Frequently asked questions about tadalafil for treating men with erectile dysfunction

NIH Consensus Development Panel on Impotence. NIH Consensus Conference. Impotence. J. Am. Med. Assoc., 1993; 270: 83–90.

Eardley I. , Sethia K. Erectile Dysfunction: Current Investigation and Management, 2nd ed. London: Mosby; 2003.

Abdullin I. Doxazosin . (Cardura) in erectile function preserving treatment of hypertension. J Hypertens, 2003; 21(Suppl. 4):313.

Derby C.A. , Barbour M.M. , Hume A.L. , McKinlay J.B. Drug therapy and prevalence of erectile dysfunction in the massachusetts male aging study cohort. Pharmacotherapy, 2001; 21(6):676–683.

Jackson G. Erectile . Dysfunction and cardiovascular disease. Int J Clin Pract, 1999; 53(5):363–368.

Jensen J. , Lendorf A. , Stimpel H. , Frost J. , Ibsen H. , Rosenkilde P. The prevalence of impotence in hypertensive men visiting a hypertension out-patient clinic. Am J Hypertens, 1994; 7:117A (4 PART 2).

Keene L.C. , Davies P.H. Drug-related erectile dysfunction. Adverse Drug React Toxicol Rev, 1999; 18(1):5–24.

Mikhailidis D.P. , Khan M.A. , Milionis H.J. , Morgan R.J. The treatment of hypertension in patients with erectile dysfunction. Curr Med Res Opin Suppl, 1999; 16(1):31–36.

Buvat J. , Lemaire A. Endocrine screening in 1,022 men with erectile dysfunction: clinical significance and cost-effective strategy. J Urol, 1997; 158(5):1764–1767.

Lue T.F. Erectile dysfunction. N Engl J Med, 2000; 342(24):1802–1813.

Angulo J. , Gadau M. , Fernandez A. , Gabancho S. , Cuevas P. , Martins T. , et al. I. IC351 enhances no-mediated relaxation of human arterial and trabecular penile smooth muscle. Eur Urol, 2001; 39(Suppl. 5):106.

Raeburn D. , Advenier C. Isoenzyme-Selective Cyclic Nucleotide Phosphodiesterase Inhibitors: Effects on Airways Smooth Muscle. Int J Biochem Cell Biol, 1995; 27(1):29–37.

Marcinkiewicz J. , Grabowska A. , Lauterbach R. , Bobek M. Differential effects of pentoxifylline, a non-specific phosphodiesterase inhibitor, on the production of IL-10, IL-12 P40 and P35 subunits by murine peritoneal macrophages. Immunopharmacology, 2000; 49(3):335–343.

Weishaar R.E. , Burrows S.D. , Kobylarz D.C. , Quade M.M. , Evans D.B. Multiple molecular forms of cyclic nucleotide phosphodiesterase in cardiac and smooth muscle and in platelets: isolation, characterization, and effects of various reference phosphodiesterase inhibitors and cardiotonic agents. Biochem Pharmacol, 1986; 35(5):787–800.

Saenz de Tejada I. , Angulo J. , Cuevas P. , Fernandez A. , Moncada I. , Allona A. , et al. The phosphodiesterase inhibitory selectivity and the in vitro and in vivo potency of the new PDE5 inhibitor vardenafil. Int J Impotence Res, 2001; 13(5):282–290.

Laties A.M. , Zrenner E. Viagra(registered trademark) (sildenafil citrate) and ophthalmology. Progress in Retinal and Eye Research, 2002; 21(5):485–506.

Fawcett L. , Baxendale R. , Stacey P. , McGrouther C. , Harrow I. , Soderling S. , et al. Molecular cloning and characterization of a distinct human phosphodiesterase gene family: PDE11A. Proc Natl Acad Sci USA, 2000; 97(7):3702–3707.

Yuasa K. , Kotera J. , Fujishige K. , Michibata H. , Sasaki T. , Omori K. Isolation and characterization of two novel phosphodiesterase PDE11A variants showing unique structure and tissue-specific expression. J Biol Chem, 2000; 275(40):31469–31479.

Hellstrom W.J.G. , Overstreet J.W. , Yu A. , Saikali K. , Shen W. , Beasley J. , et al. Tadalafil has no detrimental effect on human spermatogenesis or reproductive hormones. J Urol, 2003; 170(3):887–891.

Saenz de Tejada I. , Angulo J. , Gadau M. , Florio V. Comparative selectivity profiles of tadalafil, sildenafil, and vardenafil using an in vitro phosphodiesterase activity assay. Int J Impot Res, 2002; 14(Suppl 4):20.

Cialis (Tadalafil) Label. http://www.fda.gov/cder/foi/label/2003/021368lbl.pdf. 2003; Last Accessed 08/18/04.

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. Urol, 2003; 62(1):121–126.

Brock G.B. , McMahon C.G. , Chen K.K. , Costigan T. , Shen W. , Watkins V. , et al. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol, 2002; 168:1332–1336.

