The FDA has approved tadalafil (Cialis) for the once daily use as a treatment for benign prostatic hyperplasia (BPH). The agency also approved the medication for once daily use as a treatment for men with both erectile dysfunction (ED) and BPH. The drug had previously received FDA clearance as a treatment for ED.
The new indications for tadalafil for once daily use are based on three placebo-controlled efficacy and safety studies that included 1,989 men. Two of these studies were in men with BPH, and one study was specific to men with both ED and BPH. In the ED plus BPH study, tadalafil 5 mg for once daily use significantly improved scores on the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), a questionnaire evaluating sexual function, and the International Prostate Symptom Score (IPSS), a questionnaire evaluating symptoms of BPH.
The FDA warns that tadalafil should not be used by patients taking nitrates such as nitroglycerin, as it may cause an unsafe decrease in blood pressure.