Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension

• Published in: International journal of clinical practice (Esher) Vol. 61; no. 11; pp. 1843 - 1849
• Main Authors: McVary, K. T., Kaufman, J., Young, J. M., Tseng, L.-J.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.11.2007; Blackwell; Hindawi Limited
• Subjects: Aged; Biological and medical sciences; Clinical outcomes; Clinical trials; Double-Blind Method; Drug therapy; Erectile Dysfunction - complications; Erectile Dysfunction - drug therapy; General aspects; Humans; Male; Medical disorders; Medical sciences; Mens health; Middle Aged; Patient Satisfaction; Phosphodiesterase Inhibitors - adverse effects; Phosphodiesterase Inhibitors - therapeutic use; Piperazines - adverse effects; Piperazines - therapeutic use; Prostate; Prostatic Hyperplasia - complications; Prostatism - complications; Prostatism - drug therapy; Purines - adverse effects; Purines - therapeutic use; Quality of Life; Self Concept; Sexual disorders; Sildenafil Citrate; Sulfones - adverse effects; Sulfones - therapeutic use; Surveys and Questionnaires; Treatment Outcome; Drug; Vasodilator agent; 3',5'-Cyclic-GMP phosphodiesterase; Enzyme; Enzyme inhibitor; Citrate; Esterases; Phosphoric diester hydrolases; Medicine; Improvement; Randomization; Double blind study; Hydrolases; Clinical trial; Sildenafil
• ISSN: 1368-5031; 1742-1241
• DOI: 10.1111/j.1742-1241.2007.01585.x

Summary Aims:  To evaluate once‐daily 100‐mg sildenafil for the treatment of erectile dysfunction (ED) in men with ED and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Methods:  This was a 12‐week, randomised, double‐blind, placebo‐controlled (DBPC) trial, with an 8‐week open‐label (OL) extension, in men ≥ 45 years of age who scored ≤ 25 on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and ≥ 12 on the International Prostate Symptom Score. Results:  At DBPC end of treatment (EOT), the sildenafil group (n = 189, vs. placebo, n = 180) had improved EF (IIEF), improved emotional well‐being [Self‐Esteem And Relationship questionnaire (SEAR)], and greater treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction) (p < 0.0001). At OL EOT, IIEF and SEAR scores improved slightly in the group previously randomised to sildenafil (n = 168), but much more in the group previously randomised to placebo (N = 155), such that total improvement over the 20‐week trial was comparable between the groups. Erections at baseline were hard enough for penetration on approximately half of occasions and lasted long enough for successful intercourse on less than one quarter of occasions, increasing at sildenafil DBPC and OL EOT to approximately 90% (penetration) and 80% (intercourse success) vs. 61% (penetration) and 39% (intercourse success) for DBPC placebo. At sildenafil DBPC and OL EOT, ≥ 90% of men were taking sildenafil 100 mg. Sildenafil was generally well tolerated. Conclusions:  In this trial of men with ED and BPH‐associated LUTS, sildenafil treatment for ED was efficacious, effective and generally well tolerated.