U.S. Food and Drug Administration, Silver Spring, Maryland.
Universidad de Ciencias Médicas, San José, Costa Rica.
Am J Cardiol. 2018 Sep 15;122(6):985-993. doi: 10.1016/j.amjcard.2018.05.046. Epub 2018 Jun 22.
There are differences in the incidence, pathophysiology, and long-term effects of hypertension between women and men. We assessed sex-specific benefit-risk tradeoffs of different blood pressure (BP) goals in patients enrolled in the Systolic Blood Pressure Intervention Trial (SPRINT) after propensity score matching those with standard therapy (systolic BP <140 mm Hg) to those with intensive therapy (systolic BP <120 mm Hg; n = 9,106). Cox regression was conducted to compare standard versus intensive therapy in women and men with the composite outcome of myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. Women were generally healthier at baseline and had a lower cardiovascular risk. Men on intensive therapy had a lower risk of the composite outcome compared to those on standard therapy (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.57 to 0.86, p = 0.001) while in women no differences between therapy groups were observed (HR 0.82 [0.60 to 1.12], p = 0.206). For safety outcomes, women and men had increased risk of related serious adverse events with intensive treatment (HR 1.52 [1.06 to 2.18], p = 0.023 and HR 2.07 [1.55 to2.77], p < 0.001, respectively). In conclusion, our study demonstrated that women did not benefit from intensive compared to standard BP control. A potential explanation for this may be the lower baseline cardiovascular risk in women.
女性和男性的高血压发病率、病理生理学和长期影响存在差异。我们评估了收缩压干预试验(SPRINT)中不同血压(BP)目标的性别特异性获益-风险权衡,这些患者通过倾向评分匹配接受标准治疗(收缩压<140mmHg)和强化治疗(收缩压<120mmHg),并对那些接受强化治疗的患者(n=9106)进行了分析。Cox 回归用于比较女性和男性的标准治疗与强化治疗的复合结局,复合结局包括心肌梗死、其他急性冠状动脉综合征、卒中等。女性的基线健康状况通常更好,心血管风险较低。与标准治疗相比,强化治疗组的复合结局风险较低(风险比 [HR] 0.70,95%置信区间 [CI] 0.57 至 0.86,p=0.001),而女性组两种治疗方案之间没有差异(HR 0.82 [0.60 至 1.12],p=0.206)。对于安全性结局,女性和男性的强化治疗相关严重不良事件风险增加(HR 1.52 [1.06 至 2.18],p=0.023 和 HR 2.07 [1.55 至 2.77],p<0.001)。总之,我们的研究表明,与标准 BP 控制相比,女性并未从强化治疗中获益。造成这种结果的一个潜在原因可能是女性的基线心血管风险较低。