Erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) combined responders to tadalafil after 12 weeks of treatment.

OBJECTIVE: To analyse the proportion of men taking tadalafil 5 mg once daily who experience a combined improvement in symptoms of both erectile dysfunction (ED) and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). MATERIALS AND METHODS: The data from men aged ≥45 years randomized to tadalafil 5 mg once daily or placebo enrolled in one of four randomized, placebo-controlled LUTS/BPH clinical trials were analysed (N = 927). A novel classification of 'combined responders' to ED and LUTS/BPH treatment was defined, based on published criteria for men who showed improvement in both International Index of Erectile Function - Erectile Function domain (IIEF-EF) score and total International Prostate Symptom Score (IPSS). Descriptive analyses assessed the covariate distribution by responder status. Unadjusted and adjusted logistic regressions provided odds ratios with 95% confidence intervals comparing combined responders with all others (partial and non-responders). RESULTS: Among men randomized to tadalafil 5 mg, 40.5% were combined responders (n = 189). Among placebo randomized men, 18.3% were combined responders (n = 84). Combined responders, in the total population, had the highest baseline IPSS and lowest baseline IIEF-EF scores, corresponding to the highest level of dysfunction. The majority of men were aged ≤65 years, white, non-obese, non-smokers, and regular alcohol consumers. Only treatment, baseline IPSS, baseline IIEF-EF, obesity and psychoactive medication use were significantly associated with responder status (P ≤ 0.05). Tadalafil-treated men had 2.8 times significantly increased adjusted odds of being combined responders vs non-responders (P < 0.001). For each unit decrease in baseline IIEF-EF or alcoholic drink consumption per week there was a 4% significant increase in the adjusted odds of being a combined responder to tadalafil therapy. CONCLUSIONS: This novel measure of combined response is useful in differentiating patients with clinically relevant symptom improvement for both ED and LUTS/BPH after treatment with tadalafil 5 mg once daily vs placebo. This combined responder measure may be useful in future assessment of treatment benefits across patient groups after various types of treatment intervention (e.g. surgical vs pharmacotherapy vs non-pharmacological intervention).

The Co-occurring Syndrome-Coexisting Erectile Dysfunction and Benign Prostatic Hyperplasia and Their Clinical Correlates in Aging Men: Results From the National Health and Nutrition Examination Survey.

OBJECTIVE: To establish a descriptive profile of men with coexistent erectile dysfunction (ED) and/or benign prostatic hyperplasia (BPH), ED only or BPH only compared to those with neither condition and to identify the determinants of coexisting disease. MATERIALS AND METHODS: Self-report and/or medication use measures defining ED and BPH were assessed in men aged ≥40 years (N = 2142) between 2001 and 2004 using the National Health and Nutrition Examination Surveys. Descriptive analyses examined the ED and/or BPH covariate distribution. Logistic regressions calculated odds ratios (ORs, 95% confidence interval) comparing men with ED and/or BPH, BPH only, or ED only to men with neither condition. RESULTS: Of 393 men with BPH, 57.8% had coexistent ED, confirming the moderately strong co-occurrence of the conditions (P <.0001). Coexisting ED and/or BPH occurred in 10.6% of participants, whereas 24.4% and 7.7% reported ED and BPH. After age 60, the odds of reporting ED, BPH, or ED/BPH vs neither almost tripled per decade of increasing age, corresponding to prevalence increases. The unadjusted odds of ED and/or BPH vs no disease increased 1.3 times per prostate-specific antigen unit (ng/mL) increase and 1.1 times per C-reactive protein unit (mg/dL) increase. Other predisposing factors for ED and/or BPH included higher body mass index (OR = 2.5), increased antidiabetic (OR = 2.9) or proton pump inhibitor use (OR = 2.3), increased healthcare visits (≥4; OR = 3.5), and more frequent urinary voiding difficulties (OR = 9.7). CONCLUSION: Co-occurring ED and/or BPH is evident in ~10% of men ≥40 years old and is associated with significant clinical correlates. Clinicians need to pay greater attention to this clinically important syndrome in aging men.

Treatment patterns in alpha-blocker therapy for benign prostatic hyperplasia.

