Cialis gets FDA clearance for treatment of benign prostatic hyperplasia

Kathleen Blanchard's picture
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Medications to treat enlarged prostate – benign prostatic hyperplasia (BPH) often have side effects of sexual dysfunction that can make taking the medications difficult for men. Now the FDA has approved Cialis, a drug used for erectile dysfunction (ED), for treatment of symptoms of BPH.

Cialis treats both BPH and erectile dysfunction

The medication can help men with sexual dysfunction at the same time by treating ED, which often accompanies BPH.

Cialis (tidalafil) works differently than currently used alpha blockers prescribed for enlarged prostate, though researchers aren’t sure of the exact mechanism of how it improves BPH symptoms.

Examples of the alpha blockers include Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

Cialis relaxes blood vessels to increase blood flow to the penis. The drug inhibits an enzyme called phosphodiesterase type 5 (PDE5).

Alpha blockers, which are also used in combination with other drugs to treat high blood pressure, also relax blood vessels to improve blood flow for treatment of benign prostatic hyperplasia. Alpha blockers inhibit release of the hormone norepinephrine (noradrenaline).

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Improved blood flow and relaxed blood vessels treat symptoms of BPH by improving urine flow. Symptoms include weak urine stream, urinary urgency, especially at night and urinary leakage.

Two trials showed men given 5 mg of Cialis daily had significant improvements in symptoms of benign prostatic hyperplasia. In a third trial, men with both ED and BPH also experienced improvement.

For the trials BPH severity scores were measured using the International Prostate Symptom Score (IPSS). The Erectile Function domain score of the International Index of Erectile Function was used to find improvement in ED.

The studies included 1,989 men. Cialis was compared to placebo in the trials.

“BPH can have a big impact on a patient’s quality of life,” said Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “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.”

Cialis is manufactured by Indianapolis-based Eli Lilly and Co. Dave Ricks, Lilly USA President said in a press release, “We’re encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH.”

Men who take nitrate drugs for heart disease should not take Cialis. Nitrates are commonly used to treat chest pain associated with coronary artery disease. Examples include nitroglycerin and isosorbide. Taking Cialis with nitrates can lead to severe drops in blood pressure. As with any drug, rash or hives can occur from allergic reaction to any of the components in Cialis.

Men diagnosed with benign prostatic hyperplasia should speak with their health care providers about using Cialis for BPH treatment, which should also not be used with other medications to treat enlarged prostate.

Image credit: Wikimedia commons

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