Centre d'Investigations Cliniques Plurithématique, INSERM, F-CRIN INI-CRCT, CHRU de Nancy, Université de Lorraine, Nancy, France.
Cardiovascular Research and Development Unit, Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine, University of Porto, Porto, Portugal.
J Hypertens. 2018 Feb;36(2):428-435. doi: 10.1097/HJH.0000000000001535.
Any treatment decision should be tailored to the individual patients' characteristics. A personalized approach aims to help better selecting the patients who are likely to benefit most from a treatment decision. In the systolic blood pressure intervention trial, intensive treatment reduced the rate of major cardiovascular events, but increased the rate of serious adverse events (SAEs).
To assess the trade-off between efficacy and safety to simultaneously quantify an individual patient's absolute benefit and absolute harm, helping clinicians making better therapeutic choices in daily practice.
Multivariable Poisson regression models were used to identify independent risk factors for: primary composite cardiovascular outcome and major SAEs = safety. Estimates from the models were used to quantify each individual risk.
Subclinical cardiovascular disease, number of antihypertensive agents, current smoking, age, urine albumin-to-creatinine ratio, and serum creatinine were associated with increased risk of both primary outcome events and SAEs. Triglycerides were associated with increased primary outcome events only, and chronic kidney disease and female sex with SAEs only. The models were well calibrated and showed good performance (c-index for safety = 0.69 and c-index for efficacy = 0.72). For the primary outcome, there is a steep gradient in risk by fifths of the predicted model and a similar gradient exists for the safety outcome predicted model. Mortality within 1 year of an efficacy outcome (as assessed by the Kaplan-Meier method) was nearly three-fold higher than following a safety outcome (21.9 vs. 7.5%). If one judges the clinical importance of efficacy and safety outcomes based on their 1-year mortality, then there is a net benefit of intensive therapy for almost all patients.
Antihypertensive treatment intensification is associated with lower cardiovascular event rates; however, it increases the risk of adverse events. However, having adverse events has less weight when it comes to therapeutic decisions and antihypertensive therapy intensification is beneficial for the great majority of patients included in the systolic blood pressure intervention trial.
任何治疗决策都应根据个体患者的特点量身定制。个性化方法旨在帮助更好地选择最有可能从治疗决策中受益的患者。在收缩压干预试验中，强化治疗降低了主要心血管事件的发生率，但增加了严重不良事件（SAE）的发生率。
评估疗效和安全性之间的权衡，同时量化个体患者的绝对获益和绝对危害，帮助临床医生在日常实践中做出更好的治疗选择。
多变量泊松回归模型用于确定以下独立风险因素：主要复合心血管结局和主要 SAE=安全性。从模型中得出的估计值用于量化每个个体的风险。
亚临床心血管疾病、降压药物数量、当前吸烟、年龄、尿白蛋白与肌酐比值和血清肌酐与主要结局事件和 SAE 风险增加相关。甘油三酯仅与主要结局事件增加相关，而慢性肾脏病和女性仅与 SAE 相关。该模型具有良好的校准和性能（安全性的 C 指数为 0.69，疗效的 C 指数为 0.72）。对于主要结局，根据预测模型的五分之一，风险呈陡峭梯度，安全结局预测模型也存在类似的梯度。根据 Kaplan-Meier 方法评估的 1 年内疗效结局的死亡率几乎是安全性结局的三倍（21.9%对 7.5%）。如果根据 1 年死亡率来判断疗效和安全性结局的临床重要性，那么强化治疗对几乎所有患者都有净获益。
抗高血压治疗强化与较低的心血管事件发生率相关；然而，它增加了不良事件的风险。然而，在治疗决策中，不良事件的权重较小，强化抗高血压治疗对收缩压干预试验中纳入的绝大多数患者有益。
