Treatment satisfaction and clinically meaningful symptom improvement in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: Secondary results from a 6-month, randomized, double-blind study comparing finasteride plus tadalafil with finasteride plus placebo.

Abstract

OBJECTIVES:

To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5 mg with finasteride 5 mg versus finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia.

METHODS:

An international, randomized, double-blind, parallel study was carried out in men aged ≥45 years who were 5-alpha reductase inhibitor naïve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30 mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26 weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25% from randomization.

RESULTS:

Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/finasteride and placebo/finasteride, respectively, at week 4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07-1.97), at week 12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07-2.05) and at week 26 was 71.4% and 70.2% (OR 1.14, 95% confidence interval 0.81-1.61); for IPSS change ≥25%, the corresponding proportions were 44.8% and 32.9% (OR 1.66, 95% confidence interval 1.21-2.28), 55.5% and 51.9% (OR 1.18, 95% confidence interval 0.87-1.62), and 62.0% and 58.3% (OR 1.23, 95% confidence interval 0.89-1.70). Treatment satisfaction at week 26 was significantly greater with tadalafil/finasteride versus placebo/finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P = 0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P ≥ 0.371).

CONCLUSIONS:

Tadalafil/finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms, and in greater treatment satisfaction versus placebo/finasteride.

• Authors: Claus G Roehrborn, Adolfo Casabé, Sidney Glina, Sebastian Sorsaburu, Carsten Henneges, Lars Viktrup
• Journal: International journal of urology : official journal of the Japanese Urological Association (Int J Urol) Vol. 22 Issue 6 Pg. 582-7 (Jun 2015) ISSN: 1442-2042 [Electronic] Australia
• PMID: 25827166 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 The Japanese Urological Association.

Chemical References

• 5-alpha Reductase Inhibitors
• Phosphodiesterase 5 Inhibitors
• Finasteride
• Tadalafil

Topics

• 5-alpha Reductase Inhibitors (therapeutic use)
• Aged
• Double-Blind Method
• Drug Therapy, Combination
• Finasteride (therapeutic use)
• Humans
• Male
• Middle Aged
• Organ Size
• Patient Satisfaction
• Phosphodiesterase 5 Inhibitors (therapeutic use)
• Prostatic Hyperplasia (complications, drug therapy, pathology)
• Prostatic Neoplasms (pathology)
• Prostatism (drug therapy, etiology)
• Severity of Illness Index
• Tadalafil (therapeutic use)