Adverse events with rhGH treatment of patients with chronic renal insufficiency and end-stage renal disease.
OBJECTIVE
Recombinant human growth hormone (rhGH) has been used to improve the growth retardation associated with chronic renal insufficiency (CRI) and end-stage renal disease. We determined the incidence of one of four targeted adverse events (AEs): malignancy, slipped capital femoral epiphysis (SCFE), avascular necrosis (AN), and intracranial hypertension (ICH).


METHODS
During a 6.5-year period, we prospectively assessed patients enrolled in the CRI, dialysis, and transplant registries of the North American Renal Transplant Cooperative Study. The availability of an untreated control population facilitated determining whether or not there was the association between the AE and rhGH treatment.


RESULTS
Of the targeted AE, the only significant relation with rhGH treatment was the presence of ICH in patients with CRI; however, in all 3 instances, ICH occurred 2, 50, and 1131 days after discontinuation of rhGH. Considering that the mechanism of ICH in rhGH-treated patients is thought to be increased CSF production, rhGH probably had no role in the development of ICH in at least 2 of the 3 patients with CRI. A number of nontargeted AE were identified that have been associated with rhGH treatment in patients without renal disease. The incidence of glucose intolerance, pancreatitis, progressive deterioration of renal function, acute allograft rejection, and fluid retention were not more frequent in those receiving rhGH treatment compared with the control population.


CONCLUSIONS
This report validates the importance of a control population in ascribing AE to any therapeutic intervention. Previously identified AE associated with rhGH treatment are infrequent in patients with CRI and end-stage renal disease.
Fine
Richard N
RN
Department of Pediatrics, SUNY Stony Brook, New York 11794, USA. richard.fine@stonybrook.edu
Ho
Martin
M
Tejani
Amir
A
Blethen
Sandra
S
D000293:Adolescent; D002648:Child; D003920:Diabetes Mellitus / Q000139:chemically induced / Q000453:epidemiology; D004839:Epiphyses, Slipped / Q000139:chemically induced* / Q000453:epidemiology; D018149:Glucose Intolerance / Q000139:chemically induced / Q000453:epidemiology; D019382:Human Growth Hormone / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D019586:Intracranial Hypertension / Q000139:chemically induced* / Q000453:epidemiology; D007676:Kidney Failure, Chronic / Q000188:drug therapy* / Q000628:therapy; D009369:Neoplasms / Q000139:chemically induced* / Q000453:epidemiology; D010020:Osteonecrosis / Q000139:chemically induced* / Q000453:epidemiology; D010195:Pancreatitis / Q000139:chemically induced / Q000453:epidemiology; D011446:Prospective Studies; D006435:Renal Dialysis / Q000379:methods
D019382:Human Growth Hormone