New Study Shows Men Taking Cialis® (tadalafil) Tablets Once Daily Returned to Normal Erectile Function after Incomplete Response to As-Needed PDE5 Inhibitor Therapy

Eli Lilly and Company (NYSE: LLY) announced today that study results published in the Journal of Sexual Medicine showed a greater percentage of men who had an incomplete response to as-needed PDE5 inhibitor treatment returned to normal erectile function when given Cialis once daily, compared to placebo, as measured by the erectile function domain of the International Index of Erectile Function (IIEF-EF). In a pre-specified secondary measure, Cialis significantly improved erectile function scores versus placebo in those men who had an incomplete response to as-needed PDE5 treatment. Cialis is a phosphodiesterase type 5 inhibitor approved by the Food and Drug Administration (FDA) for erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH) and both ED and the signs and symptoms of BPH (ED+BPH). "PDE5 inhibitors are highly effective for most men when taken as-needed, but responses can range from minimal change to a return to normal erectile function," said Dr. Edward D. Kim, MD, of the Division of Urology, Department of Surgery, University of Tennessee Graduate School of Medicine and lead author of the study. "We believe the study outcome will help prescribers make better informed decisions when treating their patients." It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain; or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure; or if allergic to Cialis or Adcirca® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away. About the StudyThe randomized, double-blind, parallel, placebo-controlled trial was conducted in 51 sites in the United States and Canada. The study enrolled men with ED aged 18 years and older who had some response (IIEF-EF >/= 17) but were unable to reach normal erectile function (IIEF-EF <26) 5 623 while on a maximum dose of an as-needed pde5 inhibitor treatment. the study assessed whether cialis for once daily use is superior to placebo in returning these men normal erectile function. total subjects were randomly assigned receive treatment with or placebo.the primary objective was determine significantly greater percentage incomplete responders had return function when treated tadalafil 2.5 titrated mg and compared placebo. key secondary evaluation efficacy placebo, as measured by change from baseline endpoint iief-ef.the international index function-erectile domain (iief-ef) questionnaire evaluating sexual where higher scores indicate better met endpoint, resulting percentages (38.7 percent 39.6 percent, respectively) iief-ef range (>/= 26) through 12 weeks versus placebo (12.1 percent; both, p