Cardiovascular effects of sildenafil during exercise in men with known or probable coronary artery disease: A randomized crossover trial

Adelaide M Arruda-Olson, Douglas W. Mahoney, Ajay Nehra, Marilyn Leckel, Patricia Pellikka

Research output: Contribution to journalArticle

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Abstract

Context: The relationship between sildenafil citrate use and reported adverse cardiovascular events in men with coronary artery disease (CAD) is unclear. Objective: To evaluate the cardiovascular effects of sildenafil during exercise in men with CAD. Design, Setting, and Subjects: Randomized, double-blind, placebo-controlled crossover trial conducted March to October 2000 at a US ambulatory-care referral center among 105 men with a mean (SD) age of 66 (9) years who had erectile dysfunction and known or highly suspected CAD. Interventions: All patients underwent 2 symptom-limited supine bicycle echocardiograms separated by an interval of 1 to 3 days after receiving a single dose of sildenafil (50 or 100 mg) or placebo 1 hour before each exercise test. Main Outcome Measures: Hemodynamic effects of sildenafil during exercise (onset, extent, and severity of ischemia) assessed by exercise echocardiography. Results: Mean (SD) resting ejection fraction was 56% (7%) (range, 39%-68%). After sildenafil use, resting systolic blood pressure was reduced from 135 (19) mm Hg to 128 (17) mm Hg, for a mean change of -7 mm Hg (95% confidence interval [Cl],-9 to -4 mm Hg; P<.001). After placebo use, the mean (SD) change was from 135 (20) mm Hg to 133 (19) mm Hg, a difference of -2 mm Hg (95% Cl, -6 to 0.3 mm Hg; P=.08). The difference between mean change after sildenafil and placebo use was 4.3 (95% Cl, 0.9-7.7; P=.01). Resting heart rate, diastolic blood pressure, and wall motion score index (a measure of the extent and severity of wall motion abnormalities) did not change significantly in either group. Exercise capacity was similar with sildenafil use (mean [SD], 4.5 [1.0] metabolic equivalents) and placebo use (mean [SD], 4.6 [1.0] metabolic equivalents; mean difference, 0.07; 95% Cl, -0.06 to 0.19; P=.29). Exercise blood pressure and heart rate increments were similar. Dyspnea or angina developed in 69 patients who took sildenafil and 70 patients who took placebo (P=.89); exercise electrocardiography was positive in 12 patients (11 %) who took sildenafil and 17 patients (16%) who took placebo (P=.09). Exercise-induced wall motion abnormalities developed in similar numbers of patients after sildenafil and placebo use (84 and 86 patients, respectively; P=.53). Wall motion score index at peak exercise was similar after sildenafil and placebo use (mean [SD], 1.4 [0.4] vs 1.4 [0.4]; mean difference, 0.01; 95% Cl, -0.01 to 0.03; P=.40). Conclusion: In men with stable CAD, sildenafil had no effect on symptoms, exercise duration, or presence or extent of exercise-induced ischemia, as assessed by exercise echocardiography.

Original languageEnglish (US)
Pages (from-to)719-725
Number of pages7
JournalJournal of the American Medical Association
Volume287
Issue number6
StatePublished - Feb 13 2002

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Cross-Over Studies
Coronary Artery Disease
Exercise
Placebos
Blood Pressure
Metabolic Equivalent
Echocardiography
Sildenafil Citrate
Ischemia
Heart Rate
Erectile Dysfunction
Ambulatory Care
Exercise Test
Dyspnea
Electrocardiography
Referral and Consultation
Hemodynamics
Outcome Assessment (Health Care)
Confidence Intervals

ASJC Scopus subject areas

  • Medicine(all)

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Cardiovascular effects of sildenafil during exercise in men with known or probable coronary artery disease : A randomized crossover trial. / Arruda-Olson, Adelaide M; Mahoney, Douglas W.; Nehra, Ajay; Leckel, Marilyn; Pellikka, Patricia.

In: Journal of the American Medical Association, Vol. 287, No. 6, 13.02.2002, p. 719-725.

