Safety and Efficacy of Advanced and Targeted Acid α-Glucosidase (AT-GAA) (ATB200/AT2221) in ERT-Switch Nonambulatory Patients with Pompe Disease: Preliminary Results from the ATB200-02 Trial

In a study involving 695 men aged 45 or older with lower urinary tract symptoms (LUTS) and prostatic enlargement due to benign prostatic hyperplasia (BPH), the coadministration of tadalafil 5 mg and finasteride 5 mg over 26 weeks was evaluated for its efficacy in improving LUTS and sexual symptoms. Participants were either 5α-reductase inhibitor naïve with an International Prostate Symptom Score (I-PSS) of 13 or greater and a prostate volume of 30 ml or greater. The study was randomized and double-blind, with 350 men receiving placebo/finasteride and 345 receiving tadalafil/finasteride. Results showed that tadalafil/finasteride coadministration led to greater improvements in I-PSS scores at 4, 12, and 26 weeks compared to placebo/finasteride, with least squares mean changes from baseline of −4.0, −5.2, and −5.5, respectively. Improvements in erectile function, measured by the International Index of Erectile Function-Erectile Function (IIEF-EF), were also significantly better in the tadalafil/finasteride group. The treatment was well tolerated, with most adverse events being mild or moderate. The study concluded that tadalafil/finasteride coadministration provides early improvement in LUTS and erectile function in men with BPH and comorbid erectile dysfunction.