Cialis: Phase III data

A double-blind, international Phase III trial in 511 men aged 45 years and older with signs and symptoms of BPH showed that once-daily 5 mg Cialis met the primary endpoint of significantly improving IPSS scores from baseline to week 12 vs. placebo (2.1 point greater reduction relative to placebo, p=0.001). The active control tamsulosin also met the endpoint vs. placebo (1.5 point greater reduction relative to placebo, p=0.023). On secondary endpoints, Cialis and tamsulosin both significantly improved BII scores (p=0.003 and p=0.026) and maximum urinary flow rate (p=0.009 and p=0.014) from baseline to week 12 vs. placebo. Cialis also significantly improved IPSS Quality of Life Index and TSS-BPH scores vs. placebo (p<0.05 for both), while tamsulosin missed both endpoints (p>0.1 for both). Furthermore, Cialis significantly improved IEF EF scores vs. placebo in sexually active men with both ED and signs and symptoms of BPH (p<0.0001), but tamsulosin missed the endpoint (p=0.07). Eli Lilly said the trial was not powered to demonstrate non-inferiority of Cialis to tamsulosin or for direct comparisons between the active treatment arms. Data were published in European Urology. ...