Sildenafil citrate improves erectile function and lower urinary tract symptoms independent of baseline body mass index or LUTS severity.

OBJECTIVES: To evaluate the body mass index (BMI) and lower urinary tract symptom (LUTS) severity on treatment response to sildenafil in men with erectile dysfunction (ED) and moderate to severe LUTS associated with benign prostatic hyperplasia. METHODS: A post hoc analysis of data from a 12-week, double-blind, placebo-controlled study of sildenafil (50 mg once daily titrated to 100 mg once daily) was conducted. The BMI categories were obese (> or = 30 kg/m(2)), overweight (> or = 25 to < 30 kg/m(2)), and normal weight (< 25 kg/m(2)). ED was defined as a score of < or = 25 on the erectile function domain of the International Index of Erectile Function, and LUTS was defined by an International Prostate Symptom Score of > or = 12. The maximal urinary flow rate was determined by uroflowmetry. RESULTS: Patients receiving sildenafil (n = 189) had a significant improvement in the erectile function domain scores of the International Index of Erectile Function (P < .0001 vs placebo, n = 180), which did not vary across BMI groups. A greater improvement in LUTS score was observed with sildenafil compared with placebo for men with severe LUTS (-8.6 vs -2.4, P < .0001) than in men with moderate LUTS (-3.6 vs -1.7, P = .06). Also, the improvement in LUTS scores was significant (P < or = .02) for men taking sildenafil independent of BMI (obese, -8.9 vs -5.4; overweight, -7.3 vs -3.2; normal weight, -7.1 vs -0.84). No difference was found among the treatment groups in the change from baseline maximal urinary flow rate across all LUTS and BMI categories (range 4.5 to -4.2 mL/s). CONCLUSIONS: The results of our study have shown that daily dosing with sildenafil improved ED and LUTS independent of baseline LUTS severity or BMI.

Clinically meaningful improvement on the Self-Esteem And Relationship questionnaire in men with erectile dysfunction.

PURPOSE: To estimate the minimal clinically meaningful improvement (MCMI) on the Self-Esteem And Relationship (SEAR) questionnaire. METHODS: Using combined data from the 2 pivotal SEAR trials of men treated with sildenafil for erectile dysfunction (ED), MCMIs were estimated as the lower limit of the 2-sided 95% confidence intervals of SEAR mean change scores (from baseline to end of study) for 2 anchor groups: (1) men who improved 1 ED severity category on the Erectile Function domain of the International Index of Erectile Function, and (2) men who improved 5-60% (inclusive) on these erectile function scores. RESULTS: Both anchors gave comparable results. A 10-point MCMI was proposed because the estimates of 95% lower bounds centered on around 10 points for most SEAR components (Sexual Relationship, Confidence, Self-Esteem, Overall Score). An exception was the Overall Relationship whose 95% lower bounds were too low to recommend them as an MCMI. CONCLUSIONS: Two anchor-based approaches suggest that a change of about 10 points represents an MCMI on most components of the SEAR questionnaire.

Safety of intravenous nitroglycerin after administration of sildenafil citrate to men with coronary artery disease: a double-blind, placebo-controlled, randomized, crossover trial.

OBJECTIVE: Although contraindicated, there are situations when a patient who has recently taken a phosphodiesterase 5 inhibitor (e.g., sildenafil) might need intravenous nitroglycerin (NTG) treatment. This study determined if, and at what dose, intravenous NTG could be administered safely to men with coronary artery disease who had recently ingested sildenafil. DESIGN: Double-blind, placebo-controlled, randomized, crossover trial. SETTING: Four clinical practice sites in Canada, Scotland, and the United States. PATIENTS: A total of 34 men (>or=35 yrs) with a history of angina pectoris and coronary artery disease (>50% stenosis of at least one coronary artery), most of whom were taking antihypertensives. INTERVENTIONS: Sildenafil (100 mg) or placebo (single dose; crossover after 3-7 days) followed 45 mins later by escalating doses of intravenous NTG (160 microg/min maximum). MEASUREMENTS AND MAIN RESULTS: After sildenafil, there were slightly greater maximum (supine) blood pressure decreases and heart rate increases (e.g., 4 to 6 mm Hg [systolic] and

Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: Results from an international, multi-center, double-blind, placebo-controlled trial.

