Drug updated on 11/4/2024
Dosage Form | Injection (intramuscular; 7.5 mg, 22.5 mg, 30 mg, and 45 mg) |
Drug Class | Gonadotropin-releasing hormone agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of advanced prostate cancer.
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Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- The reviewed studies did not provide direct evidence on the clinical effectiveness of leuprolide acetate or other GnRH (gonadotropin-releasing hormone) agonists in prostate cancer treatment; instead, they focused on cardiovascular safety and rare adverse events, particularly comparing GnRH agonists to antagonists.
- Subgroup analyses were not detailed in terms of effectiveness outcomes. The only notable subgroup concern mentioned was an elevated risk of pituitary apoplexy in older prostate cancer patients with pre-existing pituitary adenomas following GnRH agonist administration.
- GnRH antagonists, such as degarelix and relugolix, presented a significantly lower risk of cardiovascular adverse events compared to GnRH agonists, with pooled risk ratios indicating reduced occurrences of adverse cardiovascular events (0.57; 95% CI: 0.39-0.81), cardiovascular death (0.49; 95% CI: 0.25-0.96), and all-cause mortality (0.48; 95% CI: 0.28-0.83).
- Pituitary apoplexy was identified as a rare but serious adverse event following GnRH agonist administration, particularly in prostate cancer patients with pre-existing pituitary adenomas. This condition manifested with symptoms such as headache (100%) and ophthalmoplegia (85.7%), with a median onset of 5 hours post-administration, and required surgical intervention in 71.4% of cases.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Lupron depot (leuprolide acetate) Prescribing Information. | 2024 | AbbVie Inc., North Chicago, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
The cardiovascular effects of gonadotropin-releasing hormone antagonists in men with prostate cancer. | 2022 | European Heart Journal |
Pituitary apoplexy induced by gonadotropin-releasing hormone (GnRH) agonist administration for treatment of prostate cancer: a systematic review | 2021 | Journal of Cancer Research and Clinical Oncology |