Long-Term Safety of Growth Hormone in Adults With Growth Hormone Deficiency: Overview of 15 809 GH-Treated Patients

Gudmundur Johannsson, Philippe Touraine, Ulla Feldt-Rasmussen, Antonio Pico, Greisa Vila, Anders F. Mattsson, Martin Carlsson, Marta Korbonits, Andre P. van Beek, Michael P. Wajnrajch, Roy Gomez, Kevin C. J. Yuen*

*Corresponding author for this work

    Research output: Contribution to journalArticleAcademicpeer-review

    17 Citations (Scopus)
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    Abstract

    Context Data on long-term safety of growth hormone (GH) replacement in adults with GH deficiency (GHD) are needed. Objective We aimed to evaluate the safety of GH in the full KIMS (Pfizer International Metabolic Database) cohort. Methods The worldwide, observational KIMS study included adults and adolescents with confirmed GHD. Patients were treated with GH (Genotropin [somatropin]; Pfizer, NY) and followed through routine clinical practice. Adverse events (AEs) and clinical characteristics (eg, lipid profile, glucose) were collected. Results A cohort of 15 809 GH-treated patients were analyzed (mean follow-up of 5.3 years). AEs were reported in 51.2% of patients (treatment-related in 18.8%). Crude AE rate was higher in patients who were older, had GHD due to pituitary/hypothalamic tumors, or adult-onset GHD. AE rate analysis adjusted for age, gender, etiology, and follow-up time showed no correlation with GH dose. A total of 606 deaths (3.8%) were reported (146 by neoplasms, 71 by cardiac/vascular disorders, 48 by cerebrovascular disorders). Overall, de novo cancer incidence was comparable to that in the general population (standard incidence ratio 0.92; 95% CI, 0.83-1.01). De novo cancer risk was significantly lower in patients with idiopathic/congenital GHD (0.64; 0.43-0.91), but similar in those with pituitary/hypothalamic tumors or other etiologies versus the general population. Neither adult-onset nor childhood-onset GHD was associated with increased de novo cancer risks. Neutral effects were observed in lipids/fasting blood glucose levels. Conclusion These final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice.

    Original languageEnglish
    Pages (from-to)1906-1919
    Number of pages14
    JournalJournal of Clinical Endocrinology & Metabolism
    Volume107
    Issue number7
    Early online date3-Apr-2022
    DOIs
    Publication statusPublished - Jul-2022

    Keywords

    • adult growth hormone deficiency
    • growth hormone
    • hypopituitarism
    • cancer
    • safety
    • KIMS
    • QUALITY-OF-LIFE
    • APOLIPOPROTEIN B100 KINETICS
    • CARDIOVASCULAR RISK-FACTORS
    • REPLACEMENT THERAPY
    • HYPOPITUITARY PATIENTS
    • PRIMARY CANCERS
    • MORTALITY
    • DIAGNOSIS
    • GLUCOSE
    • PROFILE

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