COMPLETE TITLE: Time to onset of clinically meaningful improvement with tadalafil 5mg once daily in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: Analysis of data pooled from four pivotal, double-blind, placebo-controlled studies
PURPOSE: Tadalafil once-daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH) consistently displays statistically significant improvements in International Prostate Symptom Score (IPSS). However, physicians/patients wish to know whether tadalafil provides rapid clinically meaningful improvement (CMI) in LUTS. This post-hoc analysis integrated results from four placebo-controlled studies to determine the duration of tadalafil once-daily required to achieve CMI.
MATERIALS AND METHODS: Post-hoc analysis of data integrated from four double-blind studies of tadalafil 5mg (N=742) or placebo (N=735) once-daily in men ≥45 years with total IPSS ≥13. Two CMI categories were assessed: (1) ≥3-point baseline-to-endpoint total IPSS improvement; (2) ≥25% baseline-to-endpoint total IPSS improvement. IPSS was assessed at Weeks 4, 8, and 12 (all studies), Week 1 (two studies), and Week 2 (one study). Results from tadalafil-treated men exhibiting either CMI category (responders) were further examined to determine their earliest time-to-CMI.
RESULTS: Among tadalafil-treated patients, 513/742 (69.1%) demonstrated category-1 CMI at endpoint; 444/742 (59.8%) exhibited category-2 CMI. Among 234 category-1 responders with Week 1 assessments, 140 (59.8%) achieved CMI by Week 1; 407 of 513 total category-1 responders (79.3%) exhibited it by Week 4. Among 205 category-2 responders with Week 1 assessments, 103 (50.2%) achieved CMI by Week 1; 322 of 444 total category-2 responders (72.5%) did so by Week 4.
CONCLUSIONS: Tadalafil 5mg once-daily led to CMIs in approximately two-thirds of men with LUTS/BPH. Among this group of tadalafil-treated responders, over half achieved CMI after 1 week of therapy; over 70% did so within 4 weeks.
Written by:
Oelke M, Shinghal R, Sontag A, Baygani SK, Donatucci CF. Are you the author?
Department of Urology, Hannover Medical School, Hannover, Germany; Department of Urology, Palo Alto Medical Foundation, Palo Alto, California, USA; Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
Reference: J Urol. 2014 Nov 28. pii: S0022-5347(14)05030-7.
doi: 10.1016/j.juro.2014.11.094
PubMed Abstract
PMID: 25437533