Use of Sildenafil for Safe Improvement of Erectile Function and Quality of Life in Men With New York Heart Association Classes II and III Congestive Heart Failure

Webster, Linda; Michelakis, Evangelos D.; Davis, Terry M. A.; Archer, Stephen L.

doi:10.1001/archinte.164.5.514

Cited by 85 publications

(71 citation statements)

References 53 publications

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“…Sildenafil administered to patients with HFrEF was safe and well tolerated, and observed BP reductions comparable to those observed in the present study 30. These results, consistent with previous studies, suggest that sildenafil is a suitable treatment for ED also in patients with HFrEF 31, 32. However, as indicated in the product label, initiation of sildenafil treatment or dose increase in patients with heart failure receiving treatment with sacubitril/valsartan should occur cautiously.…”

Section: Discussionsupporting

confidence: 90%

Evaluation of Pharmacokinetic and Pharmacodynamic Drug–Drug Interaction of Sacubitril/Valsartan (LCZ696) and Sildenafil in Patients With Mild‐to‐Moderate Hypertension

Hsiao¹,

Langenickel

Petruck³

et al. 2017

Clin Pharma and Therapeutics

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Sacubitril/valsartan (LCZ696) is indicated for the treatment of patients with heart failure and reduced ejection fraction (HFrEF). Since patients with HFrEF may receive sacubitril/valsartan and sildenafil, both increasing cyclic guanosine monophosphate, the present study evaluated the pharmacokinetic and pharmacodynamic drug interaction potential between sacubitril/valsartan and sildenafil. In this open‐label, three‐period, single sequence study, patients with mild‐to‐moderate hypertension (153.8 ± 8.2 mmHg mean systolic blood pressure (SBP)) received a single dose of sildenafil 50 mg, sacubitril/valsartan 400 mg once daily for 5 days, and sacubitril/valsartan and sildenafil coadministration. When coadministered with sildenafil, the AUC and Cmax of valsartan decreased by 29% and 39%, respectively. Coadministration of sacubitril/valsartan and sildenafil resulted in a greater decrease in BP (–5/–4/–4 mmHg mean ambulatory SBP/DBP/MAP (mean arterial pressure)) than with sacubitril/valsartan alone. Both treatments were generally safe and well tolerated in this study; however, the additional BP reduction suggests that sildenafil should be administered cautiously in patients receiving sacubitril/valsartan. Unique identifier: NCT01601470.

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Section: Discussionsupporting

confidence: 90%

Evaluation of Pharmacokinetic and Pharmacodynamic Drug–Drug Interaction of Sacubitril/Valsartan (LCZ696) and Sildenafil in Patients With Mild‐to‐Moderate Hypertension

Hsiao¹,

Langenickel

Petruck³

et al. 2017

Clin Pharma and Therapeutics

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“…All patients remained on their SRI antidepressant at full effective dose and maintained 17-item Hamilton Depression Rating Scale (HAM-D17) scores consistent with remission. These results are consistent with other double-blind, placebo-controlled trials [13][14][15][16][17][18][19][20] of PDE5i treatment efficacy for erectile dysfunction (ED) in men with ED and subthreshold depression, ED of various etiologies and concurrently taking an SRI, residual ED (i.e., ED present at MDD diagnosis that persisted following treatment of depression to remission, independent of antidepressant discontinuation), ED and untreated mild MDD, and ED with congestive heart failure or postprostatectomy and associated depressive symptoms.…”

Section: Introductionsupporting

confidence: 92%

Open-label sildenafil treatment of partial and non-responders to double-blind treatment in men with antidepressant-associated sexual dysfunction

