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Submitted on November 16, 2004
Accepted on January 14, 2005
Department of Molecular & Clinical Endocrinology and Oncology, Section of Endocrinology, "Federico II" University of Naples (A.C., C.D.S., F.R., R.P., M.C.S., G.L.), and Emergency Unit, "S. Maria degli Incurabili" Hospital of Naples (S.S.), Italy
* To whom correspondence should be addressed. E-mail: colao{at}unina.it.
To explore early effects of GH treatment or deprivation on cardiovascular risk factors and carotid intima-media thickness (IMT), we designed this randomized, cross-over study in adult 34 patients with severe GH deficiency (GHD). At study entry, the patients were randomized into two groups (A and B): group A (n = 17) received appropriate replacement therapy including GH at standard doses for 6 months and then were withdrawn from GH for the subsequent 6 months; group B (n = 17) received appropriate replacement therapy excluding GH for 6 months with the addition of GH in the subsequent 6 months.
After the first 6 mos, in the patients of group A was observed a significant increase of IGF-I levels and of HDL-cholesterol together with a significant decrease of diastolic blood pressure, the total/HDL-cholesterol ratio and C-reactive protein, while vascular parameters did not significantly change. In the patients of group B, none of the parameters studied significantly change. After 6 months of the GH withdrawal in the patients of group A was observed a significant decrease of IGF-I levels, a significant increase of the total/HDL-cholesterol ratio and C-reactive protein and a trend toward an impairment of carotid IMT and peak velocities. In the patients of group B, the addition of GH to the standard replacement induced a significant increase of IGF-I levels together with a decrease of systolic and diastolic blood pressure, total cholesterol and total/HDL-cholesterol ratio and C-reactive protein and increase of HDL-cholesterol levels with a trend toward an improvement of vascular parameters. At the end of the study, mean IMT was significantly lower than at baseline both in group A (from 0.88 ± 0.28 to 0.85 ± 0.27 mm, P = 0.0003) and in group B (from 0.83 ± 0.21 to 0.80 ± 0.20 mm, P = 0.003).
In conclusion, 6 months of GH replacement has beneficial effects while 6 months of GH deprivation has detrimental effects on cardiovascular risk factors and atherosclerosis. These findings support the indication for GH replacement in severe GHD adult patients.
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