ATLANTA (EGMN) – Atorvastatin did prevent early atherosclerosis in children and adolescents with lupus, based on data from 221 patients aged 10-21 years. The results were presented at the annual scientific meeting of the American College of Rheumatology.
“This is a landmark study in the pediatric rheumatology community,” said Dr. Laura Schanberg, co-chief of the division of pediatric rheumatology at Duke University Medical Center in Durham, North Carolina.
To assess the risk of cardiovascular problems, the researchers used an accepted surrogate marker: an ultrasound measurement of the thickening of the carotid arteries. The study participants underwent ultrasound examinations seven times during the 3-year study period.
Overall, the progression of thickening in the arteries was not significantly different between the statin and placebo groups.
“This was a surprise to us,” Dr. Schanberg said. The researchers had expected significantly less carotid intima-media thickening (CIMT) in the statin group.
The data were trending toward a positive effect, but the findings did not show enough benefit to recommend routine statin treatment for most children and adolescents with lupus. The difference in CIMT was 0.0024 mm/year in the statin group, vs. 0.0010 mm/year in the placebo group (P =.24).
However, the statin group did achieve statistically significant reductions in high-sensitivity C-reactive protein levels, total cholesterol, and low-density lipoprotein. Changes in lupus disease activity and damage, quality of life measures, and measures of muscle, liver, and neurotoxicity were similar between the two groups.
Previous studies have shown that lupus is a strong risk factor for cardiovascular problems. Pediatric lupus patients are considered at increased risk because they typically live with the disease for a longer period of time. Statins have not previously been studied as a way to reduce cardiovascular risk in children with lupus, but some clinicians already prescribe statins to children with lupus at especially high risk from factors such as high cholesterol, Dr. Schanberg said.
“We wanted to see whether there was a way to decrease the long-term risk” of cardiovascular problems in children with lupus, she said. In this study, the researchers enrolled children and adolescents from 21 sites through the Childhood Arthritis and Rheumatology Research Alliance.
All the children received standard lupus care including aspirin, a multivitamin, hydroxychloroquine, and counseling about a low-cholesterol diet and other cardiovascular risk factors. They were randomized to receive atorvastatin or a placebo.
Of note, the study did not include children at especially high risk for cardiovascular problems, such as those with high cholesterol, said Dr. Schanberg. In fact, a subgroup analysis may reveal certain groups that would benefit from statin use in childhood and adolescence, she said.
Despite the lack of clinical significance, the results showed that atorvastatin was safe and well-tolerated in the study population, and Dr. Schanberg advised clinicians to continue prescribing statins for pediatric lupus patients with abnormal cholesterol or lipid levels.
Dr. Schanberg has served on the advisory board for Bristol-Myers Squibb, and Pfizer provided the drugs used in the study.
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亚特兰大(EGMN)——杜克大学医学中心小儿风湿病科主任Laura Schanberg博士在美国风湿病学会科学年会上报告称,虽然阿托伐他汀的确可预防儿童和青少年狼疮患者早期动脉粥样硬化,但并不推荐将他汀类药物用于大多数儿童狼疮患者。
既往研究表明,狼疮是心血管疾病的重大风险因素,特别是由于儿童狼疮患者通常长期带病生存,其相关风险增加。虽然已有临床医生向儿童狼疮患者,特别是具有高胆固醇等高风险因素患者开具他汀类药物,但此前并没有对他汀类药物降低儿童狼疮患者心血管疾病风险进行研究。
为观察他汀类药物是否能够降低儿童狼疮患者长期心血管疾病风险,本研究纳入221例年龄介于10~21岁之间的狼疮患者,随机分组服用阿托伐他汀或安慰剂。研究者采用公认的替代指标即超声检测颈动脉厚度作为心血管风险评价指标,受试者在为期3年的研究期间共接受7次超声检测。他们均接受标准狼疮治疗,包括阿司匹林、多维元素、羟化氯喹,并接受有关低胆固醇、低饱和脂肪饮食和其他心血管风险因素的咨询。
结果显示,他汀组在降低高敏C反应蛋白、总胆固醇和低密度脂蛋白方面具有统计学显著差异,但他汀组和安慰机组颈动脉内膜中层厚度差异分别为0.0024 mm/年和0.0010 mm/年(P =0.24),两组间颈动脉增厚进程未见显著差异。此外,两组在狼疮疾病活动和损伤、生活质量、肌肉、肝脏指标以及神经毒性方面相似。
研究表明,虽然他汀类药物呈现阳性结果趋势,但没有显示出常规治疗应有的足够优势,因此,不推荐将他汀类药物用于大多数儿童狼疮患者。鉴于受试人群服用阿托伐他汀具有安全性和良好耐受性,研究者建议临床医生可继续向胆固醇或血脂水平异常的儿童狼疮患者开具他汀类药物。
研究者曾为百时美施贵宝公司顾问委员会成员,辉瑞公司为本研究提供药品。
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