Cialis approved by FDA for benign prostatic hyperplasia

The FDA has approved Cialis (tadalafil) on October 6 to treat the signs and symptoms of benign prostatic hyperplasia (BPH), and for the treatment of BPH and ED.

“BPH can have a big impact on a patient’s quality of life. A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men,” said Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research.

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).

Benign prostatic hyperplasia (benign prostatic hypertrophy, benign enlargement of the prostate, adenofibromyomatous hyperplasia), is a condition in which the size of the prostate is increased. Around half of men over 50 suffer from prostate conditions, and difficulty urinating.

Tadalafil is a phosphodiesterase type 5 inhibitor (PDE5 inhibitor), used for treating erectile dysfunction as Cialis, and as Adcirca for pulmonary arterial hypertension. PDE5 inhibitor relaxes the blood vessels supplying the corpus cavernosum.

Cialis was approved by FDA in 2003 the third ED prescription pill, after sildenafil citrate (Viagara) and vardenafil (Levitra). All of them are as needed medication. Cialis, the weekend pill, has 36-hour effectiveness and can be take as once-daily medication.

Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night.

The severity of symptoms of BPH can be measured using the International Prostate Symptom 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.

The trials based their findings on a reduction in total IPSS scores.

In a third study, men who experienced both ED and BPH took 5 mg of Cialis once daily and had improvement in both their symptoms compared to men who were treated with placebo.

Cialis should not be used in patients taking nitrates (nitroglycerin, isosorbide dinitrate), often prescribed for chest pain (ischemic heart disease), or if a person takes recreational drugs, poppers (amyl nitrite, butyl nitrite). The combination can cause an unsafe decrease in blood pressure.

The use of Cialis in combination with alpha blockers 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.

Cialis is manufactured by Indianapolis-based Eli Lilly and Co. The longer-lasting Cialis could overtake Pfizer’s drug and become the market leader for ED drugs, said John Lechleiter, Eli Lilly CEO, in July 2011.