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

Objetivo: O uso de drogas hipolipemiantes, como as estatinas, no tratamento da dislipidemia em pacientes com miopatias autoimunes sistêmicas (MAS) é comprometido pela baixa qualidade das evidências de relatos de casos e por um estudo retrospectivo. Portanto, avaliamos em um estudo prospectivo, randomizado, duplo-cego, controlado por placebo, o impacto da atorvastatina em pacientes com MAS na mialgia e outros efeitos colaterais, perfil lipídico e status da doença. Métodos: Estudo prospectivo, randomizado, duplo-cego, controlado, no qual 24 pacientes com MAS e dislipidemia foram avaliados entre 2017 e 2019. Os pacientes foram randomizados (2:1) em dois grupos: atorvastatina e placebo. Todos os pacientes foram avaliados no início e na 12ª semana para os seguintes parâmetros do International Myositis Assessment & Clinical Studies Groups (IMACS). Resultados: A média de idade dos pacientes foi de 49,0±10,0 anos, sendo 75% do sexo feminino, com mediano de tempo de doença de 5,5 (3,3-11,8) anos. Todos os pacientes apresentavam os valores de IMACS próximos da normalidade. No início do estudo, os dados demográficos, status das doenças, esquema terapêutico, comorbidades cardiovasculares e seus fatores de risco foram comparáveis entre os grupos atorvastatina e placebo (P > 0,05). Após 12 semanas de seguimento, ao comparar o grupo atorvastatina com placebo, foi observada uma redução dos níveis de LDL-colesterol: 95,5 (79,3-134,5) vs. 135,0 (123,0-174,6) mg/dL, respectivamente, P=0,011. Em relação às outras variáveis avaliadas, não houve diferença estatística (P > 0,05). Durante o estudo, não houve intercorrências clínicas relevantes. Conclusões: O uso da atorvastatina foi seguro e eficaz nos pacientes estáveis com MAS e com dislipidemia. Estudos adicionais, com casuística maior e pacientes com diferentes níveis de atividade de doença, são necessários para corroborar com os dados do presente estudoObjective: 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 stud

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

Objetivo: O uso de drogas hipolipemiantes, como as estatinas, no tratamento da dislipidemia em pacientes com miopatias autoimunes sistêmicas (MAS) é comprometido pela baixa qualidade das evidências de relatos de casos e por um estudo retrospectivo. Portanto, avaliamos em um estudo prospectivo, randomizado, duplo-cego, controlado por placebo, o impacto da atorvastatina em pacientes com MAS na mialgia e outros efeitos colaterais, perfil lipídico e status da doença. Métodos: Estudo prospectivo, randomizado, duplo-cego, controlado, no qual 24 pacientes com MAS e dislipidemia foram avaliados entre 2017 e 2019. Os pacientes foram randomizados (2:1) em dois grupos: atorvastatina e placebo. Todos os pacientes foram avaliados no início e na 12ª semana para os seguintes parâmetros do International Myositis Assessment & Clinical Studies Groups (IMACS). Resultados: A média de idade dos pacientes foi de 49,0±10,0 anos, sendo 75% do sexo feminino, com mediano de tempo de doença de 5,5 (3,3-11,8) anos. Todos os pacientes apresentavam os valores de IMACS próximos da normalidade. No início do estudo, os dados demográficos, status das doenças, esquema terapêutico, comorbidades cardiovasculares e seus fatores de risco foram comparáveis entre os grupos atorvastatina e placebo (P > 0,05). Após 12 semanas de seguimento, ao comparar o grupo atorvastatina com placebo, foi observada uma redução dos níveis de LDL-colesterol: 95,5 (79,3-134,5) vs. 135,0 (123,0-174,6) mg/dL, respectivamente, P=0,011. Em relação às outras variáveis avaliadas, não houve diferença estatística (P > 0,05). Durante o estudo, não houve intercorrências clínicas relevantes. Conclusões: O uso da atorvastatina foi seguro e eficaz nos pacientes estáveis com MAS e com dislipidemia. Estudos adicionais, com casuística maior e pacientes com diferentes níveis de atividade de doença, são necessários para corroborar com os dados do presente estudoObjective: 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 stud

The aerobic capacity in patients with antisynthetase syndrome and dermatomyositis

Abstract Background This study was aimed at evaluating the aerobic capacity of patients with antisynthetase syndrome (ASS) and dermatomyositis (DM) and analyzing possible relationships between aerobic capacity and disease status, cardiovascular diseases and their risk factors. Methods The study was a cross-sectional, single-center study that assessed the aerobic capacity of 22 women (13 with DM and 9 with ASS) who were matched by age and body mass index to 17 healthy women (control group). The aerobic capacity (oxygen uptake [VO2 peak], anaerobic threshold, respiratory compensation point and time-to-exhaustion) was evaluated using the cardiopulmonary treadmill test. Disease status was assessed using International Myositis Assessment & Clinical Studies Group (IMACS) set scores. Results The patients had low IMACS parameters that showed low or absent disease activity. The distribution of cardiovascular diseases and their risk factors was similar between the patients and the control group (P >  0.05) at the time of the analysis. The patients with DM and the control group had similar aerobic capacity. However, the patients with ASS exhibited significantly reduced aerobic capacity (relative VO2 peak, anaerobic threshold, respiratory compensation point and time to exhaustion) when compared to the control group. In addition, patients with ASS had a lower anaerobic threshold compared to the DM group. There were no significant relationships between the aerobic capacity and disease status, cardiovascular diseases and their risk factors. Conclusion In contrast to DM patients and healthy individuals, patients with stable ASS have significantly impaired aerobic capacity, which is unlikely to be totally explained by traditional cardiovascular diseases, their risk factors and disease status. Further studies are needed to corroborate our data and to clarify the cause of this reduced aerobic capacity in ASS

Núcleos de Ensino da Unesp: artigos 2008

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq