ED drugs may offer intriguing therapy for BPH/LUTS

August 15, 2007

While urologists continue to search for the most effective means of treating BPH and lower urinary tract symptoms, research presented at the 2007 AUA annual meeting suggests that drugs they may already be prescribing for other conditions could provide a novel solution.

Those findings and others on the use of lasers and the link between poor lifestyle and enlarged prostates highlighted the meeting's take-home messages in BPH/LUTS, according to Claus G. Roehrborn, MD, professor and chairman of urology at the University of Texas Southwestern Medical Center in Dallas.

The phosphodiesterase type-5 inhibitor vardenafil (Levitra) improved sexual function and quality of life scores significantly when compared with placebo in men with BPH.

"Using a drug normally indicated for treatment of erectile dysfunction is an exciting new pathway to treat BPH/LUTS in men," Dr. Roehrborn said. "It's very attractive because BPH/LUTS and erectile dysfunction coexist very commonly in the elderly population."

Evidence has been presented that other PDE-5 inhibitors have similar effects in BPH/LUTS. Dr. Roehrborn related the story of a patient in his clinic who takes tadalafil (Cialis) "once a week or once every other week, and he said that for 4 or 5 days afterward, his urination is like that of a teenager again."

Dr. Roehrborn looks forward to phase III trials of erectile dysfunction drugs for this purpose, perhaps leading toward FDA approval for the new indication.

Combination therapy using the antimuscarinic tolterodine (Detrol) and the alpha-blocker tamsulosin (Flomax) improved urge incontinence, urgency, total micturition, symptom scores, and quality of life in patients with BPH/LUTS.

"In the past, urologists were advised not to use antimuscarinics in men with severe irritative symptoms of overactive bladder because of the risk of urinary retention," Dr. Roehrborn said. "But there have been trials suggesting that it isn't quite as dangerous as we had thought, and now we see the combination of an antimuscarinic and an alpha-blocker as a highly effective treatment for these men."

Dr. Roehrborn was involved in a 12-week, multicenter study showing that, compared with placebo, the drug combination significantly improved a variety of symptoms and also resulted in a low incidence (.4%) of acute urinary retention requiring catheterization.

Men in the study were randomized to placebo, tolterodine alone, tamsulosin alone, or a combination of the two. All participants were at least 40 years of age, had IPSS ≥12, IPPS quality of life score ≥3, and bladder diary-documented frequency (eight or more voids per 24-hour period) and urgency (three or more episodes per 24-hour period).

Analysis of Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial data showed that higher prostate size correlated with signs of the metabolic syndrome.

The supposed relationship between BPH and the metabolic syndrome (ie, obesity, diabetes, hypertension, high cholesterol) is not new. Previous data from the Olmsted County Study and the Baltimore Longitudinal Study of Aging suggested the link. Recent data from the REDUCE trial confirm that the severity of BPH/LUTS is associated with the incidence of men who have signs of the metabolic syndrome.

"This is a new, interesting, and highly fascinating line of epidemiological and translational research," said Dr. Roehrborn. "We know that men with the metabolic syndrome are, in general, overweight, not very active, and living a poor lifestyle. Apparently, that lifestyle is detrimental not only to their cardiovascular and overall health, but also to their prostate."

The findings constitute "yet another reason to get off the couch, lose weight, and correct these metabolic abnormalities," he added.