions

Treatment Side Effects

Treatments

Drug: Lipid-lowering agents (Artovastatin)

Study type

Interventional

Funder types

Other

Identifiers

NCT03092154
MYO-HCFMUSP-03

Details and patient eligibility

About

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.

Full description

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

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

24 participants in 2 patient groups

Exposed
Experimental group
Description:
Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks
Treatment:
Drug: Lipid-lowering agents (Artovastatin)
No intervention
No Intervention group
Description:
Patients will not receive artovastatin (lipid-lowering agents)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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