Education Resource from the Society for Endocrinology

Adult Growth Hormone Replacement

Professor Stephen Shalet

Christie Hospital, Manchester, UK

Summer School 15-18 July 2003
University of Manchester, Hulme Hall, Manchester, UK


GHD in adult life is associated with increased fat mass, particularly distributed in the truncal region, reduced lean mass, osteopenia, an adverse lipid profile, glucose intolerance, insulin resistance, impaired fibrinolysis, altered cardiac structure and function, reduced exercise capacity, and reduced quality of life. Despite the impressive list of clinical features, there is no single symptom or sign that is pathognomonic of GHD in adult life; this is particularly true of patients with multiple pituitary hormone deficits in whom thyroxine, glucocorticoids, and sex steroids may be under- or over- replaced. There is increasing evidence, however, that the profile of adverse sequelae associated with GHD in adult life differs in adults with childhood-onset compared with adult-onset disease.

There is no single biological endpoint in an adult suspected of being GHD that offers the same diagnostic usefulness as the growth rate of a child. There is, however, the natural history of evolution of hypopituitarism in patients with a mass lesion of the hypothalamic-pituitary region or in those who have undergone surgery and/or radiotherapy to this region. GH is usually the first of the anterior pituitary hormones to be affected by these various pathological insults, which means that in a patient with multiple pituitary hormone deficits the probability of GHD being present is extremely high. Unlike the situation in the pediatric age group in whom pituitary adenomas are rare, this observation is of enormous importance in adults in whom non-functioning pituitary adenomas and/or their treatment are the most common causes of GHD.

Whom to consider for treatment ? Severe GHD
Definition of GH status

  1. GH Provocative Tests
    - Threshold for definition? 3ng/ml or 5ng/ml for all tests?
    - How many provocative tests? 1 or 2 tests?
    - Does nature of provocative stimulus matter? i.e. ITT vs Arginine?
  2. IGF-I Level
    - Diagnostic usefulness?
    - Childhood onset (CO) GHD vs Adult onset (AO) GHD?
    - Young adult GHD vs Elderly adult GHD?
  3. Are there patients for whom no tests are necessary?
    Case Study

    56 year old woman who underwent surgery elsewhere several years previously for non-functioning pituitary adenoma, and now referred for consideration of GH replacement on basis of impaired quality of life (QOL). Currently on hydrocortisone, thyroxine, and sex steroid replacement. Arginine stimulation test induced peak GH response of 7ng/ml.
    Implications of GH test result?

    Difficult issues over diagnosis of GHD that remain or lie ahead
    1. ‘Severe’ GHD - isolated
    2. Elderly - isolated
    3. ‘Transitional’ GHD - isolated
    4. Partial GHD - isolated

    Whom to offer GH Replacement?
    1. All severe GHD patients, on basis that it represents available hormone replacement for ‘measurable’ hormone deficiency?
    2. Specific indication within GHD population?
    - Reduced QOL
    - Skeletal health
    - Reduce the increased cardiovascular/cerebrovascular mortality observed in hypopituitary population not receiving GH replacement.

    3. None? - insufficient evidence?
    - cost-benefit ratio unfavourable?


QOL

Evidence
Significant benefit in QOL from GH replacement for approximately 35% of total cohort of severe GHD patients.
- Patient response, generic and “disease-specific” questionnaires
- Benefit maintained for up to 9 years in single center study
- Selection process means that only about 5% discontinue GH at end of trial on grounds of lack of effect.

Characteristics
1. Greatest gain in QOL in those with worst QOL at baseline
2. Severe ? in QOL more frequently seen in AO GHD vs CO GHD
3. No correlation between QOL at baseline or QOL response to GH, and baseline biochemistry, i.e. IGF-I status.

Missing information/explanation
1. Mechanism underlying improvement in QOL?
2. QOL improves but rarely normalises on GH replacement; Why?
3. Randomised placebo-controlled study has never been carried out in subset of patients with severe impairment of QOL.


Skeleton

Evidence
1. ? incidence of fractures in adults with hypopituitarism
2. Significant proportion of GHD patients have a pathologically reduced BMD
3. GH replacement ? BMD in those patients with reduced BMD if given for over one year; GH replacement increases markers of bone turnover.

Characteristics
1. Pathologically reduced BMD is not a feature of GHD patients over age of 45 years.
2. Reduced BMD primarily a problem in those patients under the age of 30 years.
3. Markers of bone turnover reduced in GHD.

Missing Information/Explanation
1. Reduction in fracture rate for GHD patients on GH replacement?
2. Acquisition of peak bone mass?
- window of opportunity?
- dose of GH?
3. Confounding variables?


Increased Vascular Mortality

Evidence
1. Approximately 2-fold increase in vascular mortality in hypopituitary patients on standard endocrine replacement but not GH.
2. Adverse CVS risk factors in untreated GHD patients: lipid profile, waist-hip ratio, endothelial dysfunction, cardiac dysfunction, fibrinogen, IMT, etc.
3. Improvement in CVS risk factors on GH; lipid profile, waist-hip ratio, endothelial function, IMT, and fibrinogen.

