Comparison of efficacy, safety, and tolerability of on-demand tadalafil and daily dosed tadalafil for the treatment of erectile dysfunction

Journal of Sexual Medicine

Volumn 2, Issue 3, 2005, Pages 415-427

  McMahon, Chris ^a   Kloner, Robert A ^b   Hutter Jr , Adolph M ^c   Porst, Hartmut ^d  

^a Australian Centre for Sexual Health   (Australia)

^b GOOD SAMARITAN HOSPITAL   (United States)

^c HARVARD MEDICAL SCHOOL   (United States)

^d NONE

Author keywords

Male diabetes mellitus and sexual dysfunction; Male oral vasoactive agents; Male primary care perspective in treatment of sexual dysfunction

Indexed keywords

TADALAFIL;

ADULT; AGED; ARTICLE; BACKACHE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE SEVERITY; DIZZINESS; DOSE RESPONSE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; ERECTILE DYSFUNCTION; FLUSHING; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MYALGIA; NOSE CONGESTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SEXUAL INTERCOURSE; SIDE EFFECT; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE;

EID: 19744370637     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2005.20360.x     Document Type: Article

References (44)

1. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med 1998;338:1397-404.
2. Azadzoi KM, Saenz de Tejada I. Hypercholesterolemia impairs endothelium-dependent relaxation of rabbit corpus cavernosum smooth muscle. J Urol 1991;146:238-40.
3. Azadzoi KM, Goldstein I. Erectile dysfunction due to atherosclerotic vascular disease: The development of an animal model. J Urol 1992;147:1675-81.
4. Saenz de Tejada I, Goldstein I, Azadzoi KM, Krane RJ, Cohen RA. Impaired neurogenic and endothelium-mediated relaxation of penile smooth muscle from diabetic men with impotence. N Engl J Med 1989;320:1025-30.
5. Virag R, Bouilly P, Frydman D. Is impotence an arterial disorder? A study of arterial risk factors in 440 impotent men. Lancet 1985;1:181-4.
6. Jensen J, Lendorf A, Stimpel H, Frost J, Ibsen H, Rosenkilde P. The prevalence and etiology of impotence in 101 male hypertensive outpatients. Am J Hypertens 1999;12:271-5.
7. Kaiser DR, Billups K, Mason C, Wetterling R, Lundberg JL, Bank AJ. Impaired brachial artery endothelium-dependent and -independent vasodilation in men with erectile dysfunction and no other clinical cardiovascular disease. J Am Coll Cardiol 2004;43: 179-84.
8. 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.
9. Porst H, Padma-Nathan H, Giuliano F, Anglin G, Varanese L, Rosen R. Efficacy of tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: A randomized controlled trial. Urology 2003;62:121-5.
10. Eli Lilly Corporation. Cialis® (tadalafil HCI) tablets: prescribing information (online). Available from URL: http://www.cialis.com/prescribe/index.jsp?location=prescribing.
11. Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J 1991;121(1 Part 2):293-8.
12. Montorsi F, Verheyden B, Meuleman E, Junemann KP, Moncada I, Viliquette L, Casabe A, Pacheco C, Denne J, Knight J, Segal S, Watkins VS. Long-term safety and tolerability of tadalafil in the treatment of erectile dysfunction. Eur Urol 2004;45:339-44.
13. Kloner RA, Mitchell M, Emmick JT. Cardiovascular effects of tadalafil. Am J Cardiol 2003;92(9 suppl 1):37-46.
14. Saenz de Tejada I, Anglin G, Knight JR, Emmick JT. Effects of tadalafil on erectile dysfunction in men with diabetes. Diabetes Care 2002;25:2159-64.
15. Rendell MS, Rajfer J, Wicker PA, Smith MD. Sildenafil for treatment of erectile dysfunction in men with diabetes: A randomized controlled trial. Sildenafil Diabetes Study Group. JAMA 1999;281:421-6.
16. Goldstein I, Young JM, Fischer J, Bangerter K, Segerson T, Taylor T; Vardenafil Diabetes Study Group. 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;26:777-83.
17. Emmick JT, Stuewe SR, Mitchell M. Overview of the cardiovascular effects of tadalafil. Eur Heart J 2002;4(H suppl):H32-47.
18. deHoll JD, Shin PA, Angle JF, Steers WD. Alternative approaches to the management of priapism. Int J Impot Res 1998;10:11-4.
19. Brock G, Nehra A, Lipshultz LI, Karlin GS, Gleave M, Seger M, Padma-Nathan H. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol 2003;170(4 Part 1):1278-83.
20. Hong EK, Lepor H, McCullough AR. Time dependent patient satisfaction with sildenafil for erectile dysfunction (ED) after nerve-sparing radical retropubic prostatectomy (RRP). Int J Impot Res 1999;11(1 suppl):S15-22.
