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CLINICAL STUDY

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

Udho Thadani, MD, FACC^*,*, William Smith, MD, FACC, Stephen Nash, MD, FACC, Neville Bittar, MD, FACC, Stephen Glasser, MD, FACC^||, Puneet Narayan, MD, FACC^¶, Richard A. Stein, MD, FACC^#, Sharon Larkin, RN^**, Arthur Mazzu, PhD^**, Robert Tota, MD, FACC, Kenneth Pomerantz, PhD and Pavur Sundaresan, MD, PhD^**

^* Oklahoma University, Health Sciences Center, and Veterans Affairs Medical Center, Cardiology Section, Oklahoma City, Oklahoma, USA
New Orleans Center for Clinical Research, New Orleans, Louisiana, USA
Syracuse Preventive Cardiology, Syracuse, New York, USA
Gemini Scientific, Madison, Wisconsin, USA
^|| University of Minnesota, School of Public Health, Minneapolis, Minnesota, USA
^¶ Veterans Affairs Medical Center, Washington, DC, USA
^# Brooklyn Hospital Center, Department of Cardiology, Brooklyn, New York, USA
^** Bayer Corporation, Department of Clinical Pharmacology, West Haven, Connecticut, USA
Bayer Corporation, Department of Medical Affairs, West Haven, Connecticut, USA
Bayer Corporation, Department of Scientific Relations, West Haven, Connecticut, USA

Manuscript received May 15, 2002; revised manuscript received July 12, 2002, accepted July 24, 2002.

^* Reprint requests and correspondence: Dr. Udho Thadani, OUHSC, Cardiology, 920 SL Young, WP 3120, Oklahoma City, OK 73104, USA.
udho-thadani{at}ouhsc.edu

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 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 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).

Abbreviations and Acronyms   CAD   coronary artery disease   DBP   diastolic blood pressure   ECG   electrocardiogram   ED   erectile dysfunction   ETT   exercise tolerance test   METS   metabolic equivalents   MI   myocardial infarction   PDE5   phosphodiesterase-5   SBP   systolic blood pressure

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