메뉴 건너뛰기




Volumn 31, Issue 1, 2011, Pages 27-41

Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: Results of three clinical trials

Author keywords

, therapeutic use; , treatment; Erectile dysfunction; Type 5 cyclic nucleotide phosphodiesterase inhibitors; Vardenafil

Indexed keywords

DRUG METABOLITE; N NORVARDENAFIL; PLACEBO; UNCLASSIFIED DRUG; VARDENAFIL; WATER;

EID: 78149376867     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11584950-000000000-00000     Document Type: Article
Times cited : (40)

References (32)
  • 1
    • 22244468054 scopus 로고    scopus 로고
    • Chapter 1: The management of erectile dysfunction: An AUA update
    • Jul
    • Montague DK, Jarow JP, Broderick GA, et al. Chapter 1: The management of erectile dysfunction: an AUA update. J Urol 2005 Jul; 174 (1): 230-9
    • (2005) J Urol , vol.174 , Issue.1 , pp. 230-239
    • Montague, D.K.1    Jarow, J.P.2    Broderick, G.A.3
  • 2
    • 33645794792 scopus 로고    scopus 로고
    • EAU Guidelines on erectile dysfunction: An update
    • May
    • Wespes E, Amar E, Hatzichristou D, et al. EAU Guidelines on erectile dysfunction: an update. Eur Urol 2006 May; 49 (5): 806-15
    • (2006) Eur Urol , vol.49 , Issue.5 , pp. 806-815
    • Wespes, E.1    Amar, E.2    Hatzichristou, D.3
  • 3
    • 74049102684 scopus 로고    scopus 로고
    • Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications
    • Eardley I, Lee JC, Shabsigh R, et al. Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications. J Sex Med 2010 Jan; 7 (1 Pt 1): 244-55
    • J Sex Med 2010 Jan , vol.7 , Issue.1 PART 1 , pp. 244-255
    • Eardley, I.1    Lee, J.C.2    Shabsigh, R.3
  • 4
    • 33750447970 scopus 로고    scopus 로고
    • Vardenafil improves sexual function and treatment satisfaction in couples affected by erectile dysfunction (ED): A randomized, doubleblind, placebo-controlled trial in PDE5 inhibitor-naive men with ED and their partners
    • Nov
    • Edwards D, Hackett G, Collins O, et al. Vardenafil improves sexual function and treatment satisfaction in couples affected by erectile dysfunction (ED): a randomized, doubleblind, placebo-controlled trial in PDE5 inhibitor-naive men with ED and their partners. J Sex Med 2006 Nov; 3 (6): 1028-36
    • (2006) J Sex Med , vol.3 , Issue.6 , pp. 1028-1036
    • Edwards, D.1    Hackett, G.2    Collins, O.3
  • 5
    • 28444489736 scopus 로고    scopus 로고
    • Improving the sexual quality of life of couples affected by erectile dysfunction: A double-blind, randomized, placebo-controlled trial of vardenafil
    • Sep
    • Fisher WA, Rosen RC, Mollen M, et al. Improving the sexual quality of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil. J Sex Med 2005 Sep; 2 (5): 699-708
    • (2005) J Sex Med , vol.2 , Issue.5 , pp. 699-708
    • Fisher, W.A.1    Rosen, R.C.2    Mollen, M.3
  • 6
    • 33644894518 scopus 로고    scopus 로고
    • Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury
    • Jan 24
    • Giuliano F, Rubio-Aurioles E, Kennelly M, et al. Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury. Neurology 2006 Jan 24; 66 (2): 210-6
    • (2006) Neurology , vol.66 , Issue.2 , pp. 210-216
    • Giuliano, F.1    Rubio-Aurioles, E.2    Kennelly, M.3
  • 7
    • 1842687262 scopus 로고    scopus 로고
    • The efficacy and safety of flexible-dose vardenafil (Levitra®) in a broad population of European men
    • May, discussion 41
    • Hatzichristou D, Montorsi F, Buvat J, et al. The efficacy and safety of flexible-dose vardenafil (Levitra®) in a broad population of European men. Eur Urol 2004May; 45 (5): 634-41; discussion 41
    • (2004) Eur Urol , vol.45 , Issue.5 , pp. 634-641
    • Hatzichristou, D.1    Montorsi, F.2    Buvat, J.3
  • 8
    • 0036868441 scopus 로고    scopus 로고
    • Vardenafil for treatment of men with erectile dysfunction: Efficacy and safety in a randomized, double-blind, placebo-controlled trial
    • Nov-Dec
    • Hellstrom WJ, Gittelman M, Karlin G, et al. Vardenafil for treatment of men with erectile dysfunction: efficacy and safety in a randomized, double-blind, placebo-controlled trial. J Androl 2002 Nov-Dec; 23 (6): 763-71
    • (2002) J Androl , vol.23 , Issue.6 , pp. 763-771
    • Hellstrom, W.J.1    Gittelman, M.2    Karlin, G.3
  • 9
    • 34249929977 scopus 로고    scopus 로고
