Tolterodine extended release plus tamsulosin reduced symptoms better than either agent alone.
PARIS—Men with lower urinary tract symptoms (LUTS) associated with BPH may benefit more from a combination of tolterodine extended-release and tamsulosin than from either medication alone.
The findings come from a study of more than 800 men older than 40 years who were stratified by prostate size (29 mL or smaller and larger than 29mL) and one of four treatments (placebo, 4 mg tolterodine extended release [TER], 0.4 mg tamsulosin [TAM], or TER plus TAM over 12 weeks). Thus, the study included eight groups. The 29 mL threshold was selected because it represented the median prostate size of all subjects.
At baseline and 12 weeks, the researchers, led by Claus Roehrborn, MD, professor of urology at the University of Texas Southwestern Medical Center in Dallas, used the International Prostate Symptom Score (IPSS) to evaluate micturition frequency, urgency, nocturnal frequency, and perception of symptoms. In the group with smaller prostates, both TER alone and TAM plus TER reduced frequency by 14.6% and 18.1%, respectively, compared with the 7.5% with placebo, Dr. Roehrborn reported here at tye Société Internationale d’Urologie 29th Congress, Paris.
In the group with larger prostates, only the TER+TAM combination therapy significantly decreased frequency to a greater extent than placebo (-20.8% and -12.9%, respectively).
With respect to overall IPSS, patients with larger prostates showed a significant improvement compared with placebo only with the combination treatment (-41.7% vs. -28.0%), whereas patients with smaller prostates showed improvement in response to the TAM monotherapy compared with placebo (-36.4% vs. -26.5%).
In the larger-prostate group only the TAM plus TER therapy significantly improved the IPSS storage subscore compared to placebo (-40.6% vs. -28.9%), whereas in the smaller-prostate group, both TER alone and the TAM plus TER therapies showed significant improvement of the IPSS subscore over placebo (-35.9% and -34.9%, respectively, vs. -22.6%).
“LUTS occurring in men with smaller prostates are more likely to be related to a primary bladder condition, and LUTS in men with larger prostates are more likely to be related to prostatic enlargement and a secondary or coexistent bladder condition,” Dr. Roehrborn and his colleagues concluded. Thus, they noted, prostate size could serve as a “predictor of treatment response and clinical outcome in men with LUTS including OAB symptoms.”