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埃索美拉唑在冠心病患者中的前瞻性、随机、安慰剂对照评估。EPAC:埃索美拉唑预防非典型胸痛。

Prospective, randomized, placebo-controlled evaluation of esomeprazole in coronary artery disease patients. EPAC: esomeprazole prevention of atypical chest pains.

作者信息

Liuzzo John, Ambrose John, Das Sajal, Devoe Mary, Korabathina Ravi, Agarwal Saurabh, Deshmukh Srmiti, Coppola John

机构信息

Saint Vincent Catholic Medical Centers, New York, New York, USA.

出版信息

J Invasive Cardiol. 2011 Jun;23(6):222-6.

PMID:21646646
Abstract

BACKGROUND

Coronary artery disease (CAD) patients experience chest pain (CP) from cardiac and non-cardiac etiologies.

OBJECTIVE

Proton pump inhibitor (PPI) treatment of CAD patients with atypical CP would result in less CP, as well as fewer emergency room (ER) visits for CP, medical evaluations, and hospitalizations.

METHODS

A randomized, prospective, placebo-controlled trial in patients with a history of severe CAD, without current ischemia, and not receiving acid reducing therapy. Patients received esomeprazole 40 mg or placebo daily added to standard cardiac medications for 6 months. The primary endpoint was percentage of patients experiencing CP.

RESULTS

In 162 patients randomized, 78 received esomeprazole and 84 received placebo. Esomeprazole significantly reduced the primary endpoint of patients experiencing CP (24.4% versus 54.8%; p < 0.001). The absolute number of CP episodes and CP days was also significantly reduced. Fewer patients experienced the combined endpoint of doctor office/ER visits for CP (19.2% versus 48.8%; p < 0.001), mainly due to significantly fewer office visits for CP (14.1% versus 39.3%; p < 0.001). ER visits for CP trended less with esomeprazole (12.8% versus 22.6%; p = 0.10), as did hospitalizations for CP (14.1% versus 20.2%; p = 0.30). However, the study lacked statistical power to reach these secondary endpoints.

CONCLUSIONS

Concomitant esomeprazole therapy in CAD patients without active ischemia but with a history of atypical CP reduces number of patients with further CP symptoms and medical office visits for CP. Larger studies are needed to further evaluate PPI treatment on ER CP visits and hospitalizations in this patient population.

摘要

背景

冠心病(CAD)患者会因心脏和非心脏病因出现胸痛(CP)。

目的

用质子泵抑制剂(PPI)治疗非典型CP的CAD患者,可减少CP发作次数,以及因CP前往急诊室(ER)就诊、进行医学评估和住院的次数。

方法

对有严重CAD病史、目前无缺血且未接受抑酸治疗的患者进行一项随机、前瞻性、安慰剂对照试验。患者在标准心脏药物基础上,每日服用40毫克埃索美拉唑或安慰剂,为期6个月。主要终点是出现CP的患者百分比。

结果

162例随机分组患者中,78例接受埃索美拉唑治疗,84例接受安慰剂治疗。埃索美拉唑显著降低了出现CP的患者这一主要终点(24.4%对54.8%;p<0.001)。CP发作次数和CP天数的绝对数量也显著减少。因CP前往医生办公室/ER就诊这一联合终点的患者较少(19.2%对48.8%;p<0.001),主要是因为因CP前往办公室就诊的次数显著减少(14.1%对39.3%;p<0.001)。服用埃索美拉唑后因CP前往ER就诊的趋势有所降低(12.8%对22.6%;p = 0.10),因CP住院的情况也是如此(14.1%对20.2%;p = 0.30)。然而,该研究缺乏达到这些次要终点的统计效力。

结论

在无活动性缺血但有非典型CP病史的CAD患者中,联合使用埃索美拉唑治疗可减少出现进一步CP症状的患者数量以及因CP前往医疗机构就诊的次数。需要开展更大规模的研究,以进一步评估PPI治疗对该患者群体因CP前往ER就诊和住院情况的影响。

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