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

Objectives: To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5mg with finasteride 5mg 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 ≥45years who were 5-alpha reductase inhibitor naïve, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30mL; 350 men received placebo/finasteride and 345 received tadalafil/finasteride over 26weeks. 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 week4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07-1.97), at week12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07-2.05) and at week26 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 week26 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.