The US Food and Drug Administration (FDA) has approved Cialis (tadalafil) tablets by Eli Lilly and Company for once daily use to treat men who have erectile dysfunction and symptoms of benign prostatic hyperplasia (ED+BPH).
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Cialis inhibits an enzyme, phosphodiesterase type 5 (PDE5), producing vascular relaxation and increased blood flow.
Cialis was assessed in a clinical trial program of three placebo-controlled efficacy and safety studies, comprising 1,989 men.
One study was specific to men with both ED and BPH, while two of these studies were carried out in men with only BPH .
In the ED+BPH study, Cialis 5 mg for once daily use demonstrated an improved score on International Index of Erectile Function-Erectile Function Domain (IIEF-EF), and the International Prostate Symptom Score (IPSS).
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