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Macrilen (macimorelin) stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. Stimulated growth hormone levels are measured in four blood samples over ninety minutes after oral administration of Macrilen (macimorelin) for the assessment of growth hormone deficiency (“GHD”).
Prior to the approval of Macrilen (macimorelin), the historical gold standard for evaluation of AGHD was the insulin tolerance test (“ITT”), an intravenous test requiring many blood draws over several hours. The ITT procedure is inconvenient for patients and medical practitioners and may contraindicate in patients, such as those with coronary heart disease or seizure disorder, because it requires the patient to experience hypoglycemia to obtain an accurate result.
Clinical studies have demonstrated that growth hormone stimulation testing for AGHD with oral Macrilen (macimorelin) is reliable, well-tolerated, reproducible, safe and a much simpler test to conduct than currently available options. The availability of Macrilen (macimorelin) will greatly relieve the burden of endocrinologists in reliably and accurately diagnosing AGHD.
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