Dutasteride (Avodart, Avolve) - a new, emerging treatment for hair loss DutasterideDIRECT.com is your online source for news and information on the latest treatments for hair loss. This FAQ has been compiled from a number of sources to give an overview of the use and effects of Dutasteride.

What is Dutasteride (Avodart, Avolve)?
Avolve is the European brand name for Dutasteride, an oral medicine made by GlaxoSmithKline for treating symptomatic benign prostatic hyperplasia (BPH) in men.

The active compound in Avolve, Dutasteride, has the added benefit of treating genetic male pattern hair loss on the vertex (top of the head) and the mid-scalp area. Dutasteride is chemically similar to Finasteride, the active compound in Propecia.

Avolve is also known by its US brand name, Avodart. The medicine has been approved by the US Food & Drug Administration, and in Europe, for treating BPH. Avolve is supplied in 0.5mg soft gelatin capsules.

How does Avolve work?
Researchers have discovered that men who suffer from benign prostatic hyperplasia (BPH), or from male pattern hair loss, 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.

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

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

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

What studies and trials have been done concerning Avolve?
A total of 2951 men with moderate to severe BPH were treated with 0.5 mg Avolve (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.

GlaxoSmithKline also completed Phase II trials for FDA approval of Avolve for treating 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 Avolve daily, compared to an average 72 hairs with 5mg Propecia (Finasteride) daily.

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

When will Avolve be approved for treating hair loss?
In November 2002 GlaxoSmithKline cancelled its planned Phase 3 trials for Avolve for treating hair loss. The company has not publicly given a reason for this. Industry sources speculate that the trials were stopped because the maker thinks Avolve will be perceived as too similar to Propecia in consumers' minds, and may not generate sufficient return on investment to justify the cost of the approvals process as a treatment for hair loss.

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

Will Avolve help hair re-growth for all men?
As with Propecia, Avolve 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 Avolve can significantly reduce or delay hair loss. Note that Avolve is not yet approved for treating hair loss: its effects are a side-effect of its actions against BPH.

Is Avolve safe?
Clinical trials showed that it was generally well tolerated. Most side effects were mild or moderate and generally went away while on treatment in both the Avolve 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%).
Avolve 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 Avolve 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 Avolve.



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