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An open-label, multicentre, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in men naïve to phosphodiesterase 5 inhibitor therapy.
BJU Int. 2005 Dec; 96(9):1323-32.BI

Abstract

OBJECTIVES

To compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in men naïve to phosphodiesterase 5 (PDE5) inhibitor therapy.

PATIENTS AND METHODS

This was an open-label, crossover study of sildenafil and tadalafil (taken as needed). After a 4-week baseline assessment, 367 men with ED (mean age 54 years) were randomized to receive sildenafil for 12 weeks followed by tadalafil for 12 weeks or vice versa (8-week dose optimization and 4-week assessment phases). During dose optimization, patients started taking 25- or 50-mg sildenafil or 10-mg tadalafil and could titrate to find their optimum dose (25-, 50- or 100-mg sildenafil; 10- or 20-mg tadalafil). After completing both 12-week periods, patients chose which treatment to continue during an 8-week extension. Efficacy was measured with the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) diary.

RESULTS

Of the 291 men who completed both treatments, 85 (29%) chose sildenafil and 206 (71%) chose tadalafil (P < 0.001) for the 8-week extension. The IIEF erectile function domain scores were 14.2 at baseline, 23.9 at endpoint on sildenafil, and 24.3 at endpoint on tadalafil (P = 0.08, sildenafil vs tadalafil). The mean per patient percentage success scores for SEP2 (penetration) were: baseline (46%), sildenafil (post-baseline 82%) and tadalafil (post-baseline 85%; P = 0.06, sildenafil vs tadalafil), and for SEP3 (successful intercourse) were: baseline (19%), sildenafil (post-baseline 72%), and tadalafil (post-baseline 77%; P = 0.003, sildenafil vs tadalafil). The only treatment-emergent adverse events that were reported by >5% of men were headache and flushing.

CONCLUSIONS

In men with ED who were naïve to PDE5 inhibitor therapy, sildenafil and tadalafil were both effective and well tolerated. After treatment with sildenafil and tadalafil, 29% of men chose sildenafil and 71% chose tadalafil for ED therapy during an 8-week extension.

Authors+Show Affiliations

St. James University Hospital, Pyrah Department of Urology, Leeds, UK. ian.eardley@btinternet.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16287454

Citation

Eardley, Ian, et al. "An Open-label, Multicentre, Randomized, Crossover Study Comparing Sildenafil Citrate and Tadalafil for Treating Erectile Dysfunction in Men Naïve to Phosphodiesterase 5 Inhibitor Therapy." BJU International, vol. 96, no. 9, 2005, pp. 1323-32.
Eardley I, Mirone V, Montorsi F, et al. An open-label, multicentre, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in men naïve to phosphodiesterase 5 inhibitor therapy. BJU Int. 2005;96(9):1323-32.
Eardley, I., Mirone, V., Montorsi, F., Ralph, D., Kell, P., Warner, M. R., Zhao, Y., & Beardsworth, A. (2005). An open-label, multicentre, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in men naïve to phosphodiesterase 5 inhibitor therapy. BJU International, 96(9), 1323-32.
Eardley I, et al. An Open-label, Multicentre, Randomized, Crossover Study Comparing Sildenafil Citrate and Tadalafil for Treating Erectile Dysfunction in Men Naïve to Phosphodiesterase 5 Inhibitor Therapy. BJU Int. 2005;96(9):1323-32. PubMed PMID: 16287454.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label, multicentre, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in men naïve to phosphodiesterase 5 inhibitor therapy. AU - Eardley,Ian, AU - Mirone,Vincenzo, AU - Montorsi,Francesco, AU - Ralph,David, AU - Kell,Philip, AU - Warner,Margaret R, AU - Zhao,Yanli, AU - Beardsworth,Anthony, PY - 2005/11/17/pubmed PY - 2005/12/24/medline PY - 2005/11/17/entrez SP - 1323 EP - 32 JF - BJU international JO - BJU Int. VL - 96 IS - 9 N2 - OBJECTIVES: To compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in men naïve to phosphodiesterase 5 (PDE5) inhibitor therapy. PATIENTS AND METHODS: This was an open-label, crossover study of sildenafil and tadalafil (taken as needed). After a 4-week baseline assessment, 367 men with ED (mean age 54 years) were randomized to receive sildenafil for 12 weeks followed by tadalafil for 12 weeks or vice versa (8-week dose optimization and 4-week assessment phases). During dose optimization, patients started taking 25- or 50-mg sildenafil or 10-mg tadalafil and could titrate to find their optimum dose (25-, 50- or 100-mg sildenafil; 10- or 20-mg tadalafil). After completing both 12-week periods, patients chose which treatment to continue during an 8-week extension. Efficacy was measured with the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP) diary. RESULTS: Of the 291 men who completed both treatments, 85 (29%) chose sildenafil and 206 (71%) chose tadalafil (P < 0.001) for the 8-week extension. The IIEF erectile function domain scores were 14.2 at baseline, 23.9 at endpoint on sildenafil, and 24.3 at endpoint on tadalafil (P = 0.08, sildenafil vs tadalafil). The mean per patient percentage success scores for SEP2 (penetration) were: baseline (46%), sildenafil (post-baseline 82%) and tadalafil (post-baseline 85%; P = 0.06, sildenafil vs tadalafil), and for SEP3 (successful intercourse) were: baseline (19%), sildenafil (post-baseline 72%), and tadalafil (post-baseline 77%; P = 0.003, sildenafil vs tadalafil). The only treatment-emergent adverse events that were reported by >5% of men were headache and flushing. CONCLUSIONS: In men with ED who were naïve to PDE5 inhibitor therapy, sildenafil and tadalafil were both effective and well tolerated. After treatment with sildenafil and tadalafil, 29% of men chose sildenafil and 71% chose tadalafil for ED therapy during an 8-week extension. SN - 1464-4096 UR - https://www.unboundmedicine.com/medline/citation/16287454/An_open_label_multicentre_randomized_crossover_study_comparing_sildenafil_citrate_and_tadalafil_for_treating_erectile_dysfunction_in_men_naïve_to_phosphodiesterase_5_inhibitor_therapy_ L2 - https://doi.org/10.1111/j.1464-410X.2005.05892.x DB - PRIME DP - Unbound Medicine ER -