AstraZeneca LP, 1800 Concord Pike, Wilmington, DE 19850-5437, USA.
J Am Coll Cardiol. 2011 Apr 19;57(16):1666-75. doi: 10.1016/j.jacc.2010.09.082.
The purpose of this study was to assess the impact on cardiovascular and adverse events of attaining low-density lipoprotein cholesterol (LDL-C) levels <50 mg/dl with rosuvastatin in apparently healthy adults in the JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial.
The safety and magnitude of cardiovascular risk reduction conferred by treatment to LDL-C levels below current recommended targets remain uncertain.
A cohort of 17,802 apparently healthy men and women with high-sensitivity C-reactive protein ≥2 mg/l and LDL-C <130 mg/dl were randomly allocated to rosuvastatin 20 mg daily or placebo, and followed up for all-cause mortality, major cardiovascular events, and adverse events. In a post-hoc analysis, participants allocated to rosuvastatin were categorized as to whether or not they had a follow-up LDL-C level <50 mg/dl.
During a median follow-up of 2 years (range up to 5 years), rates of the primary trial endpoint were 1.18, 0.86, and 0.44 per 100 person-years in the placebo group (n = 8,150) and rosuvastatin groups without LDL-C <50 mg/dl (n = 4,000) or with LDL-C <50 mg/dl (n = 4,154), respectively (fully-adjusted hazard ratio: 0.76; 95% confidence interval: 0.57 to 1.00 for subjects with no LDL-C <50 mg/dl vs. placebo and 0.35, 95% confidence interval: 0.25 to 0.49 for subjects attaining LDL-C <50 mg/dl; p for trend <0.0001). For all-cause mortality, corresponding event rates were 0.67, 0.65, and 0.39 (p for trend = 0.004). Rates of myalgia, muscle weakness, neuropsychiatric conditions, cancer, and diabetes mellitus were not significantly different among rosuvastatin-allocated participants with and without LDL-C <50 mg/dl.
Among adults with LDL-C <130 mg/dl and high-sensitivity C-reactive protein ≥2 mg/l, rosuvastatin-allocated participants attaining LDL-C <50 mg/dl had a lower risk of cardiovascular events without a systematic increase in reported adverse events.
本研究旨在评估在 JUPITER（使用他汀类药物预防的正当理由：评价瑞舒伐他汀的干预试验）试验中，对于 LDL-C 水平<50mg/dl 的健康成年人，使用瑞舒伐他汀对心血管和不良事件的影响。
治疗 LDL-C 水平低于当前推荐目标所带来的心血管风险降低的安全性和幅度仍不确定。
一个由 17802 名高敏 C 反应蛋白≥2mg/L 且 LDL-C<130mg/dl 的健康男性和女性组成的队列被随机分配至瑞舒伐他汀 20mg/d 或安慰剂组，并随访全因死亡率、主要心血管事件和不良事件。在事后分析中，根据是否有随访 LDL-C<50mg/dl 将接受瑞舒伐他汀治疗的参与者进行分类。
在中位随访 2 年（最长 5 年）期间，安慰剂组（n=8150）、无 LDL-C<50mg/dl（n=4000）或 LDL-C<50mg/dl 的瑞舒伐他汀组（n=4154）的主要试验终点发生率分别为 1.18、0.86 和 0.44/100 人年（经完全调整的危险比：0.76；95%置信区间：无 LDL-C<50mg/dl 与安慰剂相比为 0.57 至 1.00，对于 LDL-C<50mg/dl 的患者为 0.35，95%置信区间：0.25 至 0.49；趋势检验 p<0.0001）。对于全因死亡率，相应的事件发生率分别为 0.67、0.65 和 0.39（趋势检验 p=0.004）。在 LDL-C<50mg/dl 的瑞舒伐他汀组与无 LDL-C<50mg/dl 的瑞舒伐他汀组之间，肌痛、肌肉无力、神经精神疾病、癌症和糖尿病的发生率无显著差异。
在 LDL-C<130mg/dl 和高敏 C 反应蛋白≥2mg/L 的成年人中，LDL-C<50mg/dl 的瑞舒伐他汀组参与者的心血管事件风险较低，而报告的不良事件无系统增加。
