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Friday, December 19, 2003The federally funded Medical Therapy of Prostatic Symptoms study involved 3,047 men at 17 centers around the country. They received an inert placebo, the alpha blocker doxazosin alone, the testosterone blocker finasteride alone or the two drugs together. Compared with the placebo, the two-drug combination reduced by 66 percent the risk that the condition would get worse. Progression of symptoms was cut by 39 percent by doxazosin and by 34 percent by finasteride... ....."To have a risk reduced by almost 70 percent is almost unheard of in a medical trial," said John McConnell, the study's lead author. "We think this study will have great impact on the field." ...The combination therapy also reduced by 81 percent the risk that men would develop extreme problems urinating, and by 67 percent the need for surgery. Actually, this is an approach often used by urologists for men whose symptoms progress on doxazosin alone (or one of its close relatives), and who want to avoid surgery. However, the study(subscription required for full text), isn't as impressive as the newspaper article would lead us to believe. The researchers looked at several measures of the prostate: the prostate volume, as measured by ultrasound, the flow rate of urine from the bladder, the amount of urine left in the bladder after voiding, the prostate specific antigen, and serum creatinine, which goes up if the flow of urine is seriously obstructed, and the response to a series of questions put together by the American Urological Association to assess the impact of prostate symptoms on a patient's life. At the beginning of the study, all of the subjects scored essentially the same on each of the measures. At the end of four years, the combined therapy group had decreased their AUA symptom score by a median of seven points. They started out with a median score of 16, which means that even after four years, their symptoms would still be described as falling in the moderate category. And when you consider that there are only eight questions, even a modest improvement in most of the categories would result in a seven to eight point change in the score, without making much of a difference in the impact of the symptoms on someone's lifestyle. The urinary flow rate improved by about 4ml/second in the combination group, which is better than the placebo group (1ml/second) or the monotherapy group (2ml/sec), but not by much. Levels of prostate specific antigen decreased by 50% in the combination group (which would be expected since finasteride shrinks the prostate), but the baseline value of PSA was only two. In terms of PSA, going from a level of two nanograms per milliliter to one nanogram per milliliter is pretty small potatoes. Most importantly, the incidence of severe complications from continued prostatic enlargement - the complete blocking of the flow of urine - is fudged in the result section. The actual number of cases are divulged for placebo (18 out of 737 men) and finasteride alone (6 out of 768 men) and combination therapy (4 out of 786 men), but not given at all for the doxazosin group, and it's hard to tell from the line graph provided because it's only expressed in "relative risks." So, the bottom line remains that combining finasteride with doxazosin is probably a reasonable approach to take with men who want to avoid surgical procedures and whose symptoms are moderate to severe, but until the questions about the risks of finasteride and aggressive prostate cancer are addressed, it shouldn't be the first line of approach. SIDENOTE: Finasteride breathed new life once before after it fell out favor as therapy for prostate problems. It's other incarnation is Propecia. posted by Sydney on 12/19/2003 08:34:00 AM 0 comments 0 Comments: |
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