Phosphodiesterase type 5 (PDE5) inhibitors for the treatment of erectile dysfunction

Bibliography

• Prins J, Blanker MH, Bohnen AM, Prevalence of erectile dysfunction: a systematic review of population-based studies. Int J Impot Res 2002;14:422-32
   PubMed Web of Science ®Google Scholar
• Feldman HA, Goldstein I, Hatzichristou DG, Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61
   PubMed Web of Science ®Google Scholar
• Kubin M, Wagner G, Fugl-Meyer AR. Epidemiology of erectile dysfunction. Int J Impot Res 2003;15(1):63-71
   PubMed Web of Science ®Google Scholar
• Graham J, Raymond CR, Robert AK, John BK. The second princeton consensus on sexual dysfunction and cardiac risk: new guidelines for sexual medicine. J Sex Med 2006;3(1):28-36
   PubMed Web of Science ®Google Scholar
• Andersson KE, Wagner G. Physiology of Penile Erection. Pharmacol Rev 1995;75:191-236
   Google Scholar
• Andersson KE. Pharmacology of Penile Erection. Pharmacol Rev 2001;53(3):417-50
   PubMed Web of Science ®Google Scholar
• Ignarro LJ. Haem-dependent activation of guanylate cyclase and cyclic GMP formation by endogenous nitric oxide: a unique transduction mechanism for transcellular signaling. Pharmacol Toxicol 1990;67(1):1-7
   PubMedGoogle Scholar
• Burnett A. Role of Nitric Oxide in the Physiology of Erection. Biol Reprod 1995;52:485-9
   PubMed Web of Science ®Google Scholar
• Uckert S, Stief CG, Jonas U. Current and future trends in the oral pharmacotherapy of male erectile dysfunction. Expert Opin Investig Drugs 2003;12(9):1521-33
   PubMed Web of Science ®Google Scholar
• Leu T. Drug therapy: erectile dysfunction. N Engl J Med 2000;342:1802-12
   PubMed Web of Science ®Google Scholar
• Ghofrani HA, Osterloh IH, Grimminger F. Sildenafil: from angina to erectile dysfunction to pulmonary hypertension and beyond. Nat Rev Drug Discov 2006;5(8):689-702
   PubMed Web of Science ®Google Scholar
• Gupta M, Kovar A, Meibohm B. The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. J Clin Pharmacol 2005;45(9):987-1003
   PubMed Web of Science ®Google Scholar
• Gresser U, Gleiter CH. Erectile dysfunction: comparison of efficacy and side effects of the PDE-5 inhibitors sildenafil, vardenafil and tadalafil review of the literature. Eur J Med Res 2002;7:435-46
   PubMed Web of Science ®Google Scholar
• Ballard SA, Gingell CJ, Tang K, Effects of sildenafil on the relaxation of human corpus cavernosum tissue in vitro and on the activities of cyclic nucleotide phosphodiesterase isozymes. J Urol 1998;159(6):2164-71
   PubMed Web of Science ®Google Scholar
• Viagra. Sildenafil citrate [package insert]. New York, NY: Pfizer, Inc, 2006
   Google Scholar
• Vardenafil HCL [package insert] Eli Lilly, Indianapolis, IN; December 2008
   Google Scholar
• Cialis. Tadalafil [package insert]. Indianapolis, IN: Eli Lilly & Co., 2005
   Google Scholar
• Hedelin H, Ströberg P. Treatments for erectile dysfunction based on patient-reported outcomes. Drugs 2005;65:2245-51
   PubMed Web of Science ®Google Scholar
• Raheem AA, Kell P. Patient preference and satisfaction in erectile dysfunction therapy: a comparison of the three phosphodiesterase-5 inhibitors sildenafil, vardenafil and tadalafil. Patient Prefer Adherence 2009;3(3):99-104
   PubMed Web of Science ®Google Scholar
• Ströberg P, Hedelin H, Ljunggren C. Prescribing all phosphodiesterase 5 inhibitors to a patient with erectile dysfunction–a realistic and feasible option in everyday clinical practice--outcomes of a simple treatment regime. Eur Urol 2006;49(5):900-7
   PubMed Web of Science ®Google Scholar
• Alan WS. 2009 Update on phosphodiesterase type 5 inhibitor therapy part 2: updates on optimal utilization for sexual concerns and rare toxicities in this class (CME). J Sex Med 2009;6(9):2352-64
   PubMed Web of Science ®Google Scholar
