A Drug for ED Also Approved for BPH
Fri, October 21, 2011 at 02:00AM The FDA announced in a press release that they had approved the use of Cialis® (tadalafil) to treat benign prostatic hyperplasia (BPH), a benign enlargement of the prostate gland. BPH causes a weakened urine flow, repeated stopping and starting of urination, increased frequency of urination, and having to get up to urinate at night; there may also be sudden urges to urinate, which can sometimes cause embarrassment.
Cialis is well known through its TV ads as an effective drug to treat erectile dysfunction (ED); it’s been on the market in the USA since 2003. It belongs to the same chemical class a Viagra® (sildenafil), but has a longer duration of action and can be taken as a once-a-day pill.
Two clinical studies have been submitted to the FDA that show men with BPH who took 5 mg of Cialis daily had an improvement in their symptoms, compared with men treated with a placebo. The results were measured using the International Prostate Symptom Score, and were statistically and clinically significant. A third study reviewed by the FDA showed that men with both BPH and ED who were given 5 mg daily of Cialis had improvement in both conditions, compared with those taking a placebo. A similar scoring system was used to measure ED symptoms as for BPH.
There are already several drugs available to treat the symptoms of BPH. They fall into two classes: 5-alpha-reductase inhibitors, such as Avodart® and Proscar®, which reduce the levels of dihydrotestosterone; and alpha-blockers, such as Flomax® and Cardura®, which block alpha-1 adrenergic receptors. Jalyn® is a combination of one from each of these classes.
There’s not much detail in the FDA press release. We know little of the actual clinical studies that provided the evidence of Cialis’ effectiveness in ED – how many patients, how long was the trial, what were the side effects, etc. However, Cialis has been available for 8 years, and has a good safety record, and the dose used in the ED trials was the lowest recommended (5 mg), so there can be little harm in a trial in individual patients. Many older men with BPH also have ED, making the choice of initial therapy relatively easy for their doctor’s recommendation. However, patients already on an alpha-blocker for high blood pressure or taking a nitrate (e.g. nitroglycerin) should avoid Cialis, as there may be a risk of lowering their blood pressure too much.
Reader Comments (1)
The FDA warns that tadalafil should not be used by patients taking nitrates such as nitroglycerin, as it may cause an unsafe decrease in blood pressure.