Vardenafil: a selective inhibitor of phosphodiesterase-5 for the treatment of erectile dysfunction

Bibliography

• LAUMANN EO, WEST S, GLASSER D, CARSON C, ROSEN R, KANG JH: Prevalence and correlates of erectile dysfunction by race and ethnicity among men aged 40 or older in the United States: From the male attitudes regarding sexual health survey. J. Sex. Med. (2006) in press.
   Google Scholar
• BRAUN M, WASSMER G, KLOTZ T, REIFENRATH B, MATHERS M, ENGELMANN U: Epidemiology of erectile dysfunction: results of the ‘Cologne Male Survey’. Int. J. Impot. Res. (2000) 12:305-311.
   PubMed Web of Science ®Google Scholar
• JOHANNES CB, ARAUJO AB, FELDMAN HA, DERBY CA, KLEINMAN KP, MCKINLAY JB: Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts Male Aging Study. J. Urol. (2000) 163:460-463.
   PubMed Web of Science ®Google Scholar
• BILLUPS KL: Endothelial dysfunction as a common link between erectile dysfunction and cardiovascular disease. Current Sexual Health Reports (2004) 1:137-141.
   Google Scholar
• REFFELMANN T, KLONER RA: Sexual function in hypertensive patients receiving treatment. Vasc. Health Risk Manag. (2006) 2:447-455.
   PubMedGoogle Scholar
• LEVINE LA: Diagnosis and treatment of erectile dysfunction. Am. J. Med. (2000) 109:3S-12S.
   PubMedGoogle Scholar
• REFFELMANN T, KLONER RA: Cardiovascular effects of phosphodiesterase 5 inhibitors. Curr. Pharm. Des. (2006) 12:3437-3494.
   Web of Science ®Google Scholar
• GOLDSTEIN I, LUE TF, PADMA-NATHAN H et al.: Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N. Engl. J. Med. (1998) 338:1397-1404.
   PubMed Web of Science ®Google Scholar
• BROCK GB, MCMAHON CG, CHEN KK et al.: Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J. Urol. (2002) 168:1332-1336.
   PubMed Web of Science ®Google Scholar
• NAGAO K, ISHII N, KAMIDONO S, OSADA T: Safety and efficacy of vardenafil in patients with erectile dysfunction: results of a bridging study in Japan. Int. J. Urol. (2004) 11:515-524.
   PubMed Web of Science ®Google Scholar
• MONTORSI F: Tolerability and safety of apomorphine SL (Ixense). Int. J. Impot. Res. (2003) 15:S7-S9.
   Google Scholar
• FAGAN TC, BUTTLER S, MARBURY T, TAYLOR A, EMONDS A: Cardiovascular safety of sublingual apomorphine in patients on stable dose of oral antihypertensive agents and nitrates. Am. J. Cardiol. (2001) 88:760-766.
   PubMed Web of Science ®Google Scholar
• DOGGRELL SA: Clinical potential of nitric oxide-independent soluble guanylate cyclase activators. Curr. Opin. Investig. Drugs. (2005) 6:874-878.
   PubMedGoogle Scholar
• WALLIS RM, CORBIN JD, FRANCIS SH, ELLIS P: Tissue distribution of phosphodiesterase families and the effect of sildenafil on tissue cyclic nucleotides, platelet function, and the contractile responses of trabeculae carneae and aortic rings in vitro. Am. J. Cardiol. (1999) 83:3C-12C.
   PubMed Web of Science ®Google Scholar
• GRESSER U, GLEITER CH: Erectile dysfunction: comparison of efficacy and side effects of the PDE-5 inhibitor sildenafil, vardenafil and tadalafil: review of the literature. Eur. J. Med. Res. (2002) 7:435-446.
   PubMed Web of Science ®Google Scholar
• FRANCIS SH, TURKO IV, CORBIN: Cyclic nucleotide phosphodiesterases: relating structure and function. Prog. Nucleic Acid Res. Mol. Bio. (2001) 65:1-52.
   PubMed Web of Science ®Google Scholar
• BERKELS R, KLOTZ T, STICHT G, ENGLEMANN U, KLAUS W: Modulation of human platelet aggregation by the phosphodiesterase type 5 inhibitor Sildenafil. J. Cardiovasc. Pharmacol. (2001) 37:413-421.
   PubMed Web of Science ®Google Scholar
• BORTOLOTTI M, MARI C, LOPILATO C, PORAZZO G, MIGLIOLI G: Effects of sildenafil on esophageal motility of patients with achalasia. Gastroenterology (2000) 118:253-257.
