对于高敏 C 反应蛋白升高或血脂异常的女性，用他汀类药物进行心血管一级预防：来自评估瑞舒伐他汀用于预防的应用（JUPITER）的干预试验和来自一级预防试验的女性亚组的荟萃分析的结果。
Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials.
机构信息
Center for Cardiovascular Disease Prevention, Divisions of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02215, USA.
出版信息
Circulation. 2010 Mar 9;121(9):1069-77. doi: 10.1161/CIRCULATIONAHA.109.906479. Epub 2010 Feb 22.
BACKGROUND
Statin therapy in women without cardiovascular disease (CVD) is controversial, given the insufficient evidence of benefit. We analyzed sex-specific outcomes in the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and synthesized the results with prior trials.
METHODS AND RESULTS
JUPITER participants included 6801 women > or =60 years of age and 11 001 men > or =50 years of age with high-sensitivity C-reactive protein > or =2 mg/L and low-density lipoprotein cholesterol <130 mg/dL randomized to rosuvastatin versus placebo. Meta-analysis studies were randomized placebo-controlled statin trials with predominantly or exclusively primary prevention in women and sex-specific outcomes (20 147 women; >276 CVD events; mean age, 63 to 69 years). Absolute CVD rates (per 100 person-years) in JUPITER women for rosuvastatin and placebo (0.57 and 1.04, respectively) were lower than for men (0.88 and 1.54, respectively), with similar relative risk reduction in women (hazard ratio, 0.54; 95% confidence interval, 0.37 to 0.80; P=0.002) and men (hazard ratio, 0.58; 95% confidence interval, 0.45 to 0.73; P<0.001). In women, there was significant reduction in revascularization/unstable angina and nonsignificant reductions in other components of the primary end point. Meta-analysis of 13 154 women (240 CVD events; 216 total deaths) from exclusively primary prevention trials found a significant reduction in primary CVD events with statins by a third (relative risk, 0.63; 95% confidence interval, 0.49 to 0.82; P<0.001; P for heterogeneity=0.56) with a smaller nonsignificant effect on total mortality (relative risk, 0.78; 95% confidence interval, 0.53 to 1.15; P=0.21; P for heterogeneity=0.20). Similar results were obtained for trials that were predominantly but not exclusively primary prevention.
CONCLUSIONS
JUPITER demonstrated that in primary prevention rosuvastatin reduced CVD events in women with a relative risk reduction similar to that in men, a finding supported by meta-analysis of primary prevention statin trials. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00239681.
背景
鉴于他汀类药物治疗在女性心血管疾病（CVD）中的益处证据不足，因此在无 CVD 的女性中应用他汀类药物存在争议。我们分析了 JUSTIFICATION FOR THE USE OF STATINS IN PREVENTION：AN INTERVENTION TRIAL EVALUATING ROSUVASTATIN（JUPITER）试验中的性别特异性结局，并结合先前的试验进行了综合分析。
方法和结果
JUPITER 试验纳入了 6801 名年龄≥60 岁的女性和 11001 名年龄≥50 岁的男性，这些患者的高敏 C 反应蛋白＞2mg/L 且低密度脂蛋白胆固醇＜130mg/dL，被随机分配接受瑞舒伐他汀或安慰剂治疗。Meta 分析研究纳入了主要或仅为女性一级预防的随机安慰剂对照他汀类药物试验，共纳入 20147 名女性；＞276 例 CVD 事件；平均年龄为 63 至 69 岁。JUPITER 女性的绝对 CVD 发生率（每 100 人年），瑞舒伐他汀组为 0.57，安慰剂组为 1.04，均低于男性（分别为 0.88 和 1.54），女性和男性的相对风险降低幅度相似（危险比，0.54；95%置信区间，0.37 至 0.80；P=0.002 和危险比，0.58；95%置信区间，0.45 至 0.73；P＜0.001）。在女性中，血管重建/不稳定型心绞痛显著减少，而主要终点的其他部分则无显著减少。来自主要为一级预防试验的 13154 名女性（240 例 CVD 事件；216 例总死亡）的 Meta 分析发现，他汀类药物可使主要 CVD 事件减少三分之一（相对风险，0.63；95%置信区间，0.49 至 0.82；P＜0.001；异质性 P=0.56），但对总死亡率的影响较小（相对风险，0.78；95%置信区间，0.53 至 1.15；P=0.21；异质性 P=0.20）。主要为但非完全为一级预防的试验也得到了类似的结果。
结论
JUPITER 表明，在一级预防中，瑞舒伐他汀降低了女性的 CVD 事件，其相对风险降低与男性相似，这一发现得到了主要为一级预防的他汀类药物试验的 Meta 分析的支持。
临床试验注册- URL：http://www.clinicaltrials.gov。独特标识符：NCT00239681。
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