Cialis Approved to Treat Benign Prostatic Hyperplasia

Drug Alerts , News / September 26, 2016

The FDA has just approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostates becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. In 2003, Cialis was approved for the treatment of ED.

Common symptoms of BPH include difficulty in initiating urination and a weak urine stream, a sudden urge to urinate, and more frequent urination – particularly at night. The severity of these symptoms can be measured using the International Prostate Symptoms Score (IPSS).

In two clinical trials, men with BPH who took 5 mg of Cialis once daily experienced a statistically significant improvement in their symptoms of BPH, compared to men who were treated with placebo. These findings were based on a reduction in total IPS Scores.

In a third trial, men who experienced both ED and BPH who took 5 mg of Cialis once daily had improvement in both their symptoms of BPH and their ED compared to men treated with placebo. The improvement in ED was measured using the Erectile Function domain score of the International Index of Erectile Function.

Cialis should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure. Also, the use of Cialis in combination with alpha blockers, such as doxazosin, for the treatment of BPH is not recommended because the combination has not been adequately studied for the treatment of BPH, and there is a risk of lowering blood pressure.

The FDA has approved eight other drugs to treat symptoms of BPH: Proscar, (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers: Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

Cialis is manufactured by Indianapolis-based Eli Lilly and Co.

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