Tadalafil in the treatment of erectile dysfunction

Therapeutics and Clinical Risk Management

Volumn 4, Issue 6, 2008, Pages 1315-1329

  Coward, Robert M ^a,b   Carson, Culley C ^a  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b NONE   (United States)

Author keywords

Cialis; Erectile dysfunction; PDE5 inhibitors; Penile erection; Phosphodiesterase type 5; Tadalafil

Indexed keywords

ALCOHOL; DOXAZOSIN; NITRATE; PHOSPHODIESTERASE; PHOSPHODIESTERASE INHIBITOR; PHOSPHODIESTERASE V; PHOSPHODIESTERASE V INHIBITOR; PHOSPHODIESTERASE VI INHIBITOR; PLACEBO; SILDENAFIL; TADALAFIL; TAMSULOSIN; UNCLASSIFIED DRUG; VARDENAFIL;

ANGINA PECTORIS; BACKACHE; BLOOD PRESSURE; CANCER THERAPY; CARDIOVASCULAR RISK; CLINICAL TRIAL; COLOR DISCRIMINATION; CORPUS CAVERNOSUM; DIABETES MELLITUS; DISEASE ASSOCIATION; DRUG ABSORPTION; DRUG ALCOHOL INTERACTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG DOSE ESCALATION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG SELECTIVITY; DRUG STRUCTURE; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSPEPSIA; ENZYME INHIBITION; ERECTILE DYSFUNCTION; EXTERNAL BEAM RADIOTHERAPY; FLUSHING; FOOD; FOOD DRUG INTERACTION; HUMAN; INCIDENCE; LIMB PAIN; LOW DRUG DOSE; MALE; MYALGIA; NONHUMAN; NOSE CONGESTION; PATHOPHYSIOLOGY; PATIENT DECISION MAKING; PREVALENCE; PRIAPISM; PROSTATE CANCER; PROSTATECTOMY; RECOMMENDED DRUG DOSE; REVIEW; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SPERMATOZOON ABNORMALITY; TESTIS DISEASE; TREATMENT OUTCOME; VISUAL DISORDER; VISUAL IMPAIRMENT;

EID: 61549092523     PISSN: 11766336     EISSN: 1178203X     Source Type: Journal    
DOI: 10.2147/tcrm.s3336     Document Type: Review

References (80)

