There is an increasing amount of information, especially on the internet, about a drug called dutasteride. The brand name is Avodart® and it is manufactured by Glaxo Smith Kline. This is a drug similar to finasteride (Propecia®) in that it inhibits formation of DHT, the hormone that causes male-pattern baldness.
At the present time, dutasteride (Avodart®) is only approved by the FDA for the treatment of BPH (enlarged prostate), so if it were to be prescribed for hair loss, it would be considered 'off-label use'. That means that there is no formal FDA approval for prescribing this drug for hair loss.
On the other hand, Propecia® has been around for quite a while. This drug has proven itself to be an extremely effective medication to stop hair loss and is known to stabilize a baldness pattern in 90% of the patients who use it. It has established success with increasing the hair count in 60% of its users, especially in the top and crown areas of the scalp. The side effect profile for Propecia® shows that 2% of patients do claim some decrease in libido while taking the drug, which reverses itself when the medication is discontinued.
Propecia® was approved in 1985 when it was first prescribed for BPH. So, after twenty years, we have a fairly good track record of its effects and side effects. Avodart®, on the other hand, is a new drug, and we have far less experience with its long-term use. A very limited study of Avodart® showed that at 24 weeks of treatment, it was more effective in increasing hair counts than 5 mg. of finasteride. Although finasteride is the same drug as Propecia®, Propecia® is marketed in 1 mg doses, since research showed that 1 mg and 5 mg have the same effect on hair growth.
Although the Avodart® study showed that one capsule was more effective than finasteride and five capsules were even more effective, the trials have been very limited and further research is needed to confirm these results and its side effects for longterm use. From the limited data reported, the side effect profile of Avodart® indicated that decreased libido was more frequent in the group taking five capsules a day, while the group taking one capsule a day reported the decreased libido side effects similar to the 1 mg Propecia® (1-2%). This data is all preliminary and we are awaiting further studies before making Avodart® a regularly prescribed drug for hereditary hair loss. However, it does appear that Avodart® may be more effective than Propecia®, and it may be a suitable alternative for the 10% of patients who fail to respond to Propecia® therapy.
Propecia®, the only FDA-approved prescription medication for hair loss, reported global sales of $270 million in 2004. Another significant finding is that Americans spent $59 million on over-thecounter remedies for hair loss in the same year.
In the last issue of the Miami Hair Journal, we mentioned that Proscar®, another drug that is actually 5 mg of finasteride, was being used in a prostate cancer prevention study of 19,000 men and was showing confusing results. While 25% of the patients on Proscar® showed a decrease in the number of prostate cancers, it was found that use in this dosage actually put them at greater risk for developing a more aggressive form of prostate cancer. This issue was addressed in great detail by a panel of the most prominent urinary pathologists in the country. Their findings indicated that detection of the high number of aggressive cancers in the finasteride-treated group was related to the fact that as their enlarged prostates became smaller, the biopsies were better able to locate and detect aggressive cancers.
That makes us much more comfortable in prescribing Propecia® (1 mg of finasteride), and as far as a 5 mg dose, we see it as having the positive effect of shrinking an enlarged prostate to the point of enabling a urologist to make an early detection of a preexisting prostate tumor by needle biopsy. The conclusion is that finasteride actually aids in the detection of prostate cancer.
As you may already know, the only FDA approved treatments for male pattern hair loss or hereditary hair loss in men are Propecia® or Rogaine® (minoxidil). Patients are always asking me how the two treatments compare.
Propecia® is a pill that works systemically and Rogaine® is a lotion with a topical application. So, as you can see, they work by different mechanisms. A recent study involving 65 male patients in a 12- month trial compared Propecia® (1 mg finasteride) to 5% minoxidil. The results were fairly conclusive to what we already knew. Hair density was increased in 80% of the Propecia®-treated group and only 52% in the 5% minoxidil group. Once again, this demonstrated that Propecia®, when compared to minoxidil, is much more effective. As far as side effects, however, 1% of the patients on Propecia® complained of loss of libido, while only one patient on the minoxidil complained of scalp irritation. In conclusion, both medications proved to be safe and effective, and all side effects disappeared when the medications were discontinued.
It has also been shown that a patient using both therapies, Propecia® taken by mouth and minoxidil applied on the scalp, can expect a greater response. Minoxidil plus Propecia® have a more productive response, which has been supported by the fact that when minoxidil is withdrawn while on both therapies, patients show a decline in growth and eventual hair loss.
All News