Sildenafil citrate response correlates with the nature and the severity of penile vascular insufficiency.
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.Journal of Sexual Medicine 10/2005; 2(6):842 - 847. · 3.51 Impact Factor
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ABSTRACT: Cancer is a major health concern in the United States and in other countries: not only is cancer the second leading cause of death in the United States, accounting for one of every four deaths, but also its treatment may be associated with significant morbidity . Cancers involving the male pelvic organs and their treatments are notoriously associated with erectile dysfunction (ED) . Such cancers include prostate, bladder, and ano-rectal cancers. Prostate cancer is the second most common cancer and the third most common cause of cancer-related death among men. According to the American Cancer Society, it is estimated that in 2009, 192,280 new cases will be diagnosed (25% of all new cancer cases) and 27,360 deaths (9% of cancer-related deaths) will be attributed to prostate cancer . Currently, with prevalent testing for early detection, men are diagnosed in their fifth or sixth decades. The vast majority (91%) of men diagnosed with prostate cancer present with localized disease and have excellent chances of long-term survival . Treatment of prostate cancer includes radical pelvic surgery to remove the prostate and the seminal vesicles – radical prostatectomy (RP), prostate irradiation (radiotherapy), delivered using various techniques or hormonal manipulation, aimed at suppression of testosterone, the principal male hormone. Reported ED incidence after RP varies greatly, from 14 to 90%, with a combined incidence reported by a recent meta-analysis to be 58% . A recent prospective study reported an ED incidence of 47% a year after external beam radiotherapy for prostate cancer, however, it is must be remembered that radiation-induced damage may take more than a year to be fully manifested, thus, the eventual incidence is probably higher . A long-term sexual function follow-up of men who had radiation for localized prostate cancer revealed that at 15 years from treatment the vast majority of men (78%) were not sexually active compared with 38% of controls and that 94% had severe ED compared to 64% of controls . The addition of hormonal therapy, even short term, exerts additional deleterious effects on erectile function . Bladder and ano-rectal cancers are less common, accounting for 7 and 0.3% of all male cancers, respectively, and their treatment may include extensive pelvic surgery, radiotherapy, and/or chemotherapy .