The lack of efficacy of PDE5 treatment in women is likely attributable to gender differences in the concordance between physiological and psychological components of sexual response. Discordance between genital and subjective measures of sexual response in women may be augmented by PDE5 effects on genital vasocongestion in some populations, rendering successful treatment unlikely via pharmacological treatment alone.
The plasma vardenafil concentration increased rapidly and exhibited a median time to maximum plasma concentration (t(max)) of 1 h and a mean elimination half-life (t(1/2)) of 3.4 h. The geometric mean and standard deviation of (1) the peak plasma concentration (C(max)) was 21.4 ± 1.7 μg/L, (2) the normalized C(max) (C(max, norm)) 79.1 ± 1.6 g/L, (3) the area under the time-concentration curve (AUC) 71.5 ± 1.6 μg · h/L and (4) the normalized AUC (AUC(norm)) 261.6 ± 1.7 g · h/L. Patients co-medicated with bosentan reached t(max) later and had a 90% reduction of C(max), C(max, norm), AUC and AUC(norm).
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Phosphodiesrase type 5 inhibitors have been recently reported to induce a relaxing effect on ureteral smooth muscle. We conducted an in vitro study to elucidate the relaxing effect of various doses of vardenafil on the porcine ureter. Moreover, we propose a porcine ureter model for the evaluation of the effect of different substances on the ureter.
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Erectile dysfunction has usually been treated by a phosphodiesterase 5 inhibitor in men, especially in the past decade. Although sildenafil and vardenafil are widely used, there is a high percentage of people who do not respond to these drugs. This study was performed in order to evaluate the efficacy of the lastly presented phosphodiesterase 5 inhibitor, tadalafil, in nonresponder group of patients to sildenafil and vardenafil.
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Vardenafil concentrations of 1 and 10 μM should be considered as appropriate for ureteral relaxation. The porcine model replicates human ureteral response in vitro at least in the case of phosphodiesrase type 5 inhibitors and probably would be useful for the evaluation of other pharmaceutical agents.
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The total number of sexual intercourse attempts and Sexual Encounter Profile question 3 (SEP3) success rates were calculated per time interval.
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In the rat study, vehicle or 0.3-3 mg/kg of the PDE5-I vardenafil was given orally 30 min before testing and electrode locations were the vertex, hippocampus and the striatum. The human subjects received placebo, 10-20 mg vardenafil 85 min before testing and sensory gating was measured at the cortex (Fz, Fcz and Cz) electrodes.
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Various questionnaires on ED, such as the International Index of Erectile Function composed of 15 questions.
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Pubmed search utilizing the search terms "phosphodiesterase type 5 inhibitor," "PDE5 inhibitor,"sildenafil," "vardenafil," and "tadalafil." Articles were screened for their relevance to the clinical practice of sexual medicine and/or PDE5I toxicity. Publications on routine dose PDE5I for penile rehabilitation, lower urinary tract symptoms, and stuttering priapism are summarized in a separate manuscript in this series.
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Our findings have shown that sildenafil, vardenafil, and tadalafil relax HCC tissues in a concentration-dependent manner, but the maximal relaxation obtained with tadalafil was significantly lower than that obtained with sildenafil and vardenafil. Moreover, the PDE-5 inhibitors interacted with endogenous and exogenous NO, amplifying its HCC relaxation.
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The aim of this study is to describe general practitioners' (GPs) beliefs and attitudes toward the management of ED.
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AMS points decreased in group 1 from 38.3 +/- 0.29 to 29.2 +/- 0.32, in group 2--from 39.02 +/- 0.21 to 28.6 +/- 0.95, while testosterone rose from 9.86 +/- 0.4 to 17.77 +/- 0.42 and 9.35 +/- 0.25 to 17.21 +/- 0.63 nmol, respectively. Homocystein lowering was significantly more manifest in group 2. EF index in group 2 rose from 11.4 +/- 0.77 to 25.54 +/- 0.25 points versus 11.2 +/- 1.01 to 23.95 +/- 0.71 points in group 1, improvement of EF in group 2 occurred sooner. Endothelial function by diameter of the cavernous arteries differed after treatment in group 1 and 2 (19.55 +/- 2.88 to 39.2 +/- 0.84% and 19.51 +/- 1.28 to 48.5 +/- 1.76, respectively, p<0.001).
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Phosphodiesterase type 5 inhibitors (PDE5-Is) improve cognitive performance of rodents, but the few human studies investigating their effects did not systematically investigate cognitive effects and the results have been quite contradictory. Therefore, we examined whether the PDE5-I vardenafil improves memory and executive functioning and affect electroencephalography (EEG) in healthy young adults. Participants were selected out of a group of volunteers, based on their performance on a memory screening and they were orally treated with vardenafil (10-20 mg or placebo). Memory and executive functioning were tested while EEG activity was recorded. Additionally, a simple reaction time task and questionnaires addressing various complaints were presented. No prominent effects of vardenafil on cognition were found: participants only made more mistakes on a reaction time task after 20 mg vardenafil. During encoding of words, the P300 was generally smaller after vardenafil treatment. Furthermore, the N400 was larger after vardenafil 10 mg than placebo treatment in a spatial memory task at Fz. Finally, headache and feeling weak were reported more after vardenafil treatment. Vardenafil did not affect cognitive performance of healthy adults and showed only some incidental effects on ERPs. These findings in humans do not corroborate the cognition-enhancing effects of PDE5-Is in healthy animals.
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To investigate the gastroprotective effect of vardenafil against indomethacin-induced gastric damage.