   PubMed Web of Science ®Google Scholar
• CHEITLIN MD; HUTTER AM, BRINDIS RG et al.: ACC/AHA Expert Consensus Document. Use of sildenafil (Viagra) in patients with cardiovascular disease. J. Am Coll. Cardiol. (1999) 33:273-282.
   PubMed Web of Science ®Google Scholar
• SENZAKI H, SMITH CJ, JUANG GJ et al.: Cardiac phosphodiesterase 5(cGMP-specific) modulates ß-adrenergic signaling in vivo and is downregulated in heart failure. FASEB J. (2001) 15:1718-1726.
   PubMed Web of Science ®Google Scholar
• STIEF CG, ÜCHERT S, BECKER AJ et al.: Effects of Sildenafil on cAMP and cGMP levels in isolated human cavernous and cardiac tissue. Urology (2000) 55:146-150.
   PubMed Web of Science ®Google Scholar
• SUGIYAMA A, SATOH Y, SHIINA H, TAKAHARA A, YONEVAMA M, HASHIMOTO K: Cardiac electrophysiologic and hemodynamic effects of Sildenafil, a PDE5 inhibitor, in anesthetized dogs. J. Cardiovasc. Pharmacol. (2001) 38:940-946.
   PubMed Web of Science ®Google Scholar
• DAS S, MAULIK N, DAS DK, KADOWITZ PJ, BIVALACQUA TJ: Cardioprotection with sildenafil, a selective inhibitor of cyclic 3’,5’-monophosphate specific phosphodiesterase 5. Drugs Exp. Clin. Res. (2002) 28:213-219.
   PubMedGoogle Scholar
• OCKAILI R, SALLOUM F, HAWKINS J, KUKREJA RC: Sildenafil (Viagra) induces powerful cardioprotective effect via opening of mitochondrial K(ATP) channels in rabbits. Am. J. Physiol. (2002) 283:H263-H269.
   Google Scholar
• FEENSTRA J, VAN DRIE-PIERIK RJ, LACLE CF, STRICKER BH: Acute myocardial infarction associated with sildenafil. Lancet (1998) 352:957-958.
   PubMed Web of Science ®Google Scholar
• REFFELMANN T, KLONER RA: Therapeutic potential of phosphodiesterase 5 inhibition for cardiovascular disease. Circulation (2003) 108:239-244.
   PubMed Web of Science ®Google Scholar
• SWISSA M, OHARA T, LEE MH et al.: Sildenafil-nitric oxide donor combination promotes ventricular tachyarrhythmia in the swine right ventricle. Am. J. Physiol. (2002) 282:H1787-H1792.
   Web of Science ®Google Scholar
• GEELEN P, DROLET B, RAIL J et al.: Sildenafil citrate (Viagra) prolongs cardiac repolarisation by blocking the rapid component of the delayed rectifier potassium current. Circulation (2000) 102:275-277.
   PubMed Web of Science ®Google Scholar
• SAENZ DE TEJADA, 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) 13:282-290.
   PubMed Web of Science ®Google Scholar
• BISCHOFF E: Potency, selectivity, and consequences of nonselectivity of PDE inhibition. Int. J. Impot. Res. (2004) 16:S11-S14.
   PubMedGoogle Scholar
• SUPURAN CT, MASTROLORENZO A, BARBARO G, SCOZZAFAVA A: Phosphodiesterase 5 inhibitors – drug design and differentiation based on selectivity, pharmacokinetic and efficacy profiles. Curr. Pharm. Des. (2006) 12:3459-3465.
   PubMed Web of Science ®Google Scholar
• SUSSMAN DO: Pharmacokinetics, pharmacodynamics, and efficacy of phosphodiesterase type 5 inhibitors. J. Am. Osteopath. Assoc. (2004) 104:S11-S15.
   Google Scholar
• BAYER PHARMACEUTICALS CORP.: Levitra® (vardenafil HCl) prescribing information. Bayer Pharmaceuticals Corp., West Haven (CT) USA (2005).
   Google Scholar
• SACHSE R, ROHDE G: Safety, tolerability and pharmacokinetics of multiple dose treatment with the new PDE5-inhibitor BAY 38-9456. Eur. Urol. (2000) 37(Suppl. 2):81
   Google Scholar
• RHODE G, WENSING G, UNGER S et al.: The pharmacokinetics of vardenafil, a new selective PDE 5 inhibitor, is minimally affected by coadministration with cimetidine and ranitidine. Pharmacotherapy (2001) 21:10.
   Google Scholar
• KLONER RA: Cardiovascular effects of the 3 phosphodieserase-5 inhibitors approved for the treatment of erectile dysfunction. Circulation (2004) 110:3149-3155.
