Opinion

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Comparing the safety profile of darolutamide with other androgen receptor inhibitors in Black patients

This study highlights the safety of mHSPC drugs in black men, supported by both trial data and real-world evidence.

Safety Data from Multiple Sources

Key Themes:

  • The ARANOTE study had sufficient Black male representation for meaningful comparative analysis.
  • Safety data from other clinical trials show similar patterns.
  • Real-world evidence corroborates safety in Black men.
  • This category of drugs (androgen receptor antagonists) appears generally safe across racial groups.

Key Points for Physicians:

  • Multiple data sources support the safety of darolutamide in Black men.
  • Real-world evidence complements clinical trial findings.
  • Specific subanalysis provides higher confidence in safety conclusions.

Notable Insights: The convergence of evidence from clinical trials and real-world data strengthens confidence in safety conclusions despite relatively small sample sizes in individual studies.

Clinical Significance: The combination of clinical trial data and real-world evidence provides a comprehensive safety profile supporting the use of darolutamide in Black men with metastatic hormone-sensitive prostate cancer.

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