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他达拉非对冠状动脉疾病患者运动诱发心肌缺血时间的影响。

The effect of tadalafil on the time to exercise-induced myocardial ischaemia in subjects with coronary artery disease.

作者信息

Patterson Dean, Kloner Robert, Effron Mark, Emmick Jeffrey, Bedding Alun, Warner Margaret, Mitchell Malcolm, Braat Simon, MacDonald Thomas

机构信息

Hypertension Research Centre, Department of Medicine and Therapeutics, Ninewells Hospital and Medical School, Dundee University, Dundee DD1 9SY, Scotland, UK.

出版信息

Br J Clin Pharmacol. 2005 Nov;60(5):459-68. doi: 10.1111/j.1365-2125.2005.02479.x.

Abstract

OBJECTIVE

To investigate the effect of tadalafil on the time to exercise-induced myocardial ischaemia in subjects with coronary artery disease (CAD). Background CAD and erectile dysfunction (ED) share similar risk factors. It is important to know the cardiovascular effects of tadalafil in patients with CAD during physical exertion that is comparable with sexual activity.

METHODS

A randomized, placebo-controlled, double-blind, two-period, crossover study comparing the effects of tadalafil 10 mg and placebo on the time to exercise treadmill test (ETT)-induced myocardial ischaemia in subjects with stable CAD (n = 23; age range: 53-75 years, all exhibited ST-segment depression >1.5 mm at screening ETT at > 5METS). Haemodynamic responses to sublingual nitroglycerin (NTG) were assessed before and after ETT.

RESULTS

Compared with placebo, tadalafil did not significantly affect the time to ETT-induced ischaemia (13 min/31 s vs. 13 min/36 s, respectively). Before exercise, NTG evoked decreases in sitting systolic blood pressure (SBP) that were significantly greater when subjects received tadalafil compared with placebo, and after exercise, more subjects experienced a decrease in SBP <85 mmHg in response to NTG after taking tadalafil vs. placebo. When subjects received tadalafil compared with placebo, SBP was lower at rest (-7 mmHg; -12,-2), during ETT (-10 mmHg; -16, -3), and after ETT (-13 mmHg; -19, -7).

CONCLUSION

Tadalafil did not significantly alter the time to ETT-induced ischaemia compared with placebo in subjects with CAD. Tadalafil reduced resting and exercise SBP. Due to the potential for hypotension, the concomitant use of nitrates and tadalafil is contraindicated.

摘要

目的

研究他达拉非对冠状动脉疾病(CAD)患者运动诱发心肌缺血时间的影响。背景:CAD和勃起功能障碍(ED)有相似的危险因素。了解他达拉非在CAD患者中进行与性活动相当的体力活动时的心血管效应很重要。

方法

一项随机、安慰剂对照、双盲、两阶段、交叉研究,比较10mg他达拉非和安慰剂对稳定型CAD患者(n = 23;年龄范围:53 - 75岁,所有患者在筛选运动平板试验(ETT)时,运动负荷>5代谢当量,均表现出ST段压低>1.5mm)运动诱发心肌缺血时间的影响。在ETT前后评估舌下含服硝酸甘油(NTG)后的血流动力学反应。

结果

与安慰剂相比,他达拉非对ETT诱发缺血时间无显著影响(分别为13分钟31秒和13分钟36秒)。运动前,与安慰剂相比,受试者服用他达拉非时NTG引起的坐位收缩压(SBP)下降显著更大;运动后,服用他达拉非后与安慰剂相比,更多受试者对NTG反应出现SBP下降至<85mmHg。与安慰剂相比,受试者服用他达拉非时,静息时SBP较低(-7mmHg;-12,-2),ETT期间(-10mmHg;-16,-3),ETT后(-13mmHg;-19,-7)。

结论

与安慰剂相比,他达拉非在CAD患者中未显著改变ETT诱发缺血的时间。他达拉非降低了静息和运动时的SBP。由于存在低血压风险,硝酸盐与他达拉非联用禁忌。

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