Characteristics
1. CVS risk factors not adverse in all GHD patients.
2. No relationship between CVS risk factors and baseline biochemistry

Missing Information/Explanation
1. Confounding variables affect risk of vascular disease in hypopituitary patients, i.e. sub-optimal replacement of additional pituitary hormone deficits, pituitary radiotherapy?
2. ‘Normalise’ mortality rate in hypopituitary patients on GH replacement?
3. Is there clustering of adverse CVS risk factors?
4. No randomised placebo-controlled study carried out in selected subset of patients with most adverse CVS risk factors.


Process of GH replacement

Influenced by therapeutic indication policy;
1. QOL – start low dose GH independent of weight or surface area (lower dose in elderly GHD).
Titrate dose over 3 months and then carry out 6 month trial of GH (9 month total).
2. Adverse Vascular Prognosis – lifelong treatment.
3. Skeletal Health – GH treatment until peak bone mass acquired or lifelong?

Problems
1. If use GH replacement as HRT for all GHD patients ? cessation of ‘thinking’
2. Fail to treat on basis of lack of evidence
– neglect of patients’ needs.
3. ‘Transitional’ GHD.
4. Optimisation of GH replacement; need for alternative markers other than IGF-I.


References

  1. 1. Jorgensen JO, Pedersen SA, Thuesen L, Jorgensen J, Ingemann Hansen T, Skakkebaek NE, Christiansen JS (1989) “Beneficial effects of growth hormone treatment in GH-deficient adults”. Lancet 1:1221-1225.
  2. Salomon F, Cuneo RC, Hesp R, Sonksen PH (1989) “The effects of treatment with recombinant human growth hormone on body composition and metabolism in adults with growth hormone deficiency”. N Engl J Med 321:1797-1803.
  3. Rosen T, Bengtsson BA (1990) “Premature mortality due to cardiovascular disease in hypopituitarism”. Lancet 336:285-288.
  4. Tomlinson JW, Holden N, Hills RK, Wheatley K, Clayton RN, Bates AS, Sheppard MC, Stewart PM (2001) “Association between premature mortality and hypopituitarism”. West Midlands Prospective Hypopituitary Study Group. Lancet 357:425-431.
  5. Rosen T, Wilhelmsen L, Landin Wilhelmsen K, Lappas G, Bengtsson BA (1997) “Increased fracture frequency in adult patients with hypopituitarism and GH deficiency”. Eur J Endocrinol 137:240-245.
  6. Iranmanesh A, Lizarralde G, Veldhuis JD (1991) “Age and relative adiposity are specific negative determinants of the frequency and amplitude of growth hormone (GH) secretory bursts and the half-life of endogenous GH in healthy men”. J Clin Endocrinol Metab 73:1081-1088.
  7. Growth Hormone Research Society (1998) “Consensus guidelines for the diagnosis and treatment of adults with growth hormone deficiency: summary statement of the Growth Hormone Research Society Workshop on Adult Growth Hormone Deficiency”. J Clin Endocrinol Metab 83:379-381.
  8. Baum HB, Biller BM, Finkelstein JS, Cannistraro KB, Oppenhein DS, Schoenfeld DA, Michel TH, Wittink H, Klibanski A (1996) “Effects of physiologic growth hormone therapy on bone density and body composition in patients with adult-onset growth hormone deficiency. A randomized, placebo-controlled trial”. Ann Intern Med 125:883-890.
  9. Sesmilo G, Biller BM, Llevadot J, Hayden D, Hanson G, Rifai N, Klibanski A (2000) “Effects of growth hormone administration on inflammatory and other cardiovascular risk markers in men with growth hormone deficiency. A randomized controlled clinical trial”. Ann Intern Med 133:111-122.
  10. Drake WM, Coyte D, Camacho Hubner C, Jivanji NM, Kaltsas G, Wood DF, Trainer PJ, Grossman AB, Besser GM, Monson JP (1998) “Optimizing growth hormone replacement therapy by dose titration in hypopituitary adults”. J Clin Endocrinol Metab 83:3913-3919.
  11. Murray RD, Skillicorn CJ, Howell SJ, Lissett CA, Rahim A, Shalet SM (1999) “Dose titration and patient selection increases the efficacy of GH replacement in GHD adults”. Clin Endocrinol (Oxf) 50:749-757.
  12. Florakis D, Hung V, Kaltsas G, Coyte D, Jenkins PJ, Chew SL, Grossman AB, Besser GM, Monson JP (2000) “Sustained reduction in circulating cholesterol in adult hypopituitary patients given low dose titrated growth hormone replacement therapy: a two year study”. Clin Endocrinol (Oxf) 53:453-459.
  13. Murray RD, Wieringa GE, Lissett CA, Darzy KH, Smethurst LE, Shalet SM (2002) “Low-dose GH replacement improves the adverse lipid profile associated with the adult GH deficiency syndrome”. Clin Endocrinol (Oxf) 56:525-532.
  14. Holmes SJ, Shalet SM (1995) “Factors influencing the desire for long-term growth hormone replacement in adults”. Clin Endocrinol (Oxf) 43:151-157.
  15. Gilchrist FJ, Murray RD, Shalet SM (2002) “The effect of long-term untreated growth hormone deficiency (GHD) and 9 years of GH replacement on the quality of life (QoL) of GH-deficient adults”. Clin Endocrinol 57:363-370.

The opinions expressed in this paper are those of the speaker and do not necessarily reflect the views of the Society


Revised: 04-Sep-2003

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