Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: Results of a multicenter, randomized, double-blind, placebo-controlled trial

European Urology

Volumn 60, Issue 2, 2011, Pages 380-387

  Zhao, Chen ^a   Kim, Sae Woong ^b   Yang, Dae Yul ^c   Kim, Je Jong ^d   Park, Nam Cheol ^e   Lee, Sung Won ^f   Paick, Jae Seung ^g   Ahn, Tai Young ^h   Min, Kweon Sik ⁱ   Park, Kwangsung ^j   Park, Jong Kwan ^k  

^a Chonbuk National University Medical School   (South Korea)

^b The Catholic University of Korea   (South Korea)

^c Hallym University   (South Korea)

^d Korea University College of Medicine   (South Korea)

^e Pusan National University School of Medicine   (South Korea)

^f Sungkyunkwan University   (South Korea)

^g Seoul National University   (South Korea)

^h University of Ulsan College of Medicine   (South Korea)

ⁱ Inje University   (South Korea)

^j Chonnam National University Medical School   (South Korea)

^k Chonbuk National University   (South Korea)

more..

Author keywords

Clinical study; Erectile dysfunction (ED); Once daily dosing; Phosphodiesterase type 5 inhibitor (PDE5 I); Udenafil

Indexed keywords

PLACEBO; UDENAFIL;

ADULT; ARTICLE; BLURRED VISION; CONJUNCTIVAL HYPEREMIA; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; ERECTILE DYSFUNCTION; ERYTHEMA; FLUSHING; GLOBAL ASSESSMENT QUESTIONNAIRE; HUMAN; INTERNATIONAL INDEX OF ERECTILE FUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCULOSKELETAL STIFFNESS; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NAUSEA; NOSE CONGESTION; PRIORITY JOURNAL; PRURITUS; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SEXUAL ENCOUNTER PROFILE DIARY; SIDE EFFECT; TREATMENT OUTCOME; URTICARIA;

AGED; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ERECTILE DYSFUNCTION; HUMANS; MALE; MIDDLE AGED; PATIENT SATISFACTION; PENILE ERECTION; PHOSPHODIESTERASE 5 INHIBITORS; PLACEBO EFFECT; PYRIMIDINES; QUESTIONNAIRES; REPUBLIC OF KOREA; SEVERITY OF ILLNESS INDEX; SEXUAL BEHAVIOR; SULFONAMIDES; TIME FACTORS; TREATMENT OUTCOME;

EID: 79959568696     PISSN: 03022838     EISSN: 18737560     Source Type: Journal    
DOI: 10.1016/j.eururo.2011.03.025     Document Type: Article

References (29)

