Four-Year Study Shows Long-Term Effectiveness Of Proscar In Treating Enlarged Prostates

February 26, 1998

DALLAS * Feb. 26, 1998 ** Results of a four-year study involving 3,040 men have shown that those taking the drug finasteride (Proscar) for enlarged prostate glands reduced their risk of needing surgery or experiencing acute urinary retention by more than half.

Researchers from 95 medical centers reported their results in today's New England Journal of Medicine. UT Southwestern Medical Center at Dallas' chairman of urology, Dr. John McConnell, headed the Proscar Long-Term Efficacy and Safety Study (PLESS), the longest trial of drug therapy for men with benign prostatic hyperplasia (BPH).

The study participants either received finasteride or a placebo. Those taking finasteride had a 55 percent reduced risk of needing prostate surgery and 57 percent less risk of developing acute urinary retention, a painful blockage of the urinary tract requiring catheterization.

"This clinical trial demonstrates that finasteride clearly alters the progression of BPH," said McConnell, holder of the E.E. Fogelson and Greer Garson Fogelson Distinguished Chair in Urology. "The most significant finding of this study is the dramatic decrease in the number of men requiring prostate surgery or developing urinary retention."

"Another important outcome of this research is that the beneficial effects of this drug PROSCAR continued over the entire four years of this study," he said. Patients treated with the drug showed a 20 percent reduction in the size of their prostates. Prostates of those taking the placebo continued to increase in size.

The prostate wraps around the urethra at the point where it leaves the bladder. The gland produces some of the seminal fluid that carries sperm.

As men age, their prostates enlarge and squeeze the urethra, prompting symptoms that include poor urinary flow, frequent urination, urgency to urinate and nighttime urination. The condition can progress to acute urinary retention or require surgery to prevent further complications such as urinary- tract infections, bleeding and bladder stones. Almost 60 percent of men over the age of 50 experience problems due to prostate enlargement.

Other authors of the study included Dr. Claus Roehrborn, UT Southwestern associate professor of urology; Dr. Reginald Bruskewitz from the University of Wisconsin Center for Health Sciences; Drs. Patrick Walsh and H. Logan Holtgrewe from the Brady Urological Institute of Johns Hopkins University Medical School; Dr. Gerald Andriole from Washington University School of Medicine; Dr. Michael Lieber from the Mayo Clinic; Dr. Peter Albertsen from the University of Connecticut Health Center; Dr. J. Curtis Nickel from Queen's University Faculty of Medicine in Ontario; and Drs. Daniel Wang, Alice Taylor and Joanne Waldstreicher from Merck Research Laboratories.

Support for the study was provided by Merck, Inc., which markets the drug under the name Proscar.
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