Time of onset of vardenafil orodispersible tablet in a real-life setting – looking beyond randomized clinical trials

References

• Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151:54–61.
   PubMed Web of Science ®Google Scholar
• Shabsigh R, Perelman MA, Lockhart DC, et al. Health issues of men: prevalence and correlates of erectile dysfunction. J Urol. 2005;174:662–667.
   PubMed Web of Science ®Google Scholar
• Mirone V, Fusco F, Rossi A, et al. Tadalafil and vardenafil vs sildenafil: a review of patient-preference studies BJU Int. 2009; 103:1212–1217.
   Google Scholar
• Capogrosso P, Colicchia M, Ventimiglia E, et al. One patient out of four with newly diagnosed erectile dysfunction is a young man—worrisome picture from the everyday clinical practice. J Sex Med. 2013;10:1833–1841.
   PubMed Web of Science ®Google Scholar
• Nicolosi A, Laumann EO, Glasser DB, et al. Global study of sexual attitudes and behaviors investigators’ group. Sexual behavior and sexual dysfunctions after age 40: the global study of sexual attitudes and behaviors. Urology. 2004;64:991–997.
   PubMed Web of Science ®Google Scholar
• Scranton RE, Goldstein I, Stecher VJ. Erectile dysfunction diagnosis and treatment as a means to improve medication adherence and optimize comorbidity management. J Sex Med. 2013;10:551–561.
   PubMed Web of Science ®Google Scholar
• Gandaglia G, Briganti A, Jackson G, et al. A systematic review of the association between erectile dysfunction and cardiovascular disease. Eur Urol. 2014;65:968–978.
   PubMed Web of Science ®Google Scholar
• Schmidt HM, Munder T, Gerger H, et al. Combination of psychological intervention and phosphodiesterase-5 inhibitors for erectile dysfunction: a narrative review and meta-analysis. J Sex Med. 2014;11:1376–1391.
   PubMed Web of Science ®Google Scholar
• Porst H, Burnett A, Brock G, et al. ISSM Standards Committee for Sexual Medicine. SOP conservative (medical and mechanical) treatment of erectile dysfunction. J Sex Med. 2013;10:130–171.
   PubMed Web of Science ®Google Scholar
• Pascoal PM, Narciso Ide S, Pereira NM. What is sexual satisfaction? Thematic analysis of lay people’s definitions. J Sex Res. 2014;51:22–30.
   PubMed Web of Science ®Google Scholar
• Frederick LR, Cakir OO, Arora H, et al. Undertreatment of erectile dysfunction: claims analysis of 6.2 million patients. J Sex Med. 2014;11:2546–2553.
   PubMed Web of Science ®Google Scholar
• Yuan J, Zhang R, Yang Z, et al. Comparative effectiveness and safety of oral phosphodiesterasetype 5 inhibitors for erectile dysfunction: a systematic review and network meta-analysis. Eur Urol. 2013;63:902–912.
   PubMed Web of Science ®Google Scholar
• Hatzimouratidis K, Salonia A, Adaikan G, et al. Pharmacotherapy for erectile dysfunction: recommendations from the fourth international consultation for sexual medicine (ICSM 2015). J Sex Med. 2016;13:465–488.
   PubMed Web of Science ®Google Scholar
• Hedelin H, Ströberg P. Treatment for erectile dysfunction based on patient reported outcomes: to every man the PDE5 inhibitor that he finds superior. Drugs. 2005;65:2245–2251.
   PubMed Web of Science ®Google Scholar
• Corona G, Rastrelli G, Burri A, et al.First-generation phosphodiesterase type 5 inhibitors dropout: a comprehensive review and meta-analysis. Andrology. 2016;4:1002–1009.
   PubMedGoogle Scholar
• Axilrod AC. Phosphodiesterase type 5 inhibitor therapy: identifying and exploring what attributes matter more to clinicians and patients in the management of erectile dysfunction. Curr Med Res Opin. 2007;23:3189–3198.
   PubMed Web of Science ®Google Scholar
• Debruyne FM, Gittelman M, Sperling H, et al. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011;8:2912–2923.
   PubMed Web of Science ®Google Scholar
• Martin-Morales A, Gutiérrez-Hernández P, Romero-Otero J, et al. Vadeopen Study Group. Duration of erection: does it really matter? A randomized, double-blind clinical trial to assess the impact of vardenafil ODT on duration of erection and its correlation with patients’ and partners’ sexual quality of life and duration of intercourse: the VADEOPEN study. J Sex Med. 2014;11:1527–1538.
   PubMed Web of Science ®Google Scholar
• Saturni S, Bellini F, Braido F, et al. Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view. Pulmonary Pharmacoloy & Threpeutics. 2014;27:129–138.
   PubMed Web of Science ®Google Scholar
• NIH Consensus Development. Panel on impotence. JAMA. 1993;270:83–90.
   PubMedGoogle Scholar
• Charlson ME, Pompei P, Ales KL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373–383.
   PubMedGoogle Scholar
• Cappelleri JC, Rosen RC, Smith MD, et al. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology. 1999;54:346–351.
   PubMed Web of Science ®Google Scholar
• 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;64:594–603.
   PubMed Web of Science ®Google Scholar
• 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;7:1497–1507.
   PubMed Web of Science ®Google Scholar
• Rosen RC, Allen KR, Ni X, et al. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011;60:1010–1016.
   PubMed Web of Science ®Google Scholar
• Yang M, Ni X, Sontag A, et al. Nonresponders, partial responders, and complete responders to PDE5 inhibitors therapy according to IIEF criteria: validation of an anchor-based treatment responder classification. J Sex Med. 2013;10:3029–3037.
   PubMed Web of Science ®Google Scholar
• Heinig R, Weimann B, Dietrich H, et al. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31:27–41.
   PubMed Web of Science ®Google Scholar
• Limin M, Johnsen N, Hellstrom WJ. Avanafil, a new rapid -onset phosphodiesterase 5 inhibitor for the treatment of erectile dysfunction. Expert Opin Investig Drugs. 2010;19:1427–1437.
   PubMed Web of Science ®Google Scholar
• Padma-Nathan H, Stecher VJ, Sweeney M, et al. Minimal time to successful intercourse after sildenafil citrate: results of a randomized, double-blind, placebo-controlled trial. Urology. 2003;62:400–403.
   PubMed Web of Science ®Google Scholar
• Shabsigh R, Seftel AD, Rosen RC, et al. Review of time of onset and duration of clinical efficacy of phosphodiesterase type 5 inhibitors in treatment of erectile dysfunction. Urology. 2006;68:689–696.
   PubMed Web of Science ®Google Scholar
• Sanford M. Vardenafil orodispersible tablet. Drugs. 2012;72:87–98. Eur Urol; 63. 902-12.
   PubMed Web of Science ®Google Scholar
• Corona G, Isidori AM, Buvat J, et al. Testosterone supplementation and sexual function: a meta-analysis study. J Sex Med. 2014 Jun;11(6):1577–1592.
   PubMed Web of Science ®Google Scholar
• Salonia A, Castagna G, Sacca A, et al. Is erectile dysfunction a reliable proxy of general male health status? The case for the International Index of Erectile Function-Erectile Function domain. J Sex Med. 2012;9:2708–2715.
   PubMed Web of Science ®Google Scholar