Research output: Contribution to journalArticle

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title = "Cardiovascular effects of sildenafil during exercise in men with known or probable coronary artery disease: A randomized crossover trial",
abstract = "Context: The relationship between sildenafil citrate use and reported adverse cardiovascular events in men with coronary artery disease (CAD) is unclear. Objective: To evaluate the cardiovascular effects of sildenafil during exercise in men with CAD. Design, Setting, and Subjects: Randomized, double-blind, placebo-controlled crossover trial conducted March to October 2000 at a US ambulatory-care referral center among 105 men with a mean (SD) age of 66 (9) years who had erectile dysfunction and known or highly suspected CAD. Interventions: All patients underwent 2 symptom-limited supine bicycle echocardiograms separated by an interval of 1 to 3 days after receiving a single dose of sildenafil (50 or 100 mg) or placebo 1 hour before each exercise test. Main Outcome Measures: Hemodynamic effects of sildenafil during exercise (onset, extent, and severity of ischemia) assessed by exercise echocardiography. Results: Mean (SD) resting ejection fraction was 56{\%} (7{\%}) (range, 39{\%}-68{\%}). After sildenafil use, resting systolic blood pressure was reduced from 135 (19) mm Hg to 128 (17) mm Hg, for a mean change of -7 mm Hg (95{\%} confidence interval [Cl],-9 to -4 mm Hg; P<.001). After placebo use, the mean (SD) change was from 135 (20) mm Hg to 133 (19) mm Hg, a difference of -2 mm Hg (95{\%} Cl, -6 to 0.3 mm Hg; P=.08). The difference between mean change after sildenafil and placebo use was 4.3 (95{\%} Cl, 0.9-7.7; P=.01). Resting heart rate, diastolic blood pressure, and wall motion score index (a measure of the extent and severity of wall motion abnormalities) did not change significantly in either group. Exercise capacity was similar with sildenafil use (mean [SD], 4.5 [1.0] metabolic equivalents) and placebo use (mean [SD], 4.6 [1.0] metabolic equivalents; mean difference, 0.07; 95{\%} Cl, -0.06 to 0.19; P=.29). Exercise blood pressure and heart rate increments were similar. Dyspnea or angina developed in 69 patients who took sildenafil and 70 patients who took placebo (P=.89); exercise electrocardiography was positive in 12 patients (11 {\%}) who took sildenafil and 17 patients (16{\%}) who took placebo (P=.09). Exercise-induced wall motion abnormalities developed in similar numbers of patients after sildenafil and placebo use (84 and 86 patients, respectively; P=.53). Wall motion score index at peak exercise was similar after sildenafil and placebo use (mean [SD], 1.4 [0.4] vs 1.4 [0.4]; mean difference, 0.01; 95{\%} Cl, -0.01 to 0.03; P=.40). Conclusion: In men with stable CAD, sildenafil had no effect on symptoms, exercise duration, or presence or extent of exercise-induced ischemia, as assessed by exercise echocardiography.",
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T1 - Cardiovascular effects of sildenafil during exercise in men with known or probable coronary artery disease

T2 - A randomized crossover trial

AU - Arruda-Olson, Adelaide M

AU - Mahoney, Douglas W.

