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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). [ABSTRACT FROM AUTHOR] more...

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. [ABSTRACT FROM PUBLISHER] more...

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 more...