Treatment with tadalafil can significantly improve the symptoms of erectile dysfunction (ED) as well as lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH), according to a new analysis (Roehrborn C, et al. BJU Int. 2016 Jan 13. Epub ahead of print). Tadalafil is indicated for the treatment of patients with ED or BPH and for those with the 2 conditions combined.
The study included data from 927 men who had participated in 1 of 4 clinical trials lasting 12 weeks and involving tadalafil therapy; men who were aged ≥45 years and had at least a 6-month history of LUTS/BPH were randomized to receive tadalafil 5 mg daily (N = 467) or placebo (N = 460). The investigators used changes in the Erectile Function domain of the self-reported International Index of Erectile Function (IIEF-EF) score and the total International Prostate Symptom Score to identify patients with ED or with LUTS/BPH, respectively, who responded to therapy with tadalafil.
“This is an analysis of all available studies and data,” lead investigator Claus G. Roehrborn, MD, Professor and Chair, Department of Urology, the University of Texas Southwestern Medical Center, Dallas, told Urology Practice Management. Based on these findings related to ED and LUTS/BPH, “I tell patients the odds of having a meaningful response to both with just one drug; that is the main purpose and utility of the research.”
Among the patients who received tadalafil 5 mg, 40.5% were classified as combined responders—those who had demonstrated improvements in ED and in LUTS/BPH—compared with 18.3% of men who received placebo. Overall, men who received tadalafil were 2.8 times more likely to be combined responders than nonresponders.
In addition, 39% of men who received tadalafil had a partial response, defined as an improvement in either ED or LUTS/BPH: 19.3% of the men who received tadalafil had an improvement in their LUTS/BPH symptoms compared with 26.1% of those who received placebo. The results for ED responses only were 19.7% and 15.4%, respectively.
Combined responders were more likely to be nonwhite, have a higher body mass index, have lower baseline IIEF-EF scores, and higher baseline IPSS scores than partial responders or nonresponders.
Using a multivariable regression model to parse the outcomes, Dr Roehrborn and colleagues found that each unit increase in the patient’s baseline IIEF-EF score was associated with a 5% decreased odds of being a combined responder versus a nonresponder.
“This finding suggests, that contrary to being a treatment contraindication, men with more severe IIEF-EF symptoms are more likely to be combined responders than men with more mild ED symptoms,” Dr Roehrborn and colleagues concluded.
Of note, each additional reported alcoholic drink consumed weekly was associated with a 4% decreased odds of being a combined responder.
These results can help urologists assess patients with respect to treatment success in their own practice compared with published data. “Clinicians could use this combined response standard to judge if a patient has an improvement to treatment,” Dr Roehrborn and colleagues concluded.