This study examined treatment patterns and patient characteristics of men initiating alpha adrenergic blocker therapy (alpha-blocker) for benign prostatic hyperplasia (BPH). The 2009 Thomson Reuters MarketScan® Database was used to identify the newly initiated alpha-blocker: men ≥40 years old with continuous medical and pharmacy coverage for 12 months before and after alpha-blocker initiation, with no alpha-blocker or 5-alpha-reductase inhibitors in the previous year, and with ≥1 BPH diagnosis within 1 month before and 6 months after alpha-blocker initiation. This study analyzed patient demographics, clinical characteristics, adherence (percentage of men achieving medication possession ratio [MPR] ≥ 0.8), restarting the same alpha-blocker after discontinuation, switching to another BPH medication, and type of alpha-blocker (alpha 1 type selective or alpha 1 subtype selective agents). T tests and chi-square tests compared differences at the .05 significance level. A total of 13,474 men met the study criteria (mean age of 63.1 years). Two thirds of the men discontinued alpha-blocker in the 12-month period, among which restarts or switches were statistically different (p = .036) but numerically similar across cohorts. Adherence for alpha 1 type selective agents versus alpha 1 subtype selective agents at 6 months was 43.3% versus 38.1% (p < .01); at 12 months, 34.4% versus 30.5% (p < .01). Alpha-blocker discontinuation rates were high, which confirms low medication adherence reported among medications for several other chronic conditions; therefore, it is necessary to understand the reasons for alpha-blocker discontinuation.

Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia.

PURPOSE: Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker. We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms. MATERIALS AND METHODS: In an international, randomized, double-blind, parallel study of men 45 years old or older who were 5α-reductase inhibitor naïve and had an I-PSS (International Prostate Symptom Score) of 13 or greater and prostate volume 30 ml or greater, 350 were treated with placebo/finasteride and 345 received tadalafil/finasteride for 26 weeks. Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS, erectile dysfunction improvements were assessed with the IIEF-EF (International Index of Erectile Function-Erectile Function) in sexually active men and safety was assessed by evaluating adverse events. RESULTS: Least squares mean changes from baseline in I-PSS after 4, 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0, -5.2 and -5.5, respectively. Corresponding values for placebo/finasteride coadministration were -2.3, -3.8 and -4.5 (p ≤ 0.022 at all visits favoring tadalafil/finasteride coadministration). I-PSS subscores (storage and voiding) and quality of life index were also numerically improved with tadalafil/finasteride coadministration. Least squares mean changes from baseline in IIEF-EF with tadalafil/finasteride coadministration were 3.7 after 4 weeks, and 4.7 after 12 and 26 weeks. Corresponding values for placebo/finasteride coadministration were -1.1, 0.6 and -0.0 (p <0.001 at all visits favoring tadalafil/finasteride coadministration). Tadalafil/finasteride coadministration was well tolerated and most adverse events were mild/moderate. CONCLUSIONS: The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement. Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction.

Direct effects of tadalafil on lower urinary tract symptoms versus indirect effects mediated through erectile dysfunction symptom improvement: integrated data analyses from 4 placebo controlled clinical studies.

PURPOSE: Tadalafil has regulatory approval for the treatment of men with signs/symptoms of benign prostatic hyperplasia with and without erectile dysfunction. We assessed whether the effects of treatment with tadalafil for lower urinary tract symptoms/benign prostatic hyperplasia are independent of improvements in erectile dysfunction. MATERIALS AND METHODS: Four separate analyses used integrated data from 4 randomized, double-blind, placebo controlled studies in men with lower urinary tract symptoms/benign prostatic hyperplasia with and without erectile dysfunction to test whether total I-PSS (International Prostate Symptom Score) improvement was due to improvement in IIEF-EF (International Index of Erectile Function-Erectile Function domain score). Unidirectional and bidirectional path analysis models determined direct and indirect treatment effects mediated by improvements in lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction symptoms. RESULTS: A total of 1,496 men, of whom 77% had erectile dysfunction, received at least 1 dose of tadalafil 5 mg once daily or placebo. The placebo adjusted treatment effect for men with erectile dysfunction was represented by a mean decrease of -2.3 (p <0.0001) in total I-PSS vs -2.2 (p = 0.0007) for men without erectile dysfunction. The correlation between change from baseline in total I-PSS and IIEF-EF was weak (r(2) = 0.08, p <0.0001). The unidirectional path analysis model suggested that the total treatment effect on total I-PSS score improvement (2.25) was derived from a direct treatment effect of 1.57 (70%, p <0.001) and an indirect treatment effect of 0.67 (30% via IIEF-EF improvement, p <0.001). Bidirectional path analysis showed that total I-PSS improvement was largely attributed to direct (92.5%, p <0.001) vs indirect (7.5%, p = 0.32) treatment effects via IIEF-EF improvement. CONCLUSIONS: Regardless of the analytical approach, self-reported erectile dysfunction status did not appreciably influence tadalafil treatment response in men with lower urinary tract symptoms/benign prostatic hyperplasia, supporting the dual action of tadalafil on lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction.

Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study.

INTRODUCTION: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS) commonly coexist in aging men. Tadalafil, a phosphodiesterase type 5 inhibitor approved for treating ED, is currently being evaluated for treating BPH-LUTS. AIMS: This multinational Phase 3 study assessed effects of tadalafil 2.5 or 5 mg once daily on ED and BPH-LUTS in men with both conditions during 12 weeks of double-blinded therapy. METHODS: Men were ≥ 45 years old, sexually active, and experiencing ED for ≥ 3 months and BPH-LUTS for >6 months. Randomization (baseline) followed a 4-week placebo lead-in; changes from baseline were assessed via analysis of covariance and compared to placebo. A gatekeeping procedure controlled for multiple comparisons of co-primary and key secondary measures at end point (last post-baseline observation). MAIN OUTCOME MEASURES: The co-primary measures were the International Index of Erectile Function-erectile function (IIEF-EF) domain and International Prostate Symptom Score (IPSS) score; key secondary measures were the Sexual Encounter Profile Question 3 (SEP Q3) and BPH Impact Index (BII). Treatment-emergent adverse events, serious adverse events, orthostatic vital signs, clinical laboratory and uroflowmetry parameters, and postvoid residual volume were assessed. RESULTS: Tadalafil 2.5 mg (N = 198) and 5 mg (N = 208) significantly improved IIEF-EF domain scores (both P < 0.001) vs. placebo (N = 200) at end point. For IPSS, improvements were significant with tadalafil 5 mg (P < 0.001), but not 2.5 mg, for observations from 2 weeks through end point (least-squares mean ± standard error change from baseline at end point, placebo -3.8 ± 0.5, tadalafil 2.5 mg -4.6 ± 0.4, and 5 mg -6.1 ± 0.4). Tadalafil 5 mg significantly improved SEP Q3 and BII (P < 0.001). Overall, tadalafil was well tolerated with no clinically adverse changes in orthostatic vital signs or uroflowmetry parameters. CONCLUSIONS: Tadalafil 5 mg significantly improved both ED and BPH-related outcomes through 12 weeks and was well tolerated.

Durability of response following cessation of tadalafil taken once daily as treatment for erectile dysfunction.

INTRODUCTION: Research has focused on improvement of erectile function during treatment with phosphodiesterase type 5 (PDE5) inhibitors, but less is known about what occurs after treatment cessation. AIM: The aim of this retrospective analysis was to examine durability of response, defined as sustainability of erectogenic benefits following treatment cessation, in men with erectile dysfunction (ED) following long-term treatment with daily tadalafil. METHODS: The subjects (N=160) had participated in a 12-week double-blind trial followed by a one-year, open-label extension of tadalafil 5mg once daily. The extension was followed by a 4-week, treatment-free follow-up period. A total of 158 subjects completed International Index of Erectile Function-Erectile Function (IIEF-EF) domain score and were included in this analysis. MAIN OUTCOME MEASURES: The primary measures for this analysis were changes in ED severity category as captured by the IIEF-EF domain score. RESULTS: At the end of the 1-year open-label treatment period, a majority (86.1%, n=136) of subjects had either improved by at least one ED severity category (e.g., Severe to Moderate) (n=128), or maintained Normal erectile function (EF domain score ≥26) (n=8), compared to baseline. Following the 4-week, treatment-free period, 63 of those subjects (46.3% of the 136 subjects) had continued improvement of at least one ED severity category (n=61) or maintained scores in the Normal category (n=2) compared with baseline. Subjects who showed a sustained benefit of treatment were considered to have demonstrated a "durable response." Seventy-three subjects (53.7%) did not have a durable response following treatment cessation. A few patient characteristics were associated with durability of response. CONCLUSIONS: Of those men who demonstrated improved erectile function while taking tadalafil 5mg once daily for 1 year, 46.3% continued to show improvement compared with baseline following a 4-week treatment free period. Durability of response should be a focus of future research.

Impact of tadalafil once daily in men with erectile dysfunction--including a report of the partners' evaluation.

