Impact of early vs. delayed initiation of dutasteride/tamsulosin combination therapy on the risk of acute urinary retent
- PDF / 3,603,872 Bytes
- 9 Pages / 595.276 x 790.866 pts Page_size
- 27 Downloads / 168 Views
ORIGINAL ARTICLE
Impact of early vs. delayed initiation of dutasteride/tamsulosin combination therapy on the risk of acute urinary retention or BPH‑related surgery in LUTS/BPH patients with moderate‑to‑severe symptoms at risk of disease progression Salvatore D’Agate1 · Chandrashekhar Chavan2 · Michael Manyak3 · Juan Manuel Palacios‑Moreno4 · Matthias Oelke5 · Martin C. Michel6 · Claus G. Roehrborn7 · Oscar Della Pasqua1,8 Received: 24 June 2020 / Accepted: 30 October 2020 © The Author(s) 2020
Abstract Purpose To evaluate the effect of delayed start of combination therapy (CT) with dutasteride 0.5 mg and tamsulosin 0.4 mg on the risk of acute urinary retention or benign prostatic hyperplasia (BPH)-related surgery (AUR/S) in patients with moderate-to-severe lower urinary tract symptoms (LUTS) at risk of disease progression. Methods Using a time-to-event model based on pooled data from 10,238 patients from Phase III/IV dutasteride trials, clinical trial simulations (CTS) were performed to assess the risk of AUR/S up to 48 months in moderate-to-severe LUTS/ BPH patients following immediate and delayed start of CT for those not responding to tamsulosin monotherapy. Simulation scenarios (1300 subjects/arm) were investigated, including immediate start (reference) and alternative delayed start (six scenarios 1–24 months). AUR/S incidence was described by Kaplan–Meier survival curves and analysed using log-rank test. The cumulative incidence of events as well as the relative and attributable risks were summarised stratified by treatment. Results Survival curves for patients starting CT at month 1 and 3 did not differ from those who initiated CT immediately. By contrast, significant differences (p
Data Loading...