   PubMed Web of Science ®Google Scholar
• JACKSON G, ROSEN RC, KLONER RA, KOSTIS JB: The second Princeton consensus on sexual dysfunction and cardiac risk: new guidelines for sexual medicine. J. Sex. Med. (2006) 3:28-36.
   PubMed Web of Science ®Google Scholar
• BAYER PHARMACEUTICALS CORP.: Levitra® (vardenafil HCl) prescribing information. Bayer Pharmaceuticals Corp., West Haven (CT) USA (2003).
   Google Scholar
• BISCHOFF E, NIEWOEHNER U, HANING H, et al.: The oral efficacy of Vardenafil for inducing penile erection in a conscious rabbit model. J. Urol. (2001) 165:1316-1316.
   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) 13:192-199.
   PubMed Web of Science ®Google Scholar
• GOLDSTEIN I, YOUNG JM, FISCHER J, BANGERTER K, SEGERSON T, TAYLOR T: 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) 26:777-783.
   PubMed Web of Science ®Google Scholar
• ISHII H, NAGAO K, FUJIKAWA K, TACHIBANA T, IWAMOTO Y, KAMIDONO S: Vardenafil 20-mg demonstrated superior efficacy to 10-mg in Japanese men with diabetes mellitus suffering from erectile dysfunction. Int. J. Urol. (2006) 13:1066-1072.
   PubMed Web of Science ®Google Scholar
• GIULIANO P, RUBIO-AURIOLES E, KENNELLY M et al.: Efficacy and safety of vardenafil in men with erectile dyfunction caused by spinal cord injury. Neurology (2006) 66:210-216.
   PubMed Web of Science ®Google Scholar
• GIULIANO F, DONATUCCI C, MONTORSI F et al.: Vardenafil is effective and well-tolerated for treating erectile dysfunction in a broad population of men, irrespective of age. BJU Int. (2005) 95:110-116.
   PubMedGoogle Scholar
• DONATUCCI C, EARDLEY I, BUVAT J et al.: Vardenafil improves sexual function in men with erectile dysfunction irrespective of disease severity and disease classification. J. Sex. Med. (2004) 1:301-309.
   PubMed Web of Science ®Google Scholar
• DONATUCCI C, TAYLOR T, THIBONIER M, BANGERTER K, GITTELMAN M, CASEY R: Vardenafil improves patient satisfaction with erection hardness, orgasmic function, and overall sexual experience, while improving quality of life in men with erectile dysfunction. J. Sex. Med. (2004) 1:185-192.
   PubMed Web of Science ®Google Scholar
• EDWARDS D, HACETT G, COLLINS O, CURRAM J: Vardenafil improves sexual function and treatment satisfaction in couples affected by erectile dysfunction (ED): a randomized, double-blind, placebo-controlled trial in PDE5 inhibitor-naïve men with ED and their partner. J. Sex. Med. (2006) 3:1028-1036.
   PubMed Web of Science ®Google Scholar
• HATZICHRISTOU D, CUZIN B, MARTIN-MORALES A et al.: Vardenafil improves satisfaction rates, depressive symptomatology, an self confidence in a broad population of men with erectile dysfunction. J. Sex. Med. (2005) 2:109-116.
   PubMed Web of Science ®Google Scholar
• HELLSTROM WJ, GITTELMAN M, KARLIN G et al.: Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week placebo-controlled pivotal trial. Urology (2003) 61:8-14.
   PubMed Web of Science ®Google Scholar
• STIEF C, PORST H, SAENZDE TEJADA I, ULBRICH E, BENEKE M: Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction. Int. J. Clin. Pract. (2004) 58:230-239.
   PubMed Web of Science ®Google Scholar
• HALLEN K, WIKLUND NP, GUSTAFSSON LE: Inhibitors of phosphodiesterase 5 (PDE 5) inhibit the nerve-induced release of nitric oxide from the rabbit corpus cavernosum. Br. J. Pharmacol. (2007) 150:353-360.
   PubMed Web of Science ®Google Scholar
• VALIQUETTE L, MONTORSI F, AUERBACH S, VARDENAFIL STUDY GROUP: First-dose success with vardenafil in men with erectile dysfunction and associated comorbidities: RELY-I. Int. J. Clin. Pract. (2006) 60:1378-1385.
   PubMed Web of Science ®Google Scholar
• ZIEGLER D, MERFORT F, VAN AHLEN H, YASSIN A, REBLIN T, NEUREITHER M: Efficacy and safety of flexible-dose vardenafil in men with type 1 diabetes and erectile dysfunction. J. Sex. Med. (2006) 3:883-891.
