Home » Drug Information » FDA-Approved Drugs » 1996
Medical Areas: Endocrinology
View By: Year Company Therapeutic Areas Drug Names
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Eli Lilly
Approval Status: Approved August 1996
Treatment Area: Somatropin Deficiency Syndrome
Humatrope has been approved as a treatment for Somatropin
Deficiency Syndrome, frequently associated with hypopituitarism.
Humatrope is a synthetic human growth hormone (gGH) that has been
used since 1987 as a replacement therapy for children who do not
produce enough or any of their own hGH.
In clinical trials, Humatrope therapy improved some of the
symptoms that SDS subjects experienced. Humatrope therapy resulted
in an increase in lean muscle mass, a decrease in body fat, an
increase in exercise capacity, and normalization of low HDL
cholesterol levels in SDS subjects.
Early in clinical trials, SDS subjects taking Humatrope
experienced edema and peripheral edema more frequently than
subjects receiving placebo. Other signs and symptoms reported
during therapy include edema, joint pains or disorders, back pain,
headaches, muscle aches, hypertension, and rhinitis. Many of the
signs and symptoms reported during therapy; however, resolved
either spontaneously or in response to dosage adjustments.
SDS adults may have hypopituitarism as a result of primary
tumors, trauma, or other pituitary disorders, or they may have been
treated for growth hormone deficiency as children. Adults with SDS
suffer from metabolic disorders that affect their physical
mobility, socialization and energy levels, as well as their life
expectancy. Some epidemiologic studies have suggested that adults
with SDS are at greater risk of cardiovascular disease than adults
without the disorder.