The ENDOTRIAL Study: A spontaneous, open-label, randomized, multicenter, crossover study on the efficacy of sildenafil, tadalafil, and vardenafil in the treatment of erectile dysfunction

Journal of Sexual Medicine

Volumn 6, Issue 9, 2009, Pages 2547-2560

  Jannini, Emmanuele A ^a   Isidori, Andrea M ^b   Gravina, Giovanni Luca ^a   Aversa, Antonio ^b   Balercia, Giancarlo ^c   Bocchio, Massimo ^a   Boscaro, Marco ^c   Carani, Cesare ^d   Corona, Giovanni ^e,f   Fabbri, Andrea ^g   Foresta, Carlo ^h   Forti, Gianni ^f   Francavilla, Sandro ^a   Granata, Antonio R M ^d   Maggi, Mario ^f   Mansani, Riccardo ^f   Palego, Pierfrancesco ^h   Spera, Giovanni ^b   Vetri, Mario ⁱ   Lenzi, Andrea ^b   Carosa, Eleonora ^a   Di Tommaso, Silvia ^a   Bruzziches, Roberto ^b   Francomano, Davide ^b   Gianfrilli, Daniele ^b   Pozza, Carlotta ^b   Giannetta, Elisa ^b   Selice, Riccardo ^h   Caretta, Nicola ^h   Paggi, Francesca ^c   Buldreghini, Eddi ^c   Magini, Angela ^f   Krausz, Csilla ^f   Caprio, Massimiliano ^g   De Martino, Massimo Ulderico ^g   Falcone, Stefania ^g   Ruggiero, Alessandra ^g   Guidi, Alessandro ^d   De Mola, Giovanni ^d   Pugni, Valeria ^d   more..

^a UNIVERSITY OF L'AQUILA   (Italy)

^b SAPIENZA UNIVERSITY OF ROME   (Italy)

^c UNIVERSITÀ POLITECNICA DELLE MARCHE   (Italy)

^d UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^e BELLARIA HOSPITAL   (Italy)

^f UNIVERSITY OF FLORENCE   (Italy)

^g UNIVERSITY OF ROME TOR VERGATA   (Italy)

^h UNIVERSITY OF PADOVA   (Italy)

ⁱ Garibaldi Nesima Hospital   (Italy)

Author keywords

Doppler; Erectile Dysfunction; PDE5; Sildenafil; Tadalafil; Vardenafil

Indexed keywords

PHOSPHODIESTERASE V; SILDENAFIL; TADALAFIL; VARDENAFIL; CARBOLINE DERIVATIVE; IMIDAZOLE DERIVATIVE; PHOSPHODIESTERASE INHIBITOR; PIPERAZINE DERIVATIVE; PURINE DERIVATIVE; SULFONE; TRIAZINE DERIVATIVE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIABETES MELLITUS; DIASTOLE; DISEASE SEVERITY; DRUG EFFICACY; DYSLIPIDEMIA; ERECTILE DYSFUNCTION; HEMODYNAMICS; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SYSTOLE; VELOCITY; ANALYSIS OF VARIANCE; CONFIDENCE INTERVAL; HEALTH SURVEY; IMPOTENCE, VASCULOGENIC; MIDDLE AGED; RISK; STATISTICS; TIME;

ANALYSIS OF VARIANCE; CARBOLINES; CONFIDENCE INTERVALS; CROSS-OVER STUDIES; HEALTH SURVEYS; HUMANS; IMIDAZOLES; IMPOTENCE, VASCULOGENIC; MALE; MIDDLE AGED; PHOSPHODIESTERASE INHIBITORS; PIPERAZINES; PURINES; RISK; STATISTICS AS TOPIC; SULFONES; TIME FACTORS; TRIAZINES;

EID: 69949089081     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2009.01375.x     Document Type: Article

References (51)

1. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study group. N Engl J Med 1998;338:1397-404.
2. Jannini EA, Lenzi A, Wagner G. New perspectives in the pharmacotherapy of erectile dysfunction. IDrugs 2003;6:1165-72.
3. Carosa E, Martini P, Brandetti F, Di Stasi SM, Lombardo F, Lenzi A, Jannini EA. Type V phosphodiesterase inhibitor treatments for erectile dysfunction increase testosterone levels. Clin Endocrinol (Oxf) 2004;61:382-6.
4. Lowy M, Collins S, Bloch M, Gillman M, Lording D, Sutherland P, Wang H, Stecher V. Quality of erection questionnaire correlates: Change in erection quality with erectile function, hardness, and psychosocial measures in men treated with sildenafil for erectile dysfunction. J Sex Med 2007;4:83-92.
5. Goldstein I, Mulhall JP, Bushmakin AG, Cappelleri JC, Hvidsten K, Symonds T. The erection hardness score and its relationship to successful sexual intercourse. J Sex Med 2008;5:2374-80.
6. Althof SE, O'Leary MP, Cappelleri JC, Crowley AR, Tseng LJ, Collins S. Impact of erectile dysfunction on confidence, self-esteem and relationship satisfaction after 9 months of sildenafil citrate treatment. J Urol 2006;176:2132-7.
7. Rosen R, Goldstein I, Huang XY, Bangerter K, Taylor T. The Treatment Satisfaction Scale (TSS) is a sensitive measure of treatment effectiveness for both patients and partners: Results of a randomized controlled trial with vardenafil. J Sex Med 2007;4(4 Pt 1):1009-21.
8. Kell PD, Hvidsten K, Morant SV, Harnett JP, Bridge S. Factors that predict changing the type of phosphodiesterase type 5 inhibitor medication among men in the UK. BJU Int 2007;99:860-3.
9. Fisher WA, Rosen RC, Mollen M, Brock G, Karlin G, Pommerville P, Goldstein I, Bangerter K, Bandel TJ, Derogatis LR, Sand M. 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;2:699-708.
10. Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. 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 1999;11:319-26.
11. Petrone L, Mannucci E, Corona G, Bartolini M, Forti G, Giommi R, Maggi M. Structured interview on erectile dysfunction (SIEDY): A new, multidimensional instrument for quantification of pathogenetic issues on erectile dysfunction. Int J Impot Res 2003;15:210-20.
12. Aversa A, Sarteschi LM. The role of penile color-duplex ultrasound for the evaluation of erectile dysfunction. J Sex Med 2007;4:1437-47.
13. NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA 1993;270:83-90.
14. Aversa A, Isidori AM, Caprio M, Cerilli M, Frajese V, Fabbri A. Penile pharmacotesting in diagnosing male erectile dysfunction: Evidence for lack of accuracy and specificity. Int J Androl 2002;25:6-10.
15. Aversa A, Isidori AM, Spera G, Lenzi A, Fabbri A. Androgens improve cavernous vasodilation and response to sildenafil in patients with erectile dysfunction. Clin Endocrinol (Oxf) 2003;58:632-8.
16. Aversa A, Greco E, Bruzziches R, Pili M, Rosano G, Spera G. Relationship between chronic tadalafil administration and improvement of endothelial function in men with erectile dysfunction: A pilot study. Int J Impot Res 2007;19:200-7.
17. Brock G, Carrier S, Alarie P, Pommerville P, Casey R, Harris S, Ward R. The effect of physician and patient education when combined with vardenafil treatment in Canadian males with erectile dysfunction: An open-label, factorial-designed, cluster-randomized clinical trial. J Sex Med 2008;5:705-15.
18. Miner M, Gilderman L, Bailen J, Cook D, Dawson K, Stanislaus M, Beresford E, Barnes A. Vardenafil in men with stable statin therapy and dyslipidemia. J Sex Med 2008;5:1455-67.
