伐地那非是一种用于治疗勃起功能障碍的强效且高度选择性的磷酸二酯酶-5抑制剂，它对冠状动脉疾病患者运动时心血管反应的影响。

The effect of vardenafil, a potent and highly selective phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction, on the cardiovascular response to exercise in patients with coronary artery disease.

作者信息

Thadani Udho, Smith William, Nash Stephen, Bittar Neville, Glasser Stephen, Narayan Puneet, Stein Richard A, Larkin Sharon, Mazzu Arthur, Tota Robert, Pomerantz Kenneth, Sundaresan Pavur

机构信息

Oklahoma University, Health Sciences Center, and Veterans Affairs Medical Center, Cardiology Section, Oklahoma City, Oklahoma 73104, USA.

出版信息

J Am Coll Cardiol. 2002 Dec 4;40(11):2006-12. doi: 10.1016/s0735-1097(02)02563-9.

DOI:10.1016/s0735-1097(02)02563-9

PMID:12475462

Abstract

OBJECTIVES

The effect of vardenafil, a potent and highly selective phosphodiesterase-5 (PDE5) inhibitor, on symptom-limited exercise time, time to first awareness of angina, and time to ischemic threshold (ST-segment depression > or =1 mm from baseline) during exercise tolerance testing (ETT) was examined in patients with stable coronary artery disease (CAD).

BACKGROUND

Erectile dysfunction (ED) is common among men with CAD. PDE5 inhibition is increasingly the preferred treatment option for ED. However, the effect of PDE5 inhibition on exercise-induced ischemia in CAD patients has received limited prospective evaluation.

METHODS

In this double-blind, crossover, single-dose multicenter study, 41 men with reproducible stable exertional angina due to ischemic CAD received vardenafil 10 mg or placebo, followed by ETT (5 to 10 metabolic equivalents [METS], Bruce protocol) 1 h postdose. Sublingual nitrate use was prohibited for > or =24 h pre- and postexercise study days. End points included symptom-limited treadmill exercise time, time to first awareness of angina, time to ischemic threshold, and safety.

RESULTS

Relative to placebo, vardenafil 10 mg did not alter exercise treadmill time (427 +/- 105 s vs. 433 +/- 109 s, p = 0.39), or time to first awareness of angina (292 +/- 110 s vs. 291 +/- 123 s, p = 0.59), but significantly prolonged time to ischemic threshold (334 +/- 108 s vs. 381 +/- 108, p = 0.0004). At peak exercise, vardenafil 10 mg did not alter blood pressure, heart rate, or rate-pressure product relative to placebo. The most common adverse events (facial flushing and headache) were of mild or moderate intensity, and short-lived.

CONCLUSIONS

Vardenafil 10 mg did not impair the ability of patients with stable CAD to exercise at levels equivalent or greater than that attained during sexual intercourse (average of 2.5 to 3.3 METS).

摘要

目的

在稳定型冠状动脉疾病（CAD）患者中，研究强效且高选择性磷酸二酯酶5（PDE5）抑制剂伐地那非对症状限制运动时间、首次出现心绞痛的时间以及运动耐量测试（ETT）期间缺血阈值（ST段压低≥基线1毫米）的影响。

背景

勃起功能障碍（ED）在CAD男性患者中很常见。PDE5抑制越来越成为ED的首选治疗方案。然而，PDE5抑制对CAD患者运动诱发缺血的影响尚未得到充分的前瞻性评估。

方法

在这项双盲、交叉、单剂量多中心研究中，41名因缺血性CAD导致可重复性稳定劳力性心绞痛的男性患者服用10毫克伐地那非或安慰剂，给药1小时后进行ETT（5至10代谢当量[METS]，Bruce方案）。运动前和运动后研究日≥24小时禁止使用舌下硝酸酯类药物。终点包括症状限制跑步机运动时间、首次出现心绞痛的时间、缺血阈值以及安全性。

结果

与安慰剂相比，10毫克伐地那非未改变跑步机运动时间（427±105秒对433±109秒，p = 0.39），或首次出现心绞痛的时间（292±110秒对291±123秒，p = 0.59），但显著延长了缺血阈值时间（334±108秒对381±108秒，p = 0.0004）。在运动高峰时，10毫克伐地那非与安慰剂相比未改变血压、心率或心率血压乘积。最常见的不良事件（面部潮红和头痛）为轻度或中度，且持续时间短。