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

Research output: Contribution to journalArticle

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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 ≥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 induded 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).

Original languageEnglish (US)
Pages (from-to)2006-2012
Number of pages7
JournalJournal of the American College of Cardiology
Volume40
Issue number11
DOIs
StatePublished - Dec 4 2002

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Phosphodiesterase 5 Inhibitors
Erectile Dysfunction
Coronary Artery Disease
Exercise
Metabolic Equivalent
Type 5 Cyclic Nucleotide Phosphodiesterases
Exercise Tolerance
Therapeutics
Placebos
Vardenafil Dihydrochloride
Aptitude
Stable Angina
Coitus
Nitrates
Multicenter Studies
Headache
Ischemia
Heart Rate
Blood Pressure
Safety

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

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. / 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.

In: Journal of the American College of Cardiology, Vol. 40, No. 11, 04.12.2002, p. 2006-2012.

Research output: Contribution to journalArticle

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. / 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. In: Journal of the American College of Cardiology. 2002 ; Vol. 40, No. 11. pp. 2006-2012.
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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 ≥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 induded 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).",
author = "Udho Thadani and William Smith and Stephen Nash and Neville Bittar and Stephen Glasser and Puneet Narayan and Stein, {Richard A.} and Sharon Larkin and Arthur Mazzu and Robert Tota and Kenneth Pomerantz and Pavur Sundaresan",
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T1 - 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

AU - Thadani, Udho

AU - Smith, William

AU - Nash, Stephen

AU - Bittar, Neville

AU - Glasser, Stephen

AU - Narayan, Puneet

AU - Stein, Richard A.

AU - Larkin, Sharon

AU - Mazzu, Arthur

AU - Tota, Robert

AU - Pomerantz, Kenneth

AU - Sundaresan, Pavur

PY - 2002/12/4

Y1 - 2002/12/4

N2 - 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 induded 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).

AB - 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 induded 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).

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