Carson C.C. , Rajfer J. , Eardley I. , Carrier S. , Denne J.S. , Walker D.J. , et al. The efficacy and safety of tadalafil: an update. BJU Int, 2004; 93(9):1276–1281.

Viagra (Sildenafil Citrate) Label. http://www viagramd com/pi/propackinsert asp. 2002; Last Accessed 8/18/04.

Levitra (Vardenafil HCl) Label. http://www.fda.gov/cder/foi/label/2003/021400lbl.pdf 2003; Last Accessed 8/18/04.

Eardley I. , Ellis P. , Boolell M. , Wulff M. Onset and duration of action of sildenafil citrate for the treatment of erectile dysfunction. Br J Clin Pharmacol Suppl, 2002; 53(1):61S–65S.

Rosen R.C. , Riley A. , Wagner G. , Osterloh I.H. , Kirkpatrick J. , Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urol, 1997; 49(6):822–830.

Cappelleri J.C. , Rosen R.C. , Smith M.D. , Mishra A. , Osterloh I.H. Diagnostic evaluation of the erectile function domain of the international index of erectile function. Urol, 1999; 54(2):346–351.

Rosen R.C. , Padma-Nathan H. , Shabsigh R. , Saikali K. , Watkins V. , Pullman W. J Sex Med, 2004; 1(2):189–196.

Padma-Nathan H , Kaufman J , Rosen RC , Lipschultz L , Bangerter K , Crowley E , et al. Earliest Time of Onset of Erections With Vardenafil Determined in an at-Home Setting. J Androl, 2003; March/April Supp: 48.

Padma-Nathan H. , Stecher V.J. , Sweeney M. , Orazem J. , Tseng L.-J. , DeRiesthal H. Minimal time to successful intercourse after sildenafil citrate: results of a randomized, double-blind. Placebo-Controlled Trial Urol, 2003; 62(3):400–403.

McCullough A.R. An update on the PDE-5 inhibitors (PDE-5i). J Androl, 2003; 24(suppl. 6):S52–S58.

Seftel A.D. , Wilson S.K. , Knapp P.M. , Shin J. , Wang W.C. , Ahuja S. The efficacy and safety of tadalafil in united states and puerto rican men with erectile dysfunction. J Urol, 2004; 172(2):652–657.

Jackson G. Sex, the heart and erectile dysfunction. London: Taylor and Friends; 2004.

World Health Organization. Chronic Disease Information Sheets: Diabetes. http://www who int/dietphysicalactivity/publications/facts/diabetes/en/ 2004; Last Accessed 8/18/04.

Fonseca V. , Seftel A. , Denne J. , Fredlund P. Impact of Diabetes Mellitus on the Severity of Erectile Dysfunction and Response to Treatment: Analysis of Data From Tadalafil Clinical Trials. Diabetologia, 2004; 47:1914–1923.

Mulhall J.P. Deciphering erectile dysfunction drug trials. J Urol, 2003; 170(2):353–358.

Meuleman E.J.H. , Mulders P.F.A. Erectile function after radical prostatectomy: a review. Eur Urol, 2003; 43(2):95–101.

Montorsi F. , Padma-Nathan H. , McCullough A. , Brock G.B. , Broderick G. , Ahuja S. , et al. Tadalafil in the Treatment of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Retropubic Prostatectomy: A Randomized, Double-Blind, Placebo-Controlled Trial. J Urol, 2004; 172:1036–1041.

Schwartz E.J. , Wong P. , Graydon R.J. Sildenafil preserves intracorporeal smooth muscle after radical retropubic prostatectomy. J Urol, 2004; 171(2):771–774.

Patterson B. , Bedding A. , Forgue S.T. , Jewel H. , Payne C. , Mitchell M.I. The effect of intrinsic and extrinsic factors on the PK properties of tadalafil (IC351). Int J Impot Res, 2001; 13(suppl 5):S63.

Porst H. Restoring a normal sexual response: the ultimate goal of erectile dysfunction therapy. Eur Urol Suppl, 2002; 1(8):19–24.

Lewis R.W. Epidemiology of erectile dysfunction. Urol Clin North Am, 2001; 28(2):209–216.

Nicolosi A. , Glasser D.B. , Brock G. , Laumann E. , Gingell C. Diabetes and sexual function in older adults: results of an international survey. Br J Diab Vas Dis, 2002; 2:336–339.

Montorsi F. , Guazzoni G. , Strambi L.F. , Da Pozzo L.F. , Nava L. , Barbieri L. , et al. Recovery of spontaneous erectile function after nervesparing radical retropubic prostatectomy with and without early intracavernous injections of alprostadil: results of a prospective, randomized trial. J Urol, 1997; 158(4):1408–1410.

Padma-Nathan H. , McCullough A.R. , Giuliano F. , Toler S.M. , Wohlhuter C. , Shpilsky A.B. Postoperative nightly administration of sildenafil citrate significantly improves the return of normal spontaneous erectile function after bilateral nerve-sparing radical prostatectomy. J Urol, 2003; 169(4 suppl.):375–376.

