PDE-5 inhibitors may play a role in BPH, LUTS treatment

September 6, 2007

The therapeutic role of phosphodiesterase type-5 inhibitors could expand to include some patients with BPH and lower urinary tract symptoms, according to findings from two studies presented at the AUA annual meeting in Anaheim, CA.

The therapeutic role of phosphodiesterase type-5 inhibitors could expand to include some patients with BPH and lower urinary tract symptoms, according to findings from two studies presented at the AUA annual meeting in Anaheim, CA.

In one U.S. study, 369 men with erectile dysfunction and concomitant lower urinary tract symptoms were randomized to placebo or to sildenafil citrate (Viagra), 50 mg, taken nightly before bedtime or 1 hour before sexual activity for 12 weeks. Overall, patients treated with sildenafil had a 6.32-point improvement in the International Prostate Symptom Score compared to 1.93 for the placebo group (p<.001). Erectile function domain scores improved by an average of 9.17 in the sildenafil group and 1.86 in the placebo group (p<.001).

"The improvement in IPSS correlated with the IIEF changes," said first author Kevin McVary, MD, of Northwestern University in Chicago. "Patients with more severe symptoms had more improvement, in a sense, because they have more room for change."

A German study of 222 men with moderate to severe urinary symptoms randomized to vardenafil (Levitra), 10 mg twice daily, or placebo for 8 weeks showed vardenafil patients had a mean improvement of 5.9 compared with 3.6 for the placebo group (p=.0013) over their baseline IPSS scores. Vardenafil also led to significantly greater improvement in the IPSS subscales for obstructive symptoms (3.2 vs. 1.9, p=.0081) and irritative symptoms (2.6 vs. 1.7, p=.0017).

"These changes were associated with improvement in erectile dysfunction," said presenter Christian Stief, MD, of Ludwig-Maximilians University in Munich. "Vardenafil may offer a valuable new option for the treatment of BPH and LUTS."

Dr. McVary is a consultant/adviser to GlaxoSmithKline, Eli Lilly, Merck, Pfizer, and sanofi-aventis. Dr. Stief is a consultant/adviser to Bayer and Eli Lilly.