Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years
| Autor: | Sidney Rosenblatt, Jack Geller, John Trachtenberg, Gholam H. Malek, Michael M. Lieber, Mostafa M. Elhilali, Perinchery Narayan, Elizabeth Stoner, Reginald C. Bruskewitz, Johnny B. Roy, Amy T Ko, Nicholas A. Romas, Carol A. Jacobsen, Perry B. Hudson, Jean-Paul Perreault, Lynn A. Patterson, Richard Norman, Rex Boake |
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| Rok vydání: | 1999 |
| Předmět: |
medicine.medical_specialty
medicine.diagnostic_test business.industry Urology Cystometry Rectal examination Hyperplasia medicine.disease law.invention Surgery chemistry.chemical_compound medicine.anatomical_structure chemistry Randomized controlled trial law Prostate medicine Finasteride Prostatism Adverse effect business |
| Zdroj: | Urology. 53:690-695 |
| ISSN: | 0090-4295 |
| Popis: | Objectives. The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH). Methods. A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 mg. An enlarged prostate gland by digital rectal examination, symptoms of urinary obstruction, and a maximal urinary flow rate of less than 15 mL/s were required for entry. Patients who completed the initial 12-month, double-blind, placebo-controlled study were invited to participate in an open-label extension for 4 additional years. Results. Of the 297 patients initially randomized to receive finasteride 5 mg, 259 completed 12 months in the double-blind period and 186 completed 48 months of open-label therapy. Prostate volume reached a nadir of −24.6% at month 24, and the effect was maintained through month 60. Compared with baseline values, month 60 prostate volume was decreased by 22.7% (P |
| Databáze: | OpenAIRE |
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