The results, presented at the annual European Association of Urology ( EAU ) Congress in Milan, Italy, of a study that showed Tadalafil ( Cialis ) 5 mg once daily co-administered with Finasteride ( Proscar ) significantly improved scores on the International Prostate Symptom Score ( IPSS ), compared to placebo / Finasteride, in men with lower urinary tract symptoms of benign prostatic hyperplasia ( LUTS / BPH ) and enlarged prostates. On a pre-specified secondary measure, Tadalafil / Finasteride also improved erectile function scores versus placebo / Finasteride in those men who had both LUTS/BPH and erectile dysfunction ( ED ) at baseline.
This is the first study to report co-administration of Tadalafil and Finasteride in men with LUTS/BPH. Tadalafil is a phosphodiesterase type 5 inhibitor approved by the Food and Drug Administration ( FDA ) for the signs and symptoms of BPH and both ED and the signs and symptoms of BPH ( ED+BPH ). Finasteride is a type II 5alpha-reductase inhibitor ( 5-ARI ) approved by the FDA for the treatment of BPH in men with an enlarged prostate.
The randomized, double-blind, placebo-controlled, 26-week trial assessed the efficacy and safety of Tadalafil 5 mg for once daily use or placebo co-administered with Finasteride in 696 men aged 45 years and older with an International Prostate Symptom Score ( IPSS ) of at least 13, a urine flow rate ( Qmax ) of 4 millimeters per second ( mL/sec ) to 15 mL/sec and a prostate volume at least 30 mL.
The primary measure was the International Prostate Symptom Score ( IPSS ), a questionnaire evaluating lower urinary tract symptoms ( LUTS ) occurring during the preceding month where lower scores indicate less severe LUTS. Pre-specified secondary measures included the International Index of Erectile Function-Erectile Function Domain ( IIEF-EF ), a questionnaire evaluating sexual function where higher scores indicate better erectile function, and the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia ( TSS-BPH ), a validated, disease-specific 13-item questionnaire used to assess patients' perceptions of satisfaction with efficacy, dosing and side effects, with lower scores indicating greater satisfaction with treatment.
Tadalafil / Finasteride met the primary endpoint, significantly improving IPSS total scores through 12 weeks versus placebo / Finasteride ( -5.2 versus -3.8, p = 0.001 ). Tadalafil / Finasteride also significantly improved IPSS total scores versus placebo / Finasteride at 4 weeks ( -3.9 versus -2.3, p less than 0.001 ) and 26 weeks ( -5.5 versus -4.5, p=0.022 ).
On the key secondary measure, Tadalafil / Finasteride improved IIEF-EF scores in sexually active men with erectile dysfunction versus placebo / Finasteride at week 4 ( 2.7 versus -1.4, p less than 0.001 ), week 12 ( 4.2 versus 0.5, p less than 0.001 ) and week 26 ( 3.9 versus -0.3, p less than 0.001 ).
The TSS-BPH improved with Tadalafil / Finasteride versus placebo / Finasteride at 26 weeks ( 2.0 versus 2.1, p=0.031 ), driven by satisfaction with efficacy ( p=0.025 ), with no significant difference for dosing or side effects.
The most common treatment-emergent adverse events ( TEAEs ) were headache ( Tadalafil / Finasteride 12 [ 3% ]; placebo / Finaseteride 12 [ 3% ]), indigestion ( Tadalafil / Finasteride 8 [ 2% ]; placebo / Finaseteride 2 [ 0.5% ]) and back pain ( Tadalafil / Finasteride 1 [ 0.3% ]; placebo / Finaseteride 0 [ 0%]). ( Xagena )
Source: Lilly, 2013