Ghio Stefano, Magrini Giulia, Serio Alessandra, Klersy Catherine, Fucili Alessandro, Ronaszèki Aleksandr, Karpati Pal, Mordenti Giacomo, Capriati Angela, Poole-Wilson Philip A, Tavazzi Luigi
Division of Cardiology, IRCCS Policlinico San Matteo, Pavia, Italy.
Eur Heart J. 2006 Mar;27(5):562-8. doi: 10.1093/eurheartj/ehi735. Epub 2006 Jan 27.
The SENIORS trial recently demonstrated that nebivolol reduces the composite risk of all-cause mortality and cardiovascular hospital admission in elderly patients with chronic heart failure and, importantly, that ejection fraction does not influence the clinical effects of nebivolol. An echocardiographic substudy was designed to evaluate the effects of nebivolol on systolic and diastolic left ventricular (LV) function in patients stratified according to the presence or absence of systolic LV dysfunction.
The substudy randomized 112 patients in 29 European centres, of whom 104 were evaluable for the study; 43 had an ejection fraction (EF) <or=35% and 61 had an EF>35%. LV end-systolic volume (ESV), EF, mitral valve E/A ratio, and E-wave deceleration time were assessed at baseline and after 12 months. Echocardiograms were submitted to a core laboratory to perform quantitative analysis in blinded condition. In the group with EF</=35%, nebivolol reduced ESV (adjusted difference between treatments 25.8 mL, 95%CI: -46.6; -5.0, P=0.016) and improved EF (adjusted difference between treatments 4.6%, 95%CI: 1.3;7.9, P=0.008); no changes were observed in the E/A ratio or E-wave deceleration time. In EF>35% group, no significant changes in either systolic or diastolic parameters were observed.
In patients with heart failure and advanced systolic LV dysfunction, nebivolol reduces ventricular size and improves EF. The absence of detectable changes with standard echocardiography in patients with predominant diastolic heart failure questions the mechanism of benefit on morbidity/mortality in such patients.
SENIORS试验最近表明,奈必洛尔可降低老年慢性心力衰竭患者全因死亡率和心血管疾病住院的综合风险,重要的是,射血分数不影响奈必洛尔的临床疗效。一项超声心动图亚研究旨在评估奈必洛尔对根据左心室收缩功能障碍的有无分层的患者左心室收缩和舒张功能的影响。
该亚研究在29个欧洲中心将112例患者随机分组,其中104例可纳入研究;43例射血分数(EF)≤35%,61例EF>35%。在基线和12个月后评估左心室收缩末期容积(ESV)、EF、二尖瓣E/A比值和E波减速时间。超声心动图提交至核心实验室,在盲态下进行定量分析。在EF≤35%的组中,奈必洛尔降低了ESV(治疗间调整差异为25.8 mL,95%CI:-46.6;-5.0,P=0.016)并改善了EF(治疗间调整差异为4.6%,95%CI:1.3;7.9,P=0.008);E/A比值或E波减速时间未观察到变化。在EF>35%组中,收缩期或舒张期参数均未观察到显著变化。
在心力衰竭和晚期左心室收缩功能障碍患者中,奈必洛尔可减小心室大小并改善EF。在以舒张性心力衰竭为主的患者中,标准超声心动图未检测到变化,这对该类患者发病率/死亡率的获益机制提出了质疑。