Evidence map›Paper›PMID 35368070›Full record

Observational studyThe Journal of clinical endocrinology and metabolism2022

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, Márta Korbonits, André P van Beek, Michael P Wajnrajch and 2 more

Abstract readObservational Study
In one paragraph

Observational study in The Journal of clinical endocrinology and metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Observational
  5. Growth Hormone, Not Simply Just a Hormone for Growth.Endocrinology and metabolism (Seoul, Korea) · 2026
    Review
  6. Observational
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. The treatment of chronic anemia in heart failure: a global approach.Clinical research in cardiology : official journal of the German Cardiac Society · 2024
    Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Is GH Replacement for Adult GH Deficiency Safe?The Journal of clinical endocrinology and metabolism · 2022
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Gudmundur JohannssonDepartment of Endocrinology, Sahlgrenska University Hospital & Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, SE-413 45, Gothenburg, Sweden.ORCID 0000-0003-3484-8440
Philippe TouraineDepartment of Endocrinology and Reproductive Medicine, Center for Rare Endocrine and Gynecological Disorders, Sorbonne Université, Assistance Publique Hopitaux de Paris, Paris, France.ORCID 0000-0002-8462-7753
Ulla Feldt-RasmussenDepartment of Endocrinology and Metabolism, Rigshospitalet, and Department of Clinical Medicine, Faculty of Health and Clinical Science, Copenhagen University, Copenhagen, Denmark.ORCID 0000-0002-5903-3355
Antonio PicoBiomedical Research Networking Center in Rare Diseases (CIBERER), Institute of Health Carlos III (ISCIII), Madrid, Spain.ORCID 0000-0002-7549-7563
Greisa VilaClinical Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.ORCID 0000-0003-1918-1959
Anders F MattssonPfizer Endocrine Care, Pfizer Health AB, Sollentuna, Sweden.
Martin CarlssonRare Disease, Biopharmaceuticals, Pfizer, New York, NY, USA.ORCID 0000-0003-3106-0754
Márta KorbonitsCentre for Endocrinology, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.ORCID 0000-0002-4101-9432
André P van BeekDepartment of Endocrinology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Michael P WajnrajchRare Disease, Biopharmaceuticals, Pfizer, New York, NY, USA.
Roy GomezEuropean Medical Affairs, Pfizer, Brussels, Belgium.ORCID 0000-0001-7029-1542
Kevin C J YuenBarrow Pituitary Center, Barrow Neurological Institute, University of Arizona College of Medicine and Creighton School of Medicine, Phoenix, AZ, USA.ORCID 0000-0002-8169-2728

Funding

Pfizer
6 · The paper itself

Abstract

contextData on long-term safety of growth hormone (GH) replacement in adults with GH deficiency (GHD) are needed.

objectiveWe aimed to evaluate the safety of GH in the full KIMS (Pfizer International Metabolic Database) cohort.

methodsThe 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.

resultsA 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.

conclusionThese final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice.

Indexed as

Dwarfism, PituitaryHuman Growth HormoneHypopituitarismPituitary DiseasesPituitary NeoplasmsAdolescentAdultChildGrowth HormoneHormone Replacement TherapyHumansGrowth HormoneHuman Growth Hormoneadult growth hormone deficiencycancergrowth hormonehypopituitarismKIMSsafety

Identifiers

PMID35368070
PMCPMC9202689

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.