In these studies, the men were asked to rate the following symptoms of BPH:
Incomplete bladder emptying
Intermittent stops and starts in the urine flow
Feeling of urgency when needing to urinate
Weak urine stream
Having to get up to urinate frequently during the night.
The men who took Avodart had significant improvement in their BPH symptoms compared with the men who did not take it. While some patients saw improvement right away, in general it took about 3 to 12 months to see the improvement for most men. This improvement lasted throughout the entire study period (two years).
Acute Urinary Retention
These studies also looked at how many men had acute urinary retention. If an enlarged prostate is very severe, a man may not be able to urinate at all. This is known medically as acute urinary retention and usually requires catheterization (inserting a small tube through the penis into the bladder in order to empty the urine). Of the men who took Avodart, 1.8 percent experienced acute urinary retention that required catheterization, compared to 4.2 percent of men who did not take it.
In these studies, 2.2 percent of men who took Avodart needed to have BPH surgery, while 4.1 percent of men who did not take it needed to have surgery.
These studies showed that the drug helped to shrink the prostate gland in most men.
Men who took the medication also had an improvement in the rate of urine flow. This increased flow rate was seen as early as the third month after starting Avodart and continued throughout the entire study.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Avodart [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2011 June.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed December 3, 2013.
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