• Peterson C, Swearingen D. Pharmacokinetics of avanafil, a new PDE5 inhibitor being developed for erectile dysfunction. J Sex Med 2006;3(Suppl 3):253-4
   PubMed Web of Science ®Google Scholar
• Lewis RW, Hellstrom W, Gittelman M, Rigiscan evaluation of TA-1790, a novel PDE5 inhibitor for the treatment of men with erectile dysfunction [abstract 1196]. J Urol 2006;171(Suppl 4):316
   Web of Science ®Google Scholar
• Kaufman JM, Dietrich JW. Safety and efficacy of avanafil, a new PDE5 inhibitor for treating erectile dysfunction [abstract 923]. J Urol 2006;175(Suppl 4):299
   Web of Science ®Google Scholar
• Sidney G, Iderpol T, Celso G, Efficacy and tolerability of lodenafil carbonate for oral therapy in erectile dysfunction: a Phase II Clinical Trial. J Sex Med 2009;6(2):553-7
   PubMed Web of Science ®Google Scholar
• Kim JJ, Choi HK, Lee SW, A phase III study to evaluate the efficacy and safety of udenafil in Korean ED patients [abstract P-05-49]. J Sex Med 2006;(Suppl 3):255
   Google Scholar
• Paick JS, Kim SW, Yang DY, The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction. J Sex Med 2008;5:946-53
   PubMed Web of Science ®Google Scholar
• Paick JS, Kim SW, Park YK, The efficacy and safety of udenafil [Zydena] for the treatment of erectile dysfunction in hypertensive men taking concomitant antihypertensive agents. J Sex Med 2009;6:3166-76
   PubMed Web of Science ®Google Scholar
• Ahn GJ, Chung HK, Lee CH, Increased expression of the nitric oxide synthase gene and protein in corpus cavernosum by repeated dosing of udenafil in a rat model of chemical diabetogenesis. Asian J Androl 2009;11(4):435-42
   PubMed Web of Science ®Google Scholar
• Kim JJ, Yang D, Lee CH, Efficacy and safety of fixed dose udenafil (Zydena) in men with diabetes and erectile dysfunction [abstract P-06-056]. J Sex Med 2008;5(Suppl 2):63
   Google Scholar
• Lee S, Kim Y, Kim TK, Determination of mirodinafil and sildenafil in the plasma and copus cavernousus of SD male rats. J Pharma Biomed Anal 2009;49(2):513-8
   PubMed Web of Science ®Google Scholar
• Kim B-H, Yi S, Kim J, Influence of alcohol on the hemodynamic effects and pharmacokinetic properties of mirodenafil: a single-dose, randomized-sequence, open-label, crossover study in healthy male volunteers in Korea. Clin Ther 2009;31(6):1234-43
   PubMed Web of Science ®Google Scholar
• Jae-Seung P, Tai YA, Hyung KC, Efficacy and safety of mirodenafil, a new oral phosphodiesterase type 5 inhibitor, for treatment of erectile dysfunction. J Sex Med 2008;5(11):2672-80
   PubMed Web of Science ®Google Scholar
• Prince WT, Campbell AS, Tong W, SLx-2101, a new long-acting PDE5 inhibitor: preliminary safety, tolerability, PK and endothelial function effects in healthy subjects [abstract #50]. J Sex Med 2006;3(Suppl 1):29-30
   Google Scholar
• Gruenwald I, Leiba R, Vardi Y. Effect of sildenafil on middle-aged sexually active men with no erectile complaints: a randomized placebo controlled double-blind study. Eur Urol 2008. [Epub ahead of print]
   Google Scholar
• Bivalacqua TJ, Usta MF, Champion HC, Endothelial dysfunction in ED: role of the endothelium in erectile physiology and disease. J Androl 2003;24:S17-37
   PubMed Web of Science ®Google Scholar
• Ferrini MG, Davila HH, Valente EGA, Aging-related induction of inducible nitric oxide synthase is vasculo-protective to the arterial media. Cardiovasc Res 2004;61(4):796-805
   PubMed Web of Science ®Google Scholar
• Sharlip ID, Shumaker BP, Hakim LS, Tadalafil is efficacious and well tolerated in the treatment of erectile dysfunction (ED) in men over 65 years of age: results from multiple observations in men with ED in national tadalafil study in the United States. J Sex Med 2008;5(3):716-25
   PubMed Web of Science ®Google Scholar
• Moore CR, Wang R. Pathophysiology and treatment of diabetic erectile dysfunction. Asian J Androl 2006;8(6):675-84
