A study has analyzed the proportion of men taking Tadalafil ( Cialis ) 5 mg once-daily who reach a combined improvement ( henceforth known as a combined responder ) in symptoms of both erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia ( LUTS/BPH ).
Data from men aged greater than or equal to 45 years randomized to Tadalafil 5 mg once-daily or placebo enrolled in one of four randomized, placebo-controlled LUTS/BPH clinical trials were analyzed ( n=927 ).
A novel classification of combined responders to erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia treatment ( combined responder ) was defined, based on published criteria for improvement in both the Erectile Function domain of the International Index of Erectile Function ( IIEF-EF ) scale and the total International Prostate Symptom Score ( IPSS ).
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 less than or equal to 65 years of age, 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 less than or equal to 0.05 ).
Tadalafil-treated men had 2.8 times significantly increased adjusted-odds of being combined responders versus non-responders ( p less than 0.0001 ).
For each unit decrease in baseline IIEF-EF or alcoholic drink/week there was a 4% significant increase in the adjusted-odds of being a combined responder to Tadalafil therapy.
In conclusion, this novel measure of combined response is useful in differentiating patients with clinically relevant symptom improvement for both erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia following treatment with Tadalafil 5 mg once-daily versus placebo.
This combined responder measure may be useful in future assessment of treatment benefits across patient groups following various types of treatment intervention ( e.g., surgical vs pharmacotherapy vs non-pharmacologic intervention ). ( Xagena )
Roehrborn C et al, BJU Int 2016; Epub ahead of print