Dutasteride / Avodart and Hair Loss
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More Dutasteride Information | More | Press | Trials | Press | FDA
Overview
It must be stressed that Avodart is prescribed for Benign Prostatic Hyperplasia ( BPH ) and not for hair loss.
Propecia was first developed for prostate and then later hair loss.
Hair loss is a side effect of these drugs and they were not designed specifically for hair loss.
Avodart is only available by prescription, and many doctors will not give a prescription for the drug as it is purely for BPH not hair loss.
About Avodart
Benign Prostatic Hyperplasia ( BPH ) is one of the most common health problems in older men. BPH often begins after age 50 and can progress and worsen as men age. More than half of men over the age of 60 experience BPH, and by age 80 nearly 80% of men have the disease.
Avodart, a second-generation 5 alpha-reductase inhibitor, is the first and only medicine to inhibit both the type 1 and type 2 enzymes responsible for the conversion of testosterone to DHT (dihydrotestosterone), the primary cause of prostate growth. Advodart's dual inhibition decreases levels of DHT by 90 percent at two weeks and 93 percent at two years.
Dosage
Physical properties of Avodart:
1) white-yellowish powder.
2) insoluble in water
3) easily dissolves in ethanol (44mg/mL), methanol (64 mg/mL) and polyethylene glycol 400 (3mg/mL).
Dutasteride is active ingredient of Avodart.
Avodart dosage is 0.5mg in soft gelatin capsule.
The capsule is compounded by dissolving 0.5mg of dutaseride in a combination of mono-di-glycerides caprylic/capric acid and butylated hydroxytoluene. Other ingredients are included.
Effectiveness of Dutasteride was evaluated at different daily dosage, ranging from 0.01 mg, 0.05 mg, 0.5 mg, 2.5 mg, and 5.0 mg per day.
It was found that the highest suppression of DHT was achieved with 2.5 mg or 5.0 mg per day. At a daily dosage of 2.5 mg or 5.0 mg, Dutasteride suppresses close to 100% of the DHT whereas 5.0 mg daily dosage of Finasteride only suppresses close to 70% of the DHT.
The level of DHT suppression does not seem to different significantly between 2.5 mg and 5.0 mg. And at a daily dose of 0.5mg, DHT inhibiton is close to 90%.
The maximum effect of Avodart can be observed within 1 to 2 weeks. After 1 and 2 weeks of daily dosing with Avodart 0.5mg, median serum DHT concentrations were reduced by 85% and 90% respectively. Test patients treated with a daily dosage of 0.5mg Avodart for 2 years, the median decrease in serum DHT concentration was over 92% for both year 1 and year 2 of the 2-year trial.
- Avodart was investigated in three large, well-controlled multi-center studies involving 4,325 men aged 50 and above with a serum PSA level ³ 1.5 ng/mL and < 10 ng/mL, and BPH diagnosed by medical history and physical examination, including enlarged prostate (greater than or equal to 30 cc) and BPH symptoms that were moderate to severe according to the American Urological Association Symptom Index.
- Data from these two-year clinical trials demonstrated that treatment with Avodart (0.5 mg once daily) reduced the risk of both AUR and BPH-related surgical intervention relative to placebo, improved BPH-related symptoms, decreased prostate volume, and increased maximum urinary flow rates.
Side Effects
- Drug-related side effects during the first six months were as follows: impotence (4.7 percent vs. 1.7 percent for placebo), decreased libido (3 percent vs. 1.4 percent), breast tenderness and breast enlargement (gynecomastia; 0.5 percent vs. 0.2 percent) and ejaculation disorders (1.4 percent vs. 0.5 percent).
- Avodart should not be used in women and children. Women who are pregnant or may become pregnant should not handle Avodart because of possibility of absorption of Avodart and subsequent potential risk to a male foetus.
- Men treated with Avodart should not donate blood until at least six months after their final dose to prevent giving Avodart to a pregnant woman through a blood transfusion. Men with an allergic reaction to Avodart or its ingredients should not take it. Men with liver disease should talk to their doctor before taking Avodart.
- Clinical trials of Avodart showed that it was generally well tolerated. Most side effects were mild or moderate and generally went away while on treatment in both the Avodart and placebo groups.
- The incidence of most drug-related sexual adverse events decreased with duration of treatment. The incidence of drug-related breast tenderness and breast enlargement remained constant over the treatment period. Ejaculate volume may be decreased in some patients with continued treatment. This decrease did not appear to interfere with normal sexual function.
Hair Loss Trails
There is conflicting information on whether Glaxo are going to continue phase 3 trail for Avodart/Dutasteride for hair loss.
The latest from Glaxo site suggest the trial will be completed 2005.