Chief Cushie ~MaryO~ Posted May 14, 2022 Chief Cushie Report Share Posted May 14, 2022 A worldwide, observational study of adults and adolescents with growth hormone deficiency (GHD) found long-term GH replacement was safe. These findings were published in the Journal of Clinical Endocrinology & Metabolism. Data for this long-term follow-up study were sourced from the KIMS Pfizer International Metabolic Database cohort. Patients (N=15,809) with confirmed GHD were prescribed GH by their primary care physician. Adverse events were evaluated at up to 18 years (mean, 5.3 years). The median age of study participants was 44.8 (range, 5.6-91.2) years, 50.5% were girls or women, 94.4% were White, 57.6% were true-naive to treatment at baseline, 59.7% had pituitary or hypothalamic tumor, 21.6% had idiopathic or congenital GHD, and 67.8% had at least 2 pituitary deficiencies. Patients were administered a mean GH dosage of 0.30±0.30 mg/d. At year 15, patients (n=593) had a 1.7-kg/m2 increase in body mass index (BMI), a 4.3-kg increase in weight, a 0.4-cm decrease in height, a 6.2-cm increase in waist circumference, a 0.03 increase in waist to hip ratio, a 6.3-mm Hg increase in systolic blood pressure, a 1.0-mm Hg increase in diastolic blood pressure, and a 0.5-bpm decrease in heart rate. Approximately one-half of the patients (51.2%) experienced at least 1 adverse event, but few patients (18.8%) reported treatment-related adverse events. The most common all-cause adverse events included arthralgia (4.6%), peripheral edema (3.9%), headache (3.6%), influenza (2.8%), depression (2.8%), and recurrence of pituitary tumor (2.7%). The most common treatment-related adverse events were peripheral edema (3.1%) and arthralgia (2.6%). The rate of all-cause (P =.0141) and related (P =.0313) adverse events was significantly related with age at enrollment, with older patients (aged ³45 years) having higher rates than younger patients. The rate of all-cause and related adverse events was higher among patients with pituitary or hypothalamic tumor, adult-onset GHD, and insulin-like growth factor 1 standard deviation score greater than 0; those who had prior pituitary radiation treatment; and those who took a GH dosage of no more than 0.30 mg/d (all P £..014). A total of 1934 patients discontinued treatment, and 869 patients reduced their dose due to adverse events. Study discontinuation was highest among patients with idiopathic or congenital GHD (45.0%). At least 1 serious adverse event occurred among 4.3% of patients. The most common serious events included recurrence of pituitary tumor (n=154; 1.0%) and death (n=21; 0.1%). The highest mortality rate was observed among patients who enrolled at 45 years of age and older (4.7%). In total, 418 patients who had no history of cancer at baseline were diagnosed with cancer after starting GH treatment, which equated to a standardized incidence ratio of 0.92 (95% CI, 0.83-1.01). This study was limited as data were collected during routine clinical practice and no predefined windows or reporting were set. This study found that GH replacement therapy was safe at up to an 18-year follow-up among adolescents and adults. Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures. Reference Johannsson G, Touraine P, Feldt-Rasmussen U, et al. Long-term safety of growth hormone in adults with growth hormone deficiency: overview of 15,809 GH-treated patients. J Clin Endocrinol Metab. Published online April 3, 2022. doi:10.1210/clinem/dgac199 From https://www.endocrinologyadvisor.com/home/topics/general-endocrinology/safety-of-long-term-growth-hormone-treatment-assessed/ 1 Quote Link to comment Share on other sites More sharing options...
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