   PubMed Web of Science ®Google Scholar
• Suetomi T, Kawai K, Hinotsu S, Negative impact of metabolic syndrome on Sildenafil responsiveness in Japanese men. J Sexual Med 2008;5:1443-50
   PubMed Web of Science ®Google Scholar
• Ergin S, Gunduz B, Ugurlu H, A placebo-controlled, multicenter, randomized, double-blind, flexible-dose, two-way crossover study to evaluate the efficacy and safety of sildenafil in men with traumatic spinal cord injury and erectile dysfunction. J Spinal Cord Med 2008;31:522-31
   PubMed Web of Science ®Google Scholar
• Kovanecz I, Rambhatla A, Ferrini M, Long term continuous sildenafil treatment ameliorates corporal venocclusive dysfunction (CVOD) induced by cavernosal nerve resection in rats. Int J Impot Res 2008;20:202-12
   Google Scholar
• Kovanecz I, Rambhatla A, Ferrini MG, Chronic daily tadalafil prevents the corporal fibrosis and veno-occlusive dysfunction that occurs after cavernosal nerve resection. BJU Int 2007;101:203-10
   PubMed Web of Science ®Google Scholar
• Ferrini MG, Davila H, Kovanecz I, Vardenafil prevents fibrosis and loss of corporal smooth muscle that occurs after bilateral cavernosal nerve resection in the rat. Urology 2006;68:429-35
   PubMed Web of Science ®Google Scholar
• Mulhall JP, Müller A, Donohue JF, The functional and structural consequences of cavernous nerve injury are ameliorated by sildenafil citrate. J Sex Med 2008;5:1126-36
   PubMed Web of Science ®Google Scholar
• Bannowsky A, Schulze H, van der Horst C, Recovery of erectile function after nerve sparing radical prostatectomy: Improvement with nightly low dose sildenafil. BJU Int 2008;101:1279-83
   PubMed Web of Science ®Google Scholar
• Rosen RC, Riley A, Wagner G, The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997;49(6):822-30
   PubMed Web of Science ®Google Scholar
• Padma-Nathan H, McCullough AR, Levine LA, Randomized, double-blind, placebo-controlled study of post-operative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve sparing radical prostatectomy. Int J Impot Res 2008;20:479-86
   PubMed Web of Science ®Google Scholar
• Montorsi F, Brock G, Lee J, Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. Eur Urol 2008;54:924-31
   PubMed Web of Science ®Google Scholar
• Moreland R. Pathophysiology of ED: the contributions of trabecular structure to function and the role of functional antagonism. Int J Impot Res 2000;12:S39-46
   Web of Science ®Google Scholar
• Aversa A, Greco E, Bruzziches R, Relationship between chronic tadalafil administration and improvement of endothelial function in men with erectile dysfunction: a pilot study. Int J Impot Res 2007;19:53-60
   Web of Science ®Google Scholar
• NatiliA BM, Lucarini S, Vignolini G, Statistical evaluation of hemodynamic effects of regular use of sildenafil on teh human copora cavernosa. Urol Int 2009;82:53-60
   PubMed Web of Science ®Google Scholar
• Susanna M, Elisabetta M, Mara F, Antioxidant treatment associated with sildenafil reduces monocyte activation and markers of endothelial damage in patients with diabetic erectile dysfunction: A Double-Blind, Placebo-Controlled Study. Eur Urol 2007;52(6):1768-76
   PubMed Web of Science ®Google Scholar
• Burnett AL, Strong T, Trock BJ, Serum biomarker measurements of endothelial function and oxidative stress after daily dosing of sildenafil in type 2 diabetic men with erectile dysfunction. J Urol 2009;181(1):245-51
   PubMed Web of Science ®Google Scholar
• Porst H, Montorsi F, Rosen RC, The premature ejaculation prevalence and attitudes (PEPA) survey: prevalence, comorbidities, and professional help-seeking. J Sex Med 2006;51(3):816-24
   Google Scholar
• Uckert S, Bazrafshan S, Sonnenberg JE, Kuczyk MA. Effects of phosphodiesterase inhibitors on the contractile responses of isolated human seminal vesicle tissue to adrenergic stimulation. J Sex Med 2009;6:408-14
