THURSDAY, Oct. 6 (HealthDay News) -- The U.S. Food and Drug Administration announced late Thursday that it had approved using the erectile dysfunction drug Cialis as a treatment for enlarged prostate.
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According to the U.S. National Institutes of Health, enlarged prostate -- clinically known as benign prostatic hyperplasia (BPH) -- is a "common part of aging" for men. In fact, the NIH estimates that "more than half of men in their 60s, and as many as 90% in their 70s and 80s, have some symptoms of BPH."
The condition often leads to urinary incontinence and can raise the odds for urinary tract infections and even kidney damage.
"BPH can have a big impact on a patient's quality of life," Scott Monroe, director of the division of reproductive and urologic products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "A large number of older men have symptoms of BPH. Cialis [tadalifil] offers these men another treatment option, particularly those who also have ED, which is also common in older men," he said.
The FDA said its approval was made on the basis of three studies. Two of the studies looked at changes in BPH symptom severity based on the International Prostate Symptom Score. Those trials found that men who took the 5-milligram dose of Cialis one per day experienced an improvement in BPH symptoms vs. men who took a dummy pill.
A third study, which involved men who suffered from both impotence and enlarged prostate, found that the daily 5-milligram dose of Cialis improved symptoms for both conditions.
The FDA warned that Cialis, which is made by Eli Lilly and Co., "should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure." People taking heart medications known as alpha blockers should also avoid Cialis because its use alongside these drugs has not yet been studied and the combination might lower blood pressure.
Other drugs have already received FDA approval for the treatment of BPH. These include Proscar, (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).
-- HealthDay Staff
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SOURCE: Oct. 6, 2011, news release, U.S. Food and Drug Administration