Out Of The Pipeline

Vardenafil and tadalafil options for erectile dysfunction

Current Psychiatry. 2004 February;3(2):46-53

References

1. Rosen RC, Kostis JB. Overview of phosphodiesterase 5 inhibition in erectile dysfunction. Am J Cardiol 2003;92(suppl):9M-18M.

2. 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.

3. Keating GM, Scott LJ. Vardenafil. A review of its use in erectile dysfunction. Drugs 2003;63:2673-2703.

4. Padma-Nathan H, Rosen RC, Shabsigh R, et al. Cialis (IC351) provides prompt response and extended period of responsiveness for the treatment of men with erectile dysfunction (ED). J Urol 2001;165(suppl):224.-

5. Padma-Nathan H, Kaufman J, Taylor T. Earliest time of onset of erections with vardenafil determined in an at-home setting. Chicago, IL: American Urological Association annual meeting, 2003.

6. Padma-Nathan H, Stecher VJ, Sweeney M, et al. Minimal time to successful intercourse after sildenafil citrate: results of a randomized, double-blind, placebo-controlled trial. Urology 2003;62:400-3.

7. Porst H, Rosen R, Padma-Nathan H, et al. The efficacy and tolerability of vardenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. Int J Impot Res 2001;13:192-9.

8. 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;23:763-71.

9. Goldstein I, Young JM, Fischer J, et al. Vardenafil, a highly selective PDE5 inhibitor, improves erectile function in patients with diabetes mellitus. Diabetes 2001;50(suppl 2):924.-

10. Brock G, Taylor T, Seger M. for the Vardenafil PROSPECT Group. Efficacy and tolerability of vardenafil in men with erectile dysfunction following radical prostatectomy. Eur Urol 2002;1:52.-

11. 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;168:1332-6.

12. Sáenz de Tejada I, Anglin G, Knight JR, et al. Effects of tadalafil on erectile dysfunction in men with diabetes. Diabetes Care 2002;25:2159-64.

13. Padma-Nathan H. Efficacy and tolerability of tadalafil, a novel phosphodiesterase 5 inhibitor, in treatment of erectile dysfunction. Am J Cardiol 2003;92(suppl):19M-25M.

14. 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;86:175-81.

Vardenafil, 10 mg and 20 mg, was also an effective ED treatment in men with type 1 or type 2 diabetes mellitus⁹ and in men who underwent radical prostatectomy.¹⁰

Tadalafil (Table 3). An integrated analysis¹¹ of five randomized, placebo-controlled trials of tadalafil at 2.5, 5, 10, or 20 mg for at least 12 weeks found that the agent at all doses significantly enhanced erectile function in mild to severe ED compared with placebo. Successful intercourse was reported in 61% and 75% of sexual encounters among men treated with tadalafil, 10 and 20 mg respectively, compared with 32% in controls. Eighty-one percent of men taking tadalafil, 20 mg, reported improved erections compared with 35% of those taking placebo.

Tadalafil, 10 and 20 mg, also improved erectile function in men with type 1 or type 2 diabetes.¹²

Tolerability

All three PDE-5 inhibitors have been shown in clinical trials to be generally safe and well-tolerated. Apart from visual disturbances, all three agents have similar side effects.

Patients taking vardenafil most commonly reported headaches, flushing, rhinitis, and dyspepsia. These effects were generally mild to moderate, dose-related, and transient.¹
Headache, back pain, myalgia, and dyspepsia were most commonly reported with tadalafil.¹³ Similarly, adverse events were mild or moderate, dose-related, and generally abated with treatment.

Treatment-related visual disturbances have been reported in 3% of patients taking sildenafil, >0.1% to <1% of men taking vardenafil, and <0.1% of those taking tadalafil.¹ Laboratory parameters have been unaffected by treatment with the PDE-5 inhibitors, and treatment discontinuation due to adverse events has been consistently low.¹

All three PDE-5 inhibitors cause vasodilatory effects and are contraindicated in patients using organic nitrates. Consensus guidelines have been developed for using PDE-5 inhibitors in patients with cardiovascular conditions.¹⁴

Related resources

Rosen RC, Kostis JB. Overview of phosphodiesterase 5 inhibition in erectile dysfunction. Am J Cardiol 2003;92(suppl):9M-18M.
The Process of Care Consensus Panel. Position paper: the process of care model for evaluation and treatment of erectile dysfunction. Int J Impot Res 1999;11:59-74.
American Foundation for Urologic Disease. www.afud.org

Drug brand names

Ketoconazole • Nizoral
Rifampin • Rifadin
Ritonavir • Kaletra, Norvir
Sildenafil • Viagra
Tadalafil • Cialis
Vardenafil • Levitra

Disclosure

The author receives research/grant support and is a consultant to and speaker for Eli Lilly and Co. and Pfizer Inc.