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Effects of chronic type 5 phosphodiesterase inhibition on penile microvascular reactivity in hypertensive patients with erectile dysfunction: a randomized crossover placebo-controlled trial
Valéria Verri ● Alessandro R. Nascimento ● Andrea A. Brandao ● Eduardo Tibirica
Abstract
This randomized crossover and placebo-controlled trial evaluated the effects of daily use of sildenafil citrate (SIL, 1-month 50 mg twice daily) on penile and systemic endothelial microvascular function in hypertensive patients presenting with erectile dysfunction. The effects of SIL on arterial pressure were evaluated using ambulatory blood pressure monitoring (ABPM). Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4 ± 5.6 years), recruited in a tertiary public hospital, were treated with SIL (50 mg twice daily) or placebo (PLA) for two 30-day periods with a 30-day washout between them. Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis was used to evaluate penile and systemic (forearm) cutaneous microvascular reactivity. SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006). The area under the curve of microvascular vasodilation induced by ACh was also significantly increased (P = 0.02). Lastly, SIL treatment did not modify systemic microvascular reactivity. Twenty-four-hour ABPM (P = 0.0002) and daytime (P = 0.002) and nighttime (P = 0.001) mean diastolic blood pressure values were significantly reduced after SIL treatment. The scores of the Simplified International Index of Erectile Function (P < 0.0001) and the number of patients with positive responses to Sexual Encounter Profile question 3 (P < 0.0001) also increased after SIL treatment. Penile endothelium-dependent microvascular reactivity improved after continuous use of sildenafil in hypertensive patients with erectile dysfunction; the treatment also reduced blood pressure, suggesting that, in addition to improving erectile function, daily use of sildenafil could improve blood pressure control.
In conclusion, the main findings of this study are as follows: (i) Penile endothelium-dependent microvascular reactivity and erectile function improved after daily use of sildenafil in hypertensive patients with ED; this was the primary endpoint of the study; (ii) Concerning the secondary outcomes of the study, the treatment also reduced blood pressure, suggesting that, in addition to improving erectile function, treatment with sildenafil could improve blood pressure control; (iii) Laser-based methods may well be valuable noninvasive tools for the evaluation of penile microvascular responses to drug treatment in patients presenting with cardiovascular diseases.
Summary table
What is known about topic
● Erectile dysfunction (ED) is a health problem with high prevalence that is related to endothelial dysfunction
● Sildenafil is effective and safe in the treatment of vasculogenic ED, including hypertensive patients
● Laser-based methods are valuable noninvasive tools for the evaluation of penile microvascular function
What this study adds
● Penile microvascular baseline flow improves after 1- month twice-daily use of sildenafil in hypertensive patients with ED
● Penile endothelial-dependent microvascular reactivity also improves with sildenafil treatment
● Besides improving erectile function, sildenafil also reduces arterial blood pressure in hypertensive patients
Valéria Verri ● Alessandro R. Nascimento ● Andrea A. Brandao ● Eduardo Tibirica
Abstract
This randomized crossover and placebo-controlled trial evaluated the effects of daily use of sildenafil citrate (SIL, 1-month 50 mg twice daily) on penile and systemic endothelial microvascular function in hypertensive patients presenting with erectile dysfunction. The effects of SIL on arterial pressure were evaluated using ambulatory blood pressure monitoring (ABPM). Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4 ± 5.6 years), recruited in a tertiary public hospital, were treated with SIL (50 mg twice daily) or placebo (PLA) for two 30-day periods with a 30-day washout between them. Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis was used to evaluate penile and systemic (forearm) cutaneous microvascular reactivity. SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006). The area under the curve of microvascular vasodilation induced by ACh was also significantly increased (P = 0.02). Lastly, SIL treatment did not modify systemic microvascular reactivity. Twenty-four-hour ABPM (P = 0.0002) and daytime (P = 0.002) and nighttime (P = 0.001) mean diastolic blood pressure values were significantly reduced after SIL treatment. The scores of the Simplified International Index of Erectile Function (P < 0.0001) and the number of patients with positive responses to Sexual Encounter Profile question 3 (P < 0.0001) also increased after SIL treatment. Penile endothelium-dependent microvascular reactivity improved after continuous use of sildenafil in hypertensive patients with erectile dysfunction; the treatment also reduced blood pressure, suggesting that, in addition to improving erectile function, daily use of sildenafil could improve blood pressure control.
In conclusion, the main findings of this study are as follows: (i) Penile endothelium-dependent microvascular reactivity and erectile function improved after daily use of sildenafil in hypertensive patients with ED; this was the primary endpoint of the study; (ii) Concerning the secondary outcomes of the study, the treatment also reduced blood pressure, suggesting that, in addition to improving erectile function, treatment with sildenafil could improve blood pressure control; (iii) Laser-based methods may well be valuable noninvasive tools for the evaluation of penile microvascular responses to drug treatment in patients presenting with cardiovascular diseases.
Summary table
What is known about topic
● Erectile dysfunction (ED) is a health problem with high prevalence that is related to endothelial dysfunction
● Sildenafil is effective and safe in the treatment of vasculogenic ED, including hypertensive patients
● Laser-based methods are valuable noninvasive tools for the evaluation of penile microvascular function
What this study adds
● Penile microvascular baseline flow improves after 1- month twice-daily use of sildenafil in hypertensive patients with ED
● Penile endothelial-dependent microvascular reactivity also improves with sildenafil treatment
● Besides improving erectile function, sildenafil also reduces arterial blood pressure in hypertensive patients
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