First Phase 3 Data Show Cialis Improved Sexual Function in Men With Difficult to Treat, Diabetes-related ED
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The first Phase 3 study for Cialis, a new PDE5 inhibitor being developed by Lilly ICOS LLC to treat erectile dysfunction (ED), showed strong results among one of the most difficult to treat populations of men with ED. The findings–to be released tomorrow at the European Association of Urology Meeting (EAU)–demonstrated that 64 percent of men with diabetes-related impotence taking Cialis 20 mg on demand reported improved erections.
“The impairment of nerve and blood vessel function that accompanies diabetes makes ED prevalent and particularly difficult to treat in this population,” said Professor Inigo Saenz de Tejada, of the Foundation for Research and Development in Andrology in Madrid, Spain. “This study, alongside previously released data, suggests on demand Cialis may help most men with impotence regain sexual function, regardless of cause or severity.” Tejada noted that while direct comparisons cannot be made to the clinical trial results of other ED compounds in patients with diabetes, the 74 percent response rate seen in this Cialis study is impressive.
Sexual function or enhanced erections significantly improved across all study endpoints
In this Phase 3 study, 216 men with mild-to-severe diabetes-related impotence were randomized to receive either placebo or Cialis at doses of up to 20 mg for 12 weeks. Results indicated 74 percent of men taking Cialis 20 mg reported improved erections, compared to 25 percent for placebo. Treatment with Cialis significantly improved sexual function compared to placebo across all primary and secondary study endpoints, regardless of patient age, duration and severity of impotence or diabetes.
Importantly, study participants reflected a broad cross-section of men with diabetes and included those with poor glucose control, diabetic retinopathy
(damage to the retina in the eyes), and diabetic kidney disease. Despite including men with these diabetes-related complications, few side effects were reported in this study. Headache and dyspepsia (indigestion) were the only side effects reported by greater than five percent of study participants. Researchers observed no significant changes in clinical laboratory values, ECGs (electrocardiograms) or blood pressure in this trial. In addition, Cialis use was not associated with disturbances in color vision for men in the study, including those with diabetic retinopathy. Of the side effects that were reported, the majority were mild-to-moderate and appeared to diminish with continued treatment. Few patients discontinued treatment due to side effects.
Additional results from the Cialis global Phase 3 program will be presented at scientific meetings later this year.
Phase 2: Up to 88 percent of men with ED of varying etiologies reported improvement
Findings from a Cialis Phase 2 study are also to be presented at this meeting. In this study, a broad population of impotence sufferers of varying severity and causes (including men with diabetes) took Cialis on demand at doses of up to 25 mg for eight weeks. Results indicated that up to 88 percent of men taking Cialis reported significantly improved erections, compared with 28 percent of those taking placebo. Headache and dyspepsia were the only side effects reported by greater than five percent of all Cialis-treated study participants.
Several measures of sexual function and satisfaction indicate Cialis superior to placebo