|
The treatment of androgenetic alopecia is not an FDA-approved indication for Avodart (dutasteride). Therefore, GlaxoSmithKline may not make recommendations on the sue of Avodart for this purpose.
A phase II multi-center, double blind, placebo-controlled study was conducted on 416 males with AGA , ages 21 to 45 years, to evaluate the dose response relationship of Avodart on hair growth. Repeated doses of Avodart (0.05 mg, 0.1mg, 0.5mg, and 2.5 mg daily) were compared to placebo for 6 months. Safety and tolerability of the varying dose of Avodart and fiansteride 5 mg daily compared with placebo were also investigated.
The most common drug-related adverse events were decreased libido experienced by 13% of subjects receiving Avodart 2.5 mg/day, followed by howdahes experienced by 8% of the Avodart 0.1 mg/day group and 6% of the Avodart 0.5 mg/day and 2.5 mg/day group.
In studying a 0.79 square inch target mean hair counts decreased for placebo treated patients. At 24 weeks hair counts were 62 for Avodart 0.05 mg/day, 66 for Avodart 16.8 mg/day, 95.5 for Avodart 0.5 mg/day, 109.8 for Avodart 2.5 mg/day, 73.2 for finasteride 5 mg/day, and -29.6 for placebo.
Avodart was discontinued at the 24 week mark. Hair counts were then reassessed at the 36 week mark (12 weeks after stopping Avodart and Finasteride). Mean hair counts decreased for Avodart 0.05 mg/day, Avodart 0.1 mg/day, Finasteride 5 mg/day and placebo during the drug free time. Improvement in hair counts was maintained for Avodart 0.5 mg/day and Avodart 2.5 mg/day 12 weeks after discontinuing the medication.
In studying a 0.79 square inch target mean hair counts decreased for placebo treated patients progressively.
At 36 weeks hair counts were -17.1 for Avodart 0.05 mg/day, 16.8 for Avodart 16.8 mg/day, 84.3 for Avodart 0.5 mg/day, 119.8 for Avodart 2.5 mg/day, 13.2 for finasteride 5 mg/day, and -37.3 for placebo. |
|