Once-daily tadalafil improved erectile function similarly in men with moderate or severe symptoms.


ANAHEIM, Calif.—Tadalafil (Cialis) dosed once a  day improves erectile function in men with erectile dysfunction (ED) and BPH-related lower urinary tract symptoms (LUTS), a study shows. The drug’s  effect is similar in patients with moderate or severe LUTS.

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The severity of LUTS secondary to BPH is known to be associated with ED severity, observed study investigator Marc Gittelman, MD, director of South Florida Medical Research in Aventura. He and his colleagues investigated whether LUTS severity impacts on ED treatment response.


They used data from a randomized, double-blind, placebo-controlled study of tadalafil dosed once a day in men with moderate-to-severe BPH-related LUTS (International Prostate Symp-tom Score of 13 or higher). The study had a four-week, treatment-free, run-in period (placebo dosed once a day), which was followed by treatment with tadalafil 5 mg once a day for six weeks (with dose escalation to 20 mg a day for an additional six weeks of treatment), or placebo for 12 weeks.


Among the 281 subjects enrolled, 228 men (81%) were sexually active and 156 (68%) had a history of ED. These 156 men were included this post hoc analysis. The researchers compared change from baseline International Index of Erectile Function-Erectile Function domain scores for tadalafil compared with placebo. They also compared the responses of men with moderate LUTS compared to men with severe LUTS.


Once-daily tadalafil significantly improved ED compared with placebo, and the improvements in erectile function were no different between the men with moderate or severe LUTS, said Dr. Gittelman, who presented study findings here at the American Urological Association annual meeting. “This is an observation about how patients might respond,” Dr. Gittelman told Renal & Urology News. “We can now start thinking about using an ED product for men with BPH. For BPH, we have a whole set of treatments that we have, such as alpha blockers, that we use typically. This is a totally different concept.”


In another study presented at the conference, German researchers found that vardenafil (Levitra) provided  improvement in BPH-related LUTS compared with placebo. The randomized eight-week study of 221 ED sufferers also showed vardenafil was associated with improvement in quality of life.