21. Montorsi F, Guazzoni G, Strambi LF, Da Pozzo LF, Nava L, Barbieri L, Rigatti P, Pizzini G, Miani A. 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;158:1408-10.
22. Levine LA, McCullough AR, Padma-Nathan H. Longitudinal randomized placebo-controlled study of the return of nocturnal erections after nerve-sparing radical prostatectomy in men treated with nightly sildenafil citrate. J Urol 2004;171:231.
23. El-Galley R, Rutland H, Talic R, Keane T, Clark H. Long-term efficacy of sildenafil and tachyphylaxis effect. J Urol 2001;166:927-31.
24. Steers W, Guay AT, Leriche A, Gingell C, Hargreave TB, Wright PJ, Price DE, Feldman RA. Assessment of the efficacy and safety of Viagra (sildenafil citrate) in men with erectile dysfunction during long-term treatment. Int J Impot Res 2001;13:261-7.
25. Lin CS, Chow S, Lau A, Tu R, Lue TF. Human PDE5A gene encodes three PDE5 isoforms from two alternate promoters. Int J Impot Res 2002;14:15.
26. Gonzalez C, Bervig T, Podlasek C, Huang CF, McKenna KE, McVary KT. Sildenafil causes a dose- and time-dependent downregulation of phosphodiesterase type 6 expression in the rat retina. Int J Impot Res 1999;11:S9-14.
27. Lin G, Xin ZC, Lue TF, Lin CS. Up and down-regulation of phosphodiesterase-5 as related to tachyphylaxis and priapism. J Urol 2003;170(2 Part 2):S15-18.
28. Ferrini GF, Valente EG, Rajfer J. Long-term treatment with high doses of sildenafil does not up-regulate the levels of phosphodiesterase 5 (PDE5) in the rat penis. J Urol 2004;171:424.
29. Behr-Roussel D, Gorny D, Mevel K, Caisey S, Bernabe J, Burgess G, Wayman C, Alexandre L, Giuliano F. Chronic sildenafil enhances erectile responses and endothelium-dependent corporal relaxations of normal rats: Lack of tachyphylaxis. Eur Urol 2005;47:87-91.
30. Halcox JP, Nour KR, Zalos G, Mincemoyer RA, Waclawiw M, Rivera CE, Willie G, Ellahham S, Quyyumi AA. The effect of sildenafil on human vascular function, platelet activation, and myocardial ischemia. J Am Coll Cardiol 2002;40:1232-40.
31. Desouza C, Parulkar A, Lumpkin D, Akers D, Fonseca VA. Acute and prolonged effects of sildenafil on brachial artery flow-mediated dilatation in type 2 diabetes. Diabetes Care 2002;25:1336-9.
32. Kimura M, Higashi Y, Hara K, Noma K, Sasaki S, Nakagawa K, Goto C, Oshima T, Yoshizumi M, Chayama K. PDE5 inhibitor sildenafil citrate augments endothelium-dependent vasodilation in smokers. Hypertension 2003;41:1106-10.
33. Katz SD, Balidemaj K, Homma S, Wu H, Wang J, Maybaum S. Acute type 5 phosphodiesterase inhibition with sildenafil enhances flow-mediated vasodilation in patients with chronic heart failure. J Am Coll Cardiol 2000;36:845-51.
34. Kloner RA, Mitchell M, Emmick JT. Cardiovascular effects of tadalafil. Am J Cardiol 2003;92(9 suppl 1): 37-46.
35. Jackson G, Kloner RA, Costigan TM, Warner MR, Emmick JT. Update on clinical trials of tadalafil demonstrates no increased risk of cardiovascular adverse events. J Sex Med 2004;1:161-7.
36. Porst H. IC 351 (Tadalafil, Cialis): Update on clinical experience. Int J Impot Res 2002;14(1 suppl):S57-64.
37. Boshier A, Wilton LV, Shakir SA. Evaluation of the safety of sildenafil for male erectile experience gained in general practice use in England. BJU Int 2004;93:796-801.
38. Padma-Nathan H, Eardley I, Kloner RA, Laties AM, Montorsi F. A 4-year up-date on the safety of sildenafil citrate (Viagra®). Urology 2002;60(2B suppl):67-90.
39. Mittelman MA, Glasser DB, Orezam J. Clinical trials of sildenafil citrate (Viagra®) demonstrate no increase in risk of myocardial infarction and cardiovascular death. Int J Clin Pract 2003;57:597-600.
40. Porst H, Kloner RA, Mohan P. Cardiovascular safety of the selective PDE 5 inhibitor vardenafil in patients with erectile dysfunction: An analysis of five placebo-controlled clinical trials. Int J Impot Res 2002;14(4 suppl):S59.
41. Montorsi F, Verheyden B, Meuleman E, Junemann KP, Moncada I, Valiquette L, Casabe A, Pacheco C, Denne J, Knight J, Segal S, Watkins VS. Long-term safety and tolerability of tadalafil in the treatment of erectile dysfunction. Eur Urol 2004; 45:339-45.
42. Brock G, Iglesias J, Toulouse K. Efficacy and safety of IC351 treatment for ED. Eur Urol 2001; 39(5 suppl):106 (Abstract 414).
43. Kloner RA, Mitchell MI, Emmick JT. Cardiovascular effects of tadalafil. Am J Cardiol 2003;92(suppl): 37M-46M.
44. Jackson G, Kloner RA, Costigan TM, Warner MR, Emmick JT. Update on the clinical trials of tadalafil demonstrates no increased risk of cardiovascular adverse events. J Sex Med 2004;1:161-7.