Hôpital Lariboisiere, Assistance Publique-Hopitaux de Paris, Université Paris Diderot, INSERM U942, 2 Rue Ambroise Paré, 75475 Paris Cedex 10, France.
Eur J Heart Fail. 2009 Sep;11(9):872-80. doi: 10.1093/eurjhf/hfp104. Epub 2009 Aug 1.
To determine the safety and efficacy of nebivolol in elderly heart failure (HF) patients with renal dysfunction.
SENIORS recruited patients aged 70 years or older with symptomatic HF, irrespective of ejection fraction, and randomized them to nebivolol or placebo. Patients (n = 2112) were divided by tertile of estimated glomerular filtration rate (eGFR). Mean age of patients was 76.1 years, 35% of patients had an ejection fraction of >35%, and 37% were women resulting in a unique cohort, far more representative of clinical practice than previous trials. eGFR was strongly associated with outcomes and nebivolol was similarly efficacious across eGFR tertiles. The primary outcome rate (all-cause mortality or cardiovascular hospital admission) and adjusted hazard ratio for nebivolol use in those with low eGFR was 40% and 0.84 (95% CI 0.67-1.07), 31% and 0.79 (0.60-1.04) in the middle tertile, and 29% and 0.86 (0.65-1.14) in the highest eGFR tertile. There was no interaction noted between renal function and the treatment effect (P = 0.442). Nebivolol use in patients with moderate renal impairment (eGFR <60) was not associated with major safety concerns, apart from higher rates of drug-discontinuation due to bradycardia.
Nebivolol is safe and has a similar effect in elderly HF patients with mild or moderate renal impairment.
评估比索洛尔在合并肾功能不全的老年心力衰竭(HF)患者中的安全性和疗效。
SENIORS 研究入选了年龄 70 岁及以上、有症状的 HF 患者,不论射血分数如何,将其随机分为比索洛尔组或安慰剂组。根据估算肾小球滤过率(eGFR)的三分位将患者分组。患者平均年龄为 76.1 岁,35%的患者射血分数>35%,37%为女性,构成了一个独特的队列,比以往的试验更能代表临床实践。eGFR 与结局密切相关,比索洛尔在 eGFR 三分位的疗效相似。主要终点(全因死亡率或心血管住院)发生率和 eGFR 较低患者使用比索洛尔的调整后危险比分别为 40%和 0.84(95%CI 0.67-1.07)、eGFR 中值组为 31%和 0.79(0.60-1.04),eGFR 高值组为 29%和 0.86(0.65-1.14)。未观察到肾功能与治疗效果之间存在交互作用(P = 0.442)。除了因心动过缓而停药率较高外,中度肾功能不全(eGFR <60)患者使用比索洛尔并无重大安全性顾虑。
比索洛尔在合并轻度或中度肾功能不全的老年 HF 患者中安全有效。