Tadalafil (Page 8 of 12)

14.2 Tadalafil Tablets for Once Daily Use for ED

The efficacy and safety of tadalafil for once daily use in the treatment of erectile dysfunction has been evaluated in 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853 patients. Tadalafil, when taken once daily, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).

Tadalafil was studied in the general ED population in 2 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12- and 24-weeks duration, respectively. One of these studies was conducted in the United States and one was conducted in centers outside the US. An additional efficacy and safety study was performed in ED patients with diabetes mellitus. Tadalafil was taken once daily at doses ranging from 2.5 mg to 10 mg. Food and alcohol intake were not restricted. Timing of sexual activity was not restricted relative to when patients took tadalafil.

Results in General ED Population — The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years). The population was 86% White, 6% Black, 6% Hispanic, and 2% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (> 96%) patients reported ED of at least 1-year duration.

The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years). The population was 86% White, 3% Black, 0.4% Hispanic, and 10% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Ninety-three percent of patients reported ED of at least 1-year duration.

In each of these trials, conducted without regard to the timing of dose and sexual intercourse, tadalafil demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 17). When taken as directed, tadalafil was effective at improving erectile function.

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

T able 17: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Tadalafil for Once Daily Use Studies

Study Ha

Study Ib

Placebo

Tadalafil 2.5 mg

Tadalafil 5 mg

Placebo

Tadalafil 5 mg

(N=94)

(N=96)

(N=97)

p-value

(N=54)

(N=109)

p-value

EF Domain Score

Endpoint

14.6

19.1

20.8

15.0

22.8

Change from baseline

1.2

6.1c

7.0c

<.001

0.9

9.7c

<.001

Insertion of Penis (SEP2)

Endpoint

51%

65%

71%

52%

79%

Change from baseline

5%

24%c

26%c

<.001

11%

37%c

<.001

Maintenance of Erection (SEP3)

Endpoint

31%

50%

57%

37%

67%

Change from baseline

10%

31%c

35%c

<.001

13%

46%c

<.001

a Twenty-four-week study conducted in the US.

b Twelve-week study conducted outside the US.

c Statistically significantly different from placebo.

Efficacy Results in ED Patients with Diabetes Mellitus — Tadalafil for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. Patients with diabetes were included in both studies in the general ED population (N=79). A third randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design trial included only ED patients with type 1 or type 2 diabetes (N=298). In this third trial, tadalafil demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 18).

T able 18: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil fo r Once Daily Use Study in ED Patients with Diabetes

Placebo

Tadalafil 2.5 mg

Tadalafil 5 mg

(N=100)

(N=100)

(N=98)

p-value

EF Domain Score

Endpoint

14.7

18.3

17.2

Change from baseline

1.3

4.8a

4.5a

<.001

Insertion of Penis (SEP2)

Endpoint

43%

62%

61%

Change from baseline

5%

21%a

29%a

<.001

Maintenance of Erection (SEP3)

Endpoint

28%

46%

41%

Change from baseline

8%

26%a

25%a

<.001

a Statistically significantly different from placebo.

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