Evaluating the effects of switching from dutasteride to tadalafil in benign prostatic hyperplasia patients with lower urinary tract symptoms: A randomized, open‐label, multicenter study
Abstract
DOI: 10.1111/iju.13908 There are several treatment options for LUTS with BPH, such as an a-blocker, a PDE5I or a 5ARI. However, there has been limited evidence on how long a man should take these agents for LUTS and on whether men with BPH/LUTS can discontinue one agent from combination therapy. Therefore, we carried out a randomized trial to compare the treatment outcomes of discontinued dutasteride alone with a switch to TAD. A prospective, randomized, open-label, multicenter trial was carried out to evaluate the efficacy of switching from dutasteride to TAD in patients with LUTS/BPH. Patients underwent dutasteride discontinuation or were switched to TAD 5 mg. The primary outcome measure was the change in IPSS from baseline to 12 weeks. The secondary end-points included changes in IPSS subscore, peak urinary flow rate, postvoid residual urine volume, blood pressure, testosterone, serum 8OHdG level, erectile function and patient preference. This study was approved by the institutional ethics committee of Hirosaki University School of Medicine (K11H27001) and registered as a clinical trial (UMIN000020369). All participants provided written informed consent. Differences were considered statistically significant at P < 0.05. Participants were randomly assigned 5 mg of TAD daily (TAD group, n = 34) or underwent dutasteride discontinuation (Ctrl group, n = 34). The patients’ backgrounds are shown in Table S1. There were no significant differences at baseline between the two…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 34 participants or records.
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