Cialis (Tadalafil) Approved For Benign Prostatic Hyperplasia Treatment, USA

Editor's Choice
Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Erectile Dysfunction / Premature Ejaculation
Article Date: 07 Oct 2011 - 0:00 PST


Tadalafil (Cialis) has been approved by the FDA (Food and Drug Administration) for the treatment of BPH (benign prostatic hyperplasia) signs and symptoms - a condition in which the prostate gland enlarges. It has also been approved for the treatment of simultaneous BPH and ED (erectile dysfunction). Since 2003, the medication has been on the market legally in the USA for ED treatment.

Benign prostatic hyperplasia (BPH), also called benign prostatic hypertrophy (really a misnomer), benign enlargement of the prostate (BEP), or adenofibromyomatous hyperplasia, are all terms which refer to an increase in the size of the prostate gland. Signs and symptoms can include difficulty in starting urination, a weakened urine flow which causes stopping and starting, strain when passing urine, urinating too frequently, waking up in the night often to urinate (Nocturia), sudden urges to urinate which can result in incontinence if a toilet is not found immediately, inability to fully empty the bladder during urination, and sometimes blood in urine.



Normal prostate on left, Benign prostatic hyperplasia on right


IPSS (International Prostate Symptom Score) is commonly used to measure BPH severity of symptoms. Two human studies demonstrated that patients with BPH who were prescribed 5 mg of tadalafil once a day had statistically significant improvements in BPH symptoms compared to those on a placebo. The findings were based on lower total IPSS scores.

Another study reviewed by the FDA showed that males with both BPH and ED combined who were given 5 mg of tadalafil had improvements in both conditions, compared to those in the placebo group. ED symptom improvements were measured using the Erectile Function domain score of the International Index of Erectile Function.

Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said:

"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."

Patients taking nitrates, such as nitroglycerin, should not take Cialis - those who do, run the risk of a dangerous drop in blood pressure. The FDA does not recommend Cialis use together with alpha blockers for BPH treatment because studies on their use together have not been conclusive, also there is a risk of a drop in blood pressure.

The following medications have already been approved by the FDA for BPH symptoms:

• Avodart (dutasteride)
• Jalyn (dutasteride plus tamsulosin)
• Proscar, (finasteride)
and the following alpha blockers:


• Cardura (doxazosin)
• Flomax (tamsulosin)
• Hytrin (terazosin)
• Rapaflo (silodosin)
• Uroxatral (alfuzosin)

Cialis is made and marketed by Eli Lilly and Co.

Written by Christian Nordqvist


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