Vardenafil: efficacy, tolerability and future directions

Bibliography

• NIH Consensus Conference. Impotence. NIH consensus development panel on impotence. JAMA 1993;270:83
   PubMed Web of Science ®Google Scholar
• Benet AE, Melman A. The epidemiology of erectile dysfunction. Urol Clin North Am 1995;22:699
   PubMed Web of Science ®Google Scholar
• Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54
   PubMed Web of Science ®Google Scholar
• Berner MM, Kriston L, Harms A. Efficacy of PDE-5-inhibitors for erectile dysfunction. A comparative meta-analysis of fixed-dose regimen randomized controlled trials administering the international index of erectile function in broad-spectrum populations. Int J Impot Res 2006;18:229
   PubMed Web of Science ®Google Scholar
• Porst H, Arnds S, Kleingarn M. The three PED 5 inhibitors sildenafil, tadalafil, and vardenafil – Results of a comparative preference trial in 222 patients with erectile dysfunction. Eur Urol 2004;2(Suppl 3):408
   Google Scholar
• Stroberg P, Ljunggren C, Hedelin H. Patient preference in clinical practice in treatment of erectile dysfunction with PDE-5 inhibitors. J Sex Med 2004;1(Suppl 1):41
   Google Scholar
• Park NC, Park HJ, Kim JM. Efficacy and side effects of the PDE-5 inhibitors sildenafil, vardenfail, and tadalafil: results of an open label study of patient preference in Korea. J Sex Med 2004;1(Suppl 1):55
   Google Scholar
• Sommer F, Mathers M, Klotz T, et al. German Men's Health Study Group. Which PDE5 inhibitor do you prefer? A comparitive randomized multicenter study of sildenafil, tadalafil, and vardenafil. J Urol 2004;171(Suppl 4):314
   Google Scholar
• Mulhall JP, Montorsi F. Evaluating preference trials of oral phosphodiesterase 5 inhibitors for erectile dysfunction. Eur Urol 2006;49:30
   PubMed Web of Science ®Google Scholar
• Doggrell S. Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction? Int J Impot Res 2007;19:281
   PubMed Web of Science ®Google Scholar
• Dean RC, Lue TF. Physiology of penile erection and pathophysiology of erectile dysfunction. Urol Clin North Am 2005;32:379
   PubMed Web of Science ®Google Scholar
• Beavo JA. Cyclic nucleotide phosphodiesterases: functional implications of multiple isoforms. Physiol Rev 1995;75:725
   PubMed Web of Science ®Google Scholar
• Saenz de Tejada I, Angulo J, Cuevas P, et al. The phosphodiesterase inhibitory selectivity and the in vitro and in vivo potency of the new PDE5 inhibitor vardenafil. Int J Impot Res 2001;13:282
   PubMed Web of Science ®Google Scholar
• Saenz de Tejada I, AFJ, Gaudo M, et al. Comparative selectivity profiles of tadalafil, sildenafil, and vardenafil using an in vitro phosphodiesterase activity assay [abstract no. P-081]. Presented at the 5th Congress of the European Society for Sexual and Impotence Research, Hamburg, Germany, 2002
   Google Scholar
• Gbekor E, Bethell S, Fawcett L, et al. Phosphodiesterase 5 inhibitor profiles against all human phosphodiesterase families: implications for use as pharmacological tools [abstract no. 967]. J Urol 2002;167:246
   PubMedGoogle Scholar
• Klotz T, Sachse R, Heidrich A, et al. Vardenafil increases penile rigidity and tumescence in erectile dysfunction patients: a RigiScan and pharmacokinetic study. World J Urol 2001;19:32
   PubMed Web of Science ®Google Scholar
• Bischoff E. Vardenafil preclinical trial data: potency, pharmacodynamics, pharmacokinetics, and adverse events. Int J Impot Res 2004;16(Suppl 1):S34
   PubMed Web of Science ®Google Scholar
• Porst H, Rosen R, Padma-Nathan H, et al. The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. Int J Impot Res 2001;13:192
   PubMed Web of Science ®Google Scholar
• Hellstrom WJ, Gittelman M, Karlin G, et al. Vardenafil for treatment of men with erectile dysfunction: efficacy and safety in a randomized, double-blind, placebo-controlled trial. J Androl 2002;23:763
   PubMed Web of Science ®Google Scholar
• Goldstein I, Young JM, Fischer J, et al. Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study. Diabetes Care 2003;26:777
   PubMed Web of Science ®Google Scholar
• Brock G, Nehra A, Lipshultz LI, et al. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol 2003;170:1278
   PubMed Web of Science ®Google Scholar
