Eli Lilly announced that the FDA has approved an addition to the Cialis (tadalafil) label to include data from a 26-week study that showed Cialis 5mg once daily started in combination with finasteride significantly improved the signs and symptoms of benign prostatic hyperplasia (BPH) as early as 4 weeks.

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Cialis is a phosphodiesterase type 5 inhibitor (cGMP-specific) indicated to treat erectile dysfunction (ED), the signs and symptoms of BPH, and both ED and the signs and symptoms of BPH. Finasteride is a type II 5 alpha-reductase inhibitor approved for the treatment of BPH in men with an enlarged prostate.

The approved clinical data is from a Phase 3b, randomized, double-blind, placebo-controlled, 26-week trial that assessed the efficacy and safety of Cialis 5mg for once-daily use or placebo administered with finasteride 5mg in 696 men aged >45 years. 

Enrolled patients had an International Prostate Symptom Score (IPSS) >13, a urine flow rate (Qmax) of 4–15mL/sec, and a prostate volume at >30mL. IPSS is a questionnaire evaluating lower urinary tract symptoms occurring during the preceding month.

The primary endpoint of the study  was  the change in total International IPSS at 12 weeks . Results showed that symptom improvement in patients starting BPH treatment with Cialis 5mg once-daily with finasteride was greater than those starting with placebo and finasteride (-5.2 vs. -3.8; P=0.001).

The initial combination therapy is recommended for up to 26 weeks because the incremental benefit of Cialis decreases from 4 weeks until 26 weeks, and the incremental benefit of Cialis beyond 26 weeks is unknown.

For more information call (800) 654-2452 or read more about this Phase 3b study