Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia

To summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important. The North American and International Phase III Finasteride trials enrolled symptomatic men with enla...

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Published in:Urology (Ridgewood, N.J.) N.J.), 2003-04, Vol.61 (4), p.791-796
Main Authors: Lowe, Franklin C, McConnell, John D, Hudson, Perry B, Romas, Nicholas A, Boake, Rex, Lieber, Michael, Elhilali, Mostafa, Geller, Jack, Imperto-McGinely, Juliane, Andriole, Gerald L, Bruskewitz, Reginald C, Walsh, Patrick C, Bartsch, Georg, Nacey, John N, Shah, Sukrut, Pappas, Frances, Ko, Amy, Cook, Thomas, Stoner, Elizabeth, Waldstreicher, Joanne
Format: Article
Language:English
Subjects:
5-alpha Reductase Inhibitors
Antineoplastic agents
Biological and medical sciences
Chemotherapy
Enzyme Inhibitors - adverse effects
Enzyme Inhibitors - therapeutic use
Erectile Dysfunction - chemically induced
Finasteride - adverse effects
Finasteride - therapeutic use
Follow-Up Studies
Humans
Longitudinal Studies
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Placebos
Prostate - pathology
Prostatic Hyperplasia - diagnosis
Prostatic Hyperplasia - drug therapy
Prostatic Hyperplasia - pathology
Sexual Dysfunctions, Psychological - chemically induced
Treatment Outcome
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Summary:To summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important. The North American and International Phase III Finasteride trials enrolled symptomatic men with enlarged prostate glands. The initial 1-year placebo-controlled study was followed by a 5-year open-label extension. In total, 6-year finasteride data were available in 487 patients originally randomized to finasteride, and 5-year data were available on 238 patients originally randomized to placebo. After 6 years of treatment with finasteride 5 mg, the mean quasi-American Urological Association Symptom Score improved by 4.0 points, the median prostate volume decreased by 24%, and the mean maximal urinary flow rate increased by 2.9 mL/s ( P
ISSN:0090-4295
1527-9995
DOI:10.1016/S0090-4295(02)02548-7