• Hayreh SS. Erectile dysfunction drugs and non-arteritic anterior ischemic optic neuropathy: is there a cause and effect relationship? J Neuroophthalmol 2005;25:295
   PubMed Web of Science ®Google Scholar
• Pomeranz HD, Bhavsar AR. Nonarteritic ischemic optic neuropathy developing soon after use of sildenafil (viagra): a report of seven new cases. J Neuroophthalmol 2005;25:9
   PubMed Web of Science ®Google Scholar
• Stief C, Porst H, Saenz De Tejada I, et al. Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction. Int J Clin Pract 2004;58:230
   PubMed Web of Science ®Google Scholar
• Kim CM, Kim YS, Sunwoo S, et al. Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care. Int J Impot Res 2007;19:393
   PubMed Web of Science ®Google Scholar
• Kostis JB, Jackson G, Rosen R, et al. Sexual dysfunction and cardiac risk (the Second Princeton Consensus Conference). Am J Cardiol 2005;96:85M
   PubMedGoogle Scholar
• DeBusk R, Drory Y, Goldstein I, et al. Management of sexual dysfunction in patients with cardiovascular disease: recommendations of The Princeton Consensus Panel. Am J Cardiol 2000;86:175
   PubMed Web of Science ®Google Scholar
• Cheitlin MD, Hutter AM Jr, Brindis RG, et al. ACC/AHA expert consensus document. Use of sildenafil (Viagra) in patients with cardiovascular disease. American College of Cardiology/American Heart Association. J Am Coll Cardiol 1999;33:273
   PubMed Web of Science ®Google Scholar
• Kloner RA, Hutter AM, Emmick JT, et al. Time course of the interaction between tadalafil and nitrates. J Am Coll Cardiol 2003;42:1855
   PubMed Web of Science ®Google Scholar
• Available from: http://www.fda.gov/cder/foi/nda/2003/21-400_Levitra_Prntlbl.pdf: Data on file: US Food and Drug Administration
   Google Scholar
• Auerbach SM, Gittelman M, Mazzu A, et al. Simultaneous administration of vardenafil and tamsulosin does not induce clinically significant hypotension in patients with benign prostatic hyperplasia. Urology 2004;64:998
   PubMed Web of Science ®Google Scholar
• Data on file. US Food and Drug Administration Website. Available from: http://www.fda.gov/cder/foi/label/2008/0214002011lbl.pdf, vol. 2009
   Google Scholar
• Morganroth J, Ilson BE, Shaddinger BC, et al. Evaluation of vardenafil and sildenafil on cardiac repolarization. Am J Cardiol 2004;93:1378
   PubMed Web of Science ®Google Scholar
• McCullough AR. Rehabilitation of erectile function following radical prostatectomy. Asian J Androl 2008;10:61
   PubMed Web of Science ®Google Scholar
• Leungwattanakij S, Bivalacqua TJ, Usta MF, et al. Cavernous neurotomy causes hypoxia and fibrosis in rat corpus cavernosum. J Androl 2003;24:239
   PubMed Web of Science ®Google Scholar
• Mulhall J, Land S, Parker M, et al. The use of an erectogenic pharmacotherapy regimen following radical prostatectomy improves recovery of spontaneous erectile function. J Sex Med 2005;2:532
   PubMed Web of Science ®Google Scholar
• Montorsi F, Guazzoni G, Strambi LF, et al. Recovery of spontaneous erectile function after nerve-sparing radical retropubic prostatectomy with and without early intracavernous injections of alprostadil: results of a prospective, randomized trial. J Urol 1997;158:1408
   PubMed Web of Science ®Google Scholar
• Gontero P, Fontana F, Bagnasacco A, et al. Is there an optimal time for intracavernous prostaglandin E1 rehabilitation following nonnerve sparing radical prostatectomy? Results from a hemodynamic prospective study. J Urol 2003;169:2166
   PubMed Web of Science ®Google Scholar
• Costabile RA, Spevak M, Fishman IJ, et al. Efficacy and safety of transurethral alprostadil in patients with erectile dysfunction following radical prostatectomy. J Urol 1998;160:1325
   PubMed Web of Science ®Google Scholar
• Raina R, Agarwal A, Zaramo CE, et al. Long-term efficacy and compliance of MUSE for erectile dysfunction following radical prostatectomy: SHIM (IIEF-5) analysis. Int J Impot Res 2005;17:86
   PubMed Web of Science ®Google Scholar
• Padma-Nathan H, McCullough A, Forest C. Erectile dysfunction secondary to nerve-sparing radical retropubic prostatectomy: comparative phosphodiesterase-5 inhibitor efficacy for therapy and novel prevention strategies. Curr Urol Rep 2004;5:467
   PubMedGoogle Scholar
