Safety of Atorvastatin in Patients With Stable Systemic Autoimmune Myopathies

Abstract

Background/Objective: Patients with systemic autoimmune myopathies (SAMs) have high prevalence of dyslipidemia and, consequently, possible endothelial dysfunction and vascular stiffness. Our objective was to evaluate the possible benefits on endothelial function and vascular stiffness, as well as adverse effects of atorvastatin in SAMs.Methods: A pilot longitudinal, double-blind, randomized, placebo-controlled study was conducted. Twenty-four of 242 patients were randomized at a 2:1 ratio to receive atorvastatin (20 mg/d) or placebo for a period of 12 weeks. Demographic data, comorbidities, and clinical and laboratory parameters, as well as endothelial function and arterial stiffness, were evaluated.Results: Of the 24 randomized patients, 4 patients were excluded, with remaining 20 patients (14 in the atorvastatin group and 6 in the placebo group). The mean age of the patients was 49.0 years, and 75% of the patients were female. At baseline, the demographic data, disease status, treatment, cardiovascular comorbidities, and risk factors were comparable between the atorvastatin and placebo groups. After 12 weeks of follow-up of atorvastatin therapy, no improvements were observed for endothelial function and arterial stiffness in either group (p > 0.05). As expected, a significant reduction in total and low-density lipoprotein cholesterol levels was observed. During the study, no clinical intercurrences or disease relapses were observed in either group. Conclusions:The atorvastatin drug attenuated low-density lipoprotein cholesterol without worsening clinical outcomes in SAMs. No change was observed for endothelial function and arterial stiffness. Additional studies, with long-term follow-up time and different atorvastatin dosage, are needed to corroborate the results of this study.

The Significance of Statin Associated Muscle Symptoms and Its Impact on Patients Adherence and Outcomes

“…Similarly, studies showed that autoimmune diseases especially the muscle-related ones were significantly associated with higher risk for SAMS. 37 Also, studies suggested that diabetes mellitus type 2, renal diseases, and liver dysfunction were significantly associated with SAMS which contradict our results as we did not find any association between these comorbidities and SAMS. 38 Moreover, our analysis showed that patients taking antiepileptic medications had significantly higher risk of SAMS compared with their counterparts.…”

Effect of atorvastatin on muscle tissues of dermatomyositis and antisynthetase syndrome patients with dyslipidemia

“…From a laboratory point of view, a previous study 15 showed that the use of atorvastatin did not promote alterations in serum glucose, insulin, and C‐peptide levels, evaluating the HOMA index and corroborating the data obtained at the molecular level in the present study.…”

“…According to a study carried out in patients without SAMs who used statins, this class of medications, even if rarely, can induce the release of COX, which may be responsible for the formation of apoptosomes and consequently cause cell apoptosis. 11 From a laboratory point of view, a previous study 15 showed that the use of atorvastatin did not promote alterations in serum glucose, insulin, and C-peptide levels, evaluating the HOMA index and corroborating the data obtained at the molecular level in the present study.…”

“…This is an extension of a prospective, randomized, double‐blind, placebo‐controlled study 15 approved by the local ethics committee (CAAE 33558414.7.0000.0068), in which the patients signed an informed consent form. A total of 16 out of 20 dyslipidemia patients with DM or ASS underwent a muscle biopsy of the vastus lateralis before and after 12 weeks of drug intervention with atorvastatin 20 mg/day or placebo (Figure 1).…”

Impacto de atorvastatina nos tecidos musculares de pacientes com dermatomiosite e síndrome antissintetase

“…Foram coletados, em período menor do que uma semana após a entrevista dos pacientes, no tempo 0 (início do estudo), e na 12ª semana, amostras de soro (10 mL de soro e de plasma) para análise de CPK, AST, ALT, DHL, além de colesterol total, HDL-colesterol, LDL-colesterol, triglicerídeos, glicemia de jejum, insulina e resistência à insulina (Homeostatic Model Assessment: HOMA) (78). Esses dados estão publicados em artigo prévio (72).…”