Investigational drug is found effective, safe in BPH

Feb 01, 2007

A course of the investigational drug silodosin, 8 mg once daily for 12 weeks, was superior to placebo for the relief of both obstructive and irritative symptoms in men with BPH, two phase III studies showed. Secondary endpoints included improvement in maximum urine flow.

A course of the investigational drug silodosin, 8 mg once daily for 12 weeks, was superior to placebo for the relief of both obstructive and irritative symptoms in men with BPH, two phase III studies showed. Secondary endpoints included improvement in maximum urine flow. Very rapid and statistically significant improvements were seen in both endpoints, researchers reported.

The agent preferentially binds to the alpha (1A) receptors in the prostate and bladder neck relative to cardiovascular-associated receptors, maximizing target organ activity and minimizing potential effects on blood pressure.

Silodosin was well tolerated in both studies, according to its manfucturer, Watson Pharmaceuticals. Incidences of cardiovascular- and blood pressure-related side effects, including dizziness and orthostasis, were low in both trials. As expected in highly uroselective (1A)-adrenoceptor antagonists, ejaculations with little or no semen were the most commonly reported side effect reported in the trials. The vast majority of these side effects were mild to moderate in intensity, and patient withdrawal from the trial was low.