Elsevier

Urology

Volume 80, Issue 4, October 2012, Pages 858-864
Urology

Male Sexual Dysfunction
Response to On-demand Vardenafil was Improved by its Daily Usage in Hypertensive Men

https://doi.org/10.1016/j.urology.2012.06.042Get rights and content

Objective

To evaluate whether the response to on-demand vardenafil could be improved by its daily usage in hypertensive men with erectile dysfunction (ED) who previously did not answer to on-demand regime.

Methods

Our main efficacy criterion was per patient percentage of positive answers on the Sexual Encounter Profile question 3 (SEP3). Carotid intima-media thickness (IMT), flow-mediated dilation (FMD), and nitrate-mediated dilation on brachial artery were considered as vascular parameters. A total of 74 hypertensive men with ED aged 50 to 70 years with no major cardiovascular disease were selected from 284 patients initially referred. After vardenafil on-demand usage during 4 weeks, patients with more than 50% of positive answers on the SEP3, or 50% and more than 6 points on the International Index of Erectile Function-Erection Function Domain (IIEF-EF) basal score or positive answer to global evaluation question were considered “responders.” “Nonresponders” (n = 35) were randomized to daily vardenafil 10 mg or placebo during 5 weeks along with open 10 mg of vardenafil before intercourse.

Results

In the active group, 38.8% of patients became responders to vardenafil (P < .05). Clinical response to continuous vardenafil correlated with sexual frequency (r = .68, P < .01), Framingham risk score (r = −.65, P < .01), carotid IMT (r = −.61, P = .01) and low-density lipoprotein (LDL)-cholesterol (r = −.64, P < .01).

Conclusion

Daily vardenafil during 5 weeks rescued response to on-demand regime among ED hypertensive men with no major cardiovascular disease. Further clinical trials and cost-effectiveness studies are necessary to confirm these findings.

Section snippets

Study Population

Sexually active men aged between 50 and 70 years were selected from the Outpatient Hypertension Clinic at the State University of Rio de Janeiro over a 12-month period. Inclusion criteria were essential hypertension, moderate to severe ED with no evidence of major cardiovascular disease, and nonresponsiveness to at least 4 sexual attempts with 20 mg of vardenafil. ED severity was classified according to a self-administered and validated questionnaire: the International Index of Erectile

Results

From 284 hypertensive patients initially screened, we first selected 74 men who were sexually active, heterosexual, with a stable partner for more than 6 months, no evidence of major cardiovascular disease, and no changes in baseline medication for the last 6 months. All 74 patients met criteria for ED for ≥6 months and had less than 50% positive answers on SEP-3 without medications. They tried 20 mg of on-demand vardenafil in at least 4 attempts. Thirty-five individuals were considered

Comment

In this study, the main result shows that continuous use of vardenafil taken nightly during 5 weeks improved erectile function among men with ED and hypertension with no major cardiovascular disease who did not respond to previous on-demand regimen. To date, there are few studies in the literature that clarify the clinical efficacy of continuous regimens in such populations and none, to our knowledge, with an adequate design or a homogenous sample that allows external validation.

The therapeutic

Conclusions

In conclusion, in this sample of hypertensive men with ED and no other clinical evidence of atherosclerosis who did not respond to on-demand PDE-5 inhibitor, the use of continuous vardenafil was able to improve erectile function. This beneficial effect was not observed in patients with diabetes. Continuous PDE-5 effectiveness was associated with sexual frequency and LDL-cholesterol levels. Despite these findings, further clinical trials are necessary to confirm the beneficial effects of

References (30)

Cited by (8)

  • Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

    2016, Journal of Sexual Medicine
    Citation Excerpt :

    There also is clear evidence that vardenafil is efficacious in the treatment of ED in special populations of men with ED. These populations include men with (i) diabetes and ED189–191 (consistent level 1 studies), (ii) ED secondary to radical retropubic prostatectomy192 (single level 1 study), (iii) depression and ED193 (single level 1 study), (iv) hypertension and ED194 (single level 1 study and single level 2 study),188 (v) spinal cord injury and ED195 (single level 1 study), (vi) hyperlipidemia and ED196 (single level 1 study), (vii) previous failed responses to sildenafil197 (single level 1 study and single level 2 study),198 (viii) metabolic syndrome199 (single level 1 study), (ix) previous failed responses to on-demand vardenafil 20 mg treated with daily dosing of vardenafil 10 mg plus 10 mg before intercourse200 (single level 2 study), (x) renal transplantation201 (single level 2 study), (xi) schizophrenia202 (single level 2 study), and (xii) end-stage renal disease treated with hemodialysis94 (single level 2 study). There is consistent evidence that vardenafil not only is efficacious in the treatment of ED but also significantly improves several psychosocial outcomes.

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Financial Disclosure: The authors declare that they have no relevant financial interests.

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