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this off-label use is not backed by the same level of controlled human trial evidence as the lipodystrophy indication Known risks and side effects: Injection site reactions, including erythema, pruritus, pain, and bruising at the injection site Arthralgia (joint pain) and peripheral edema (fluid retention), recognized class effects of GH-axis stimulation Increases in blood glucose and reduced insulin sensitivity, with clinical trials showing a higher rate of elevated HbA1c and new-onset hyperglycemia versus placebo Formation of anti-tesamorelin antibodies, reported in a substantial proportion of treated patients, with unclear long-term clinical significance Contraindicated in people with active malignancy, pituitary or hypothalamic disruption, or pregnancy, per FDA labeling Evidence snapshot: The strongest evidence is a set of Phase 3 human randomized controlled trials that supported FDA approval of tesamorelin for reducing visceral abdominal fat in HIV-associated lipodystrophy (approved 2010), plus a separate placebo-controlled human RCT (Baker et al., 2012, Archives of Neurology) showing improved executive function in older adults
Analyzed were karyopyknotic cells in the affected brain areas (04), cerebral (NTP-7, Level 3), cerebellar cortex (NTP-7, Level 6), and hippocampus, thalamus, and hypothalamus (NTP-7, Level 3) as follows (score 0 indicates no change): score 1: a few karyopyknotic of neuronal cells (20%)
