BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Saturday, 30 November 1996

(ADVANCE) SAN FRANCISCO--(BUSINESS WIRE)--Nov. 30, 1996--AIDS patients who took daily injections of human growth hormone gained a significantly greater amount of weight, particularly lean body mass, than patients on placebo, according to the results of a newly published multicenter trial coordinated by researchers from UC San Francisco.

The researchers also found that patients on growth hormone performed significantly better on treadmill tests at the conclusion of the three month study, indicating an improvement in functional performance.

"Our results clearly demonstrate that growth hormone can help AIDS patients with wasting to gain lean tissue and lose fat," said Morris Schambelan, MD, a UCSF professor of medicine (endocrinology) at the UCSF-affiliated San Francisco General Hospital and principal investigator in the study. "The magnitude of this response varies from individual to individual, and we are currently unable to predict who will benefit most. Patients who continue to take growth hormone, eat well, and are free of opportunistic infections, have gained up to 40 pounds over a two-year period."

The study is published in the December 1 issue of the Annals of Internal Medicine. Schambelan also will present the results Monday, December 2 at a 10:30 a.m. news conference at the Millenium Broadway Hotel in New York.

The study included 178 patients -- 172 men and six women -- who were suffering from AIDS-associated wasting. Wasting is a serious concern for AIDS patients as it can compromise their ability to perform daily tasks. Studies have also found that patients with wasting are more likely to die sooner than those who maintain their lean tissues.

In the study, the patients who continued on growth hormone throughout the three months gained an average of 3.5 pounds. More important, these patients gained an average of 6.6 pounds of lean body tissue, with the difference accounted for by the loss of fat. By contrast, patients on placebo had no net change in weight, lean body tissue or fat, the researchers found.

"Our study demonstrates that there are therapies that can correct or reverse the loss of lean tissue in patients with HIV-associated wasting," Schambelan said. "Other therapies, such as appetite stimulants, can cause weight gain but have not been as successful in restoring lean tissue."

To measure possible changes in function among the two patient groups, the researchers performed treadmill tests at both the beginning and end of the study. After three months, the patients on growth hormone had increased their work output by 13 percent, while those on placebo had improved their output by only two percent. The output measure is based on the speed and grade of the treadmill achieved at the time of exhaustion.

The researchers also asked the patients to fill out quality-of-life questionnaires that asked them a range of questions, including questions about their general mood, pain levels, and ability to work and perform daily activities.

"There was no significant difference in these subjective responses to treatment in those who received growth hormone or placebo," Schambelan said.

"We are under the impression that people feel better, but the questions that were posed in this questionnaire didn't pick up on the types of improvement that the patients were experiencing," he said. The researchers have subsequently devised a new assessment tool that may be more accurate in gauging perceived changes in quality of life among patients undergoing trials for the treatment of wasting, Schambelan said

The patients on growth hormone did experience some minor side-effects, with the most common being swelling or puffiness, joint or muscle pain and diarrhea. In most cases, these side-effects disappeared when the drug dosage was reduced. There was no difference in survival rates among the two groups of patients.

Schambelan's co-authors in the study are Kathleen Mulligan, PhD, UCSF assistant professor of medicine; Carl Grunfeld, MD, PhD, UCSF professor of medicine at the Veterans Affairs Medical Center in San Francisco; Eric S. Daar, MD, UCLA assistant professor of medicine at Cedars-Sinai Medical Center in Los Angeles; Anthony LaMarca, MD, of Therafirst Medical Center in Fort Lauderdale; Donald P. Kotler, MD, and Jack Wang, MS, of St. Luke's-Roosevelt Hospital in New York City; Samuel A. Bozzette, MD, PhD, UCSD professor of medicine at the Veterans Affairs Medical Center in San Diego; and James B. Breitmeyer, MD, PhD, of Serono Laboratories in Norwell, Mass.

The study was sponsored by Serono Laboratories, which makes mammalian cell-derived human growth hormone.

(End of advance for release 5 p.m. EST on Nov. 30)

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CONTACT: UCSF Ruthann Richter, 415/476-3804

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