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| |  AUA MEETING: New Data Reaffirms Benefits Of Proscar In Enlarged Prostate SAN DIEGO, CA -- June 3, 1998 -- Additional information from the landmark PLESS (Proscar(R) Long-term Efficacy and Safety Study) trial presented this week at the American Urological Association annual meeting reaffirms the benefits of Proscar (finasteride 5 mg) as the first and only medication indicated to reduce the need for prostate surgery and the risk of developing acute urinary retention, a serious and painful complication of benign prostate hyperplasia (BPH). BPH is a non-cancerous enlargement of the prostate common among older men. Earlier this year, in a study published in The New England Journal of Medicine, PLESS demonstrated that therapy with Proscar in men with an enlarged prostate and moderate to severe urinary symptoms upon study entry could reduce the risk of BPH-related surgery and acute urinary retention by more than 50 percent. Now, a series of new analyses from the study presented this week reinforce those findings in all subgroups studied and show that the risk of acute urinary retention and surgery in men with the largest prostates can be as high as 22 percent over just four years. Recently, there has been increased documentation about the progressive nature of BPH. In the four-year, 3,040 patient PLESS, the largest and longest controlled clinical trial of men ever completed in urology, almost all of the men who did not receive treatment experienced an increase in prostate size. "As the prostate grows, a man's risk for complications increases. One out of eight men who did not receive treatment in PLESS either had surgery or developed acute urinary retention," said Logan Holtgrewe, M.D., associate professor of urology, Johns Hopkins School of Medicine, Annapolis, MD. Patients taking Proscar had their risk of these events reduced by more than 50 percent (from 13.2 percent for placebo versus 6.6 percent for Proscar). "These new data reaffirm the long-term benefits of Proscar for the patient most at risk of suffering from the complications, such as acute urinary retention and surgery, frequently associated with BPH," said John McConnell, M.D., chairman of urology at the University of Texas Southwestern Medical Center at Dallas. In an analysis of all participants, patients with the largest prostates had the greatest symptomatic response to Proscar in comparison to placebo, as well as the greatest reduction in the risk of acute urinary retention or surgery. Men treated with Proscar in PLESS with prostate sizes in the top third of all patients experienced a drop in symptom score of 3.9 points versus only 0.7 points on placebo, a noticeable difference to the men. (This compares with 3.8 points versus 2.4 points respectively in the lowest third.) Men with the largest prostates also experienced the highest drop in absolute risk of acute urinary retention or the need for BPH-related surgery -- from 22 percent (placebo) to 5.6 percent (Proscar). No other therapies have been reported to decrease the incidence of acute urinary retention in long-term studies. Symptom severity also was demonstrated to predict response. "Patients with the most severe symptoms had the greatest improvement with Proscar," said Steven Kaplan, M.D., vice chairman, department of urology, College of Physicians and Surgeons, Columbia University, N.Y. "But even patients with mild or moderate symptoms had better symptomatic responses to finasteride than placebo.” The PLESS data has also helped extend the understanding of prostate size as it relates to PSA. "We learned that in men with symptomatic BPH, the prostate grows by an average of 1.8 cc or 3.5 percent a year, or 7.2 cc or 14 percent over four years," said Claus Roehrborn, M.D., associate professor, department of urology, Southwestern Medical Center at Dallas. "The growth rate depends most on the serum PSA level. Men in the lowest PSA group had a growth of 2.8 cc over four years, while men in the highest PSA group had a growth of 13.3 cc during the same period." PSA is a substance that is measured in a common blood test to screen for prostate cancer. An elevated PSA can indicate prostate cancer, or BPH, which does not lead to cancer. PSA is also correlated with age and volume. In an analysis of all participants, patients with the highest PSA levels had the greatest symptomatic response to Proscar, compared to patients who were not treated. Men with a baseline PSA over 1.3 had symptom scores 2.8 to 3.1 points lower than those on placebo, a noticeable difference to the men. In men treated with Proscar, greater reduction in risk of surgery and acute urinary retention was also observed in those with the highest PSA levels. Men with baseline PSA levels of: The double-blind, placebo-controlled PLESS trial was designed to evaluate the long-term effects of Proscar on urinary symptoms of prostate enlargement and 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. 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. Prior to initiating therapy with Proscar, appropriate evaluation should be performed to identify other conditions such as infection, prostate cancer, stricture disease, hypotonic bladder or other neurogenic disorders that might mimic BPH. 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. Women should not handle crushed or broken tablets when they are pregnant or may potentially be pregnant, because doing so may cause abnormalities of the male baby's sex organs. Tablets of Proscar are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. 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. 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