To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves New Proscar Indication To Reduce Need For Prostate Surgery URL: http://www.pslgroup.com/dg/67AAA.htm Doctor's Guide March 26, 1998
WEST POINT, PA -- March 26, 1998 – The United States Food and Drug Administration has cleared Merck & Co., Inc.'s Proscar(R) (finasteride 5 mg) as the first and only medication to reduce the need for prostate surgery and the risk of developing acute urinary retention, a serious and painful complication of benign prostatic hyperplasia (BPH). BPH is a common condition that affects more than half of men age 60 and older and prostate surgery to correct it is the second most commonly performed surgery on older men. The expanded indication is based on the results of the landmark PLESS study (Proscar Long-term Efficacy and Safety Study), the largest and longest controlled clinical trial of men ever completed in urology. PLESS was recently published in the New England Journal of Medicine. In the four-year trial compared with placebo, Proscar: -- reduced by 51 percent the combined risk of prostate surgery and acute urinary retention (13.2 percent placebo versus 6.6 percent for Proscar over the four years) -- reduced by 55 percent the need for prostate surgery (10.1 percent placebo versus 4.6 percent for Proscar over the four years) -- reduced by 57 percent the risk of developing acute urinary retention (6.6 percent placebo versus 2.8 percent for Proscar over the four years), which occurs suddenly and is treated through insertion of a catheter. Researchers found that these reductions in risk associated with therapy with Proscar occurred as early as four months into the trial and were maintained throughout the four-year study. The study also demonstrated that the risk of requiring prostate surgery or suffering from urinary retention was significant for untreated men. In fact, one out of seven men in the placebo group in this study had one of these serious events over the four-year study. Prostate surgery, including TURP (transurethral prostatectomy), is a common treatment for BPH. There are approximately 400,000 TURPs for BPH performed in the U.S. annually. "Patients and their physicians now have a proven treatment for the long-term management of BPH that can reduce the need for surgery and the risk of urinary retention, two often painful consequences of this common yet often very bothersome condition," said Stephen Kaplan, MD, vice chairman and professor, department of urology, Columbia University in New York. The double-blind, placebo-controlled PLESS trial was designed to evaluate the long-term effects of Proscar on urinary symptoms of prostate enlargement and to determine the effect of Proscar on the natural history of BPH (by reducing the need for prostate surgery and the risk of acute urinary retention). Conducted at 95 U.S. sites, the trial randomised 3,040 men to receive Proscar or placebo daily. The men, ranging in age from 45 to 78, were all diagnosed with BPH, had urinary symptoms considered to be moderate to severe, and showed enlarged prostates upon initial exam. Complete event information was available for 92 percent of the patients. Safety was evaluated in 3,040 men. Proscar was generally well tolerated by most patients and no new side effects beyond those already identified in earlier experience were identified. The most frequent adverse events noted by men receiving Proscar versus those on placebo were impotence (8.1 percent versus 3.7 percent), decreased libido (6.4 percent versus 3.4 percent) and decreased volume of ejaculate (3.7 percent versus 0.8 percent). After the first year of treatment, there was no longer a significant difference between treatment groups in the incidence of impotence and decreased libido. PLESS also confirmed that Proscar does not affect the usefulness of PSA as a tool for prostate cancer detection. As shown previously, PSA decreased to about one-half the level prior to therapy. PSA, an enzyme produced in the prostate, can be checked in a simple blood test and elevated levels of it can signal prostate cancer. Patients in the trial were carefully monitored for prostate cancer during the study. A physician can monitor PSA by doubling its value for men taking Proscar and then comparing it to the normal range, as is done for other patients. Proscar acts against an underlying cause of BPH by decreasing the size of the prostate and is the only medication for BPH that works by shrinking a man's prostate. In the PLESS study, Proscar reduced the size of the prostate by 17.9 percent (from 55.9 cc at baseline to 45.8 cc). Men on placebo had a 14.1 percent increase in prostate size from baseline (from 51.3 cc to 58.5 cc), resulting in an overall difference of 32 percent in prostate volume by the end of the study. "We now have important evidence that this treatment is effective over the long term," said Gerald Andriole, MD, professor of urology, University of Washington in St. Louis. "This finding should encourage physicians and patients with enlarged prostates who are experiencing urinary difficulty to discuss this therapy as a way to reduce the need for prostate surgery." BPH is among the most common age-related disorders of men, affecting approximately seven million men in the U.S. It affects more than half of all men age 60 and older with virtually all men having pathologic evidence of an enlarged prostate by age 80. Located at the base of the bladder and surrounding the urethra (a narrow tube that drains urine from the bladder), the normal prostate is generally the size of a walnut (approximately 20 grams). However, enlarged prostates can gradually compress the urethra and cause a range of urinary symptoms including frequent urination, reduced urine flow, and night-time urination. In a very small percentage of men, such urinary problems may lead to infection, major bleeding and kidney damage. Proscar is not indicated for use in children or women. Proscar is contraindicated in patients who are hypersensitive to any components of this medication and in women when they are or may potentially be pregnant because it may cause abnormalities to the male baby's sex organs. Women should not handle crushed or broken tablets when they are pregnant or may potentially be pregnant. Tablets of Proscar have a coating that will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. Two other studies of Proscar are ongoing. The National Cancer Institute is conducting the Prostate Cancer Prevention Trial to determine if Proscar reduces the risk of prostate cancer. The study includes 18,000 patients from 222 trial sites across the country. In addition, the National Institute of Diabetes and Digestive and Kidney Diseases is conducting a five-year study of Proscar, doxazosin and a combination of the two therapies. This study of 2,800 patients will monitor the progression of BPH as measured by the need for surgery and changes in prostate tissue. Introduced in 1992 to treat symptomatic BPH and to improve urinary flow and symptoms associated with the condition, Proscar has been prescribed to more than 1.2 million men in over 100 countries. More information on: Proscar, Merck & Co., Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. 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