• Vignozzi L, Filippi S, Morelli A, et al. Effect of chronic tadalafil administration on penile hypoxia induced by cavernous neurotomy in the rat. J Sex Med 2006;3:419
   PubMed Web of Science ®Google Scholar
• Montorsi F, Brock G, Lee J, et al. Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. Eur Urol 2008;54:924
   PubMed Web of Science ®Google Scholar
• El-Galley R, Rutland H, Talic R, et al. Long-term efficacy of sildenafil and tachyphylaxis effect. J Urol 2001;166:927
   PubMed Web of Science ®Google Scholar
• Ferrini MG, Davila HH, Kovanecz I, et al. Vardenafil prevents fibrosis and loss of corporal smooth muscle that occurs after bilateral cavernosal nerve resection in the rat. Urology 2006;68:429
   PubMed Web of Science ®Google Scholar
• Rambhatla A, Kovanecz I, Ferrini M, et al. Rationale for phosphodiesterase 5 inhibitor use post-radical prostatectomy: experimental and clinical review. Int J Impot Res 2008;20:30
   PubMed Web of Science ®Google Scholar
• Zhang R, Wang Y, Zhang L, et al. Sildenafil (Viagra) induces neurogenesis and promotes functional recovery after stroke in rats. Stroke 2002;33:2675
   PubMed Web of Science ®Google Scholar
• Foresta C, Caretta N, Lana A, et al. Relationship between vascular damage degrees and endothelial progenitor cells in patients with erectile dysfunction: effect of vardenafil administration and PDE5 expression in the bone marrow. Eur Urol 2007;51:1411
   PubMed Web of Science ®Google Scholar
• De Young LX, Domes T, Lim K, et al. Endothelial Rehabilitation: the impact of chronic PDE5 inhibitors on erectile function and protein alterations in cavernous tissue of diabetic rats. Eur Urol 2008;54:213
   PubMed Web of Science ®Google Scholar
• Masson P, Lambert SM, Brown M, et al. PDE-5 inhibitors: current status and future trends. Urol Clin North Am 2005;32:511
   PubMed Web of Science ®Google Scholar
• Rosen R, Altwein J, Boyle P, et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol 2003;44:637
   PubMed Web of Science ®Google Scholar
• Shiri R, Hakkinen J, Koskimaki J, et al. Erectile dysfunction influences the subsequent incidence of lower urinary tract symptoms and bother. Int J Impot Res 2007;19:317
   PubMed Web of Science ®Google Scholar
• Costabile RA, Steers WD. How can we best characterize the relationship between erectile dysfunction and benign prostatic hyperplasia? J Sex Med 2006;3:676
   PubMed Web of Science ®Google Scholar
• Tinel H, Stelte-Ludwig B, Hutter J, et al. Pre-clinical evidence for the use of phosphodiesterase-5 inhibitors for treating benign prostatic hyperplasia and lower urinary tract symptoms. BJU Int 2006;98:1259
   PubMed Web of Science ®Google Scholar
• Sairam K, Kulinskaya E, McNicholas TA, et al. Sildenafil influences lower urinary tract symptoms. BJU Int 2002;90:836
   PubMed Web of Science ®Google Scholar
• Mulhall JP, Guhring P, Parker M, et al. Assessment of the impact of sildenafil citrate on lower urinary tract symptoms in men with erectile dysfunction. J Sex Med 2006;3:662
   PubMed Web of Science ®Google Scholar
• McVary KT, Monnig W, Camps JL Jr, et al. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial. J Urol 2007;177:1071
   PubMed Web of Science ®Google Scholar
• McVary KT, Roehrborn CG, Kaminetsky JC, et al. Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 2007;177:1401
   PubMed Web of Science ®Google Scholar
• Stief CG, Porst H, Neuser D, et al. A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol 2008;53:1236
   PubMed Web of Science ®Google Scholar
• Kaplan SA, Gonzalez RR, Te AE. Combination of alfuzosin and sildenafil is superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction. Eur Urol 2007;51:1717
   PubMed Web of Science ®Google Scholar
• Galie N, Ghofrani HA, Torbicki A, et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med 2005;353:2148
   PubMed Web of Science ®Google Scholar
• Aizawa K, Hanaoka T, Kasai H, et al. Long-term vardenafil therapy improves hemodynamics in patients with pulmonary hypertension. Hypertens Res 2006;29:123
   PubMed Web of Science ®Google Scholar
• Toque HA, Teixeira CE, Priviero FB, et al. Vardenafil, but not sildenafil or tadalafil, has calcium-channel blocking activity in rabbit isolated pulmonary artery and human washed platelets. Br J Pharmacol 2008;154:787
   PubMed Web of Science ®Google Scholar