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Dutasteride (Avodart) Now in the Drugstores

Dutasteride is the generic name for the new prostate drug that is now being marketed as Avodart. This dual (type l and type ll) 5 alpha-reductase inhibitor is made by GlaxoSmithKline.

The drug has been approved by the FDA for the treatment of benign prostatic hyperplasia (BPH). The active ingredient in Avodart may also benefit men with male pattern baldness (MPB). It does this by inhibiting both types of the enzyme 5 alpha-reductase. This is the enzyme that converts testosterone circulating in the bloodstream into DHT. DHT is the main cause of prostate hyperplasia (enlargement) and hair loss in males. Studies indicate that Avodart lowers levels of DHT by almost 90 percent in a two week period.

Comment: Well, dutasteride is now in the drugstores and it's called Avodart. It's a prescription drug specifically for benign prostatic hyperplasia (BPH). The drug was tested on men between the ages of 47 and 94 (the average being 66) for this condition.

But I'm sure that an enlarged prostate gland is not on the minds of the men visiting this site. The questions men are asking here (and the drug is only for men) are these:

1. How can I get dutasteride if I need a prescription and don't have one? That's a problem. Doctors will be reluctant to write a prescription for this drug if a man is suffering from hair loss and not BPH. If a doctor is a good friend, though, he or she might be a little flexible here. Continue to the next section to find another way to get around the prescription angle. (If the drug is used for something other than what it is prescribed for and there are side effects, no legal action can be taken.)

2. How much does it cost? Go to a drugstore and pay from $90 to $95 for 30 capsules (0.5mg). Click on and you get the same 30 caps for $74.77 and 90 caps for $211.99. If you don't have a prescription and you can't get one, you can click on and get hit with a wallet-buster - one bottle (100 capsules of Avodart 0.5mg) $425. This overseas company gives you a great break, though, if you order two bottles - $800.

3. How effective will the drug be in halting hair loss and in growing new hair? A Phase II clinical trial was conducted to test the effectiveness of dutasteride for hair loss. In a Phase ll study, a drug is administered to a relatively small group of people to see if the drug does what it's supposed to, and to see if it's safe. The results of the Phase ll study indicate that dutasteride is more effective than Propecia (finasteride) or much more effective than Propecia depending on the dose. Effectiveness is defined as either maintenance of hair or growth of new hair. Photos show significant growth of new hair in the crown area after using dutasteride for six months. 

A phase lll clinical trial for dutasteride as a hair-loss treatment is scheduled to begin in February or March of 2003. Phase lll studies are conducted with a large group of people (1000 to 4000), some of whom are given the specific drug and some of whom are given a placebo. This large-scale study will confirm the effectiveness of the drug, monitor its side effects, and compare its effectiveness with other treatments. So it looks like we'll have to wait for the results of this study before any definitive evaluation can be made.

4. What will be the proper dose? Glaxo tested doses of 0.1, 0.5, 1.0, and 2.5mg. The higher the dose, the better in inhibiting 5 alpha-reductase - but not by much. Glaxo settled on 0.5mg for Avodart, but no one knows what the recommended dose for hair-loss treatment will be. I'm sure, though, that people who can get the drug will be experimenting with different doses and posting their results on the various hair-related Web sites. 

5. What are the potential short-term and long-term side effects? I saved the best for last. No one can intelligently speculate on the long-term side effects of this drug because the drug is new - and long term by definition is long term. But there can be educated speculation about the short-term side effects. Glaxo states that there were no serious side effects. Here is a list of the "nonserious" side effects: impotence, ejaculatory disorders, decreased sex drive, abnormally large breasts in the male (gynecomastia), increased blood estrogen and testosterone, etc. These side effects were found in from 1 to 3 percent of the men in the clinical trails. Some of the men who experienced these side effects dropped out of the trials early. (Dutasteride remains in the blood up to six months after discontinuation.)

Some professionals expect perhaps double the side effects of Propecia. When the hormone balance is tampered with - depletion of DHT from tissues, excess of estrogen and testosterone - something has to give in a small number of users.

So that's the story. It's good news tempered with a few warnings. Many will rush in and take their chances. Others may wait till the smoke clears a little. (Dutasteride for hair loss is expected to be on the market in 2006 if it gets approval from the FDA.) Since hair loss is a strong emotional issue, one can't be too critical of people who go all out no matter what the risk. But still a little caution here might be appropriate.

December 12, 2002 - I just learned that GlaxoSmithKline cancelled their Phase lll clinical trials of Dutasteride as a hair loss drug. A statement said that the drug is not sufficiently differentiated from Propecia. There is speculation that the company is afraid of law suits coming from people who would use the drug for hair loss and might suffer some side effects.

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