Cialis Clinical Pharmacology

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Cialis - Clinical Pharmacology [tadalafil]

Effects on Exercise Stress Testing ?

The effects of tadalafil on cardiac function, hemodynamics, and exercise tolerance were investigated in a single clinical pharmacology study. In this blinded crossover trial, 23 subjects with stable coronary artery disease and evidence of exercise-induced cardiac ischemia were enrolled. The primary endpoint was time to cardiac ischemia. The mean difference in total exercise time was 3 seconds (tadalafil 10 mg minus placebo), which represented no clinically meaningful difference.

Further statistical analysis demonstrated that tadalafil was non-inferior to placebo with respect to time to ischemia. Of note, in this study, in some subjects who received tadalafil followed by sublingual nitroglycerin in the post-exercise period, clinically significant reductions in blood pressure were observed, consistent with the augmentation by tadalafil of the blood-pressure-lowering effects of nitrates.

Effects on Vision ? Single oral doses of phosphodiesterase inhibitors have demonstrated transient dose-related impairment of color discrimination (blue/ green), using the

Time (Hours)
-10
-8
-6
-4
-2
0
2
4
6

4 8 24 48 72 96
Supine Diastolic BP
0

Difference
(Tadalafil
minus
Placebo,

mmHg)

-10
-8
-6
-4
-2
0
2
4
6

4 8 24 48 72 96
Standing Systolic BP
0 -10
-8
-6
-4
-2
0
2
4
6

4 8 24 48 72 96
Standing Diastolic BP
0

Time (Hours)
Difference
(Tadalafil
minus
Placebo,

mmHg)

-10
-8
-6
-4
-2
0
2
4
6

4 8 24 48 72 96
Supine Systolic BP
0
Time (Hours)

-10
-8
-6
-4
-2
0
2
4
6

4 8 24 48 72 96
Supine Diastolic BP
0

Difference
(Tadalafil
minus
Placebo,

mmHg)

-10
-8
-6
-4
-2
0
2
4
6

4 8 24 48 72 96
Standing Systolic BP
0 -10
-8
-6
-4
-2
0
2
4
6

4 8 24 48 72 96
Standing Diastolic BP
0

Time (Hours)
Difference
(Tadalafil
minus
Placebo,

mmHg)

-10
-8
-6
-4
-2
0
2
4
6

4 8 24 48 72 96
Supine Systolic BP

Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. In a study to assess the effects of a single dose of tadalafil 40 mg on vision (N= 59), no effects were observed on visual acuity, intraocular pressure, or pupillometry. Across all clinical studies with CIALIS, reports of changes in color vision were rare (< 0.1% of patients).