Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia
| Autor: | Eric T. Wolford, Marc Gittleman, Leonard S. Marks, John P. Tuttle, Claus G. Roehrborn, Sheldon Freedman, Betsy Morrill, Tom Fenter |
|---|---|
| Rok vydání: | 2004 |
| Předmět: |
Male
medicine.medical_specialty medicine.drug_class Urology Prostatic Hyperplasia Antiandrogen Placebos 5 Alpha-Reductase Inhibitor chemistry.chemical_compound 5-alpha Reductase Inhibitors Double-Blind Method Erectile Dysfunction Prostate Lower urinary tract symptoms American Urological Association Symptom Score Humans Medicine Ejaculation Longitudinal Studies Sexual Dysfunctions Psychological Enzyme Inhibitors Aged Ultrasonography business.industry Urinary retention Dutasteride Middle Aged Prostate-Specific Antigen Hyperplasia medicine.disease Isoenzymes Urodynamics Treatment Outcome medicine.anatomical_structure chemistry Azasteroids Gynecomastia medicine.symptom business |
| Zdroj: | Urology. 63:709-715 |
| ISSN: | 0090-4295 |
| DOI: | 10.1016/j.urology.2004.01.001 |
| Popis: | Objectives To assess the long-term safety and efficacy of dutasteride, a dual type 1 and type 2 5-α-reductase inhibitor, in the treatment of symptomatic benign prostatic hyperplasia and associated lower urinary tract symptoms. Methods Data from two Phase IIIa multicenter, randomized, placebo-controlled trials of 2-year duration plus a 2-year open-label extension were pooled and analyzed. The entry criteria included age 50 years old or older, clinical diagnosis of benign prostatic hyperplasia, prostate volume of 30 cm 3 or greater, American Urological Association symptom score of 12 or greater, peak urinary flow rate of 15 mL/s or less, and prostate-specific antigen level of 1.5 ng/mL or greater but less than 10 ng/mL. Results A total of 2802 men were randomized into the double-blind phase of the two studies with 1908 patients (68%) completing the study. Of these, 1570 subjects were enrolled in the open-label phase, and 569 subjects received dutasteride for 48 months. Changes at the 48-month visit for dutasteride/dutasteride-treated subjects included improvement in prostate volume (−26.2%), American Urological Association Symptom Index (−6.1 points), and peak urinary flow rate (+2.8 mL/s). Changes for the placebo/dutasteride group included prostate volume (−20.7%), American Urological Association Symptom Index (−5.3 points), and peak urinary flow rate (+1.8 mL/s). Acute urinary retention and surgery occurred in a small percentage of subjects (less than 2% and less than 1%) in the open-label extension phase. Dutasteride was well tolerated with no statistically significant increase in drug-related adverse events during the open-label extension and no adverse laboratory trends. Conclusions Dual inhibition of 5-α-reductase with dutasteride provided sustained efficacy in subjects with symptomatic benign prostatic hyperplasia treated for 48 months. Near-complete, long-term suppression of dihydrotestosterone (93% at 48 months) with dutasteride did not lead to an increase in adverse events compared with that reported in the 2-year period. |
| Databáze: | OpenAIRE |
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