目的:全身性自身免疫性肌病(SAMs)患者血脂异常患病率高,因此,可能的内皮功能障碍和血管僵硬。我们的目的是评估内皮功能和血管僵硬的可能益处,以及阿托伐他汀在SAMs中的不良反应。
方法:飞行员纵向,双盲,随机化,进行了安慰剂对照研究.242名患者中有24名患者以2:1的比例随机接受阿托伐他汀(20mg/d)或安慰剂,为期12周。人口统计数据,合并症,以及临床和实验室参数,以及内皮功能和动脉僵硬度,进行了评估。
结果:在24名随机患者中,4名患者被排除在外,其余20例患者(阿托伐他汀组14例,安慰剂组6例)。患者的平均年龄为49.0岁,75%的患者为女性。在基线,人口统计数据,疾病状态,治疗,心血管合并症,阿托伐他汀组和安慰剂组的危险因素相当.阿托伐他汀治疗12周后,两组血管内皮功能和动脉硬度均无改善(p>0.05).不出所料,观察到总脂蛋白胆固醇水平和低密度脂蛋白胆固醇水平显著降低.在研究期间,两组均未出现临床间断性或疾病复发.
结论:阿托伐他汀类药物可降低低密度脂蛋白胆固醇,而不会恶化SAMs的临床结局。未观察到内皮功能和动脉僵硬度的变化。其他研究,长期随访时间和不同阿托伐他汀剂量,需要证实这项研究的结果。
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.