Overview of the cardiovascular effects of tadalafil
a Eli Lilly and Company, Indianapolis, Indiana, U.S.A.
b Eli Lilly and Company Ltd., Lilly Research Centre, Erl Wood Manor, Windlesham, Surrey, U.K.
* Correspondence: Jeffrey T. Emmick, MD, PhD, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, U.S.A.
Abstract
Because erectile dysfunction (ED) and cardiovascular disease share a number of risk factors, it is important to understand the haemodynamic and cardiovascular effects of treatments for ED, including the phosphodiesterase (PDE) type 5 inhibitors. In healthy subjects, administration of tadalafil (a potent and selective inhibitor of PDE5 indicated for the treatment of ED) resulted in small decreases in standing blood pressure. In the general population of men with ED, the effects of tadalafil on haemodynamic parameters were similar to those observed with placebo. As with sildenafil, administration of tadalafil with any nitrate is contraindicated. Tadalafil administration was not associated with prolongation in QT interval. Safety data show that the incidence rate of myocardial infarction following treatment with tadalafil was comparable to that observed in the age-standardized male population, and incidence rates of cardiovascular events observed in patients who were and were not treated with concomitant antihypertensive therapy were comparable. These results demonstrate that tadalafil has no clinically relevant effects on haemodynamics, although it should not be used in combination with nitrates. In addition, integrated analyses of the cardiovascular adverse events in the phase III safety database as a whole, and in patients taking concomitant antihypertensive medication, demonstrate that tadalafil is not associated with increased risk for clinically significant cardiovascular events.
Key Words: Erectile dysfunction cardiovascular adverse effects haemodynamics nitrates tadalafil
References
- Lue TF. Erectile dysfunction. N Engl J Med. 2000;342:18021813
[Free Full Text] - Kaiser FE, Viosca SP, Morley JE, Mooradian AD, Davis SS, Korenman SG. Impotence and aging: clinical and hormonal factors. J Am Geriatr Soc. 1988;36:511519[Web of Science][Medline]
- Wagner G, Mulhall J. Pathophysiology and diagnosis of male erectile dysfunction. BJU Int. 2001;88(suppl 3):310
- Kirby M, Jackson G, Betteridge J, Friedli K. Is erectile dysfunction a marker for cardiovascular disease? Int J Clin Pract. 2001;55:614618[Web of Science][Medline]
- 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;9:123126[CrossRef][Web of Science][Medline]
- Jackson G, Benjamin N, Jackson N, Allen MJ. Effects of sildenafil citrate on human hemodynamics. Am J Cardiol. 1999;83:1320C
- Webb DJ, Freestone S, Allen MJ, Muirhead GJ. Sildenafil citrate and blood-pressure-lowering drugs: results of drug interaction studies with an organic nitrate and a calcium antagonist. Am J Cardiol. 1999;83:2128C[Web of Science][Medline]
- Webb DJ, Muirhead GJ, Wulff M, Sutton JA, Levi R, Dinsmore WW. Sildenafil citrate potentiates the hypotensive effects of nitric oxide donor drugs in male patients with stable angina. J Am Coll Cardiol. 2000;36:2531
[Abstract/Free Full Text] - Vardi Y, Klein L, Nassar S, Sprecher E, Gruenwald I. Effects of sildenafil citrate (Viagra) on blood pressure in normotensive and hypertensive men. Urology. 2002;59:747752[CrossRef][Web of Science][Medline]
- Kloner RA, Brown M, Prisant LM, Collins M. Effect of sildenafil in patients with erectile dysfunction taking antihypertensive therapy. Sildenafil Study Group. Am J Hypertens. 2001;14:7073[CrossRef][Web of Science][Medline]
- Herrmann HC, Chang G, Klugherz BD, Mahoney PD. Hemodynamic effects of sildenafil in men with severe coronary artery disease. N Engl J Med. 2000;342:16221626
[Abstract/Free Full Text] - Conti CR, Pepine CJ, Sweeney M. Efficacy and safety of sildenafil citrate in the treatment of erectile dysfunction in patients with ischemic heart disease. Am J Cardiol. 1999;83:29C34C
- Sadovsky R, Miller T, Moskowitz M, Hackett G. Three-year update of sildenafil citrate (Viagra) efficacy and safety. Int J Clin Pract. 2001;55:115128[Web of Science][Medline]
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