Serostim Approved In Canada For Treatment Of HIV Wasting
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Serostim Approved In Canada For Treatment Of HIV Wasting

OAKVILLE, ON -- Dec. 1, 1998 -- Serono Canada, Inc.’s human growth hormone, Serostim(R) [somatropin (rDNA origin) for injection], has been approved in Canada for the treatment of HIV wasting associated with catabolism or cachexia.

HIV/AIDS wasting causes the body to inappropriately burn lean body mass (LBM), including vital muscle and organ tissue, instead of fat. Today, wasting remains a leading cause of death among people with AIDS and is the second most frequently reported AIDS-related clinical condition in the U.S.

As an anabolic (protein building) and anticatabolic (protein sparing) agent, Serostim therapy results in a significant increase in lean body mass and weight, with a decrease in body fat. During the course of earlier Phase III trials, it was learned that preventing the continued loss, as well as promoting the accrual of lean body mass, are keys to improving quality of life and physical function.

AIDS wasting affects a small, well-defined patient population, estimated at 15 percent of the total HIV/AIDS population, or approximately 1,350 people in Canada. People with AIDS should carefully monitor changes in their total weight, as well as overall body shape. Wasting can be easily diagnosed right in a doctor's office by weighing the patient and by a simple, non-invasive test to measure his/her body composition, which includes the ratio of muscle to fat. Monitoring weight and body composition should become part of the standard of care for people with AIDS.

The two Phase III trials reported that the most common adverse reactions judged to be associated with Serostim therapy were musculoskeletal discomfort (pain, swelling and/or stiffness) and increased tissue turgor (swelling of the hands or feet). These symptoms, generally characterised as mild to moderate, usually subsided with continued treatment. Concomitant antiviral therapy is necessary.

Growth hormone has been shown to have immunomodulatory and hematopoietic properties, promoting positive effects on the production of important blood cells.

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