Dutasteride ( Avodart / Avolve )?

Dutasteride is the active compound in a new oral medicine made by GlaxoSmithKline, which has proved very effective in treating genetic male pattern hair loss on the vertex (top of the head) and the mid-scalp area.

The medicine has been approved for prescription by the US Food & Drug Administration, and in Europe. The US brand name for the new medicine is Avodart. It is also known by its European brand name, Avolve.

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Things you will need to know about Dutasteride before you buy.

Why was Dutasteride developed?
Dutasteride was developed for treating symptomatic benign prostatic hyperplasia (BPH) in men. Dutasteride is chemically similar to Finasteride, the active compound in Propecia, but has proven more effective in clinical trials. Like Propecia, Dutasteride has proved to be effective in treating male pattern hair loss as well as BPH.

How does Dutasteride work?
Researchers have discovered that men who suffer from either male pattern hair loss or benign prostatic hyperplasia (BPH), have increased levels of the hormone dihydrotestosterone (DHT).

DHT is produced from testosterone by an enzyme called 5-alpha-reductase. Biochemical analysis reveals higher levels of 5-alpha-reductase in the bloodstream of men with BPH, and in the scalps of men with hair loss; and less of this enzyme in men with no BPH or no hair loss.

Dutasteride inhibits 5-alpha-reductase, blocking the formation of DHT. This interrupts a key trigger element in development of male pattern hair loss and in development of BPH.

How is Dutasteride different from Propecia?
Both medicines work in a similar way. However, Dutasteride inhibits the activities of two types of 5-alpha-reductase enzymes. In contrast, Propecia (Finasteride) only inhibits one type. Dutasteride has been shown to decrease levels of DHT by 90% after only two weeks, making it a more powerful and faster-acting weapon against hair loss and BPH than Finasteride.

What is dihydrotesterone (DHT)?
DHT is one of several male hormones in the body. DHT is responsible for the development of the external genitals in the male foetus. However, in adult males DHT appears to cause:

• male pattern hair loss
• prostate enlargement
• shortening of the growing phase of hair
• progressive miniaturisation of hair follicles
• decreasing number of visible hairs
• acne

What studies and trials have been done concerning Dutasteride?
GlaxoSmithKline completed Phase II trials for FDA approval of Dutasteride for treating male pattern baldness hair loss. After six month of treatment, the hair counts measured in a 1 inch diameter circle increased by an average 96 hairs with 0.5mg Dutasteride, compared to an average 72 hairs with 5mg Propecia (Finasteride). The drug was shown to be well tolerated.

Also, a total of 2951 men with moderate to severe BPH were treated with 0.5 mg Dutasteride daily. The study found that acute urinary retention was reduced by 57%, and the risk of benign prostatic hyperplasia-related surgical intervention was cut by 48% compared with placebo. The drug was shown to be well tolerated.

So these initial trials show that Dutasteride is around 30% more effective than Propecia in promoting hair regrowth. However, please note that Dutasteride has only been specifically approved for treating BPH. It has not yet been approved specifically for treating hair loss.

When will Dutasteride be approved for treating hair loss?
In November 2002 GlaxoSmithKline cancelled its planned Phase 3 trials for Dutasteride for treating hair loss. The company has not publicly given a reason for this.

However, industry sources speculate that the reason is commercial rather than medical: the suggestion is that trials were stopped because the maker thinks Dutasteride will be perceived as too similar to Propecia in consumers' minds, and may not generate sufficient return on investment to justify the cost of approvals as a treatment for hair loss.

However, Dutasteride is approved by the US FDA and by European bodies for the treatment of BPH, and so has passed all relevant safety standards.

Will Dutasteride help hair re-growth for all men?
As with Propecia, Dutasteride increases the number of scalp hairs, helping to fill-in thin areas of the scalp. Although results will vary, generally men will not re-grow all of the hair they have lost. Male pattern hair loss occurs gradually over time, but Dutasteride can significantly reduce or delay hair loss.

How should I take Dutasteride?
Dutasteride is supplied as gel-filled capsules with 0.5mg dosage (GSK's Avodart). Take dutasteride exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water, swallow the capsules whole. Do not chew, crush or break the capsules. Dutasteride can be taken with or without food.

What dosage should I take?
You should only take the dose as recommended by your doctor. Do not change the dose without consulting your doctor.

Effectiveness of Dutasteride has been evaluated at different daily dosages, ranging from 0.01mg, 0.05mg, 0.5mg, 2.5mg, and 5.0mg per day.

It was found that the highest suppression of DHT was achieved with 2.5mg or 5.0mg per day. At a daily dosage of 2.5mg or 5.0mg, Dutasteride suppresses close to 100% of DHT. This compares favourably with 5.0mg daily dosage of Propecia (Finasteride) which suppresses only 70% of DHT.

You should note, however, that Dutasteride is very effective at small doses. At a daily dose of 0.5mg, DHT inhibition is close to 90%. Also, the level of DHT suppression is not significantly greater between 2.5mg and 5.0 mg.

Is Dutasteride safe?
Clinical trials showed that it was generally well tolerated. Most side effects were mild, and generally went away while on treatment in both the Dutasteride and placebo groups.

Drug-related side effects during the first six months were as follows:

• impotence (4.7% vs. 1.7% for placebo)
• decreased libido (3% vs. 1.4%)
• breast tenderness and breast enlargement (gynecomastia; 0.5% vs. 0.2%)
• ejaculation disorders (1.4% vs. 0.5%).

Dutasteride should not be used in women and children. Women who are pregnant or may become pregnant should not handle this medicine because of possibility of absorption and subsequent potential risk to a male foetus.

Men treated with Dutasteride should not donate blood until at least six months after their final dose to prevent the medicine going to a pregnant woman through a blood transfusion.

Men with liver disease should talk to their doctor before taking Dutasteride.

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