Objectives: Patients with acquired growth hormone (GH) deficiency secondary to hypopituitarism, have a significant increased risk of cardiovascular events. However, variable data of the effects of GH replacement and its benefits reducing such risk, is available. The aim of this study was to determine the impact of 0.4 milligrams of GH on cardiovascular markers in severe GH deficient adults with hypopituitarism.
Methods: A total of 17 patients (10 males and 7 females) with severe GH deficiency completed a double blind, randomized, cross-over, placebo controlled trial of subcutaneous recombinant GH (Lilly rGH, dose 0.004 milligrams per kilogram per day) versus placebo (sterile diluent containing glycerol and m-cresol) of 12 weeks duration per arm. Thereafter, patients continued GH therapy for a further 6 months. Reported here is the interim analysis of the basal values of the randomised controlled study.
Results: Compliance was more than 90%, all patients normalised their IGF-1 within the reference range. Treatment with rGH reduced body fat by 5.6% when compared with baseline(mean plus/minus SD, 36.2 plus/minus 10.7 versus 38 plus/minus 10, units equal to % of body fat),a significantly higher reduction than that obtained in the placebo phase (p=0.018). IGF1 rose by 57% in the active treatment phase (123 micrograms per litre plus/minus 49 versus 191.3 micrograms per litre plus/minus 73) which was significantly higher than the levels in the placebo arm (p=0.005). No significant changes were observed in BMI, waist/hip ratio, BP, blood glucose, total cholesterol or triglycerides.
Conclusions: Short term administration of low dose of subcutaneous rGH in patients with severe growth hormone deficiency favourably alters body fat mass and levels of IGF1 without significant changes in blood glucose levels or blood pressure. However, this dose did not confer additional benefits reducing elevated total cholesterol or triglycerides over the 3 month period.
04 - 06 Apr 2005
British Endocrine Societies