PMID- 12756387
OWN - NLM
STAT- MEDLINE
DCOM- 20030707
LR  - 20041117
IS  - 0022-3476 (Print)
IS  - 0022-3476 (Linking)
VI  - 142
IP  - 5
DP  - 2003 May
TI  - Adverse events with rhGH treatment of patients with chronic renal insufficiency 
      and end-stage renal disease.
PG  - 539-45
AB  - 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). STUDY DESIGN: 
      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.
FAU - Fine, Richard N
AU  - Fine RN
AD  - Department of Pediatrics, SUNY Stony Brook, New York 11794, USA. 
      richard.fine@stonybrook.edu
FAU - Ho, Martin
AU  - Ho M
FAU - Tejani, Amir
AU  - Tejani A
FAU - Blethen, Sandra
AU  - Blethen S
LA  - eng
PT  - Journal Article
PL  - United States
TA  - J Pediatr
JT  - The Journal of pediatrics
JID - 0375410
RN  - 12629-01-5 (Human Growth Hormone)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Diabetes Mellitus/chemically induced/epidemiology
MH  - Epiphyses, Slipped/*chemically induced/epidemiology
MH  - Glucose Intolerance/chemically induced/epidemiology
MH  - Human Growth Hormone/*adverse effects/therapeutic use
MH  - Humans
MH  - Incidence
MH  - Intracranial Hypertension/*chemically induced/epidemiology
MH  - Kidney Failure, Chronic/*drug therapy/therapy
MH  - Neoplasms/*chemically induced/epidemiology
MH  - Osteonecrosis/*chemically induced/epidemiology
MH  - Pancreatitis/chemically induced/epidemiology
MH  - Prospective Studies
MH  - Renal Dialysis/methods
EDAT- 2003/05/21 05:00
MHDA- 2003/07/08 05:00
CRDT- 2003/05/21 05:00
PHST- 2003/05/21 05:00 [pubmed]
PHST- 2003/07/08 05:00 [medline]
PHST- 2003/05/21 05:00 [entrez]
AID - S0022-3476(03)00115-X [pii]
AID - 10.1067/mpd.2003.189 [doi]
PST - ppublish
SO  - J Pediatr. 2003 May;142(5):539-45. doi: 10.1067/mpd.2003.189.