Hormone Therapy

Sex Differences in Long-Term Safety and Tolerability of GH Replacement Therapy in GH Deficient Adults.

TL;DR

GHD women might be treated suboptimally, reflected as lower IGF-1 status and lower GHRT tolerability, leading to more frequent changes in treatment regimen but not discontinuation of GHRT, while GHD men had a higher risk for development of malignancies.

Key Findings

IGF-1 SD scores remained subnormal more often in women during GH replacement therapy, while scores above normal were more frequent in men.

  • Sensitivity analysis showed IGF-1 SD scores remained subnormal more often in women (P < 0.001)
  • IGF-1 SD scores above normal were more frequent in men (P < 0.001)
  • Study included 1335 GHD men and 1251 GHD women treated with GHRT
  • Data were obtained from the Dutch National Registry of GH Treatment in Adults

Women reported more adverse events during GHRT, especially symptoms related to fluid retention.

  • Women reported more adverse events compared to men (P < 0.001)
  • Adverse events were especially symptoms related to fluid retention
  • Women more often needed a dose reduction or temporary stop of GHRT (P = 0.001)
  • Despite more adverse events and treatment modifications, both sexes discontinued GHRT at equal percentages

The risk of developing malignant neoplasms during GHRT was higher in men than in women.

  • The risk of developing malignant neoplasms was higher in men (P = 0.012)
  • Both sexes had equal risk in developing type 2 diabetes mellitus, benign neoplasms, and tumor recurrence
  • Study design was a retrospective cohort study at a nationwide outpatient clinic

Both sexes discontinued GHRT at equal percentages despite differences in tolerability and treatment modifications.

  • In percentages, both sexes equally discontinued GHRT
  • Women more often needed dose reduction or temporary stop of GHRT (P = 0.001) but did not discontinue at higher rates
  • This finding was observed in a cohort of 1335 men and 1251 women

Previous studies have reported that outcomes of GH replacement therapy might be less beneficial in GHD women compared with men.

  • This finding from prior literature motivated the current retrospective cohort study
  • The study investigated possible contributing factors regarding this previously found sex difference
  • The study was conducted using data from the Dutch National Registry of GH Treatment in Adults
  • Patient baseline characteristics, GHRT details, tolerability, and long-term safety were all measured as outcomes

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Citation

Slagboom T, van Bunderen C, van der Lely A, Drent M. (2023). Sex Differences in Long-Term Safety and Tolerability of GH Replacement Therapy in GH Deficient Adults.. The Journal of clinical endocrinology and metabolism. https://doi.org/10.1210/clinem/dgad013