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Long-term experience with GH replacement therapy: efficacy and safety
1Department of Endocrinology, Division of General and Developmental Medicine, St Bartholomew's Hospital, West Smithfield, London ECIA 7BE, UK. J.P.Monson@qmul.ac.uk
European Journal of Endocrinology
|April 3, 2003
Summary
Long-term growth hormone (GH) replacement in GH-deficient adults improves body composition, lipid profiles, and reduces cardiovascular risks. The KIMS study shows GH therapy is safe, with mortality rates similar to the general population.
Area of Science:
- Endocrinology
- Metabolic Medicine
- Pharmacoepidemiology
Background:
- Hypopituitarism in adults is linked to increased premature mortality, primarily due to cardiovascular and cerebrovascular diseases.
- Common metabolic issues in hypopituitary adults include central adiposity, hyperlipidemia, insulin resistance, and diabetes mellitus.
- Long-term efficacy and safety data for growth hormone (GH) replacement in GH-deficient adults are crucial.
Purpose of the Study:
- To evaluate the long-term safety and efficacy of GH replacement therapy in adults with GH deficiency.
- To analyze mortality rates and adverse events in a large cohort of GH-treated adults.
- To assess the impact of GH replacement on body composition, metabolic parameters, bone health, and quality of life.
Main Methods:
- Utilized data from the Pharmacia International Metabolic Surveillance (KIMS) study, a large multinational database of over 8000 adult patients.
- Employed pharmacoepidemiological methods to analyze safety, efficacy, and mortality outcomes.
- Monitored parameters including body composition, lipid profiles, glucose metabolism, bone mineral density, and patient-reported outcomes.
Main Results:
- GH replacement improved central adiposity and lipid profiles, with benefits sustained for at least two years.
- Bone mineral density increased in men and stabilized in women; bone remodeling returned to baseline within five years.
- GH therapy reduced the need for daily living assistance, sick leave, and hospital admissions, while improving psychological well-being.
- No increased risk of de novo neoplasia or pituitary tumor regrowth was observed; mortality rates were similar to the general population.
Conclusions:
- Prolonged GH replacement therapy in GH-deficient adults is safe and effective, leading to significant improvements in metabolic health, body composition, and quality of life.
- GH therapy normalizes mortality rates in GH-deficient adults, mitigating the increased risks associated with hypopituitarism.
- The KIMS study provides robust evidence supporting the long-term benefits and safety of GH replacement in this patient population.