Pharmacotherapeutic Report on Abarelix (Plenaxis®) for the Treatment of Adult Male Patients with Advanced Hormone- Dependent Prostate Cancer

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Pharmacotherapeutic report on abarelix (Plenaxis®) for the treatment of adult male patients with advanced hormone- dependent prostate cancer Medicine. abarelix, powder for injection, 100 mg. Summary of the therapeutic value Intended effects. Data from two head-to-head trials showed that abarelix was not inferior to the GnHR-agonist leuprolide. Primary efficacy endpoints were the percentage of patients with testosterone surge, the percentage of patients who reached castration levels and the percentage of patients who achieved and maintained castration levels. Unlike the GnRH-agonists, for abarelix there are no data available on survival. Untended effects. The frequency and characteristics of most common side effects are comparable between abarelix and the GnRH-agonists and the GnRH-antagonist degarelix. The long-term safety of abarelix is unknown. Experience. Limited experience has been gained with abarelix and degarelix and considerable experience with the GnRH-agonists. Applicability. There are no major differences in ease of use between abarelix and the GnRH-agonists and degarelix. Final conclusion. Data from two head-to-head trials showed that abarelix was not inferior to the GnHR-agonist leuprolide. The unintended effects of abarelix are comparable with the unintended effects of the GnRH-agonists and degarelix. In addition, there are no clinically important differences in the applicability or ease of use between these agents. Unlike the GnRH-agonists, data on the long-term intended (e.g., survival) and unintended effects are not available for abarelix. For the treatment of adult male patients with advanced or metastatic castrate resistant (hormone refractory) prostate cancer, the therapeutic value of abarelix is comparable with that of the GnRH-agonists leuprolide, buserelin, goserelin and triptorelin en the GnRH-antagonist degarelix. .

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