1. Althof SE, Corty EW, Levine SB, et al. 1999. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology, 53:793-9.
2. Briganti A, Salonia A, Gallina A, et al. 2005. Drug Insight: oral phosphodiesterase type 5 inhibitors for erectile dysfunction. Nat Clin Pract Urol, 2:239-47.
3. Burnett AL, Bivalacqua TJ, Champion HC, et al. 2006. Long-term oral phosphodiesterase 5 inhibitor therapy alleviates recurrent priapism. Urology, 67:1043-8.
4. Butcher RW, Sutherland EW 1962. Adenosine 3′,5′-phosphate in biological materials. I. Purification and properties of cyclic 30,50-nucleotide phosphodiesterase and use of this enzyme to characterize adenosine 3′,5′-phosphate in human urine. J Biol Chem, 237:1244-50.
5. Brock GB, McMahon CG, Chen KK, et al. 2002a. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol, 168:1332-6.
6. Brock G, McMahon C, Point P, et al. 2002b. Efficacy and safety of tadalafil in men with erectile dysfunction: an integrated analysis of registration trials [abstract]. J Urol, 167:178.
7. Cappelleri JC, Rosen RC, Smith MD, et al. 1999. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology, 54:346-51.
8. Carson CC. 2005. Cardiac safety in clinical trials of phosphodiesterase 5 inhibitors. Am J Cardiol, 96:37M-41M.
9. Carson CC. 2007. Phosphodiesterase type 5 inhibitors: state of the therapeutic class. Urol Clin North Am, 34:507-15.
10. Carson CC, Giuliano F, Goldstein I, et al. 2004b. The 'effectiveness' scale - therapeutic outcome of pharmacologic therapies for ED: an international consensus panel report. Int J Impot Res, 16:207-13.
11. Carson CC, Hubbard JS, Wallen E. 2005b. Erectile dysfunction and treatment of carcinoma of the prostate. Curr Urol Rep, 6:461-9.
12. Carson CC, Lue TF. 2005. Phosphodiesterase type 5 inhibitors for erectile dysfunction. BJU Int, 96:257-80.
13. Carson CC, Rajfer J, Eardley I, et al. 2004a. The efficacy and safety of tadalafil: an update. BJU Int, 93:1276-81.
14. Carson CC, Shabsigh R, Segal S, et al. 2005a. Efficacy, safety, and treatment satisfaction of tadalafil versus placebo in patients with erectile dysfunction evaluated at tertiary-care academic centers. Urology, 65:353-9.
15. Conaglen HM, Conaglen JV. 2008. Investigating women's preference for sildenafil or tadalafil use by their partners with erectile dysfunction: the partners' preference study. J Sex Med, 5:1198-207.
16. Corbin JD, Francis SH. 2002. Pharmacology of phosphodiesterase-5 inhibitors. Int J Clin Pract, 56:453-9.
17. DeFrances CJ, Cullen KA, Kozak LJ. 2007. National Hospital Discharge Survey: 2005 annual summary with detailed diagnosis and procedure data. Vital Health Stat, 13:1-209.
18. De Berardis G, Pellegrini F, Franciosi M, et al. 2003. Identifying patients with type 2 diabetes with a higher likelihood of erectile dysfunction: the role of the interaction between clinical and psychological factors. J Urol, 169:1422-8.
19. Dean RC, Lue TF. 2005. Physiology of penile erection and pathophysiology of erectile dysfunction. Urol Clin North Am, 32:379-95.
20. Eardley I, Mirone V, Montorsi F, et al. 2005. An open-label, multicentre, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in men nalve to phosphodiesterase 5 inhibitor therapy. BJU Int, 96:1323-32.
21. Francis SH, Corbin JD. 2003. Molecular mechanisms and pharmacokinetics of phosphodiesterase-5 antagonists. Curr Urol Rep, 4:457-65.
22. Francis SH, Turko IV, Corbin JD. 2001. Cyclic nucleotide phosphodiesterases: relating structure and function. Prog Nucleic Acid Res Mol Biol, 65:1-52.
23. Forgue ST, Patterson BE, Bedding AW, et al. 2006. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol, 61:280-8.
24. Fonseca V, Seftel A, Denne J, et al. 2004. Impact of diabetes mellitus on the severity of erectile dysfunction and response to treatment: analysis of data from tadalafil clinical trials. Diabetologia, 47:1914-23.
25. Govier F, Potempa AJ, Kaufman J, et al. 2003. A multicenter, randomized, double-blind, crossover study of patient preference for tadalafil 20 mg or sildenafil citrate 50 mg during initiation of treatment for erectile dysfanction. Clin Ther, 25:2709-23.
26. Gupta M, Kovar A, Meibohm B. 2005. The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. J Clin Pharmacol, 45:987-1003.
27. Hanson-Divers C, Jackson SE, Lue TF, et al. 1998. Health outcomes variables important to patients in the treatment of erectile dysfunction. J Urol, 159:1541-7.
