2/7/2012 12:48 PM ET
(RTTNews) - Eli Lilly and Co. (LLY: News ) Tuesday said Cialis improved urinary symptoms and erectile dysfunction in a study of the drug in parallel with Tamsulosin in men with signs and symptoms suggestive of Benign Prostatic Hyperplasia. While Tamsulosin improved urinary symptoms, it did not improve erectile function.
Benign prostatic hyperplasia or BPH is a condition where the prostate enlarges, which can cause urinary symptoms. Erectile dysfunction or ED and BPH are conditions that may occur in the same patient. Several studies have shown that many men with ED also experience the symptoms of BPH.
Cialis for daily use is approved to treat ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions.
Eli Lilly said this was the first Cialis study to show significant improvement in signs and symptoms of BPH after one week and a significant increase in maximum urinary flow rate at 12 weeks. Both treatments significantly improved total International Prostate Symptom Score (IPSS) as early as one week. Maximum urinary flow rate or Qmax increased significantly versus placebo with both Cialis and Tamsulosin.
In the phase III study, published online by European Urology, Cialis improved ED in those men who had both signs and symptoms of BPH and ED. The study also showed that maximum urinary flow rate increased significantly versus placebo with both Cialis and Tamsulosin.
The randomized, double-blind, placebo-controlled, parallel-group, 12-week trial, conducted in 44 urology centers in 10 countries, assessed the efficacy and safety of Cialis 5 mg for daily use in parallel with Tamsulosin 0.4 mg in men aged 45 years and older with signs and symptoms of BPH.
The primary measure was the International Prostate Symptom Score (IPSS), a questionnaire evaluating lower urinary tract symptoms or LUTS occurring during the preceding month where lower scores indicate less severe LUTS.
Cialis improved IPSS total scores by 2.1 through 12 weeks versus placebo. Tamsulosin improved IPSS total scores by 1.5 through 12 weeks versus placebo. The maximum score is 35 with lower scores indicating less severe LUTS.
The IIEF-EF domain, where higher scores indicate better erectile function, improved with Cialis versus placebo but not with tamsulosin versus placebo. The score improved by 4.0 for Cialis while decreasing 0.4 for Tamsulosin.
The proportion of subjects reporting at least one treatment-emergent adverse event was: Cialis 23.4 percent, Tamsulosin 23.8 percent and placebo 20.3 percent.
The study did not directly compare Cialis versus Tamsulosin.
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