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

    February 2019 in “ Molecular genetics and metabolism ”
    Paula R. Clemens, Tahseen Mozaffar, Benedikt G. H. Schoser, Drago Bratkovic, Barry Byrne, Özlem Göker-Alpan, Mark Roberts, Peter Schwenkreis, Kumaraswamy Sivakumar, Ans T. van der Ploeg, Jacquelyn Wright, Sheela Sitaraman, Jay Barth, Hjalmar Lagast, Priya S. Kishnani, Xue Ming
    TLDR The combination of tadalafil and finasteride improves urinary symptoms and erectile function in men with enlarged prostates.
    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.
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