et al. 2006

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Fifty partial and non-responders (Clinical Global Impression-Sexual Function (CGI-SF) score42), out of 76 men who completed a 6-week, double-blind, placebo-controlled trial of sildenafil treatment for serotonergic antidepressant-associated sexual dysfunction, were eligible for an additional 6-week trial of open-label sildenafil (50 mg adjustable to 100 mg) under the same protocol, with blind maintained to initial assignment. Participation (double-blind and open-label) required major depressive disorder in remission (MDD-R) and continuing antidepressant medication. Forty-three entered open-label study: 16/17 initially randomized to sildenafil (sildenafil/sildenafil) and 27/33 initially randomized to placebo (placebo/sildenafil). Thirty-five of 43 (81%) achieved full response (CGI-SFp2): placebo/sildenafil 23/27 (85%); sildenafil/sildenafil 12/16 (75%); Po0.0001 for changes and P ¼ 0.4 between groups. Secondary measures of erectile function and overall satisfaction improved in both groups (Po0.03). Hamilton Depression Rating Scale scores improved (placebo/sildenafil; Pp0.05) or remained stable (sildenafil/sildenafil). In men with MDD-R who maintained antidepressant adherence, 81% of double-blind partial and nonresponders treated with open-label sildenafil responded fully.

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“…Sympathetic activity was estimated by the measurements of cardiac and total-body norepinephrine spillover according to the radiotracer technique of Esler et al [6] For these measurements, tritiated norepinephrine (1.6 ACi/ min with a 16-ACi priming bolus of L- [2,5, …”

Section: Norepinephrine Spillover Measurementsmentioning

confidence: 99%

“…Sildenafil, a selective inhibitor of phosphodiesterase-5, is an effective therapy for erectile dysfunction in heart failure patients [1,2]. Despite this documented efficacy, there has been some concern about the safety of the use of phosphodiesterase-5 inhibitors in patients with severe cardiac disease.…”

Section: Introductionmentioning

confidence: 99%

The effects of intravenous sildenafil on hemodynamics and cardiac sympathetic activity in chronic human heart failure

Al‐Hesayen

Floras

Parker

2006

European J of Heart Fail

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Background: Erectile dysfunction is common in patients with chronic heart failure and sildenafil is an effective treatment option in this population. Sildenafil has been reported to increase sympathetic outflow in normal volunteers. To date, experience with sildenafil in patients with congestive heart failure is limited and the impact of phosphodiesterase-5 inhibition on sympathetic activity in this population has not been evaluated. Methods and results: 10 patients with heart failure (ejection fraction 23 T 3%) were studied. Generalized and cardiac sympathetic activity responses to an intravenous infusion of sildenafil were measured by the norepinephrine spillover method. In response to sildenafil, there was a significant reduction in mean pulmonary artery (À 26 T 5%, P < 0.01) and mean arterial pressures (À 8 T 1%, P < 0.01). These hemodynamic responses were accompanied by a 22 T 5% reduction in cardiac norepinephrine spillover ( P < 0.02) but no change in total body norepinephrine spillover. Conclusions: The acute administration of sildenafil is associated with a modest reduction in systemic arterial blood pressure and a more substantial reduction in pulmonary arterial pressure. These hemodynamic changes are observed in the absence of systemic sympathetic activation and are associated with a reduction in cardiac norepinephrine spillover in patients with chronic heart failure. These observations are relevant given the high prevalence of erectile dysfunction in this patient population.

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Use of Sildenafil for Safe Improvement of Erectile Function and Quality of Life in Men With New York Heart Association Classes II and III Congestive Heart Failure

Abstract: Sildenafil is a safe and effective treatment for ED in men with New York Heart Association classes II and III CHF and provides relief of depressive symptoms, explaining an improvement in the perception of quality of life.

Cited by 85 publications

References 53 publications

Evaluation of Pharmacokinetic and Pharmacodynamic Drug–Drug Interaction of Sacubitril/Valsartan (LCZ696) and Sildenafil in Patients With Mild‐to‐Moderate Hypertension

Evaluation of Pharmacokinetic and Pharmacodynamic Drug–Drug Interaction of Sacubitril/Valsartan (LCZ696) and Sildenafil in Patients With Mild‐to‐Moderate Hypertension

Open-label sildenafil treatment of partial and non-responders to double-blind treatment in men with antidepressant-associated sexual dysfunction

The effects of intravenous sildenafil on hemodynamics and cardiac sympathetic activity in chronic human heart failure

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