OBJECTIVES: To evaluate the effect of tadalafil 5 mg taken once daily on efficacy (erection achievement and penetration) and overall sexual satisfaction in men with erectile dysfunction (ED) and their female partners. METHODS: This retrospective analysis included data pooled from 2 multicenter, randomized, double-blind, placebo-controlled trials that included 505 couples (tadalafil, n=373; placebo, n=132) in which the men received tadalafil 5 mg once daily or placebo for 12 weeks. Individual Sexual Encounter Profile (SEP) diaries were completed independently by the male subject and his female partner after each sexual intercourse attempt. The mean per-subject/per-partner percentage of "yes" responses to SEP diary questions were assessed, as was agreement between subjects' and partners' responses. RESULTS: Subjects and partners in the tadalafil-treated group reported significantly greater improvements in the man's ability to achieve some erection, vaginal penetration, and overall sexual satisfaction compared with the placebo-treated group (P<.001). For all intercourse attempts, the mean per-couple percentage of agreement for those in the tadalafil and placebo groups, respectively, was high for erection achievement (99.0% and 96.6%), vaginal penetration (98.6% and 97.4%), and overall satisfaction (84.3% and 82.8%). CONCLUSIONS: Tadalafil 5 mg taken once daily as treatment for ED improved overall satisfaction for men and their female partners. This analysis demonstrates the high concordance among couples in their responses to the man's treatment for ED.

Impact on erectile function and sexual quality of life of couples: a double-blind, randomized, placebo-controlled trial of tadalafil taken once daily.

INTRODUCTION: Clinical research on erectile dysfunction (ED) has focused primarily on the male and the impact of treatment on their erectile function (EF) and sexual quality of life. However, ED affects the quality of life of both the male and the female partner. The literature examining the impact on the female partner resulting from treating the male's ED is somewhat limited. AIMS: To determine the efficacy of tadalafil 5 mg taken once daily compared with placebo on men's EF and sexual quality of life, and to determine the impact of this treatment on the female partner's sexual quality of life. MAIN OUTCOME MEASURES: The co-primary outcome measures for this study were changes from baseline to end point in the EF domain of the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) question 2 (SEP-2) and question 3 (SEP-3), and the Sexual Quality of Life (SQoL) domain of the Sexual Life Quality Questionnaire (SLQQ) (subject and partner). Methods. Following a 4-week treatment-free run-in phase, 342 subjects and their partners were randomly assigned to either placebo (N = 78) or tadalafil 5 mg (N = 264) for 12 weeks. The subjects' and partners' responses to study measures were collected throughout the study. RESULTS: Compared with placebo, tadalafil-treated subjects showed a significant improvement on efficacy measures (P < 0.001) including changes in the IIEF-EF, SEP-2 and SEP-3. In addition, the sexual quality of life of men and their female partners, as measured by the SQoL domain, was significantly improved with tadalafil 5 mg taken once daily (P < 0.001) compared with placebo. CONCLUSIONS: Tadalafil 5 mg once daily significantly improved EF and sexual quality of life for men with ED. In addition, the sexual quality of life of the female partners of the men treated with tadalafil was significantly improved.

Efficacy and safety of tadalafil once daily: considerations for the practical application of a daily dosing option.

OBJECTIVE: To provide clinically relevant information on tadalafil 2.5 or 5 mg once daily for the treatment of erectile dysfunction (ED), by reviewing safety and efficacy study findings. Findings from an integrated analysis of trials of tadalafil 10 and 20 mg as needed are presented to provide context for the daily dosing regime. RESEARCH DESIGN AND METHODS: Of the three studies that included approved once-daily doses, two were conducted in the general ED population and one in a diabetic ED population. An integrated analysis was performed using 12-week efficacy and safety data from the studies conducted in the general ED population. RESULTS: In the general ED population, the 12-week mean International Index of Erectile Function (IIEF) erectile function (EF) domain scores increased by 6.2 to an endpoint score of 19.2 and by 8.6 to 21.9 for 2.5 and 5 mg doses, respectively, versus an increase of 1.3 to 14.9 for placebo (p < 0.01). Mean successful intercourse attempts (SEP3) were 50% and 62% for tadalafil 2.5 and 5 mg once daily, respectively, versus 33% for placebo (p < 0.01). These findings were consistent with those for tadalafil as needed. In 1- and 2-year open label extensions of tadalafil 5 mg once daily, efficacy was maintained. In the diabetic ED population, 12-week mean IIEF EF scores increased by 4.8 to 18.3 and 4.5 to 17.2 with tadalafil 2.5 and 5 mg, respectively, versus an increase of 1.3 to 14.7 for placebo (p < 0.01). Mean successful intercourse attempts were more than 40% for each tadalafil dose, versus 28% for placebo (p < 0.01). The profile of treatment-emergent adverse events with tadalafil once daily was similar to that previously reported with as-needed treatment; the most common adverse events with tadalafil (dyspepsia, nasopharyngitis, headaches) were reported in