   PubMed Web of Science ®Google Scholar
• RUBIO-AURIOLES E, PORST H, EARDLEY I et al.: Comparing vardenafil and sildenafil in the treatment of men with erectile dysfunction and risk factors for cardiovascular disease: a randomized, double-blind, pooled crossover study. J. Sex. Med. (2006) 3:1037-1049.
   PubMed Web of Science ®Google Scholar
• HATZICHRISTOU DG, ALIOTTA P, AUERBACH S et al.: Erectile response to vardenafil in men with a history of nonresponse to sildenafil: a time-from-dosing descriptive analysis. Clin. Ther. (2005) 27:1452-1461.
   PubMed Web of Science ®Google Scholar
• KLONER RA, MOHAN P, SEGERSON T et al.: Cardiovascular safety of vardenafil in patients receiving antihypertensive medications: a post-hoc analysis of five placebo controlled trials. J. Am. Coll. Cardiol. (2003) 41 (Suppl A): 276A-277A.
   Google Scholar
• PADMA-NATHAN H, PORST H, EARDLEY I et al.: Efficacy and safety of vardenafil, a selective phosphodiesterase 5 inhibitor, in men with erectile dysfunction on antihypertensive therapy. Presented at The American Society Of Hypertension, 17th Annual Scientific Meeting. New York, NY (16 – 20 May 2002).
   Google Scholar
• ROHDE G, JORDAN P: Influence of vardenafil on blood pressure and pharmacokinetics in hypertensive patients on nifedipine therapy. Pharmacotherapy (2002) 22:418 (Abstr.).
   Google Scholar
• VAN AHLEN H, WAHLE K, KUPPERW, YASSIN A, REBLIN T, NEUREITHER M: Safety and efficacy of vardenafil, a selective phosphodiesterase 5 inhibitor, in patients with erectile dysfunction and arterial hypertension treated with multiple antihypertensives. J. Sex. Med. (2005) 2:856-864.
   PubMed Web of Science ®Google Scholar
• KLONER RA: Pharmacology and drug interaction effects of the phosphodiesterase 5 inhibitors: focus on alpha-blocker interactions. Am. J. Cardiol. (2005) 96:42M-46M.
   Google Scholar
• WYSOWSKI DK, FARINAS E, SWARTZ L: Comparison of reported and expected deaths in sildenafil (Viagra) users. Am. J. Cardiol. (2002) 89:1331-1334.
   PubMed Web of Science ®Google Scholar
• THADANI U, SMITH W, NASH S et al.: The effect of vardenafil, a potent and highly selective phosphodiesterase 5 inhibitor for the treatment of erectile dysfunction, on the cardiovascular response to exercise in patients with coronary artery disease. J. Am. Coll. Cardiol. (2002) 40:2006-2012.
   PubMed Web of Science ®Google Scholar
• MORGANROTH J, ILSON BE, SHADDINER BC et al.: Evaluation of vardenafil and sildenafil on cardiac repolarization. Am. J. Cardiol. (2004) 93:1378-1383.
   PubMed Web of Science ®Google Scholar
• BELLA AJ, BRANT WO, LUE TF, BROCK GB: Non-arteritic anterior optic neuropathy (NAION) and phosphodiesterase type-5 inhibitors. Can. J. Urol. (2006) 13:3233-3238.
   PubMedGoogle Scholar
• MCGEE HT, EGAN RA, CLARK WM: Visual field defects and intracerebral hemorrhage associated with use of vardenafil (Levitra). Neurology (2005) 64:1095-1096.
   PubMedGoogle Scholar
• STRIANO P, ZARA F, MINETTI C, STRIANO S: Epileptic seizures can follow high doses of oral vardenafil. BMJ (2006) 333:785.
   PubMed Web of Science ®Google Scholar
• KOUSSA S, HAGE CHAHINE S, TOHME A, RIACHI M: Epileptic seizures and vardenafil. Rev. Neurol. (2006) 162:651-652.
   PubMedGoogle Scholar
• MINCIULLO PL, SAIJA A, PATAFI M et al.: Vardenafil-induced generalized urticaria. J. Clin. Pharm. Ther. (2004) 29:483-484.
   PubMed Web of Science ®Google Scholar
• GHOFRANI HA, VOSWINCKEL R, REICHENBERGER F et al.: Differences in hemodynamic and oxygenation responses to three different phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension: a randomized prospective study. J. Am. Coll. Cardiol. (2004) 44:1488-1496.
   PubMed Web of Science ®Google Scholar