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Comparative Safety of Testosterone Dosage Forms.

J Bradley Layton1, Christoph R Meier2, Julie L Sharpless3

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Testosterone injections are linked to higher risks of cardiovascular events, hospitalizations, and death compared to gels. Testosterone patches and gels show similar safety profiles for cardiovascular health.

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Area of Science:

  • Endocrinology
  • Cardiovascular Medicine
  • Pharmacology

Background:

  • Rising testosterone use has prompted concerns regarding cardiovascular safety.
  • Different testosterone delivery methods (injections, patches, gels) have varying pharmacokinetic profiles.
  • Comparative cardiovascular safety data across these delivery methods are lacking.

Purpose of the Study:

  • To compare the cardiovascular safety of testosterone injections, patches, and gels.
  • To evaluate risks of major adverse cardiovascular events, hospitalizations, and mortality associated with different testosterone formulations.

Main Methods:

  • Retrospective cohort study utilizing administrative claims and general practitioner records from the US and UK.
  • Inclusion of over 544,000 men initiating testosterone therapy (injections, patches, or gels).
  • Monitoring for cardiovascular events, venous thromboembolism, and mortality for up to one year.

Main Results:

  • Testosterone injections were associated with significantly higher hazards of cardiovascular events (MI, unstable angina, stroke), hospitalization, and death compared to gels.
  • Testosterone patches demonstrated similar cardiovascular risk profiles to gels.
  • No increased risk of venous thromboembolism was observed for injections compared to gels.

Conclusions:

  • Testosterone injections are associated with increased risks of cardiovascular events, hospitalizations, and mortality compared to gels.
  • Testosterone patches and gels appear to have comparable cardiovascular safety profiles.
  • Further research is needed to assess testosterone safety in relation to appropriate patient selection and comparison with non-users.