EFFICACY AND SAFETY OF TADALAFIL FOR THE TREATMENT OF ERECTILE DYSFUNCTION IN DIABETIC PATIENTS
Abstract
Objective: We evaluated the efficacy and safety of tadalafil, a potent, selective phosphodiesterase 5 inhibitor, for the treatment of erectile dysfunction in diabetic patients. Patients And Methods: Between September 2008 to July 2010, 124 men their mean age was 49.8 years with a clinical diagnosis of type 1 or type 2 diabetes (mean duration 11.7 years), a minimum 3-month history of mild-to-severe ED, (60.5%) of them had moderate ED of ≥1 year's duration were randomly allocated to one of two groups: the first group receive placebo (n = 61), the second group receive tadalafil 20 mg as needed (n = 63) for 12 weeks the dose taken as needed without food restrictions. Changes from baseline of erectile dysfunction to the ability to complete successful sexual intercourse and the side effect of the drug was noticed and fallowed. Results: A total of 109 (88%) of 124 patients completed the study. Patients receiving 20 mg tadalafil experienced a significant mean improvement, 75% of them were successfully completed intercourse attempts compared with 28% in the control group (p <0.001). Compared with placebo, tadalafil significantly improve the outcomes. Tadalafil was consistently efficacious across disease severities and etiologies, as well as in patients of all ages. Tadalafil was well tolerated, and the most common adverse events were headache (11.2%), dyspepsia (6.0% ), nasopharyngitis (4.7% ), and flushing (2.8%) . Conclusions: Tadalafil therapy significantly enhanced erectile function and was well tolerated by men with diabetes and EDReferences
L.R. Derogatis and A.L. Burnett, The epidemiology of sexual dysfunctions, J Sex Med 5 (2008), p. 389.
J.B. Kostis, G. Jackson, R. Rosen, E. Barrett-Conner, K. Billups and A.L. Burnett et al., Sexual dysfunction and cardiac risk (the Second Princeton Consensus Conference), Am J Cardiol 96 (2005), p. 313.
A. Aversa, R. Bruzziches, M. Pili and G. Spera, Phosphodiesterase 5 inhibitors in the treatment of erectile dysfunction, Curr Pharm Des 12 (2006), p. 3467.
G.F. Watts, K.K. Chew and B.G. Stuckey, The erectile-endothelial dysfunction nexus: new opportunities for cardiovascular risk prevention, Nat Clin Pract Cardiovasc Med 4 (2007), p. 263.
Pfizer Inc. Protocol No. A1481146: A multicenter, double-blind study to evaluate the effect of pre-treatment with a daily dose of Viagra (sildenafil citrate) on the PRN efficacy of Viagra in men with erectile dysfunction and Type 2 diabetes. Available at www.ClinicalStudyResults.org. Accessed February 4, 2008.
R.C. Rosen, J.C. Cappelleri, M.D. Smith, J. Lopsky and B.M. Peña, Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction, Int J Impot Res 11 (1999), p. 319.
Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, Diabetes Care 26 (2003), p. S5.
J. Lincoln, C.H.V. Hoyle and G. Burnstock, Pharmacology, Nitric Oxide in Health and Disease, Cambridge University Press, Cambridge (1997), pp. 159–173 chapt 11.
C. Patrono and G.A. FitzGerald, Isoprostanes: potential markers of oxidant stress in atherothrombotic disease, Arterioscler Thromb Vasc Biol 17 (1997), p. 2309.
G.J. Blake and P.M. Ridker, Novel clinical markers of vascular wall inflammation, Circ Res 89 (2001), p. 763.
R.C. Rosen, Sexual function assessment in the male: physiological and self-report measures, Int J Impot Res 10 (1998), p. S59.
J.P. Mulhall, I. Goldstein, A.G. Bushmakin, J.C. Cappelleri and K. Hvidsten, Validation of the erection hardness score, J Sex Med 4 (2007), p. 1626.
D. Hatzichristou, M. Gambla, E. Rubio-Aurioles, J. Buvat, G.B. Brock and G. Spera et al., Efficacy of tadalafil once daily in men with diabetes mellitus and erectile dysfunction, Diabet Med 25 (2008), p. 138
A. Aversa, R. Bruzziches, C. Vitale, G. Marazzi, D. Francomano and G. Barbaro et al., Chronic sildenafil in men with diabetes and erectile dysfunction, Expert Opin Drug Metab Toxicol 3 (2007), p. 451.
