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SHIFT 研究:慢性心力衰竭和慢性阻塞性肺疾病患者的临床特征和结局:疗效和安全性分析。

Clinical profiles and outcomes in patients with chronic heart failure and chronic obstructive pulmonary disease: an efficacy and safety analysis of SHIFT study.

机构信息

Maria Cecilia Hospital, GVM Care & Research, Ettore Sansavini Health Science Foundation, Cotignola, Italy.

出版信息

Int J Cardiol. 2013 Dec 10;170(2):182-8. doi: 10.1016/j.ijcard.2013.10.068. Epub 2013 Oct 25.

DOI:10.1016/j.ijcard.2013.10.068
PMID:24225201
Abstract

BACKGROUND

Heart failure (HF) and chronic obstructive pulmonary disease (COPD) frequently coexist, with undefined prognostic and therapeutic implications. We investigated clinical profile and outcomes of patients with chronic HF and COPD, notably the efficacy and safety of ivabradine, a heart rate-reducing agent.

METHODS

6505 ambulatory patients, in sinus rhythm, heart rate ≥ 70 bpm and stable systolic HF were randomised to placebo or ivabradine (2.5 to 7.5mg bid). Multivariate Cox model analyses were performed to compare the COPD (n=730) and non-COPD subgroups, and the ivabradine and placebo treatment effects.

RESULTS

COPD patients were older and had a poorer risk profile. Beta-blockers were prescribed to 69% of COPD patients and 92% of non-COPD patients. The primary endpoint (PEP) and its component, hospitalisation for worsening HF, were more frequent in COPD patients (HRs f, 1.22 [p=0.006]; and 1.34 [p<0.001]) respectively, but relative risk was reduced similarly by ivabradine in both COPD (14%, and 17%) and non-COPD (18% and 27%) patients (p interaction=0.82, and 0.53, respectively). Similar effect was noted also for cardiovascular death. Adverse events were more common in COPD patients, but similar in treatment subgroups. Bradycardia occurred more frequently in ivabradine subgroups, with similar incidence in patients with or without COPD.

CONCLUSIONS

The association of COPD and HF results in a worse prognosis, and COPD represents a barrier to optimisation of beta-blocker therapy. Ivabradine is similarly effective and safe in chronic HF patients with or without COPD, and can be safely combined with beta-blockers in COPD.

摘要

背景

心力衰竭(HF)和慢性阻塞性肺疾病(COPD)常同时存在,其预后和治疗意义尚不清楚。我们研究了慢性 HF 和 COPD 患者的临床特征和结局,特别是心率降低剂伊伐布雷定的疗效和安全性。

方法

6505 名门诊患者,窦性心律,心率≥70bpm,稳定收缩性 HF,随机分为安慰剂或伊伐布雷定(2.5 至 7.5mg bid)组。采用多变量 Cox 模型分析比较 COPD(n=730)和非 COPD 亚组,以及伊伐布雷定和安慰剂的治疗效果。

结果

COPD 患者年龄较大,风险状况较差。β受体阻滞剂分别用于 69%的 COPD 患者和 92%的非 COPD 患者。主要终点(PEP)及其组成部分,因 HF 恶化而住院,在 COPD 患者中更为常见(HRf,1.22 [p=0.006];和 1.34 [p<0.001]),但伊伐布雷定在 COPD(14%和 17%)和非 COPD(18%和 27%)患者中同样降低了相对风险(p 交互=0.82 和 0.53)。心血管死亡也有类似的效果。在 COPD 患者中,不良事件更为常见,但在治疗亚组中相似。在伊伐布雷定亚组中,心动过缓更为常见,而 COPD 患者和非 COPD 患者的发生率相似。

结论

COPD 和 HF 的并存导致预后更差,而 COPD 是优化β受体阻滞剂治疗的障碍。伊伐布雷定在慢性 HF 患者中同样有效和安全,无论是否存在 COPD,都可以与β受体阻滞剂安全联合使用。

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