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Once-Yearly Leuprolide for Advanced Prostate Cancer Available

Once-Yearly Leuprolide for Advanced Prostate Cancer Available

The Bayer Corporation announced recently that Viadur (leuprolide acetate implant), a once-yearly implant for the palliative treatment of advanced prostate cancer, is now available in the United States. The new product offers patients 12 months of continuous testosterone suppression—an alternative to the 1-, 3-, or 4-month injections currently in use.

The Viadur implant is inserted under the skin of the patient’s upper arm during an office procedure. It provides steady serum concentrations of leuprolide throughout the 12-month dosing period. Leuprolide is the primary drug used for testosterone-suppression therapy of advanced prostate cancer.

"Viadur was effective in suppressing testosterone below the castrate threshold. It also was generally well tolerated in open-label clinical trials, in which 90% of patients chose to continue Viadur therapy for a second 12-month period," said James Gottesman, md, of the University of Washington Medical School.

Clinical Studies

In two open-label, multicenter studies, 131 patients with advanced prostate cancer were treated with the 12-month leuprolide implant and evaluated for up to 2 years. Following the initial surgical insertion of the implant, mean serum testosterone concentrations decreased to therapeutically desirable levels by week 4 in 99% of the patients in the studies. Once serum testosterone suppression was achieved, testosterone levels remained suppressed for the duration of the 12-month treatment phase.

The most common side effects associated with the use of once-yearly leuprolide were hot flashes (67.9%), asthenia (7.6%), gynecomastia (6.9%), depression (5.3%), and sweating (5.3%). The most common local side effects were bruising (34.6%) and burning (5.6%).

 
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