Institute of Pharmaceutical and Biomedical Sciences, University of Strathclyde, Glasgow, UK.
J Hum Hypertens. 2011 Jan;25(1):63-70. doi: 10.1038/jhh.2010.19. Epub 2010 Feb 25.
A retrospective analysis of the database from A Coronary Disease Trial Investigating Outcome with Nifedipine (ACTION) evaluated the effectiveness of nifedipine gastrointestinal therapeutic system (GITS) (i) in combination with renin angiotensin system (RAS) blockers and (ii) in patients with isolated systolic hypertension (ISH). Analysed on an intention-to-treat basis, treatment groups were compared by the log-rank test without adjustment for covariates and hazard ratios with 95% CIs were obtained using Cox proportional hazards models. Of 7665 randomized patients, 1732 patients were receiving RAS blockade at baseline, the addition of nifedipine GITS significantly reduced any cardiovascular (CV) event (-20%; P<0.05), the composite of death, any CV event and revascularization (-16%; P<0.05) and coronary angiography (-22%; P<0.01). These benefits were achieved with relatively small differences in systolic (3.2 mm Hg) and diastolic blood pressure (BP) (2.3 mm Hg). In 2303 patients (30.0%) who had ISH at baseline (1145 nifedipine GITS and 1158 placebo), nifedipine significantly reduced the primary efficacy end point (-18%; P<0.03), any CV event (-22%; P<0.01) and new heart failure (-40%; P<0.01). The benefits were associated with between-group differences in achieved BP of 4.7 and 3.3 mm Hg for systolic and diastolic BP, respectively. In summary, the lowest CV event rates were seen in those receiving (i) the combination of RAS blockade and nifedipine GITS and (ii) in those specifically treated for ISH.
一项对 ACTION 研究数据库的回顾性分析评估了硝苯地平胃肠道治疗系统(GITS)(i)与肾素-血管紧张素系统(RAS)阻滞剂联合使用的效果,以及(ii)在单纯收缩期高血压(ISH)患者中的效果。基于意向治疗进行分析,未对协变量进行调整,使用 Cox 比例风险模型获得了对数秩检验的治疗组比较和 95%CI 的风险比。在 7665 名随机患者中,有 1732 名患者在基线时接受 RAS 阻滞剂治疗,硝苯地平 GITS 的添加显著降低了任何心血管(CV)事件(-20%;P<0.05)、死亡、任何 CV 事件和血运重建的复合终点(-16%;P<0.05)和冠状动脉造影(-22%;P<0.01)。这些益处是通过收缩压(3.2mmHg)和舒张压(BP)(2.3mmHg)相对较小的差异实现的。在基线时有 ISH 的 2303 名患者(30.0%)(硝苯地平 GITS 组 1145 名,安慰剂组 1158 名)中,硝苯地平显著降低了主要疗效终点(-18%;P<0.03)、任何 CV 事件(-22%;P<0.01)和新发心力衰竭(-40%;P<0.01)。这些益处与组间差异相关,收缩压和舒张压的差异分别为 4.7mmHg 和 3.3mmHg。总之,接受(i)RAS 阻滞剂联合硝苯地平 GITS 治疗和(ii)专门治疗 ISH 的患者的 CV 事件发生率最低。