Is atorvastatin safe to patients with systemic autoimmune myopathies?: a prospective, randomized, double-blind, placebo-controlled study

Author(s)

Isabela Bruna Pires Borges

• Document type: Master's Dissertation
• Press: São Paulo.
• Institution: Universidade de São Paulo (USP). Faculdade de Medicina (FM/SBD)
• Defense date: 2019-08-28

Examining board members

Samuel Katsuyuki Shinjo; Eduardo Ferreira Borba Neto; Fernando Henrique Carlos de Souza; Dawton Yukito Torigoe

• Advisor: Samuel Katsuyuki Shinjo

Abstract

Objective: The use of lipid-lowering drugs, such as statins, to treatment of dyslipidemia in patients with systemic autoimmune myopathies (SAMs) is hampered by the low quality of evidence of case reports and one retrospective study. We therefore assessed in a prospective, randomized double-blinded placebo controlled study design the impact of atorvastatin in SAMs patients on myalgia and other side-effect, lipid profile and disease status. Methods: A prospective, double-blinded, randomized, controlled study in which 24 patients with SAMs and dyslipidemia had evaluated between 2017 and 2019. Patients were randomized (2:1) into two groups: atorvastatin and placebo. All patients were evaluated at baseline and 12 weeks for the International Myositis Assessment & Clinical Studies Groups (IMACS) set scores. Results: The mean age of the patients was 49.0±10.0 years, being 75% female, with a median disease time of 5.5 (3.3-11.8) years. All patients presented IMACS values close to normal. At baseline, demographic data, disease status, treatment, cardiovascular comorbidities, and risk factors were comparable between the atorvastatin and placebo groups (P > 0.05). After 12 weeks of follow-up, when comparing the atorvastatin group with placebo, we observed a reduction in LDLcholesterol levels: 95.5 (79.3-134.5) vs. 135.0 (123.0-174.6) mg/dL, respectively (P > 0.011). In relation to the other variables evaluated, there was no statistical difference (P > 0.05). During the study, there were no relevant clinical intercurrences. Conclusions: The use of atorvastatin was safe and effective in patients stable with SAMs and with dyslipidemia. Additional studies, with a larger sample and patients with different levels of disease activity, are necessary to corroborate with the data of the present study (AU)

• FAPESP's process: 16/20371-1 - Effect of lipid-lowering drugs on endothelial function and vascular stiffness in patients with dermatomyositis and polymyositis: a prospective, double-blind, randomized controlled trial
• Grantee: Isabela Bruna Pires Borges
• Support Opportunities: Scholarships in Brazil - Master