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Title: Growth Hormone Injections Increase Muscle Mass, Decrease Fat Mass in Patients With Chronic Obstructive Pulmonary Disease: Presented at ERS

"Growth Hormone Injections Increase Muscle Mass, Decrease Fat Mass in Patients With Chronic Obstructive Pulmonary Disease: Presented at ERS"

By Cameron Johnston GLASGOW, SCOTLAND -- September 10, 2004 -- Daily subcutaneous injections of a synthetic human growth hormone-releasing factor analogue (hGRF TH-9507) have resulted in significant increases in lean muscle mass, as well as reductions in fat mass, among patients with severe chronic obstructive pulmonary disease. The growth hormone was developed by Theratechnologies Inc. of Montreal, Canada, and was tested among 109 subjects over a 3-month period. In the study, 36 subjects received a placebo, 36 received daily 1 mg subcutaneous injections and 37 received daily 2 mg injections. In all, 96 completed the study (placebo = 32; 1 mg = 31; and 2 mg = 33). Only one patient out of all those who discontinued did so because of reactions to the study drug. Overall, lean body mass increased significantly in the two growth hormone groups compared with placebo and with baseline. The gains were noticeable as early as 1 month into treatment. At month 3, the 1-mg group increased by a mean of 1.3 kg, the 2-mg group increased by a mean of 0.9 kg, and the placebo group lost a mean of 0.1 kg. Similarly, fat free mass index showed a significant increased with both doses compared with baseline and with placebo. The mean increase in lean body mass at the end of 3 months was 1.2 kg in the 1-mg group and 1.7 kg in the 2-mg group. There was a loss of 0.1 kg in the placebo group. Fat mass decreased significantly in both growth hormone groups when compared with baseline whereas an increase was observed in the placebo group. The change between the treatment groups was not significant. According to Luc Vachon, PhD, Director of Research and Development, Theratechnologies, these results are important given that muscle wasting is such as serious problem for individuals with COPD. In this case, the subjects were already experiencing significant wasting (mean BMI was approximately 22 at enrollment). The degree of wasting is an independent risk factor for morbidity and mortality among these patients, he said. Despite the increase in muscle mass, however, this did not translate into functional improvements for these patients, he said. Both breathing and leg discomfort decreased markedly when the subjects were performing a cycle test, but they were not able to perform any longer on the cycle test or on a 6-minute walking test than they did before the study began. [Presentation title: "Anabolic Effects and Safety Assessments of TH9507, a Growth Hormone Releasing Factor (GRF) Analog, in Patients With COPD-associated Wasting." Poster 1888]

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