USRF Research

Proscar, Cardura, Placebo Compared in MTOPS BPH Study

Results of NIH study reported by John McConnell at 2002 AUA Meeting
Combination drug therapy reported to give best results

MTOPS published in New England Journal of Medicine (12/18/03):
Slides Summary slides from
Dr. McConnell's presentation

Leonard S. Marks, M.D.
Medical Director, USRF

3rd Quarter, 2002 - The long-awaited results of the 'MTOPS' study (Medical Therapy of Prostatic Symptoms) were unveiled May 27 at the 2002 meeting of the American Urological Association in Orlando, FL. The NIH-sponsored trial of 3000 men with symptomatic BPH was a 5-year study comparing the effects of finasteride (Proscar), doxazosin (Cardura), the combination of the two, and placebo. It is the largest, longest study of its kind. The results were presented by John McConnell, principle investigator, who concluded that the combination of the two drugs yielded results superior to those seen with either drug alone or with placebo.

Cardura (doxazosin)The study is important because it provides a clear comparison of two major drugs used in the treatment of prostatic obstruction, a problem seen in some 10 million American men over the age of 50 y.o. Finasteride (Proscar) was approved in 1992 and doxazosin (Cardura), one of the alpha-blocking agents, was approved in 1995. When drug therapy has been selected, one drug alone has usually been chosen. However, the MTOPS data indicate that the use of finasteride and an alpha-blocking agent together have become the drug therapy of choice for long-term symptomatic relief and prevention of disease progression.

Proscar (finasteride)17 academic medical centers contributed patients to the MTOPS trial, which was organized in the early 1990s. Randomization of patients into the study was completed between 1995 and 1998. Other results from the MTOPS study will be forthcoming over the next several years.



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