Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk.
Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk.
复制标题
DOI：
10.1136/heartjnl-2016-310897
复制
发表时间：
2017-10
期刊：
影响因子：
--
通讯作者：
SUMMIT Investigators
中科院分区：
文献类型：
--
作者：
Brook RD;Anderson JA;Calverley PM;Celli BR;Crim C;Denvir MA;Magder S;Martinez FJ;Rajagopalan S;Vestbo J;Yates J;Newby DE;SUMMIT Investigators
心血管疾病（CVD）和慢性阻塞性肺疾病（COPD）经常共存。我们评估了吸入COPD治疗对COPD患者和CVD高风险患者CVD结局和安全性的影响。SUMMIT（了解死亡率和发病率的研究）是一项多中心、随机、双盲、安慰剂对照、事件驱动的试验，纳入了16485例患有或处于心血管疾病高风险的中度慢性阻塞性肺病患者。在这里，我们通过Cox回归和临床报告的四组CVD不良事件评估了预先指定的第一次治疗复合CVD事件（CVD死亡，心肌梗死，卒中，不稳定型心绞痛或短暂性缺血性发作（TIA））的次要终点时间：每日一次吸入安慰剂（n=4111），长效β -受体激动剂(维兰特罗（VI） 25µg；n=4118)，皮质类固醇(糠酸氟替卡松（FF） 100µg；n=4135)和联合治疗（FF/VI; n=4121）。参与者主要是中年（平均65岁（SD 8））男性（75%），伴有明显的CVD（66%）。688名患者出现了复合心血管疾病终点（第一事件：猝死（35%），急性冠状动脉综合征（37%）和卒中或TIA(23%)），与安慰剂相比，任何治疗组的复合心血管疾病终点均未降低：VI (HR 0.99, 95% CI 0.80至1.22),FF （HR 0.90, 95% CI 0.72至1.11）及其联合（HR 0.93, 95% CI 0.75至1.14）。所有亚组的结果相似。不良事件，包括心悸和心律失常，没有因治疗而不同。对于中度气流受限且CVD风险升高的COPD患者，吸入VI、FF或其联合治疗具有极好的安全性，且不影响CVD结果。NCT01313676。
Cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD) often coexist. We assessed the effect of inhaled COPD treatments on CVD outcomes and safety in patients with COPD and at heightened CVD risk. The SUMMIT (Study to Understand Mortality and MorbidITy) was a multicentre, randomised, double-blind, placebo-controlled, event-driven trial in 16 485 patients with moderate COPD who had or were at high risk of CVD. Here, we assessed the prespecified secondary endpoint of time to first on-treatment composite CVD event (CVD death, myocardial infarction, stroke, unstable angina or transient ischaemic attack (TIA)) by Cox regression and by clinician-reported CVD adverse events across the four groups: once-daily inhaled placebo (n=4111), long-acting beta2-agonist (vilanterol (VI) 25 µg; n=4118), corticosteroid (fluticasone furoate (FF) 100 µg; n=4135) and combination therapy (FF/VI; n=4121). Participants were predominantly middle-aged (mean 65 (SD 8) years) men (75%) with overt CVD (66%). The composite CVD endpoint occurred in 688 patients (first event: sudden death (35%), acute coronary syndrome (37%) and stroke or TIA (23%), and was not reduced in any treatment group versus placebo: VI (HR 0.99, 95% CI 0.80 to 1.22), FF (HR 0.90, 95% CI 0.72 to 1.11) and their combination (HR 0.93, 95% CI 0.75 to 1.14). Outcomes were similar among all subgroups. Adverse events, including palpitations and arrhythmias, did not differ by treatment. In patients with COPD with moderate airflow limitation and heightened CVD risk, treatment with inhaled VI, FF or their combination has an excellent safety profile and does not impact CVD outcomes. NCT01313676.
登录
查看更多内容
影响因子：
168.9
作者：
Lozano, Rafael;Naghavi, Mohsen;Murray, Christopher J. L.
通讯作者：
Murray, Christopher J. L.
影响因子：
24.3
作者：
Mannino, D. M.;Thorn, D.;Holguin, F.
通讯作者：
Holguin, F.
影响因子：
158.5
作者：
Wise, Robert A.;Anzueto, Antonio;Calverley, Peter
通讯作者：
Calverley, Peter
影响因子：
3.7
作者：
Cazzola, Mario;Bettoncelli, Germano;Biscione, Gianluca
通讯作者：
Biscione, Gianluca
影响因子：
2.9
作者：
Rothnie KJ;Yan R;Smeeth L;Quint JK
通讯作者：
Quint JK