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首页> 外文期刊>Pulmonary pharmacology & therapeutics >Cardiac safety of formoterol 12mug twice daily in patients with chronic obstructive pulmonary disease.
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Cardiac safety of formoterol 12mug twice daily in patients with chronic obstructive pulmonary disease.

机译：慢性阻塞性肺疾病患者每天两次服用福莫特罗12杯的心脏安全性。

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Background: Some evidence suggests an increased risk of myocardial infarction and dysrhythmia events associated with beta(2)-agonist use in patients with chronic obstructive pulmonary disease (COPD). This prospective, multicenter, randomized, double-blind, placebo-controlled study compared the cardiac safety of formoterol and placebo in patients with COPD. Methods: After a 3-14-day run-in, 204 patients were randomized to receive formoterol 12mug dry powder inhalation or matching placebo twice daily for 8 weeks. Twenty four-hour continuous electrocardiography (Holter monitoring) was performed at screening and after 2 and 8 weeks of treatment. Results: Only a small number of patients met the predefined criteria for a proarrhythmic event (4 formoterol and 2 placebo patients). No patients had sustained postbaseline ventricular tachycardia events, postbaseline run of ventricular ectopic beats associated with relevant symptoms (e.g. hypotension, syncope), or an episode of ventricular flutter or fibrillation.Holter monitoring data were variable but showed no clinically meaningful differences between the formoterol and placebo groups, respectively, for variables such as (mean+/-SD at end of treatment): heart rate (80+/-8.6 vs. 80+/-10.6bpm), number and rate of ventricular premature beats (total 732+/-2685.4 vs. 650+/-2090.6; rate 35+/-131.0 vs. 30+/-101.3perh), ventricular tachycardia events (total 0.4+/-1.70 vs. 1.0+/-9.23; rate 0.02+/-0.082 vs. 0.05+/-0.479 per h), and supraventricular premature beats (total 504+/-1844.1 vs. 823+/-2961.8; rate 22+/-80.6 vs. 37+/-129.6perh). Vital signs and electrocardiogram data, including corrected QT intervals (Bazett and Fridericia), were similar across treatment groups. The overall adverse event experience was similar in the formoterol (n=26 [27%]) and placebo (n=33 [31%]) groups. The most common adverse events, infections and respiratory events, were expected for this patient population. The incidence of cardiac adverse events was low (1 formoterol and 4 placebo patients). Conclusions: The results of this study confirm the good cardiovascular safety profile of formoterol in patients with COPD.
机译：背景：一些证据表明，慢性阻塞性肺疾病（COPD）患者使用β（2）-激动剂会增加心肌梗塞和心律失常事件的风险。这项前瞻性，多中心，随机，双盲，安慰剂对照研究比较了福莫特罗和安慰剂对COPD患者的心脏安全性。方法：经过3-14天的磨合，随机将204例患者接受福莫特罗12杯干粉吸入或匹配的安慰剂，每天两次，共8周。筛选时以及治疗2周和8周后进行二十四小时连续心电图检查（动态心电图监测）。结果：只有少数患者符合心律失常事件的既定标准（4名福莫特罗和2名安慰剂患者）。没有患者持续基线后室性心动过速事件，基线后室性异位搏动伴有相关症状（例如低血压，晕厥）或心室扑动或纤维性颤动发作。安慰剂组的变量，例如（治疗结束时的平均+/- SD）：心率（80 +/- 8.6 vs. 80 +/- 10.6bpm），室性早搏的次数和速率（总计732 + / -2685.4 vs.650 +/- 2090.6;速率35 +/- 131.0 vs.30 +/- 101.3perh），室性心动过速事件（总计0.4 +/- 1.70 vs.1.0 +/- 9.23;速率0.02 +/- 0.082 vs. 0.05 +/- 0.479 / h）和室上早搏（总计504 +/- 1844.1 vs. 823 +/- 2961.8;速率22 +/- 80.6 vs.37 +/- 129.6perh）。各个治疗组的生命体征和心电图数据（包括校正的QT间隔）（Bazett和Fridericia）相似。福莫特罗（n = 26 [27％]）和安慰剂（n = 33 [31％]）组的总体不良事件经历相似。预期该患者人群最常见的不良事件，感染和呼吸系统事件。心脏不良事件的发生率较低（1名福莫特罗和4名安慰剂患者）。结论：这项研究的结果证实了福莫特罗在COPD患者中具有良好的心血管安全性。

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