Sildenafil Citrate 100 mg Starting Dose in Men with Erectile Dysfunction in an International, Double-Blind, Placebo-Controlled Study: Effect on the Sexual Experience and Reducing Feelings of Anxiety About the Next Intercourse Attempt

Abstract

Introduction Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy. Aim Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED. Methods Men with ED (score ≤25 on the Erectile Function domain of the International Index of Erectile Function) who had received ≤6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg). Main Outcome Measures Efficacy, tolerability, treatment satisfaction, and other end points were measured at baseline and/or the end of the double-blind and open-label phases and compared between placebo and sildenafil initiated at doses of 50 and 100 mg. Results Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and 100 mg compared with placebo. At the end of DBPC treatment, 56% of men on the 100-mg dose felt no anxiety about the next intercourse attempt compared with 39% in the 50-mg group (odds ratio 2.03; P = 0.0197). Changes in functional scores from baseline were not statistically significant with the 100-mg dose compared with the 50-mg dose in the DBPC. Measures of treatment satisfaction and sexual experience significantly favored the 100-mg dose compared with the 50-mg dose in the DBPC. There was no increase in adverse events with the higher dose. Conclusions Sildenafil at 50 mg or 100 mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Sildenafil 100 mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the 50-mg dose.

Correlations With Satisfaction Measures in Men Treated With Phosphodiesterase Inhibitors for Erectile Dysfunction

“…The QEQ was used in four trials of sildenafil (Buvat et al, 2008;Jones et al, 2008;Kadioglu et al, 2008;Loran et al, 2009), one of which sought correlations with the IIEF Erectile Function domain and the EHS (Loran et al, 2009), and one of which sought correlations with the EHS (Kadioglu et al, 2008; Tables 5 and 6). The TSS Satisfaction With Erection domain was used in three trials of vardenafil (Edwards et al, 2006;Rosen, Goldstein, et al, 2007;Rubio-Aurioles, Porst, Eardley, & Goldstein, 2006), one of which sought correlations with the IIEF Erectile Function domain (Rosen, Goldstein, et al, 2007;Table 5).…”

“…The SEAR Overall Relationship Satisfaction subscale of the Confidence domain was used in several trials of sildenafil (Althof, O'Leary, Cappelleri, Glina, et al, 2006;Althof, O'Leary, Cappelleri, Hvidsten, et al, 2006;Heiman et al, 2007;Jones et al, 2008;Kadioglu et al, 2008;Loran et Table 6). The SEX-Q Couples Satisfaction domain was used in three trials of sildenafil (Buvat et al, 2008;Jones et al, 2008;Loran et al, 2009), two of which sought correlations with the IIEF Erectile Function domain and the EHS (Jones et al, 2008;Loran et al, 2009; Tables 5 and 6). …”

“…The SEX-Q Individual Satisfaction domain was used in two trials of sildenafil, both of which sought correlations with the IIEF Erectile Function domain and the EHS (Jones et al, 2008;Loran et al, 2009; Tables 5 and 6). The mSLQQ Sexual QoL domain was used in three trials of vardenafil (Fisher, Rosen, Eardley, Sand, & Goldstein, 2005;Goldstein et al, 2005;Rosen, Goldstein, Huang, Bangerter, & Taylor, 2007), one of which sought correlations with the EQS Table 7).…”

Perceptions and opinions of men and women on a man's sexual confidence and its relationship to ED: results of the European Sexual Confidence Survey

“…Respondents felt this would reduce a man's confidence about the next sexual encounter, a finding supported by data demonstrating that treatment for ED reduces anxiety about the next intercourse attempt, 25 probably through the effect of improved erectile function on sexual confidence. For Denmark, quotas were placed using the highest education level of participants instead of social grade.…”

Evaluation of Pharmacokinetic and Pharmacodynamic Drug–Drug Interaction of Sacubitril/Valsartan (LCZ696) and Sildenafil in Patients With Mild‐to‐Moderate Hypertension

“…Sildenafil is a widely prescribed medicine for the treatment of ED and pulmonary hypertension, and exerts its effects by increasing cGMP levels through inhibition of its degradation by PDE5 7, 14. The recommended dose of sildenafil for treatment of ED is 50 mg once daily but may be increased to 100 mg for improved efficacy, if tolerated 15. Since there is an overlap in the incidence of heart failure and ED, sildenafil may be coadministered with sacubitril/valsartan.…”