1. K. Hatzimouratidis, E. Amar, and I. Eardley Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation Eur Urol 57 2010 804 814
2. C. Hanson-Divers, S.E. Jackson, T.F. Lue, S.Y. Crawford, and R.C. Rosen Health outcomes variables important to patients in the treatment of erectile dysfunction J Urol 159 1998 1541 1547 (Pubitemid 29117337)
3. A.J. Bella, L.X. DeYoung, M. al-Numi, and G.B. Brock Daily administration of phosphodiesterase type 5 inhibitors for urological and nonurological indications Eur Urol 52 2007 990 1005 (Pubitemid 47334787)
4. C. McMahon Efficacy and safety of daily tadalafil in men with erectile dysfunction previously unresponsive to on-demand tadalafil J Sex Med 1 2004 292 300 (Pubitemid 40424638)
5. H. Porst, F. Giuliano, and S. Glina Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5 mg and 10 mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial Eur Urol 50 2006 351 359 (Pubitemid 44038075)
6. M. Kimura, Y. Higashi, and K. Hara PDE5 inhibitor sildenafil citrate augments endothelium-dependent vasodilation in smokers Hypertension 41 2003 1106 1110 (Pubitemid 36548611)
7. L. De Young, D. Yu, D. Freeman, and G.B. Brock Effect of PDE5 inhibition combined with free oxygen radical scavenger therapy on erectile function in a diabetic animal model Int J Impot Res 15 2003 347 354 (Pubitemid 37376940)
8. E.J. Schwartz, P. Wong, and R.J. Graydon Sildenafil preserves intracorporeal smooth muscle after radical retropubic prostatectomy J Urol 171 2004 771 774 (Pubitemid 38090480)
9. E.A. Salem, M. Kendirci, and W.J. Hellstrom Udenafil, a long-acting PDE5 inhibitor for erectile dysfunction Curr Opin Investig Drugs 7 2006 661 669 (Pubitemid 44018351)
10. J.S. Paick, S.W. Kim, and D.Y. Yang The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction J Sex Med 5 2008 946 953 (Pubitemid 351472204)
11. H.J. Park, J.K. Park, K. Park, K. Min, and N.C. Park Efficacy of udenafil for the treatment of erectile dysfunction up to 12 hours after dosing: a randomized placebo-controlled trial J Sex Med 7 2010 2209 2216
12. J.D. Corbin, and S.H. Francis Pharmacology of phosphodiesterase-5 inhibitor Int J Clin Pract 56 2002 453 459
13. B.H. Kim, H.S. Lim, and J.Y. Chung Safety, tolerability and pharmacokinetics of udenafil, a novel PDE-5 inhibitor, in healthy young Korean subjects Br J Clin Pharmacol 65 2008 848 854
14. G.J. Ahn, J.Y. Yu, and S.M. Choi Chronic administration of phosphodiesterase 5 inhibitor improves erectile and endothelial function in a rat model of diabetes Int J Androl 28 2005 260 266 (Pubitemid 41306365)
15. K.K. Kang, J.Y. Yu, M. Yoo, and J.W. Kwon The effect of DA-8159, a novel PDE5 inhibitor, on erectile function in the rat model of hypercholesterolemic erectile dysfunction Int J Impot Res 17 2005 409 416 (Pubitemid 43093241)
16. C.H. Lee, J.H. Shin, G.J. Ahn, K.K. Kang, B.O. Ahn, and M. Yoo Udenafil enhances the recovery of erectile function and ameliorates the pathophysiological consequences of cavernous nerve resection J Sex Med 7 2010 2564 2571
17. NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA 1993;270:83-90.
18. R.C. Rosen, A. Riley, G. Wagner, I.H. Osterloh, J. Kirkpatrick, and A. Mishra The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction Urology 49 1997 822 830 (Pubitemid 27246947)
19. J.C. Cappelleri, R.C. Rosen, M.D. Smith, A. Mishra, and I.H. Osterloh Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function Urology 54 1999 346 351 (Pubitemid 29367263)
20. R.C. Rosen, J.C. Cappelleri, and N. Gendrano 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review Int J Impot Res 14 2002 226 244 (Pubitemid 34947726)
21. D. Hatzichristou, R.C. Rosen, and G. Broderick Clinical evaluation and management strategy for sexual dysfunction in men and women J Sex Med 1 2004 49 57
22. G.I. Hackett Patient preferences in treatment of erectile dysfunction: the continuing importance of patient education Clin Cornerstone 7 2005 57 65
23. S.L. Washington 3rd, and A.W. Shindel A once-daily dose of tadalafil for erectile dysfunction: compliance and efficacy Drug Des Devel Ther 4 2010 159 171
24. F. Fusco, E. Razzoli, C. Imbimbo, A. Rossi, P. Verze, and V. Mirone A new era in the treatment of erectile dysfunction: chronic phosphodiesterase type 5 inhibition BJU Int 105 2010 1634 1639
25. D. Kouvelas, A. Goulas, G. Papazisis, C. Sardeli, and C. Pourzitaki PDE5 inhibitors: in vitro and in vivo pharmacological profile Curr Pharm Des 15 2009 3464 3475
26. A. Makhlouf, A. Kshirsagar, and C. Niederberger Phosphodiesterase 11: a brief review of structure, expression and function Int J Impot Res 18 2006 501 509 (Pubitemid 44658541)
27. H. Porst, J. Rajfer, and A. Casabé Long-term safety and efficacy of tadalafil 5 mg dosed once daily in men with erectile dysfunction J Sex Med 5 2008 2160 2169
28. S.E. Althof, M.M. Berner, and I. Goldstein Interrelationship of sildenafil treatment effects on the physiological and psychosocial aspects of erectile dysfunction of mixed or organic etiology J Sex Med 7 2010 3170 3178
29. V. Mirone, F. Fusco, A. Rossi, R. Sicuteri, and F. Montorsi Tadalafil and vardenafil vs sildenafil: a review of patient-preference studies BJU Int 103 2009 1212 1217