Sildenafil citrate response correlates with the nature and the severity of penile vascular insufficiency.

Weill Medical College of Cornell University-Department of Urology, New York, NY, USA.
Journal of Sexual Medicine (Impact Factor: 3.51). 02/2005; 2(1):104-8. DOI: 10.1111/j.1743-6109.2005.20110.x
Source: PubMed

ABSTRACT Sildenafil citrate is a highly effective erectogenic agent. However, predicting which patients will respond to this agent is often difficult. While the patient response to this agent is dependent on the nitric oxide-guanylate cyclase-cyclic guanosine monophosphate cascade, the integrity of penile arterial flow and venocclusive mechanism is also important. Duplex Doppler penile ultrasonography can reliably document penile hemodynamics. This study aimed at defining response rates based on degree of penile vascular sufficiency.
This study enrolled patients who met strict criteria for sildenafil citrate response who had also undergone penile ultrasound. Correlation was drawn between the nature and the severity of the vascular insufficiency and the response rate to sildenafil citrate.
The distribution of vascular diagnoses was arteriogenic 64%, venogenic 6%, mixed vascular insufficiency 18%, and normal 12%. The best response was seen in those men with normal vascular studies, 80% responding. Fifty-three percent of all men with any abnormality on penile ultrasound responded; 65% of men with arteriogenic erectile dysfunction (ED), 25% of patients with venogenic ED, and 6% of men with a mixed vascular insufficiency were responders. There was a correlation between the degree of vascular impairment and the response rate. All men with venogenic ED who responded had mild leak.
These data demonstrate a correlation between the nature and severity of penile vascular disease and the ability to respond to sildenafil citrate. These data may be useful to the sexual medicine practitioner when counseling patients regarding oral erectogenic therapy.

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    ABSTRACT: Aim To evaluate the efficacy, safety, and tolerability of a flexible-dose regimen of vardenafil in a community-based population of men with erectile dysfunction (ED).Methods This was a 12-week, open-label, flexible-dose, multicenter study of unselected men with ED of diverse origins and severity. Unlike previous studies, prostatectomy-induced ED and previous unresponsiveness to sildenafil were not exclusion criteria. After 4 weeks of treatment with 10 mg of vardenafil, the dose could be continued or titrated to 5 mg or 20 mg, depending on efficacy and tolerability. After 8 weeks, another dose change was possible. Efficacy was assessed with International Index of Erectile Function erectile function (IIEF-EF) domain scores, diary questions of the Sexual Encounter Profile (SEP), and a global assessment question (GAQ) about erection improvement during the previous 4 weeks.Results Safety was evaluated in 497 patients, and 480 were suitable for intention-to-treat analysis. After 12 weeks of treatment, the mean per patient rate of successful intercourse, defined by an affirmative response to SEP questions 1–3, was 72%, and was related to age and ED duration. The overall success rate increased from 66% at week 4 to 77% at week 12. The mean IIEF-EF domain score of the whole population increased from 17.2 (baseline) to 24.4 (endpoint). At week 12, the best scores were obtained by patients taking 5 mg and 10 mg. At week 12, GAQ scores showed improved erection in 97.4%, 94.8%, and 78.8% of patients in the 5 mg, 10 mg, and 20 mg group, respectively. Safety was excellent: no serious drug-related event was reported, and only 2.2% of patients discontinued treatment because of side-effects.Conclusions Vardenafil was effective and well tolerated in this community-based ED population that is truly representative of the general ED population. Dose titration meets the patient's needs and optimizes clinical outcome. Mirone V, Palmieri A, Cucinotta D, Parazzini F, Morelli P, Bettocchi C, Fusco F, and Montorsi F. Flexible-dose vardenafil in a community-based population of men affected by erectile dysfunction: a 12-week open-label, multicenter trial. J Sex Med 2005;2:842–847.
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