CIALIS 5 mg once daily versus placebo in two programs

01U.S. once-daily program

One U.S. program randomized 287 men to once-daily CIALIS or placebo. 97 people took 5 mg. 94 people took placebo. At endpoint, EF Domain scores were 20.8 on 5 mg and 14.6 on placebo. SEP2 rates were 71% on 5 mg and 51% on placebo. SEP3 rates were 57% on 5 mg and 31% on placebo.

02Who sat in the once-daily ED programs

Three once-daily ED programs enrolled 853 men. Two of those programs lasted 12 weeks. One lasted 24 weeks.

The two general-ED programs were randomized, multicenter, double-blind, placebo-controlled, parallel-arm studies. One ran in the United States. One ran outside the United States. A third program enrolled only men with type 1 or type 2 diabetes and erectile dysfunction.

Daily doses in those programs ranged from 2.5 to 10 mg. Food and alcohol were not restricted. Sexual activity was not timed to the tablet.

The U.S. general-ED program enrolled 287 men. Mean age was 59 years, range 25 to 82. The group was 86% White, 6% Black, 6% Hispanic, and 2% other ethnicities. Most men, more than 96%, had had erectile dysfunction for at least a year. The program included organic, psychogenic, and mixed etiologies, and it included men with diabetes, hypertension, and other cardiovascular disease.

The program outside the United States enrolled 268 men. Mean age was 56 years, range 21 to 78. That group was 86% White, 3% Black, 0.4% Hispanic, and 10% other ethnicities. Ninety-three percent of those men had had erectile dysfunction for at least a year. The same mix of etiologies and the same class of co-morbid conditions sat in that cohort.

Men with diabetes also sat inside the two general-ED programs (79 people). The diabetes-only program enrolled 298 men.

In the 6-month double-blind stretch, the treatment effect of CIALIS did not diminish over time.

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03Diabetes once-daily program

One once-daily program in men with type 1 or type 2 diabetes and erectile dysfunction randomized 298 people. 98 people took CIALIS 5 mg. 100 people took placebo. At endpoint, EF Domain scores were 17.2 on 5 mg and 14.7 on placebo. SEP2 rates were 61% on 5 mg and 43% on placebo. SEP3 rates were 41% on 5 mg and 28% on placebo.