Rabbani F. , Stapleton AMF , Kattan M.W. , Wheeler T.M. , Scardino P.T. Factors predicting recovery of erections after radical prostatectomy. J Urol, 2000; 164(6):1929–1934.

Carson C.C. Long-term use of sildenafil. Expert Opinion on Pharmacotherapy, 2003; 4(3):397–405.

Montorsi F. , Verheyden B. , Meuleman E. , Junemann K.-P. , Moncada I. , Valiquette L. , et al. Long-term safety and tolerability of tadalafil in the treatment of erectile dysfunction. Eur Urol, 2004; 45(3):339–345.

Giuliano F. , Meuleman E. , Saoud J. , Ferguson K. , Whitaker S. , Porst H. Daily IC351 treatment of erectile dysfunction. Eur Urol, 2000; 37(suppl. 2):80.

Debusk R. , Drory Y. , Goldstein I. , Jackson G. , Kaul S. , Kimmel S.E. , et al. Management of sexual dysfunction in patients with cardiovascular disease: recommendations of the princeton consensus panel. Am J Cardiol, 2000; 86(2):175–181.

Jackson G. , Betteridge J. , Dean J. , Hall R. , Holdwright D. , Holmes S. , et al. A systematic approach to erectile dysfunction in the cardiovascular patient: a consensus statement. Int J Clin Pract, 1999; 53(6):445–451.

Jackson G. , Kloner R.A. , Costigan T.M. , Warner M.R. , Emmick J.T. Update on Clinical Trials of Tadalafil Demonstrates No Increased Risk of Cardiovascular Adverse Events. J Sex Med, 2004; 1:161–167.

Sadovsky R. , Miller T. , Moskowitz M. , Hackett G. Three-year update of sildenafil citrate (viagra^®) efficacy and safety. Int J Clin Pract, 2001; 55(2):115–128.

Shakir S.A. , Wilton L.V. , Boshier A. , Layton D. , Heeley E. Cardiovascular events in users of sildenafil: results from first phase of prescription event monitoring in england. BMJ, 2001; 322(7287):651–652.

Shakir S.A. , Wilton L.V.H.E. , Layton D. Sildenafil prescription-event monitoring study. no evidence of an increase in cardiovascular outcomes among 5,000 men prescribed sildenafil in general practice in England. J Am Col Cardiol, 2001; 37(2 Supplement 1):A299.

Emmick J.T. , Stuewe S.R. , Mitchell M. Overview of the cardiovascular effects of tadalafil. Eur Heart J Suppl, 2002; 4(H):32–47.

Kloner R.A. , Jackson G. , Emmick J.T. , Mitchell M.I. , Bedding A. , Warner M.R. , et al. Interaction Between the Phosphodiesterase 5 Inhibitor, Tadalafil, and Two Alpha Blockers, Doxazosin and Tamsulosin, in Healthy Normotensive Men. J Urol, 2004; 172:1935–1940.

Jackson G. , Kloner R.A. , Emmick J.T. , Mitchell M.I. , Bedding A. , Pereira A. Interaction between tadalafil and two alpha blockers: doxazosin and tamsulosin. Int J Impot Res, 2003; 15(Suppl 6):S60.

Buvat J. , Denne J. , Costigan T. , Chang S. , Emmick J.T. Evaluation of tadalafil in men with erectile dysfunction taking antihypertensive medication. Int J Impot Res, 2003; 15(Suppl 6):S58.

Kloner R.A. , Mitchell M. , Emmick J.T. Cardiovascular effects of tadalafil in patients on common antihypertensive therapies. Am J Cardiol, 2003; 92(9 Suppl. 1):47M–57M.

Yusuf S. , Collins R. , MacMahon S. , Peto R. Effect of intravenous nitrates on mortality in acute myocardial infarction: an overview of the randomised trials. Lancet, 1988; 1(8594):1088–1092.

ISIS-4: A Randomised Factorial Trial Assessing Early Oral Captopril, Oral Mononitrate, and Intravenous Magnesium Sulphate in 58,050 Patients With Suspected Acute Myocardial Infarction. ISIS-4 (Fourth International Study of Infarct Survival) Collaborative Group. Lancet, 1995; 345(8951):669–85.

GISSI-3: Effects of Lisinopril and Transdermal Glyceryl Trinitrate Singly and Together on 6-Week Mortality and Ventricular Function After Acute Myocardial Infarction. Gruppo Italiano Per Lo Studio Della Sopravvivenza Nell’Infarto Miocardico. Lancet, 1994; 343(8906):1115–22.

Jackson G. , Kloner R.A. , Hutter A.M. , Emmick J.T. , Mitchell M.I. , Denne J. Interaction with nitrates no longer evident 48 hours after dosing of tadalafil. Int J Impot Res, 2003; 15(Suppl 6):S20.

Pollack C.V. Jr. , Roe M.T. , Peterson E.D. 2002 update to the ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: implications for emergency department practice. Ann of Emerg Med, 2003; 41(3):355–369.