Tadalafil is efficacious and well tolerated in the treatment of erectile dysfunction (ED) in men over 65 years of age: results from Multiple Observations in Men with ED in National Tadalafil Study in the United States.

INTRODUCTION: Erectile dysfunction is increasingly common with advancing age, yet sexual activity and intimacy are important to elderly men. AIM: To assess the efficacy and tolerability of tadalafil in men over the age of 65 years. METHOD: In this multicenter open-label study, 188 men (mean age = 71.6 years) who were over age 65 and did not have diabetes mellitus or clinical depression received tadalafil 20 mg, taken on demand, for up to 12 weeks. MAIN OUTCOME MEASURES: Efficacy was assessed using the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP). Psychosocial outcomes were evaluated using the Psychological and Interpersonal Relationship Scale (PAIRS). RESULTS: Tadalafil treatment significantly improved all domains of the IIEF from baseline, including the erectile function (EF) domain (change = 8.8, end point = 21.6; P < 0.001). Mean per-patient percentage of "yes" responses to SEP questions concerning successful penetration (SEP2; change = 33.5%, end point = 73.5%; P < 0.001) and successful intercourse (SEP3; change = 39.6%, end point = 59.6%; P < 0.001) also improved significantly from baseline. Forty percent of the patients with baseline EF scores < 26 had normal EF (IIEF-EF domain scores > or = 26) at end point, and 81% reported improved erections in the Global Assessment Questionnaire. At least 56% of attempts at sexual intercourse were successfully completed (SEP3) at all time intervals up to 36 hours after tadalafil administration. The patients also experienced significant improvement in both the sexual self-confidence and spontaneity domains of the PAIRS. Tadalafil was well tolerated, with < 5% of the patients discontinuing because of adverse events. CONCLUSION: Tadalafil 20 mg was effective and well tolerated in elderly men with ED.

Efficacy and safety of tadalafil in men with erectile dysfunction with a high prevalence of comorbid conditions: results from MOMENTUS: multiple observations in men with erectile dysfunction in National Tadalafil Study in the US.

INTRODUCTION: Limited efficacy and safety data exist from open-label clinical trials of phosphodiesterase 5 inhibitors in men with erectile dysfunction (ED) and multiple comorbid (MCM) conditions, historically a difficult group to treat. AIM: A multicenter study (Multiple Observations in Men with Erectile Dysfunction in National Tadalafil Study in the US) assessed efficacy and safety of tadalafil in men with ED and MCM conditions. MAIN OUTCOME MEASURES: The primary end point was change from baseline in the erectile function (EF) domain of the International Index of Erectile Function. Secondary end points included the Sexual Encounter Profile, Global Assessment Questions, and Sexual Self-Confidence and Spontaneity Domains of the Psychological and Interpersonal Relationship Scales. METHODS: This was an open-label, multicenter study in men with ED. Tadalafil 20 mg was administered as needed prior to sexual activity, up to once/day, for 12 weeks following a 4-week ED-treatment-free period. The MCM group was 155 of 1,911 men enrolled in this study. Men in the MCM group met eligibility criteria but could not be included in other predefined groups: (i) Caucasian; (ii) Black American; (iii) Hispanic (groups 1-3, < or =65 years, no diabetes or depression); (iv) depression, < or =65 years, no diabetes; (v) diabetes, < or =65 years, no depression; (vi) >65 years, no diabetes or depression; and (vii) ED subsequent to traumatic spinal cord injury. RESULTS: Mean baseline EF domain score in MCM (mean age 65 +/- 9 years) was 12.2 +/- 6.5; 52% of subjects had severe ED; 72% diabetes mellitus; 67% cardiovascular disease (including hypertension); 49% hyperlipidemia; 38% depression; 84% had two or more comorbidities. At end point, there was a significant (P < 0.001) mean change of 7.6 from baseline in mean EF domain score. Among men with severe ED, 22% achieved an EF domain score > or =26. Most common adverse events were headache 5.2%; flushing 3.9% and nasal congestion 3.2%; 3% discontinued use because of an adverse event. CONCLUSIONS: In this open-label clinical trial of older men with ED and MCMs, tadalafil 20 mg significantly increased all efficacy end points and was well-tolerated.

