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Effect of Growth Hormone on Biomarkers of Nutrition and Cardiovascular Disease
found no difference in blood glucose between zero and six months, and attempting to increase the nutritional status through dietary
a small but non-significant decrease in insulin levels.
36
This may reflect interventions is cumbersome and can at best correct only a minor part of
direct beneficial effect on body composition and a subsequent indirect the malnourished state of the majority of patients on chronic MHD. Thus,
effect on glucose metabolism. The studies used a GH dose of 66.7 and a major unmet medical need exists.
28.6g/kg/day, respectively. In registered indications such as Turner
syndrome, GH doses of 50–67g/kg/day are used without evidence of an A new global phase III trial was launched in 2007. It is a multinational
increased risk of developing diabetes. In addition, the results from the study including 2,500 patients on chronic MHD. The goal for the trial is
recently performed phase II trial
51
showed that there were no serious to establish the efficacy and safety of Norditropin on mortality in the
safety concerns with regard to glucose metabolism in any of the
treatment groups (20, 35 and 50µg/kg/day).
Given the correlation between
Clinical experience in acromegaly, a state of GH excess, indicates that
morbidity/mortality and biochemical
patients with co-existing diabetes often have worsening of
hyperglycaemia that improves when GH levels are reduced. Patients with
markers of protein-energy malnutrition,
diabetes have differing degrees of insulin resistance and different levels
it is appropriate to assess the impact
of endogenous beta-cell function, so the response of an individual with
of growth hormone on subjects on
diabetes to GH cannot be predicted prior to the start of treatment. It is
possible that there will be an accentuation of the effects of GH on chronic haemodialysis with evidence
glucose metabolism in subjects with pre-existing diabetes, and these
of malnutrition.
subjects will require careful monitoring and additional diabetes treatment
if this occurs. A number of subjects with diabetes previously controlled
on oral agents may require insulin therapy during treatment with GH in chronic HD population during a treatment period of 24 months. The
order to achieve and maintain appropriate levels of glucose control. procedures for diagnosis, treatment and withdrawal to be used in
the trial are aimed at adapting the current clinical guidelines to meet the
A New Phase III Trial Has Been Initiated realities of daily clinical practice in a dialysis population. Based on
Given the correlation between morbidity/mortality and biochemical feedback from regulatory authorities, subjects with diabetes will be
markers of protein-energy malnutrition, it is appropriate to assess the included in the current trial as they represent a substantial percentage of
impact of GH on subjects on chronic HD with evidence of malnutrition. the chronic HD population. The treatment of patients with diabetes will
Clinical studies support the potential beneficial effects of low doses of be monitored carefully to assure that appropriate therapeutic
Norditropin in this condition.
32–51
Increasing the dialysis dose and interventions are undertaken if glycaemic control worsens. ■
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