    • Improvement in erectile function on vardenafil treatment correlates with treatment satisfaction in both patients and their partners
    • Jul
    • Ralph D, Eardley I, Kell P, et al. Improvement in erectile function on vardenafil treatment correlates with treatment satisfaction in both patients and their partners. BJU Int 2007 Jul; 100 (1): 130-6
    • (2007) BJU Int , vol.100 , Issue.1 , pp. 130-136
    • Ralph, D.1    Eardley, I.2    Kell, P.3
  • 10
    • 30044451279 scopus 로고    scopus 로고
    • Efficacy and tolerability of vardenafil in men with mild depression and erectile dysfunction: The depression-related improvement with vardenafil for erectile response study
    • Jan
    • Rosen R, Shabsigh R, Berber M, et al. Efficacy and tolerability of vardenafil in men with mild depression and erectile dysfunction: the depression-related improvement with vardenafil for erectile response study. Am J Psychiatry 2006 Jan; 163 (1): 79-87
    • (2006) Am J Psychiatry , vol.163 , Issue.1 , pp. 79-87
    • Rosen, R.1    Shabsigh, R.2    Berber, M.3
  • 11
    • 84995315685 scopus 로고    scopus 로고
    • Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction
    • Mar
    • Stief C, Porst H, Saenz De Tejada I, et al. Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction. Int J Clin Pract 2004 Mar; 58 (3): 230-9
    • (2004) Int J Clin Pract , vol.58 , Issue.3 , pp. 230-239
    • Stief, C.1    Porst, H.2    Saenz De Tejada, I.3
  • 12
    • 84974716235 scopus 로고    scopus 로고
    • Comparison of pharmacokinetics of vardenafil administered using an ultrasonic nebulizer for inhalation vs. A single 10-mg oral tablet
    • Jul 28
    • Berry B, Altman P, Rowe J, et al. Comparison of pharmacokinetics of vardenafil administered using an ultrasonic nebulizer for inhalation vs. a single 10-mg oral tablet. J Sex Med. Epub 2009 Jul 28
    • (2009) J Sex Med. Epub
    • Berry, B.1    Altman, P.2    Rowe, J.3
  • 13
    • 3343005292 scopus 로고    scopus 로고
    • Vardenafil preclinical trial data: Potency, pharmacodynamics, pharmacokinetics, and adverse events
    • Jun
    • Bischoff E. Vardenafil preclinical trial data: potency, pharmacodynamics, pharmacokinetics, and adverse events. Int J Impot Res 2004 Jun; 16 Suppl. 1: S34-7
    • (2004) Int J Impot Res , vol.16 , Issue.SUPPL. 1
    • Bischoff, E.1
  • 15
    • 0003979209 scopus 로고    scopus 로고
    • Bayer Schering, Apr 7
    • Data on file, Bayer Schering, Apr 7, 2008
    • (2008) Data on File
  • 16
    • 0003979209 scopus 로고    scopus 로고
    • Bayer Schering, May 28
    • Data on file, Bayer Schering, May 28, 2009
    • (2009) Data on File
  • 17
    • 77955254138 scopus 로고    scopus 로고
    • The POTENT i randomized trial: Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction
    • Mar 3
    • Sperling H, Debruyne F, Boermans A, et al. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med 2010 Mar 3; 7 (4 Pt 1): 1497-507
    • (2010) J Sex Med , vol.7 , Issue.4 PART 1 , pp. 1497-1507
    • Sperling, H.1    Debruyne, F.2    Boermans, A.3
  • 18
    • 0242350785 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research (CDER), [online]. Available from URL, [Accessed 2010 Feb 2]
    • Center for Drug Evaluation and Research (CDER). Guidance for industry: food-effect bioavailability and fed bioequivalence studies, 2002 [online]. Available from URL:http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf [Accessed 2010 Feb 2]
    • (2002) Guidance for Industry: Food-effect Bioavailability and Fed Bioequivalence Studies
  • 19
    • 84942949401 scopus 로고
    • Impotence: NIH consensus development panel on impotence
    • NIH Consensus Conference, Jul 7
    • NIH Consensus Conference. Impotence: NIH consensus development panel on impotence. JAMA 1993 Jul 7; 270 (1): 83-90
    • (1993) JAMA , vol.270 , Issue.1 , pp. 83-90
  • 20
    • 0003484310 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research (CDER), [online]. Available from URL, [Accessed 2010 Feb 2]
    • Center for Drug Evaluation and Research (CDER). Guidance for industry: bioanalytical method validation, 2001 [online]. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM070107.pdf [Accessed 2010 Feb 2]
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 21
    • 0003979209 scopus 로고    scopus 로고
