Abstract
BackgroundGH may be beneficial in treating patients with end-stage renal disease (ESRD). However, the efficacy and safety of GH could be compromised by the potential for accumulation in the circulation.ObjectiveThe objective was to investigate the pharmacokinetics and safety of GH treatment in ESRD patients.DesignThis was an open, nonrandomized, single-centre parallel-group study lasting 8–9 days.SubjectsEleven adult ESRD patients and 10 matched healthy individuals received recombinant human GH (50 µg/kg/day for 7 days) by subcutaneous injection; there were two dose reductions (25%) from Day 5/7. ESRD patients underwent dialysis four times.MeasurementsSerum concentrations of GH, insulin-like growth factor-I (IGF-I), insulin-like growth factor binding protein-I (IGFBP-I), IGFBP-III and GHBP were measured. The primary end-point was GH exposure [area-under-the-curve (AUC) calculated from the 24-h profile] on Days 7–8.ResultsGH AUC0–24 h was greater for patients (387·91 ± 134·13 µg h/l) than healthy subjects (225·35 ± 59·63 µg h/l) and the 90% confidence interval (CI) for the estimated patient : healthy subject ratio (1·40–2·07) was not within the acceptance interval (0·67–1·50). GH AUC18–24 h for patients and healthy subjects (3·03 ± 2·71 µg h/l and 6·37 ± 4·21 µg h/l) returned approximately to baseline (2·86 ± 3·91 µg h/l and 1·09 ± 1·43 µg h/l); terminal half-life (t1/2,z) was shorter for patients (2·28 ± 00·43 h vs. 3·23 ± 00·75 h). No major safety issues were identified.ConclusionsResults demonstrate a difference between patients and healthy subjects regarding GH AUC0–24 h. However, GH concentrations for both groups were comparable to baseline by 20–22 h, thus GH was not retained in the circulation of ESRD patients.
Highlights
Patients with end-stage renal disease undergoing haemodialysis commonly suffer from malnutrition, which represents one of the main clinical problems for these patients.[1]
The state of malnutrition and the malnutritioninduced systemic inflammation in patients with end-stage renal disease (ESRD) have been associated with the increased mortality and morbidity observed in these patients.[4,5,6,7,8,9]
insulin-like growth factor binding protein-I (IGFBP-I) and IGFBP-III values were significantly higher in patients compared with healthy subjects at baseline (Table 2), whereas GHBP values in healthy subjects at baseline were almost double those in patients (P = 0·01)
Summary
Patients with end-stage renal disease undergoing haemodialysis commonly suffer from malnutrition, which represents one of the main clinical problems for these patients.[1]. A number of preventive and therapeutic measures have been used to treat malnutrition in patients with ESRD, including anabolic hormones such as GH
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