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 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.