   PubMed Web of Science ®Google Scholar
• Aversa A, Pili M, Francomano D, Effects of vardenafil administration on intravaginal ejaculatory latency time in men with lifelong premature ejaculation. Int J Impot Res 2009;21(4):221-7
   PubMed Web of Science ®Google Scholar
• Kedia GT, Uckert S, Jonas U, The nitric oxide pathway in the human prostate: clinical implications in men with lower urinary tract symptoms. World J Urol 2008;26:603-9
   PubMed Web of Science ®Google Scholar
• Alan WS. 2009 Update on phosphodiesterase type 5 inhibitor therapy part 1: recent studies on routine dosing for penile rehabilitation, lower urinary tract symptoms, and other indications (CME). J Sex Med 2009;6(7):1794-808
   PubMed Web of Science ®Google Scholar
• Oger S, Behr-Roussel D, Gorny D, Combination of doxazosin and sildenafil exerts an addititive relaxing effect compaired with each compound on human cavenosal and prostatic tissue. J Sex Med 2009;6:836-47
   PubMed Web of Science ®Google Scholar
• Oger S, Behr-Roussel D, Gorny D, Combination alfuxosin and tadalafil exerts in vitro an additive relaxant effect on human corpus cavernosum. J Sex Med 2008;5:935-45
   PubMed Web of Science ®Google Scholar
• Charles RB, Carla M, Mohamad WS, The effect of sildenafil citrate on bladder outlet obstruction: a mouse model. BJU Int 2009;104(2):252-6
   PubMed Web of Science ®Google Scholar
• Seiji M, Tadashi H, Hirotsugu U, Robert ML. Effects of chronic treatment with vardenafil, a phosphodiesterase 5 inhibitor, on female rat bladder in a partial bladder outlet obstruction model. BJU International 2009;103(7):987-90
   PubMed Web of Science ®Google Scholar
• McVary KT, Monnig W, Camps JL Jr, Sildinafil citrate improves erectile function and urinary symptoms in men with erectrile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double blind trial. J Urol 2007;177:1071-7
   PubMed Web of Science ®Google Scholar
• Steif CJ, Porst H, Neuser D, A randomized, placebo-controlled study to assess the efficacy of twice-daily vardenafl in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol 2008;53:1236-44
   PubMed Web of Science ®Google Scholar
• Roehrborn CG, McVary K, Elion-Mbousaa A, Vikrup L. Tadalafil administered once daily for Lower Urinary tract symptoms secondary to benign prostatic hyperplasia: a Dose Finding Study. J Urol 2008;180:1228-34
   PubMed Web of Science ®Google Scholar
• Giovanni L, Carlo T, Gioacchino De G, Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report. J Sex Med 2009;6(2):544-52
   PubMed Web of Science ®Google Scholar
• Amado B, Salomon R, Adolfo C, Comparative efficacy assessment of tamsulosin vs. tamsulosin plus tadalafil in the treatment of LUTS/BPH. Pilot Study. J Sex Med 2008;5(9):2170-8
   PubMed Web of Science ®Google Scholar
• Galie N, Ghofrani HA, Torbicki A, Sildenafil use in pulmonary arterial hypertension (SUPER) study Group. Sildinafil citrate therapy for pulmonary arterial hypertension. N Engl J Med 2005;353:2148-57
   PubMed Web of Science ®Google Scholar
• Galie N, Ghofrani HA, Torbicki A, Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med 2005;353(20):2148-57
   PubMed Web of Science ®Google Scholar
• Wang T, Liu Y, Chen L, Wang X, Effect of sildenafil on acrolein-induced airway inflammation and mucus production in rats. Eur Respir J 2009;33(5):1122-32
   PubMed Web of Science ®Google Scholar
• Farooq MU, Naravetla B, Moore PW, Role of sildenafil in neurological disorders. Clin Neuropharmacol 2008;31(6):353-62
   PubMed Web of Science ®Google Scholar
• Ko I-G, Shin M-S, Kim B-K, Tadalafil improves short-term memory by suppressing ischemia-induced apoptosis of hippocampal neuronal cells in gerbils. Pharmacol Biochem Behav 2009;91(4):629-35
   PubMed Web of Science ®Google Scholar
