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New Study Of Cialis® (tadalafil) Tablets Co-administered With Finasteride Meets Primary Endpoint In Men With Lower Urinary Tract Symptoms Of Benign Prostatic Hyperplasia

INDIANAPOLIS, March 18, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) presented results today at the annual European Association of Urology (EAU) Congress in Milan, Italy, of a study that showed Cialis 5 mg once daily co-administered with finasteride 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, Cialis/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 Cialis and finasteride in men with LUTS/BPH. Cialis 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.

"Symptomatic improvement with 5-ARI therapy (finasteride) is observed after six to twelve months of treatment; therefore, the study aimed to understand if men with prostatic enlargement experience earlier improvement of BPH symptoms when tadalafil is co-administered with a 5-ARI therapy," said Claus Roehrborn, MD, chairman, Department of Urology, The University of Texas Southwestern Medical Center, who presented the results during the EAU Congress. "These results can help prescribers make better informed decisions when treating their patients."

About the Study The randomized, double-blind, placebo-controlled, 26-week trial assessed the efficacy and safety of Cialis 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.

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