28. Hatzichristou D, Gambla M, Rubio-Aurioles E, et al. 2008. Efficacy of tadalafil once daily in men with diabetes mellitus and erectile dysfunction. Diabet Med, 25:138-46.
29. Hellstrorn WJ, Overstreet JW, Yu A, et al. 2003. Tadalafil has no detrimental effect on human spermatogenesis or reproductive hormones. J Urol, 170:887-91.
30. Hurt KJ, Musicki B, Palese MA, et al. 2002. Akt-dependent phosphorylation of endothelial nitric-oxide synthase mediates penile erection. Proc Natl Acad Sci USA, 99:4061-66.
31. ICOS. 2008. Tadalafil (Cialis) US prescribing information. Accessed June 25, 2008. URL: http://www.lilly.com/us/cialis-pi.pdf.
32. Incrocci L, Slagter C, Slob AK, et al. 2006. A randomized, double-blind, placebo-controlled, cross-over study to assess the efficacy of tadalafil (Cialis) in the treatment of erectile dysfunction following three-dimensional conformal external-beam radiotherapy for prostatic carcinoma. Int J Radiat Oncol Biol Phys, 66:439-44.
33. Incrocci L, Slob AK, Hop WC. 2007. Tadalafil (Cialis) and erectile dysfunction after radiotherapy for prostate cancer: an open-label extension of a blinded trial. Urology, 70:1190-3.
34. Johannes CB, Araujo AB, Feldman HA, et al. 2000. Incidence of erectile dysfunction in men 40-69 years old: longitudinal results from the Massachusetts Male Aging Study. J Urol, 163:460-3.
35. Kaminetsky J. 2008. Epidemiology and pathophysiology of male sexual dysfunction. Int J Impot Res, 20: S3-10.
36. King SH, Hallock M, Strote J, et al. 2005. Tadalafil-associated priapism. Urology, 66:432.
37. Kloner RA. 2004. Cardiovascular effects ofthe 3 phosphodiesterase-5 inhibitors approved for the treatment of erectile dysfunction. Circulation, 110:3149-55.
38. Kloner RA, Hurter AM, Emmick JT. 2003a. Time course of the interaction between Tadalafil and Nitrates. J Am Coll Cardiol, 42:1985-60.
39. Kloner RA, Jackson G, Emmick JT, et al. 2004. Interaction between the phosphodiesterase 5 inhibitor, tadalafil and 2 alpha-blockers, doxazosin and tamsulosin in healthy normotensive men. J Urol, 172:1935-40.
40. Kloner RA, Jackson G, Hutter AM, et al. 2006. Cardiovascular safety update of Tadalafil: retrospective analysis of data from placebo-controlled and open-label clinical trials of Tadalafil with as needed, three timesper-week or once-a-day dosing. Am J Cardiol, 97:1778-84.
41. Kloner RA, Mitchell M, Emmick JT. 2003b. Cardiovascular effects of tadalafil. Am J Cardiol, 92:37M-46M.
42. Kloner RA, Mitchell M, Emmick JT. 2003c. Cardiovascular effects of tadalafil in patients on common antihypertensive therapies. Am J Cardiol, 92:47M-57M.
43. Kostis JB, Jackson G, Rosen R, et al. 2005. Sexual dysfunction and cardiac risk (the Second Princeton Consensus Conference). Am J Cardiol, 96:313-21.
44. Kovanecz I, Rambhatla A, Ferrini MG, et al. 2008. Chronic daily tadalafil prevents the corporal fibrosis and veno-occlusive dysfunction that occurs after cavernosal nerve resection. BJU Int, 101:203-10.
45. Krane RJ. 1986. Sexual Function and Dysfunction. In Walsh, Gittes, Perlmutter, Stamey (ed). Campbell's Urology. 5th ed. Philadelphia: WB. Saunders Company. Vol 1, p 731.
46. Lin CS, Xin ZC, Lin G et al. 2003. Phosphodiesterases as therapeutic targets. Urology, 61:685-91.
47. Lincoln TM, Cornwell TL. 1991. Towards an understanding of the mechanism of action of cyclic AMP and cyclic GMP in smooth muscle relaxation. Blood Vessels, 28:129-37.
48. Lue TF. 2000. Erectile dysfunction. N Engl J Med, 342:1802-13.
49. McKinlay, JB. 2000. The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res, 12:S6-S11.
50. McMahon C. 2004. Efficacy and safety of daily tadalafil in men with erectile dysfunction previously unresponsive to on-demand tadalafil. J Sex Med, 1:292-300.
51. McMahon C. 2005. Comparison of efficacy, safety, and tolerability of on-demand tadalafil and daily dosed tadalafil for the treatment of erectile dysfunction. J Sex Med, 2:415-25.
52. McVary KT, McKenna KE. 2004. The relationship between erectile dysfunction and lower urinary tract symptoms: epidemiological, clinical, and basic science evidence. Curr Urol Rep, 5:25 1-7.
53. McVary KT, Roehrborn CG, Kaminetsky JC, et al. 2007. Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol, 177:1401-7.
54. Menon M, Kaul S, Bhandari A, et al. 2005. Potency following robotic radical prostatectomy: a questionnaire based analysis of outcomes after conventional nerve sparing and prostatic fascia sparing techniques. J Urol, 174:2291-6.