AU - Nehra, Ajay

AU - Leckel, Marilyn

AU - Pellikka, Patricia

PY - 2002/2/13

Y1 - 2002/2/13

N2 - Context: The relationship between sildenafil citrate use and reported adverse cardiovascular events in men with coronary artery disease (CAD) is unclear. Objective: To evaluate the cardiovascular effects of sildenafil during exercise in men with CAD. Design, Setting, and Subjects: Randomized, double-blind, placebo-controlled crossover trial conducted March to October 2000 at a US ambulatory-care referral center among 105 men with a mean (SD) age of 66 (9) years who had erectile dysfunction and known or highly suspected CAD. Interventions: All patients underwent 2 symptom-limited supine bicycle echocardiograms separated by an interval of 1 to 3 days after receiving a single dose of sildenafil (50 or 100 mg) or placebo 1 hour before each exercise test. Main Outcome Measures: Hemodynamic effects of sildenafil during exercise (onset, extent, and severity of ischemia) assessed by exercise echocardiography. Results: Mean (SD) resting ejection fraction was 56% (7%) (range, 39%-68%). After sildenafil use, resting systolic blood pressure was reduced from 135 (19) mm Hg to 128 (17) mm Hg, for a mean change of -7 mm Hg (95% confidence interval [Cl],-9 to -4 mm Hg; P<.001). After placebo use, the mean (SD) change was from 135 (20) mm Hg to 133 (19) mm Hg, a difference of -2 mm Hg (95% Cl, -6 to 0.3 mm Hg; P=.08). The difference between mean change after sildenafil and placebo use was 4.3 (95% Cl, 0.9-7.7; P=.01). Resting heart rate, diastolic blood pressure, and wall motion score index (a measure of the extent and severity of wall motion abnormalities) did not change significantly in either group. Exercise capacity was similar with sildenafil use (mean [SD], 4.5 [1.0] metabolic equivalents) and placebo use (mean [SD], 4.6 [1.0] metabolic equivalents; mean difference, 0.07; 95% Cl, -0.06 to 0.19; P=.29). Exercise blood pressure and heart rate increments were similar. Dyspnea or angina developed in 69 patients who took sildenafil and 70 patients who took placebo (P=.89); exercise electrocardiography was positive in 12 patients (11 %) who took sildenafil and 17 patients (16%) who took placebo (P=.09). Exercise-induced wall motion abnormalities developed in similar numbers of patients after sildenafil and placebo use (84 and 86 patients, respectively; P=.53). Wall motion score index at peak exercise was similar after sildenafil and placebo use (mean [SD], 1.4 [0.4] vs 1.4 [0.4]; mean difference, 0.01; 95% Cl, -0.01 to 0.03; P=.40). Conclusion: In men with stable CAD, sildenafil had no effect on symptoms, exercise duration, or presence or extent of exercise-induced ischemia, as assessed by exercise echocardiography.

AB - Context: The relationship between sildenafil citrate use and reported adverse cardiovascular events in men with coronary artery disease (CAD) is unclear. Objective: To evaluate the cardiovascular effects of sildenafil during exercise in men with CAD. Design, Setting, and Subjects: Randomized, double-blind, placebo-controlled crossover trial conducted March to October 2000 at a US ambulatory-care referral center among 105 men with a mean (SD) age of 66 (9) years who had erectile dysfunction and known or highly suspected CAD. Interventions: All patients underwent 2 symptom-limited supine bicycle echocardiograms separated by an interval of 1 to 3 days after receiving a single dose of sildenafil (50 or 100 mg) or placebo 1 hour before each exercise test. Main Outcome Measures: Hemodynamic effects of sildenafil during exercise (onset, extent, and severity of ischemia) assessed by exercise echocardiography. Results: Mean (SD) resting ejection fraction was 56% (7%) (range, 39%-68%). After sildenafil use, resting systolic blood pressure was reduced from 135 (19) mm Hg to 128 (17) mm Hg, for a mean change of -7 mm Hg (95% confidence interval [Cl],-9 to -4 mm Hg; P<.001). After placebo use, the mean (SD) change was from 135 (20) mm Hg to 133 (19) mm Hg, a difference of -2 mm Hg (95% Cl, -6 to 0.3 mm Hg; P=.08). The difference between mean change after sildenafil and placebo use was 4.3 (95% Cl, 0.9-7.7; P=.01). Resting heart rate, diastolic blood pressure, and wall motion score index (a measure of the extent and severity of wall motion abnormalities) did not change significantly in either group. Exercise capacity was similar with sildenafil use (mean [SD], 4.5 [1.0] metabolic equivalents) and placebo use (mean [SD], 4.6 [1.0] metabolic equivalents; mean difference, 0.07; 95% Cl, -0.06 to 0.19; P=.29). Exercise blood pressure and heart rate increments were similar. Dyspnea or angina developed in 69 patients who took sildenafil and 70 patients who took placebo (P=.89); exercise electrocardiography was positive in 12 patients (11 %) who took sildenafil and 17 patients (16%) who took placebo (P=.09). Exercise-induced wall motion abnormalities developed in similar numbers of patients after sildenafil and placebo use (84 and 86 patients, respectively; P=.53). Wall motion score index at peak exercise was similar after sildenafil and placebo use (mean [SD], 1.4 [0.4] vs 1.4 [0.4]; mean difference, 0.01; 95% Cl, -0.01 to 0.03; P=.40). Conclusion: In men with stable CAD, sildenafil had no effect on symptoms, exercise duration, or presence or extent of exercise-induced ischemia, as assessed by exercise echocardiography.

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