Efficacy and safety of tadalafil across ethnic groups and various risk factors in men with erectile dysfunction: Use of a novel noninferiority study design.

AIM: This U.S. multicenter open-label study used a noninferiority trial design to assess the efficacy of tadalafil 20 mg to treat erectile dysfunction (ED) in the black American and Hispanic groups compared with a reference group of Caucasians. A secondary objective was to demonstrate the efficacy and safety of tadalafil 20 mg in various populations of men with ED. METHODS: A total of 1,911 patients with ED were enrolled into eight predefined groups: (1-3) Caucasian (Reference group), Black American, or Hispanic patients, < or =65 years of age with no diabetes mellitus or depression; (4) patients with depression, < or =65 years of age, no diabetes; (5) patients with diabetes, < or =65 years of age, no depression; (6) patients >65 years of age, no diabetes or depression; (7) patients who met enrollment criteria but were not included in any other group; and (8) patients with ED due to traumatic spinal cord injury. The study had a 4-week run-in period, followed by a 12-week treatment period with tadalafil taken as needed, up to one dose/day, prior to sexual activity. Change from baseline to endpoint in the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) was used to determine noninferiority of groups 2 and 3 from group 1. Secondary efficacy measures included other IIEF domains and Sexual Encounter Profile (SEP). RESULTS: Noninferiority analyses based on the EF domain score showed that tadalafil was as efficacious in the Hispanic and Black American groups as in the Reference group. Patients in each of the eight groups had a significant change from baseline (P < 0.001) in the IIEF EF domain score and positive responses to SEP Questions 1-5. The most common treatment-emergent adverse events reported by patients in all eight groups were headache, nasal congestion, dyspepsia, flushing, and back pain. CONCLUSION: Tadalafil 20 mg was as efficacious in the Hispanic and black American groups as in the Caucasian/Reference group. Tadalafil was efficacious and well tolerated in each of the groups studied in this trial.

The efficacy of tadalafil in clinical populations.

OBJECTIVES: To evaluate the efficacy of tadalafil in men with erectile dysfunction (ED) by demographic and ED characteristics, in patients having various comorbid medical conditions, and in patients receiving drug treatment for other medical conditions. METHODS: This is an analysis of 11 double-blind, placebo-controlled trials with 2,102 men with a broad spectrum of ED etiology and various comorbid medical conditions as participants. The variables analyzed in this report included race, age, body mass index (BMI), ED etiology, ED severity, ED duration, smoking, prior sildenafil use, presence of comorbid conditions (diabetes mellitus, hypertension, cardiovascular disease, hyperlipidemia, depression, benign prostatic hyperplasia), and treatment with antihypertensives or antidepressants. Patients were randomly assigned to receive tadalafil 10 mg (N=321), tadalafil 20 mg (N=1,143), or placebo (N=638). The primary efficacy variables included mean changes from baseline in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) questionnaire, and the mean per-patient percentage of "yes" responses to the Sexual Encounter Profile (SEP) diary question 3 (SEP3--successful intercourse). The Global Assessment Question 1 (GAQ) was evaluated, as was the percentage of men attaining a normal IIEF EF domain score at end point. RESULTS: Patients taking tadalafil 10 mg or 20 mg demonstrated significant improvement (P<0.005) from baseline to end point on the IIEF EF domain score in all subpopulations analyzed compared with patients receiving placebo. The mean-per-patient percentage of "yes" responses to SEP3 increased significantly in all subpopulations taking tadalafil compared with placebo (P<0.05). Tadalafil-treated patients had a significantly greater positive response rate on the GAQ in all subpopulations analyzed compared with placebo-treated patients (P<0.03) except for the tadalafil 10 mg cardiovascular subpopulation (placebo, 46.8%; tadalafil 10 mg, 71.0%; P=0.127). The percentage of positive responses ranged from 72% to 91% for patients on tadalafil 20 mg and from 52% to 94% for tadalafil 10 mg compared with a range of 20% to 47% for placebo-treated patients. CONCLUSIONS: Tadalafil was effective in improving erectile function across a wide spectrum of ED patients including patients with various comorbid conditions.