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

被引：24

作者：

Johannsson, Gudmundur ^{[1
,2
]}

Touraine, Philippe ^{[3
]}

Feldt-Rasmussen, Ulla ^{[4
,5
]}

Pico, Antonio ^{[6
,7
,8
]}

Vila, Greisa ^{[9
]}

Mattsson, Anders F. ^{[10
]}

Carlsson, Martin ^{[11
]}

Korbonits, Marta ^{[12
]}

van Beek, Andre P. ^{[13
]}

Wajnrajch, Michael P. ^{[11
,14
]}

Gomez, Roy ^{[15
]}

Yuen, Kevin C. J. ^{[16
,17
]}

机构：

[1] Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, SE-41345 Gothenburg, Sweden

[2] Univ Gothenburg, Sahlgrenska Acad, Inst Med, SE-41345 Gothenburg, Sweden

[3] Sorbonne Univ, AP HP, Dept Endocrinol & Reprod Med, Ctr Rare Endocrine & Gynecol Disorders, F-75013 Paris, France

[4] Univ Copenhagen, Rigshosp, Dept Endocrinol & Metab, DK-2100 Copenhagen, Denmark

[5] Univ Copenhagen, Fac Hlth & Clin Sci, Dept Clin Med, DK-2100 Copenhagen, Denmark

[6] Inst Hlth Carlos III ISCIII, Biomed Res Networking Ctr Rare Dis CIBERER, Madrid 28029, Spain

[7] Hosp Gen Univ Alicante, Inst Hlth & Biomed Res ISABIAL, Alicante 03010, Spain

[8] Miguel Hernandez Univ, Dept Clin Med, Elche 03202, Spain

[9] Med Univ Vienna, Dept Internal Med 3, Clin Div Endocrinol & Metab, A-1090 Vienna, Austria

[10] Pfizer Hlth AB, Pfizer Endocrine Care, S-19190 Sollentuna, Sweden

[11] Pfizer, Biopharmaceut, Rare Dis, New York, NY 10017 USA

[12] Queen Mary Univ London, Ctr Endocrinol, Barts & London Sch Med & Dent, William Harvey Res Inst, London E1 4NS, England

[13] Univ Groningen, Univ Med Ctr Groningen, Dept Endocrinol, NL-9718 BG Groningen, Netherlands

[14] NYU, Dept Pediat, Langone Med Ctr, New York, NY 10016 USA

[15] Pfizer, European Med Affairs, B-1050 Brussels, Belgium

[16] Univ Arizona, Barrow Pituitary Ctr, Barrow Neurol Inst, Coll Med, Phoenix, AZ 85013 USA

[17] Creighton Sch Med, Phoenix, AZ 85013 USA

来源：

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM | 2022年 / 107卷 / 07期

关键词：

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;

D O I：

10.1210/clinem/dgac199

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1906 / 1919

页数：14