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To evaluate the safety and efficacy of flexible-dose vardenafil therapy in a prospective randomized study in phosphodiesterase 5 inhibitor-naïve subjects with type 1 diabetes and ED.
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To investigate the efficacy and safety of an ODT formulation of 10 mg vardenafil administered on demand vs. placebo in a general population of men with erectile dysfunction (ED).
The phosphodiesterase-11A (PDE11) family consists of four splice variants (PDE11A1-PDE11A4) that contain a conserved carboxyl-terminal (C-terminal) catalytic domain that hydrolyzes cAMP and cGMP; the amino-termini (N-termini) vary in length and amino acid sequence. PDE11A2, PDE11A3, and PDE11A4 contain one or more GAF (cGMP-binding phosphodiesterase, Anabaena adenylyl cyclase, and Escherichia coli FhlA) subdomains. In the present study, PDE11A1 and PDE11A2 demonstrated higher affinity for cAMP and cGMP when directly compared to that of the longest isoform, PDE11A4. Moreover, PDE11A3, PDE11A2, and PDE11A1, which contain progressively shorter N-termini, were more sensitive than PDE11A4 to inhibition by two structurally unrelated inhibitors, tadalafil (Cialis) and vardenafil (Levitra). The substrate and inhibitor affinity differences among the PDE11 isozymes could not be ascribed to differences in their quaternary structure since PDE11A4, PDE11A3, and PDE11A2 were determined to be dimers, and PDE11A1 was a tetramer. These data also demonstrate that PDE11 isozymes containing at least 123 C-terminal amino acids of the GAF-B domain are stable oligomers and that GAF-A is not required for oligomerization. The isolated PDE11 catalytic domain (Met-563-Asn-934) displayed both monomeric and dimeric forms, and upon dilution, this domain was primarily monomeric, indicating that the main oligomerization contacts are within the N-termini of PDE isozymes. This report is the first to describe an inhibitory effect of the N-terminal region of PDE11A4 on the affinity of the catalytic domain for both substrates and inhibitors and the first to define the quaternary structure and the regions that contribute to this structure within the human PDE11A family.
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Once-daily vardenafil did not produce greater sustained effects on EF than on-demand vardenafil in men with mild-to-moderate ED, suggesting that daily dosing of PDE5 inhibitors does not produce sustained clinical benefits beyond cessation of treatment above those observed with on-demand administration.
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Of the 473 men enrolled in the study (51.4% aged > or =65 years), 331 were included in the intent-to-treat population (vardenafil ODT, n = 169; placebo, n = 162). Vardenafil ODT therapy was statistically significantly superior to placebo for all primary (i.e. IIEF-EF, SEP2, SEP3) and secondary efficacy variables (p < 0.0001). Treatment-emergent adverse events were mostly mild to moderate in severity, and comparable in both incidence and type with those of the film-coated tablet formulation.
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The relaxation of the smooth muscle in the vagina and clitoris and the increase of blood flow into these organs is thought to be essential in the female sexual response. Vardenafil is a type 5 phosphodiesterase (PDE5) inhibitor that potentiates the nitric oxide (NO)/cGMP pathway facilitating penile smooth muscle relaxation and improving penile erection in men. Although the potentiation of the NO/cGMP pathway through PDE5 inhibitors can clearly enhance blood flow into the penis and is used in the therapy of male sexual dysfunction, there is controversy about the efficacy of these agents in improving female sexual function. The aim of this work was to evaluate the effects of vardenafil on the increase of blood flow into the vagina and clitoris induced by pelvic nerve electrical stimulation (PNES) in a female dog model. Application of PNES produced consistent and frequency-related increased blood flow into the vagina and clitoris of anesthetized female dogs. The magnitude and duration of the blood flow responses to PNES were variable among the different animals but remained stable over time within the same animal. The intravenous administration of vardenafil (1 mg/kg) significantly potentiated the increases in blood flow produced by PNES into the vagina (381.4 and 206.2% of control response at 5 and 10 Hz, respectively, P<0.01, n=6) and clitoris (379.4 and 238.5% of control response at 5 and 10 Hz, respectively, P<0.01, n=6) 20 min after administration. The significant enhancement of PNES-induced responses was maintained 50 min (224.5 and 181.0%, P<0.01 in vagina; 294.8 and 258.9%, P<0.05 in clitoris) and 80 min after vardenafil administration (209.5 and 156.9%, P<0.05 in vagina; 268.9 and 194.9%, P<0.05 in clitoris). Here we present a feasible model for research into female sexual function. Our results show that vardenafil effectively potentiates the blood flow responses to PNES in the genitalia of female dogs. These results emphasize the role of the NO/cGMP pathway in the local vasodilatory response in female sexual organs and provide a rationale for testing PDE5 inhibitors, such as vardenafil, as a treatment for certain forms of female sexual dysfunction.
More TGF-beta1 and less nNOS are expressed when the junction is obstructed. PDE5 inhibitors may be able to regulate these 2 factors, or other factors that have not been discussed in this experiment, in order to halt the progression of UPJO.
Home- and clinic-based assessments in the outpatient department at the Centre Bouffard Vercelli, Cerbère France.
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In the multicenter STEADY-(safety, tolerability, efficacy and impact on quality of life of vardenafil 10 mg in patients with erectile dysfunction)-study, 996 patients with erectile dysfunction were treated with vardenafil for a period of 12 weeks. The results within a time window of up to 6 hours post-administration and beyond (up to 12 hours) were evaluated. The effectiveness of vardenafil was analysed on the basis of the parameters Sexual Encounter Profile (SEP) 2 (vaginal penetration) and SEP3 (erection maintenance) as also the "erectile function score" and overall satisfaction.