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Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia
Franklin C Lowe1, John D McConnell, Perry B Hudson
1Department of Urology, Saint Luke's-Roosevelt Hospital Center, New York, NY 10019, USA.
Urology
|April 3, 2003
Summary
Long-term finasteride treatment for benign prostatic hyperplasia (BPH) shows durable symptom improvement and reduced prostate volume. Safety data indicate a low incidence of adverse events over six years.
Area of Science:
- Urology
- Pharmacology
Background:
- Benign prostatic hyperplasia (BPH) is a progressive condition requiring long-term management.
- Assessing the long-term safety and efficacy of BPH treatments is crucial.
Purpose of the Study:
- To evaluate the 6-year clinical trial data for finasteride in treating symptomatic BPH.
- To summarize the long-term safety and efficacy of finasteride therapy.
Main Methods:
- Phase III clinical trials (North American and International) enrolled men with symptomatic BPH.
- A 1-year placebo-controlled study was followed by a 5-year open-label extension.
- 6-year data were analyzed for 487 patients initially randomized to finasteride and 5-year data for 238 placebo patients.
Main Results:
- Finasteride (5 mg) treatment for 6 years resulted in significant improvements in symptom scores (mean 4.0 points).
- Median prostate volume decreased by 24%, and maximal urinary flow rate increased by 2.9 mL/s (P <0.001).
- Long-term treatment was well-tolerated, with a low and decreasing incidence of drug-related sexual adverse events.
Conclusions:
- Finasteride provides durable improvements in urinary symptoms, prostate volume, and flow rate in men with BPH.
- The prevalence of drug-related adverse events did not increase over the 6-year treatment period.
- Finasteride demonstrates a favorable long-term safety profile for BPH management.