19. Doggrell SA. Comparison of clinical trials with sildenafil, vardenafil and tadalafil in erectile dysfunction. Expert Opin Pharmacother 2005;6:75-84.
20. Moore RA, Derry S, McQuay HJ. Indirect comparison of interventions using published randomised trials: Systematic review of PDE-5 inhibitors for erectile dysfunction. BMC Urol 2005;5:18.
21. Berner MM, Kriston L, Harms A. Efficacy of PDE-5-inhibitors for erectile dysfunction. A comparative meta-analysis of fixed-dose regimen randomized controlled trials administering the International Index of Erectile Function in broad-spectrum populations. Int J Impot Res 2006;18:229-35.
22. Rubio-Aurioles E, Porst H, Eardley I, Goldstein I. Comparing vardenafil and sildenafil in the treatment of men with erectile dysfunction and risk factors for cardiovascular disease: A randomized, double-blind, pooled crossover study. J Sex Med 2006;3:1037-49.
23. Traish A, Kim N. Is vardenafil "noninferior" or superior to sildenafil in the management of erectile dysfunction? Revisiting the biochemical, physiological, and clinical evidence. J Sex Med 2008;5:1762-8; discussion 1768-9.
24. Tolra JR, Campana JM, Ciutat LF, Miranda EF. Prospective, randomized, open-label, fixed-dose, crossover study to establish preference of patients with erectile dysfunction after taking the three PDE-5 inhibitors. J Sex Med 2006;3:901-9.
25. Ahn TY, Lee SW, Kim SW, Yang DY, Park NC, Min KS, Park K, Paick JS, Dyachkova Y, Dwight T, Lee MS. Treatment preferences in men with erectile dysfunction: An open label study in Korean men switching from sildenafil citrate to tadalafil. Asian J Androl 2007;9:760-70.
26. Brock G, Chan J, Carrier S, Chan M, Salgado L, Klein AH, Lang C, Horner R, Gutkin S, Dickson R. The treatment of erectile dysfunction study: Focus on treatment satisfaction of patients and partners. BJU Int 2007;99:376-82.
27. Eardley I, Montorsi F, Jackson G, Mirone V, Chan ML, Loughney K, Vail GM, Beardsworth A. Factors associated with preference for sildenafil citrate and tadalafil for treating erectile dysfunction in men naive to phosphodiesterase 5 inhibitor therapy: Post hoc analysis of data from a multicentre, randomized, open-label, crossover study. BJU Int 2007;100:122-9.
28. Conaglen HM, Conaglen JV. Investigating women's preference for sildenafil or tadalafil use by their partners with erectile dysfunction: The partners' preference study. J Sex Med 2008;5:1198-207.
29. Martin-Morales A, Haro JM, Beardsworth A, Bertsch J, Kontodimas S. Therapeutic effectiveness and patient satisfaction after 6 months of treatment with tadalafil, sildenafil, and vardenafil: Results from the erectile dysfunction observational study (EDOS). Eur Urol 2007;51:541-50; discussion 550.
30. Hedelin H, Stroberg P. Treatment for erectile dysfunction based on patient-reported outcomes: To every man the PDE5 inhibitor that he finds superior. Drugs 2005;65:2245-51.
31. Fabbri A, Aversa A. The therapeutic dilemma: How to use short-acting PDE5 inhibitor drugs. Int J Androl 2005;28(suppl 2):69-73.
32. Carosa E, Lombardo F, Martini P, Brandetti F, Jannini EA. The therapeutic dilemma: How to use tadalafil. Int J Androl 2005;28(suppl 2):74-80.
33. Doggrell S. Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction? Int J Impot Res 2007;19:281-95.
34. Mulhall JP, Montorsi F. Evaluating preference trials of oral phosphodiesterase 5 inhibitors for erectile dysfunction. Eur Urol 2006;49:30-7.