    • Bayer Schering, May 23
    • Data on file, Bayer Schering, May 23, 2000
    • (2000) Data on File
  • 22
    • 0003979209 scopus 로고    scopus 로고
    • Bayer Schering, Jun 20
    • Data on file, Bayer Schering, Jun 20, 2001
    • (2001) Data on File
  • 23
  • 24
    • 78149364832 scopus 로고    scopus 로고
    • United States Pharmacopeia. USP 28, [online]. Available from URL, [Accessed 2010 Sep 19]
    • United States Pharmacopeia. USP 28 physical tests <701> disintegration [online]. Available from URL: http://www.usp.org/pdf/EN/USPNF/ chapter701.pdf [Accessed 2010 Sep 19]
    • Physical Tests <701> Disintegration
  • 25
    • 0028489710 scopus 로고
    • Flow rates of resting whole and stimulated parotid saliva in relation to age and gender
    • Aug
    • Percival RS, Challacombe SJ, Marsh PD. Flow rates of resting whole and stimulated parotid saliva in relation to age and gender. J Dent Res 1994 Aug; 73 (8): 1416-20
    • (1994) J Dent Res , vol.73 , Issue.8 , pp. 1416-1420
    • Percival, R.S.1    Challacombe, S.J.2    Marsh, P.D.3
  • 26
    • 77949382405 scopus 로고    scopus 로고
    • The POTENT II randomised trial: Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction
    • Gittelman M, McMahon CG, Rodríguez-Rivera JA, et al. The POTENT II randomised trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. Int J Clin Pract 2010; 64 (5): 594-603
    • (2010) Int J Clin Pract , vol.64 , Issue.5 , pp. 594-603
    • Gittelman, M.1    McMahon, C.G.2    Rodríguez-Rivera, J.A.3
  • 27
    • 20144365253 scopus 로고    scopus 로고
    • Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification
    • Nov
    • Donatucci C, Eardley I, Buvat J, et al. Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification. J SexMed 2004 Nov; 1 (3): 301-9
    • (2004) J SexMed , vol.1 , Issue.3 , pp. 301-309
    • Donatucci, C.1    Eardley, I.2    Buvat, J.3
  • 28
    • 0037378435 scopus 로고    scopus 로고
    • Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: Results of a randomized, double-blind, 26-week placebo-controlled pivotal trial
    • Apr
    • Hellstrom WJ, Gittelman M, Karlin G, et al. Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week placebo-controlled pivotal trial. Urology 2003 Apr; 61 (4 Suppl. 1): 8-14
    • (2003) Urology , vol.61 , Issue.4 SUPPL. 1 , pp. 8-14
    • Hellstrom, W.J.1    Gittelman, M.2    Karlin, G.3
  • 29
    • 0037370684 scopus 로고    scopus 로고
    • Effect of high-fat breakfast and moderate-fat evening meal on the pharmacokinetics of vardenafil, an oral phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction
    • Mar
    • Rajagopalan P, Mazzu A, Xia C, et al. Effect of high-fat breakfast and moderate-fat evening meal on the pharmacokinetics of vardenafil, an oral phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction. J Clin Pharmacol 2003 Mar; 43 (3): 260-7
    • (2003) J Clin Pharmacol , vol.43 , Issue.3 , pp. 260-267
    • Rajagopalan, P.1    Mazzu, A.2    Xia, C.3
  • 30
    • 34247876061 scopus 로고    scopus 로고
    • The role of pharmacokinetics and pharmacodynamics in phosphodiesterase-5 inhibitor therapy
    • May-Jun
    • Mehrotra N, Gupta M, Kovar A, et al. The role of pharmacokinetics and pharmacodynamics in phosphodiesterase-5 inhibitor therapy. Int J Impot Res 2007 May-Jun; 19 (3): 253-64
    • (2007) Int J Impot Res , vol.19 , Issue.3 , pp. 253-264
    • Mehrotra, N.1    Gupta, M.2    Kovar, A.3
  • 31
    • 70149103802 scopus 로고    scopus 로고
    • Pharmacokinetics and drug metabolism in the elderly
    • Klotz U. Pharmacokinetics and drug metabolism in the elderly. Drug Metab Rev 2009; 41 (2): 67-76
    • (2009) Drug Metab Rev , vol.41 , Issue.2 , pp. 67-76
    • Klotz, U.1
  • 32
    • 79960362605 scopus 로고    scopus 로고
    • Patient preference and satisfaction in erectile dysfunction therapy: A comparison of the three phosphodiesterase-5 inhibitors sildenafil, vardenafil and tadalafil
    • Raheem AA, Kell P. Patient preference and satisfaction in erectile dysfunction therapy: a comparison of the three phosphodiesterase-5 inhibitors sildenafil, vardenafil and tadalafil. Patient Prefer Adherence 2009; 3: 99-104
    • (2009) Patient Prefer Adherence , vol.3 , pp. 99-104
    • Raheem, A.A.1    Kell, P.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.