Human Growth Hormone Approved
for
HYPOPITUITARY DISEASE
and
SOMATOTROPIN DEFICIENCY SYNDROME

Humatrope is a synthetic human growth hormone (hGH) that has beeen used since 1987 as a replacement therapy for children who do not produce enough or any of their own hGH. The FDA cleared the new adult indication for Humatrope after reviewing clinical data from multinational studies that were submitted to the federal agency by Lilly in August 1995.

"This new use for Humatrope is an example of how continued study of a drug can offer new hope to patients who before now had no therapuetic option for their disorder," said August M. Watanabe, M.D., executive vice-president of science and technology for Lilly.

SDS adults may have hypopituitarism as a result of pituitary tumors, trauma, or other pituitary disorders or they may 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 a greater risk of cardiovascular disease than adults without the disorder.

In clinical trials, Humatrope therapy improved some of the symptoms that SDS patients 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 patients. Patients who developed SDS in adulthood also reported, in a general, health-related quality of life questionnaire (the Nottingham Health Profile), improvement in physical mobility and social isolation, two health- related domains measured by the Profile. An increase in another domain, energy level, was also reported by adult onset SDS patients after 18 months of Humatrope therapy. The data for patients who developed SDS in childhood did not reflect Nottingham Health Profile improvements. Early in clinical trials, SDS patients taking Humatrope experienced edema and peripheral edema more frequently than patients 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 adjustment.

Hypopituitary and somatropin deficient adults should consult with an endocrinologists regarding the potential benefits and risks of replacement therapy with Humatrope. Humatrope therapy would be a supplement to any other hormone replacement therapy that hypopituitary patients may already be receiving (for example, estrogen, thyroid or hydrocortisone).

Humatrope already has been approved for somatropin replacement therapy in adults in several countries outside the United States--Greece, New Zealand, Sweden, Denmark, France, Germany, Spain, the Netherlands, Mexico, the United Kingdom, Norway and Finland. The drug also has been approved to treat growth hormone deficiency in children and Turner Syndrome in many countries outside the United States.

LILLY is a global research based pharmaceutical corporation headquartered in Indianapolis, Indiana, that is dedicated to creating and delivering superior health care solutions-- by combining pharmaceutical innovation, existing pharmaceutical technology, disease prevention and management and information technologies-- in order to provide customers worldwide with optimal clinical and economic outcomes. Endocrine diseases are one of five therapeutic areas in which the company is focusing its efforts.

Human Growth Hormone Treatable Diseases
Learn More About Treating with Human Growth Hormone

Hypopituitarism
Somatotropin Deficiency Disorder

fibromyalgia
chronic fatigue
dilated cardiomyopathy
ischemic heart disease

The information in this newsletter does not dictate an exclusive course of treatment or procedure to be followed and should not be construed as excluding other acceptable methods of practice.

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