However, they occurred in 5% or less of the patient group. The second trial was a dose-ranging study conducted in 49 adults aged 23-70 years.
They all had been diagnosed with adult-onset growth hormone deficiency, but had stable pituitary function.
These preparations are currently in various stages of development, with some already approved in Europe and Asia.
Somavaratan (VRS-317) is a fusion protein produced in . The growth hormone loses some potency in this construct, but its delayed clearance, with a half-life 30-60 times longer than recombinant human growth hormone (rh GH) allows it to exert a prolonged effect in target tissue.
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If you have access to a journal via a society or association membership, please browse to your society journal, select an article to view, and follow the instructions in this box.These findings were almost superimposable with those in the ANSWER registry. At baseline, the mean hemoglobin A was 5.2%; this was unchanged at 3 years. The most commonly reported adverse event was injection site pain (48%).Bone age and chronological age came into alignment within the first year and that association was maintained throughout the study – again, in almost superimposable curves with the registry data. Injection site erythema was reported in 5% of patients, but no injection site nodules occurred.Overall, somavaratan induced a rapid and dramatic increase in IGF-1 that tailed off over 30 days.By day 8 after injection, IGF-1 had risen from a mean baseline of -1 SDs to more than 2 SDs above. The response to the fifth injection was identical to that of the first, Dr. Response varied somewhat by cohort, with the younger, mixed-gender group responding the most dramatically, with a mean increase of about 4 SDs from baseline.The active portion is recombinant human growth hormone, which is bound to long chains of hydrophilic amino acids. Of the two phase II studies of the molecule, in 36 adults with adult-onset growth hormone deficiency.The company also has made these presentations available online.All subjects received one injection per month for 5 months.Cohort A comprised 21 men and women aged 35 years or older, who took 0.6 mg/kg per month.Cohort B comprised six men and women younger than 35 years, who took 0.8 mg/kg per month.Cohort C comprised eight women taking oral estrogen contraceptives. The cohorts were similar in body mass index and weight, but they did differ significantly in baseline IGF-1 levels. In cohort B, it was 2.89 SDs below normal, and in cohort C, it was 2.29 SDs below.