INTRODUCTION: Erectile dysfunction (ED) can significantly impact a man's relationships and well-being. AIM: We assessed changes in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction in men with ED using the validated Self-Esteem And Relationship questionnaire (SEAR). METHODS: This was a 12-week, double-blind, placebo-controlled, flexible-dose (25, 50, 100 mg, as needed) international study of sildenafil in men > or =18 years of age in Mexico, Brazil, Australia, and Japan. MAIN OUTCOME MEASURES: The primary study outcome was change in self-esteem from baseline to the end of treatment. Secondary study measures were changes in other SEAR components, International Index of Erectile Function (IIEF) domains, percentage of intercourse attempts that were successful, and the response to a global efficacy question at the end of treatment. RESULTS: Patients were well balanced for age and duration of ED (placebo = 149 and sildenafil = 151). Compared with placebo, sildenafil significantly improved self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction (P < 0.0001). The psychosocial measures of well-being assessed with the SEAR were positively correlated (range 0.60-0.86, P < 0.0001) with erectile function, the frequency of achieving erections that allowed satisfactory sexual intercourse, the percentage of successful sexual intercourse attempts, and global treatment efficacy. CONCLUSIONS: Significant improvements in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction after treatment of ED with sildenafil were consistent among countries. These data suggest a substantial cross-cultural improvement in well-being after successful treatment of ED with sildenafil.

Comparison between sildenafil-treated subjects with erectile dysfunction and control subjects on the Self-Esteem And Relationship questionnaire.

INTRODUCTION: Erectile dysfunction (ED) can negatively impact psychosocial measures of a patient's sexual life. AIM: To evaluate self-esteem, confidence, and relationships in men with ED, before and after treatment with sildenafil citrate (Viagra), with reference to controls without ED. METHODS: Sildenafil-naïve patients with ED were enrolled in a 10-week, open-label, flexible-dose (25 mg, 50 mg, or 100 mg) trial of sildenafil. In a separate study, men without ED who did not take sildenafil also completed the Self-Esteem And Relationship (SEAR) questionnaire. In addition to traditional statistical testing, equivalency testing was applied to compare the ED group, before and after treatment, with the control group and to examine whether the ED group improved to normative ranges on the SEAR questionnaire after treatment (within half a standard deviation of the normative or control group mean). MAIN OUTCOME MEASURES: Baseline and end-of-treatment responses on psychosocial aspects of ED were measured with the validated SEAR. RESULTS: Mean SEAR scores between subjects with ED (N = 93, mean age 55.0 years) at baseline and control subjects without ED (N = 94, mean age 52.5 years) were statistically different from zero and not statistically equivalent. Conversely, mean SEAR scores between ED subjects after treatment and control subjects were statistically equivalent and not statistically different from zero. CONCLUSIONS: The results indicate that sildenafil is associated with normalization of relationships, confidence, and self-esteem in men with ED.

Association between the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship Questionnaire following treatment with sildenafil citrate for men with erectile dysfunction.

OBJECTIVES: Research is lacking on the correlation between treatment satisfaction and confidence, self-esteem, and relationships for men receiving treatment for erectile dysfunction (ED). We sought to correlate scores between the validated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index and the validated Self-Esteem And Relationship (SEAR) questionnaire following treatment with sildenafil citrate (VIAGRA). METHODS: This study was based on an open-label, flexible-dose trial of 93 sildenafil-naive patients with ED. Pearson correlation coefficients between EDITS index and SEAR questionnaire scores, each of which can range from 0 to 100 (most favorable), were calculated at end of treatment (EOT). An analysis of covariance model was applied to associate changes from baseline to EOT in SEAR scores with EDITS score at EOT, controlling for baseline SEAR score. RESULTS: Significant and sizable Pearson's correlations between SEAR and EDITS scores (P < or = 0.0001; range: 0.49-0.84) were observed. A 10-point higher EDITS scores at EOT corresponded to a significant and tangible average improvement in SEAR scores from baseline to EOT (P < or = 0.0001; range: 6.6-8.7). Average SEAR scores at EOT were markedly different between patients with greater treatment satisfaction at EOT (EDITS score > or = median EDITS score of 88.6; n = 50) and those with lesser treatment satisfaction at EOT (EDITS score <88.6; n = 43). CONCLUSIONS: The data add to the validity of the SEAR questionnaire, suggest a tangible relationship between treatment satisfaction and psychosocial benefit among men with ED treated with sildenafil, and highlight the importance of assessing the psychosocial impact of ED in men undergoing treatment.