Long-term safety of growth hormone in adults with growth hormone deficiency: Overview of 15,809 GH-treated patients
| Autor: | Johannsson G, Touraine P, Feldt-Rasmussen U, Pico A, Vila G, Mattsson AF, Carlsson M, Korbonits M, van Beek AP, Wajnrajch MP, Gomez R, Yuen KCJ |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante instname |
| ISSN: | 0021-972X |
| Popis: | CONTEXT: Data on long-term safety of growth hormone (GH) replacement in adults with GH deficiency (GHD) are needed. OBJECTIVE: To evaluate the safety of GH in the full KIMS (Pfizer International Metabolic Database) cohort. DESIGN, PATIENTS, SETTING, AND INTERVENTION: 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. MAIN OUTCOME MEASURES: Adverse events (AEs) and clinical characteristics (e.g., lipid profile, glucose) were collected. RESULTS: 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. 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. CONCLUSIONS: These final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice. |
| Databáze: | OpenAIRE |
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