• Takimoto E, Champion HC, Li M, Chronic inhibition of cyclic GMP phosphodiesterase 5A prevents and reverses cardiac hypertrophy. Nature Med 2005;11:214-22
   PubMed Web of Science ®Google Scholar
• Perk H, Armagan A, Naziroglu M, Sildenafil citrate as a phosphodiesterase inhibitor has an antioxidant effect in the blood of men. J Clin Pharm Ther 2008;33(6):635-40
   PubMed Web of Science ®Google Scholar
• Fries R, Shariat K, von Wilmowsky H, Bohm M. Sildenafil in the Treatment of Raynaud's Phenomenon Resistant to Vasodilatory Therapy. Circulation 2005;112(19):2980-5
   PubMed Web of Science ®Google Scholar
• Maggiorini M, Brunner-La Rocca H-P, Peth S, Both tadalafil and dexamethasone may reduce the incidence of high-altitude pulmonary edema. Ann Intern Med 2006;145(7):497-506
   PubMed Web of Science ®Google Scholar
• F.D.A. Orange Book: approved Drug Products with Therapeutic Equivalence Evaluation: Patent and Exclusivity Search. [cited 2/4/2010]; Available from: http://www.accessdata.fda.gov/scripts/cder/ob/docs/querytn.cfm
   Google Scholar
• Bayer Pharmaceuticals investor annual report 2008 [cited; Available from: http://www.investor.bayer.com/ no_cache/en/
   Google Scholar
• Lexchin J. The effect of generic competition on the price of brand-name drugs. Health Policy 2004;68(1):47-54
   PubMed Web of Science ®Google Scholar
• Caves RE, Whinston M, Hurwitz MA. Patent expiration, and competition in the US pharmaceutical industry. In: Winston C, Baily MN, editors, Brookings papers on economic activity microeconomics: Brookings Institution Press: Washington, DC, USA; 1991
   Google Scholar
• Shrank WH, Cox ER, Fischer MA, Patients' Perceptions Of Generic Medications. Health Aff 2009;28(2):546-56
   Web of Science ®Google Scholar
• WHO. General information on counterfeit medicines. Programmes and Projects 2010; Available from: http://www.who.int/medicines/services/counterfeit/overview/en/. [Cited 6 Feburary 2010]
   Google Scholar
• Dorsey PH, Wayne JG. The illicit sale of medications for the treatment of erectile dysfunction. Medscape Today 2007. Available from: http://www.medscape.com/viewarticle/717412. [Last accessed 17 March 2010]
   Google Scholar
• Jackson G, Arver S, Banks I, Stecher VJ. Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. Int J Clin Pract 2010;64(4):497-504
   PubMed Web of Science ®Google Scholar
• Jack A. Counterfeit medicines. Bitter pills. Br Med J 2007;335:1120-1
   PubMed Web of Science ®Google Scholar
• Kripalani J. Customs Seizes Fifty Pounds Of Counterfeit Viagra CBS4 Miami. 2009
   Google Scholar
• Harris W. Knock-Off Viagra Among Goods Seized in Raids NBC Los Angeles. 2009
   Google Scholar
• Kao SL, Chan CL, Sc B, An unusual outbreak of hypoglycemia. N Engl J Med 2009;360(7):734-6
   PubMed Web of Science ®Google Scholar
• Jackson G, Arver S, Banks I, Stecher VJ. Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. Int J Clin Pract 2010. [Epub ahead of print]
   Google Scholar
• Hallén K, Gustafsson LE, Wiklund NP. Nerve-induced release of nitric oxide from the rabbit corpus cavernosum is modulated by cyclic guanosine 3′,5′-monophosphate. Neuroscience 2005;133(1):169-74
   PubMed Web of Science ®Google Scholar
• Miller LN, Nakane M, Hsieh GC, A-350619: a novel activator of soluble guanylyl cyclase. Life Sci 2003;72(9):1015-25
   PubMed Web of Science ®Google Scholar
• Levitra. Vardenafil HCl [package insert]. West Haven, CT: Bayer Pharmaceuticals Corporation, November 2008
   Google Scholar
• Bo-Hyung K, Hyeong-Seok L, Jae-Yong C, Safety, tolerability and pharmacokinetics of udenafil, a novel PDE-5 inhibitor, in healthy young Korean subjects. Br J Clin Pharmacol 2008;65(6):848-54
   PubMed Web of Science ®Google Scholar
• Young HC, Young SL, Soo HB, Dose-dependent pharmacokinetics and first-pass effects of mirodenafil, a new erectogenic, in rats. Biopharm Drug Dispos 2009;30(6):305-17
   PubMed Web of Science ®Google Scholar