35. Stroberg P, Hedelin H, Ljunggren C. Prescribing all phosphodiesterase 5 inhibitors to a patient with erectile dysfunction - A realistic and feasible option in everyday clinical practice - Outcomes of a simple treatment regime. Eur Urol 2006;49:900-7; discussion 907.
36. Ljunggren C, Hedelin H, Salomonsson K, Stroberg P. Giving patients with erectile dysfunction the opportunity to try all three available phosphodiesterase type 5 inhibitors contributes to better long-term treatment compliance. J Sex Med 2008;5:469-75.
37. Corona G, Jannini EA, Maggi M. Inventories for male and female sexual dysfunctions. Int J Impot Res 2006;18:236-50.
38. Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology 1997;49:822-30.
39. Caretta N, Palego P, Ferlin A, Garolla A, Bettella A, Selice R, Foresta C. Resumption of spontaneous erections in selected patients affected by erectile dysfunction and various degrees of carotid wall alteration: Role of tadalafil. Eur Urol 2005;48:326-31; discussion 331-2.
40. Reffelmann T, Kloner RA. Cardiovascular effects of phosphodiesterase 5 inhibitors. Curr Pharm Des 2006;12:3485-94.
41. Ghofrani HA, Wiedemann R, Rose F, Schermuly RT, Olschewski H, Weissmann N, Gunther A, Walmrath D, Seeger W, Grimminger F. Sildenafil for treatment of lung fibrosis and pulmonary hypertension: A randomised controlled trial. Lancet 2002;360:895-900.
42. Kukreja RC, Ockaili R, Salloum F, Yin C, Hawkins J, Das A, Xi L. Cardioprotection with phosphodiesterase-5 inhibition - A novel preconditioning strategy. J Mol Cell Cardiol 2004;36:165-73.
43. Ghofrani HA, Voswinckel R, Reichenberger F, Olschewski H, Haredza P, Karadas B, Schermuly RT, Weissmann N, Seeger W, Grimminger F. Differences in hemodynamic and oxygenation responses to three different phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension: A randomized prospective study. J Am Coll Cardiol 2004;44:1488-96.
44. Aversa A, Vitale C, Volterrani M, Fabbri A, Spera G, Fini M, Rosano GM. Chronic administration of sildenafil improves markers of endothelial function in men with type 2 diabetes. Diabet Med 2008;25:37-44.
45. Burnett AL, Strong TD, Trock BJ, Jin L, Bivalacqua TJ, Musicki B. Serum biomarker measurements of endothelial function and oxidative stress after daily dosing of sildenafil in type 2 diabetic men with erectile dysfunction. J Urol 2009;181:245-51.
46. Morano S, Mandosi E, Fallarino M, Gatti A, Tiberti C, Sensi M, Gandini L, Buchetti B, Lenti L, Jannini EA, Lenzi A. Antioxidant treatment associated with sildenafil reduces monocyte activation and markers of endothelial damage in patients with diabetic erectile dysfunction: A double-blind, placebo-controlled study. Eur Urol 2007;52:1768-74.
47. Broderick GA. Non-invasive vascular imaging for erectile dysfunction. In: Carson CC, Kirby RS, Goldstein I, eds. Texbook of erectile dysfunction. Oxford: Isis Medical Media; 1999:233-56.
48. Lue TF. Impotence: A patient goal-directed approach to treatment. World J Urol 1990;8:67-74.
49. Burnett AL. Erectile dysfunction. J Urol 2006;175(3 Pt 2):S25-31.
50. Deveci S, O'Brien K, Ahmed A, Parker M, Guhring P, Mulhall JP. Can the International Index of Erectile Function distinguish between organic and psychogenic erectile function? BJU Int 2008;102:354-6.
51. Porst H, Rajfer J, Casabe A, Feldman R, Ralph D, Vieiralves LF, Esler A, Wolka AM, Klise SR. Long-term safety and efficacy of tadalafil 5mg dosed once daily in men with erectile dysfunction. J Sex Med 2008;5:2160-9.