Vardenafil for the treatment of erectile dysfunction: an overview of the clinical evidence

Abstract

Many men with erectile dysfunction (ED) also have associated underlying cardiovascular and metabolic conditions, for which they are likely to be taking medication. Therefore, cardiovascular safety and potential drug interactions are two of the major concerns when using PDE-5 inhibitors in these patients. The PDE-5 inhibitor, vardenafil, is characterized by a rapid onset of action, increased duration of erection, high rates of first-dose success and reliable efficacy that can be maintained with continued use. In both clinical trials and real-life observational studies, vardenafil has demonstrated a favorable efficacy and safety profile in men with ED, including those with associated underlying conditions such as diabetes, hypertension and dyslipidemia. Importantly, the concomitant use of medication for these conditions is not associated with any noteworthy changes in the efficacy and safety of vardenafil. The evidence presented in this review supports the use of vardenafil as a first-line treatment for men with ED, including those with underlying conditions.

Keywords: efficacy; erectile dysfunction; safety; underlying conditions; vardenafil.

Figure 1

LS mean IIEF-EF scores in patients with ED and diabetes, stratified by type of antidiabetic medication, at baseline and following 12 weeks of treatment with vardenafil or placebo. Reproduced with permission from Eardley I, Lee Jay C, Shabsigh R, et al. Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications. J Sex Med. 2009. In press. Copyright © 2009 Wiley-Blackwell. *P < 0.0001 for vardenafil vs placebo, **P = 0.1972 for comparison of antidiabetic medication subgroups. Abbreviations: ED, erectile dysfunction; IIEF-EF, erectile function domain of the International Index of Erectile Function; LOCF, last observation carried forward; LS, least squares.

Figure 2

LS mean SEP3 success rates in patients with ED and diabetes, stratified by type of antidiabetic medication, at baseline and following 12 weeks of treatment with vardenafil or placebo. Reproduced with permission from Eardley I, Lee Jay C, Shabsigh R, et al. Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications. J Sex Med. 2009. In press. Copyright © 2009 Wiley-Blackwell. *P < 0.0001 for vardenafil vs placebo, **P = 0.0986 for comparison of antidiabetic medication subgroups. Abbreviations: ED, erectile dysfunction; LOCF, last observation carried forward; LS, least squares; SEP, sexual encounter profile question.

Figure 3

LS mean IIEF-EF scores in patients with ED and hypertension, stratified by type of antihypertensive medication, at baseline and following 12 weeks of treatment with vardenafil or placebo. Reproduced with permission from Eardley I, Lee Jay C, Shabsigh R, et al. Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications. J Sex Med. 2009. In press. Copyright © 2009 Wiley-Blackwell. *P < 0.0001 for vardenafil vs placebo, **P = 0.1651 for comparison of antihypertensive medication subgroups. Abbreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor antagonists; B, beta blockers; C, calcium channel antagonists; D, thiazide or thiazide-like diuretics; ED, erectile dysfunction; IIEF-EF, erectile function domain of the International Index of Erectile Function; LOCF, last observation carried forward; LS, least squares.

Figure 4

LS mean SEP3 success rates in patients with ED and hypertension, stratified by type of antihypertensive medication, at baseline and following 12 weeks of treatment with vardenafil or placebo. Reproduced with permission from Eardley I, Lee Jay C, Shabsigh R, et al. Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications. J Sex Med. 2009. In press. Copyright © 2009 Wiley-Blackwell. *P < 0.0001 for vardenafil vs placebo, **P = 0.7957 for comparison of antihypertensive medication subgroups. Abbreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor antagonists; B, beta blockers; C, calcium channel antagonists; D, thiazide or thiazide-like diuretics; ED, erectile dysfunction; LOCF, last observation carried forward; LS, least squares; SEP, sexual encounter profile question.

Figure 5

LS mean IIEF-EF scores in patients with ED and dyslipidemia, stratified by type of lipid-lowering medication, at baseline and following 12 weeks of treatment with vardenafil or placebo. Reproduced with permission from Eardley I, Lee Jay C, Shabsigh R, et al. Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications. J Sex Med. 2009. In press. Copyright © 2009 Wiley-Blackwell. *P < 0.0001 for vardenafil vs placebo, **P = 0.9169 for comparison of lipid-lowering medication subgroups. Abbreviations: ED, erectile dysfunction; IIEF-EF, erectile function domain of the International Index of Erectile Function; LOCF, last observation carried forward; LS, least squares.

Figure 6

LS mean SEP3 success rates in patients with ED and dyslipidemia, stratified by type of lipid-lowering medication, at baseline and following 12 weeks of treatment with vardenafil or placebo. Reproduced with permission from Eardley I, Lee Jay C, Shabsigh R, et al. Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications. J Sex Med. 2009. In press. Copyright © 2009 Wiley-Blackwell. *P < 0.0001 for vardenafil vs placebo, **P = 0.3536 for comparison of lipid-lowering medication subgroups. Abbreviations: ED, erectile dysfunction; LOCF, last observation carried forward; LS, least squares; SEP, sexual encounter profile question.