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67th Annual Meeting Abstracts
Effect of Age on the Efficacy and Safety of Silodosin in Men With Symptoms of Benign Prostatic Hyperplasia
*Marc C. Gittelman1, *Lawrence Hill2, *Weining Volinn2, *Gary Hoel2
1South Florida Medical Research, Aventura, FL;2Watson Laboratories, Salt Lake City, UT
Introduction: Efficacy and safety data from 2 US phase 3 studies in men with BPH symptoms were combined and analyzed by age group
Materials & Methods: Men aged ≥50 years with International Prostate Symptom Scores (IPSS) ≥13 received 8 mg silodosin or placebo once daily for 12 weeks. Endpoints were changes from baseline to last observation in IPSS (primary) and Qmax (secondary). Treatment effects were compared by analysis of covariance, with patients stratified by age (≥65y, <65y).
Results: Most (55%) study participants (N=923) were aged <65y. Among patients receiving silodosin (n=466), discontinuation due to adverse events was 8.1% for those <65y and 4.3% for those ≥65y. Improvement in IPSS, including irritative and obstructive subscores, and in Qmax was significantly greater for silodosin than placebo in both age groups (Table). The percentage of patients reporting silodosin-related retrograde ejaculation decreased with age (<65y, 38.6%; ≥65y, 15%). Treatment-related orthostatic hypotension was more common in the older than the younger age group, but incidence overall was similar for silodosin vs placebo (<65y, 1.5% vs 1.2%; ≥65y, 2.4% vs 1.9%). No treatment-related cardiac events occurred. The single serious drug-related event (syncope) occurred in a patient (85y) who took a prohibited concomitant medication (prazosin).
Conclusions: Silodosin promoted significant symptom relief and was well tolerated, regardless of patient age, with a cardiovascular safety profile similar to that of placebo.
Summary of Treatment Effects (Silodosin vs Placebo) by Age Group | <65 years, n=508 | <65 years, n=508 | ≥65 years, n=415 | ≥65 years, n=415 | | LSM (95% CI) | P value | LSM (95% CI) | P value | | IPSS Total | −2.9 (−4.0, −1.8) | <.001 | −2.7 (−3.8, −1.6) | <.001 | | IPSS Irritative | −1.0 (−1.5, −0.5) | <.001 | −0.9 (−1.4, −0.4) | <.001 | | IPSS Obstructive | −1.9 (−2.6, −1.2) | <.001 | −1.8 (−2.5, −1.1) | <.001 | | Qmax, mL/s | 1.0 (0.2, 1.8) | .020 | 0.9 (0.2, 1.7) | .014 |
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