Proposal of a clinical response score and predictors of clinical response to 2 years of GH replacement therapy in adult GH deficiency

Eur J Endocrinol. 2015 Dec;173(6):843-51. doi: 10.1530/EJE-15-0305. Epub 2015 Sep 14.

Abstract

Objective: There is no single clinical marker to reliably assess the clinical response to growth hormone replacement therapy (GHRT) in adults with growth hormone deficiency (GHD). The objective of this study was to propose a clinical response score to GHRT in adult GHD and to establish clinical factors that predict clinical response.

Design: This was a prospective observational cohort study from the international KIMS database (Pfizer International Metabolic Database).

Methods: We included 3612 adult patients with GHD for proposing the response score and 844 patients for assessing predictors of response. We propose a clinical response score based on changes in total cholesterol, waist circumference and QoL-AGHDA quality of life measurements after 2 years of GHRT. A score point was added for each quintile of change in each variable, resulting in a sum score ranging from 3 to 15. For clinical response at 2 years, we analysed predictors at baseline and after 6 months using logistic regression analyses.

Results: In a baseline prediction model, IGF1, QoL-AGHDA, total cholesterol and waist circumference predicted response, with worse baseline parameters being associated with a favourable response (AUC 0.736). In a combined baseline and 6-month prediction model, baseline QoL-AGHDA, total cholesterol and waist circumference, and 6-month change in waist circumference were significant predictors of response (AUC 0.815).

Conclusions: A simple clinical response score might be helpful in evaluating the success of GHRT. The baseline prediction model may aid in the decision to initiate GHRT and the combined prediction model may be helpful in the decision to continue GHRT.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cholesterol / metabolism
  • Cohort Studies
  • Dwarfism, Pituitary / drug therapy*
  • Dwarfism, Pituitary / metabolism
  • Female
  • Hormone Replacement Therapy
  • Human Growth Hormone / deficiency
  • Human Growth Hormone / therapeutic use*
  • Humans
  • Hypopituitarism / drug therapy
  • Insulin-Like Growth Factor I / metabolism
  • Male
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Recombinant Proteins
  • Treatment Outcome
  • Waist Circumference

Substances

  • IGF1 protein, human
  • Recombinant Proteins
  • Human Growth Hormone
  • Insulin-Like Growth Factor I
  • Cholesterol