Abstract | PURPOSE: MATERIALS AND METHODS: We performed post hoc analysis of data integrated from 4 double-blind studies of tadalafil 5 mg and placebo once daily in 742 and 735 men, respectively, 45 years old or older with total I-PSS 13 or greater. Two clinically meaningful improvement categories were assessed, including 1) 3-point or greater baseline to end point total I-PSS improvement and 2) 25% or greater baseline to end point total I-PSS improvement. I-PSS was assessed at weeks 4, 8 and 12 in all studies, week 1 in 2 and week 2 in 1. Results in men treated with tadalafil who showed clinically meaningful improvement (responders) were further examined to determine the earliest time to clinically meaningful improvement. RESULTS: Of 742 tadalafil treated patients 513 (69.1%) and 444 (59.8%) demonstrated category 1 and 2 clinically meaningful improvement, respectively, at the study end point. Of 234 category 1 responders with week 1 assessments 140 (59.8%) achieved clinically meaningful improvement by week 1 and 407 of the total of 513 category 1 responders (79.3%) showed it by week 4. Of the 205 category 2 responders with week 1 assessments 103 (50.2%) achieved clinically meaningful improvement by week 1 while 322 of the 444 category 2 responders (72.5%) did so by week 4. CONCLUSIONS:
|
Authors | Matthias Oelke, Rajesh Shinghal, Angelina Sontag, Simin K Baygani, Craig F Donatucci |
Journal | The Journal of urology
(J Urol)
Vol. 193
Issue 5
Pg. 1581-9
(May 2015)
ISSN: 1527-3792 [Electronic] United States |
PMID | 25437533
(Publication Type: Journal Article, Randomized Controlled Trial)
|
Copyright | Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Carbolines
- Phosphodiesterase 5 Inhibitors
- Tadalafil
|
Topics |
- Carbolines
(administration & dosage)
- Double-Blind Method
- Drug Administration Schedule
- Humans
- Lower Urinary Tract Symptoms
(drug therapy, etiology)
- Male
- Middle Aged
- Phosphodiesterase 5 Inhibitors
(administration & dosage)
- Prostatic Hyperplasia
(complications)
- Remission Induction
- Tadalafil
- Time Factors
|