Update on clinical trials of tadalafil demonstrates no increased risk of cardiovascular adverse events

Journal of Sexual Medicine

Volumn 1, Issue 2, 2004, Pages 161-167

  Jackson, Graham ^a   Kloner, Robert A ^b   Costigan, Timothy M ^c   Warner, Margaret R ^c   Emmick, Jeffrey T ^c  

^a GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c ELI LILLY AND COMPANY   (United States)

Author keywords

Cardiovascular; Erectile dysfunction; Myocardial infarction; Placebo; Safety; Tadalafil

Indexed keywords

PLACEBO; TADALAFIL;

ADULT; AGED; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CEREBROVASCULAR DISEASE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY OBSTRUCTION; DEMOGRAPHY; DIABETES MELLITUS; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG MECHANISM; DRUG SAFETY; ERECTILE DYSFUNCTION; FEMALE; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HEART RATE VARIABILITY; HEART VENTRICLE ARRHYTHMIA; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; HYPOTENSION; INCIDENCE; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MORTALITY; PRIORITY JOURNAL; PULMONARY HYPERTENSION; RETROSPECTIVE STUDY; RISK FACTOR; SEXUAL DYSFUNCTION; SIDE EFFECT; SYNCOPE; TACHYCARDIA;

EID: 15844395323     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2004.04024.x     Document Type: Article

References (24)

1. Lue TF. Erectile dysfunction. N Engl J Med 2000;342:1802-13.
2. Feldman HA, Goldstein I, Hatzichristou D, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: Results of the Massachusetts male aging study. J Urol 1994;151:54-61.
3. Martin-Morales A, Sanchez-Cruz JJ, Saenz De Tejada I, Rodriguez-Vela L, Jimenez-Cruz JF, Burgos-Rodriguez R. Prevalence and independent risk factors for erectile dysfunction in Spain: Results of the epidemiolgia de le difuncion erectile masculina study. J Urol 2001;166:596-75.
4. Roumeguere Th, Wespes E, Carpentier Y, Hoffman P, Schulman CC. Erectile dysfunction is associated with a high prevalence of hyperlipidemia and coronary heart disease risk. Eur Urol 2003;44:355-9.
5. Greenstein A, Chen J, Miller H, Matzkin H, Villa Y, Braf Z. Does severity of ischemic coronary disease correlate with erectile function? Int J Impot Res 1997;9:123-6.
6. Brock GB, McMahon CG, Chen KK, Costigan T, Shen W, Watkins VS, Anglin G, Whitaker JS. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: Results of integrated analyses. J Urol 2002;168:1332-6.
7. 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.
8. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N Engl J Med 1998;338:1397-404.
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;62:121-6.
10. Cheitlin MD, Hutter AM, Brindis RG, Ganz P, Kaul S, Russell RO, Zusman RM. Use of sildenafil (Viagra) in patients with cardiovascular disease. ACC/AHA Expert Consensus Document. J Am Coll Cardiol 1999;33:273-82.
11. Emmick JT, Stuewe SR, Mitchell M. Overview of the cardiovascular effects of tadalafil. Eur Heart J 2002;4(H Suppl):H32-47.
12. Kloner RA, Mitchell M, Emmick JT. Cardiovascular effects of tadalafil. Am J Cardiol 2003;92:37M-46M.
13. Zusman RM, Morales A, Glasser DB, Osterloh IH. Overall cardiovascular profile of sildenafil citrate. Am J Cardiol 1999;83:35C-44C.
14. United States Package Insert, United States Food and Drug Administration, 2003.
15. Carson CC, Rajfer J, Eardley I, Carrier S, Denne J, Walker DJ, Shen W, Cordell WH. The efficacy and safety of tadalafil: An update. BJU Int 2004;93: 1276-81.
16. Sáenz 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.
17. Montorsi F, Padma-Nathan H, McCullough A, Brock GB, Broderick G, Ahuja S, Whitaker S, Hoover A, Novack D, Murphy A, Varanese L. 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:in press.
18. Sadovsky R, Miller T, Moskowitz M, Hackett G. Three-year update of sildenafil citrate (Viagra®) efficacy and safety. IJCP 2001;55:115-28.
19. Shakir SA, Wilton LV, Boshier A, Layton D, Heeley E. Cardiovascular events in users of sildenafil: Results from first phase prescription event monitoring in England. BMJ 2001;322:651-2.
20. Shakir SA, Wilton LV, Heeley 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 Coll Cardiol 2001;37(A suppl):299.
21. Fung MM, Bettencourt R, Barrett-Connor E. Heart disease risk factors predict erectile dysfunction 25 years later. J Am Coll Cardiol 2004;43: 1405-11.
22. Kloner RA, Mullin SH, Shook T, Matthews R, Mayeda G, Burstein S, Peled H, Pollick C, Choudhary R, Rosen R, Padma-Nathan H. Erectile dysfunction in the cardiac patient: How common and should we treat? J Urol 2003;170:S46-50.
23. Wolf PA, Cobb J, D'Agostino RB. Epidemiology of stroke. In: Barnett H, Mohr J, Stein B, Yatsu F, editors. Stroke: pathophysiology, diagnosis, and management. New York: Churchill Livingstone; 1992:3-27.
24. Mittleman MA, Glasser DB, Orazem J. Clinical trials of sildenafil citrate (Viagra) demonstrate no increase in risk of myocardial infarction and cardiovascular death compared with placebo. Int J Clin Pract 2003;57:597-600.