55. Montorsi F, Brock G, Lee J, et al. 2008. Effect of Nightly versus On-Demand Vardenafil on Recovery of Erectile Function in Men Following Bilateral Nerve-Sparing Radical Prostatectomy. Ear Urol, Jul 9
56. Montorsi F, McDermott TE, Morgan R, et al. 1999. Efficacy and safety of fixed-dose oral sildenafil in treatment of erectile dysfunction of various etiologies. Urology, 55:1011-8.
57. Montorsi F, Nathan HP, McCullough A, et al. 2004. Tadalafil in the treatment of erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy: a randomized, double-blind, placebo controlled trial. Urology, 172:1036-41. Erratum in: J Urol, 2005; 173:664.
58. NIH Consensus Development Panel on Impotence. 1993. NIH Consensus Conference: impotence. JAMA, 270:83-90.
59. Padma-Nathan H, McCullough AR, Levine LA, et al. 2008. Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention oferectile dysfunction after bilateral nerve-sparing radical prostatectorny. Int J Impot Res, Jul 24
60. Penson DF, Latini DM, Lubeck DP, et al. 2003. Do impotent men with diabetes have more severe erectile dysfunction and worse quality of life than the general population of impotent patients? Results from the Exploratory Comprehensive Evaluation of Erectile Dysfunction (ExCEED) database. Diabetes Care, 26:1093-9.
61. Penson DF, McLerran D, Feng Z, et al. 2008- 5-year urinary and sexual outcomes after radical prostatectomy: results from the Prostate Cancer Outcomes Study. J Urol, 179:S40-4.
62. Porst H, Giuliano F, Glina S, et al. 2006. Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5 mg and 10 mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial. Eur Urol, 50:351-9.
63. Porst H, Padma-Nathan H, Giuliano F, et al. 2003. Efficacy of tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: a randomized controlled trial. Urology, 62:121-5.
64. Porst H, Rajfer J, Casabé A, et al. 2008. Long-term safety and efficacy of tadalafil 5 mg dosed once daily in men with erectile dysfunction. J Sex Med, Jun 13
65. Porst H, Rosen RC, Padma-Nathan H, et al. 2002. Tadalafil allows men with erectile dysfimction to have successful intercourse up to 36 hours postdose [abstract]. J Urol, 167:177.
66. Raina R, Pahlajani G, Agarwal A, et al. 2008. Early penile rehabilitation following radical prostatectomy: Cleveland clinic experíence. Int J Impot Res, 20:121-6.
67. Rajfer J, Aliotta PJ, Steidle CP, et al. 2007. Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US. Int J Impot Res, 19:95-103,
68. Rambhatla A, Kovanecz I, Ferrini M, et al. 2008. Rationale for phosphodiesterase 5 inhibitor use post-radical prostatectomy: experimental and clinical review. Int J Impot Res, 20:30-4.
69. Roehrbom CG, McVary KT, Elion-Mboussa A, et al. 2008. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol, 180:1228-34.
70. Rosen RC, Riley A, Wagner G, et al. 1997. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology, 49:822-30.
71. Sáenz de Tejada I, Anglin G, Knight JR, et al. 2002. Effects of tadalafil on erectile dysfunction in men with diabetes. Diabetes Care, 25:2159-64.
72. Stanford JL, Feng J, Hamilton AS, et al. 2000. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study. JAMA, 283:354-60.
73. Ströberg P, Murphy A, Costigan T. 2003. Switching patients with erectile dysfunction from sildenafil citrate to tadalafil: results of a European multicenter, open-label study of patient preference. Clin Ther, 25:2724-37.
74. Sutherland EW, Rall TW 1958. Fractionation and characterization of a cyclic adenine ribonucleotide formed by tissue particles. J Biol Chem, 232:1077-91.
75. Talcott JA, Rieker P, Propert KJ, et al. 1997. Patient-reported impotence and incontinence after nerve-sparing radical prostatectomy. J Natl Cancer Inst, 89:1117-23.
76. Uckert S, Kuthe A, Jonas U, et al. 2001. Characterization and functional relevance of cyclic nucleotide phosphodiesterase isoenzymes of the human prostate. J Urol, 166:2484-90.
77. Vignozzi L, Filippi S, Morelli A, et al. 2006. Effect of chronic tadalafil administration on penile hypoxia induced by cavernous neurotomy in the rat. J Sex Med, 3:419-31.
78. von Keitz A, Rajfer J, Segal S, et al. 2004. A multicenter, randomized, double-blind, crossover study to evaluate patient preference between tadalafil and sildenafil. Eur Urol, 45:499-507.
79. Walsh PC, Lepor H, Eggleston JC. 1983. Radical prostatectomy with preservation of sexual function: anatomical and pathological considerations. Prostate, 4:473-85.
80. Walsh PC, Marschke P, Ricker D, et al. 2000. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. Urology, 55:58-61.