A. Aversa, C. Vitale, M. Volterrani, A. Fabbri, G. Spera and M. Fini et al., Chronic administration of sildenafil improves markers of endothelial function in men with Type 2 diabetes, Diabet Med 25 (2008), p. 37.
C. Desouza, A. Parulkar, D. Lumpkin, D. Akers and V.A. Fonseca, Acute and prolonged effects of sildenafil on brachial artery flow-mediated dilation in type 2 diabetes, Diabetes Care 25 (2002), p. 1336.
G.M. Rosano, A. Aversa, C. Vitale, A. Fabbri, M. Fini and G. Spera, Chronic treatment with tadalafil improves endothelial function in men with increased cardiovascular risk, Eur Urol 47 (2005), p. 214.
N. Caretta, P. Palego, A. Ferlin, A. Garolla, A. Bettella and R. Selice et al., Resumption of spontaneous erections in selected patients affected by erectile dysfunction and various degrees of carotid wall alteration: role of tadalafil, Eur Urol 48 (2005), p. 326.
C. Foresta, N. Caretta, A. Lana, L. De Toni, A. Biagioli and C. Vinanzi et al., Relationship between vascular damage degrees and endothelial progenitor cells in patients with erectile dysfunction: effect of vardenafil administration and PDE5 expression in the bone marrow, Eur Urol 51 (2007), p. 1411.
H. Porst, F. Giuliano, S. Glina, D. Ralph, A.R. Casabé and A. Elion-Mboussa et al., Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial, Eur Urol 50 (2006), p. 351
B. Musicki, H.C. Champion, R.E. Becker, T. Liu, M.F. Kramer and A.L. Burnett, Erection capability is potentiated by long-term sildenafil treatment: role of blood flow-induced endothelial nitric oxide synthase phosphorylation, Mol Pharmacol 68 (2005), p. 226.
D. Behr-Roussel, D. Gorny, K. Mevel, S. Caisey, J. Bernabé and G. Burgess et al., Chronic sildenafil improves erectile function and endothelium-dependent cavernosal relaxations in rats: lack of tachyphylaxis, Eur Urol 47 (2005), p. 87.
N.E. Nielsen, J. Ahlner, J. Malmstedt, K.P. Ohman and E. Swahn, Plasma levels of cyclic GMP and endothelin in postmenopausal women with unstable coronary artery disease, Scand J Clin Lab Invest 59 (1999), p. 325.
J.E. Deanfield, J.P. Halcox and T.J. Rabelink, Endothelial function and dysfunction, Circulation 115 (2007), p. 1285
McKinlay JB: The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res 12(suppl 4): S6–S11, 2000.
Chun J, and Carson CC: Physician-patient dialogue and clinical evaluation of erectile dysfunction. Urol Clin NorthAm 28: 249–258, 2001.
McMahon CG, Samali R, and Johnson H: Efficacy, safety and patient acceptance of sildenafil citrate as treatment for erectile dysfunction. J Urol 164: 1192–1196, 2000.
Guay AT, Perez JB, Jacobson J, et al: Efficacy and safety of sildenafil citrate for treatment of erectile dysfunction in a population with associated organic risk factors. J Androl 22: 793–797, 2001.
Hultling C, Giuliano F, Quirk F, et al: Quality of life in patients with spinal cord injury receiving Viagra (sildenafil citrate) for the treatment of erectile dysfunction. Spinal Cord
: 363–370, 2000.
Lewis R, Bennett CJ, Borkon WD, et al: Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment
Satisfaction Questionnaire. Urology 57: 960–965, 2001.
Madduri SD: After two years, did Viagra live up to its expectations? Missouri Med 98: 243–245, 2001.
El-Galley R, Rutland H, Talic R, et al: Long-term efficacy of sildenafil and tachyphylaxis effect. J Urol 166: 927– 931, 2001.
Brock G, McMahon CG, Chen KK, et al: Efficacy and safety of tadalafil in the treatment of erectile dysfunction: results of integrated analyses. J Urol 168: 1332–1336, 2002.
Rosen RC, Padma-Nathan H, Shabsigh R: Cialis (IC351) provides prompt response and extended period of responsiveness for the treatment of men with erectile dysfunction (ED). Program and abstracts of the 96th Annual Meeting of the American Urological Association, June 2–7, 2001, Anaheim, California.
Viagra_ (sildenafil citrate) prescribing information. New York, New York, Pfizer, 2000.
Ixense_ (apomorphine hydrochloride) prescribing information. London, United Kingdom, Takeda Europe Research & Development Centre, 2001
