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Katrina Bolar, Andrew R. Hoffman, Thomas Maneatis, and Barbara Lippe
J. Clin. Endocrinol. Metab., Feb 2008;93: 344 - 351.
The purpose of
this study was to determine frequencies of specific targeted adverse events
(AEs) and additional AEs of interest in Turner syndrome (TS) patients. TS
affects more than 50,000 girls and women in the United States. It is a genetic
disorder affecting the sexual development and appearance of girls and women.
Women with TS are much shorter than normal women within their respective
populations (by about 21 cm or eight inches).
The National Cooperative
Growth Study (NCGS) has collected efficacy and safety data for 5220 TS children
treated with recombinant human GH (rhGH) during the last 20 years. Investigators
submit AE reports describing any event that is potentially rhGH related or is a
targeted event.
The Genentech Drug Safety department received 442 AE
reports for TS NCGS patients as of June 30, 2006, including 117 serious AEs.
Seven deaths occurred; five resulted from aortic dissections/ruptures. The
incidence of certain events known to be associated with rhGH (targeted events),
including intracranial hypertension, slipped capital femoral epiphysis,
scoliosis, and pancreatitis, was increased compared with other non-TS patients
in NCGS. There were 10 new-onset malignancies that occurred, including six in
patients without known risk factors. Type 1 diabetes also appeared to be
increased compared with other NCGS groups.
Children with TS who were
treated with rhGH exhibit an increased underlying risk for selected AEs
associated with rhGH and for type 1 diabetes, which is likely unrelated to rhGH.
The aortic dissection/rupture incidence reflects the higher baseline risk for
these events in TS and is likely unrelated to rhGH. It is not known whether the
reported malignancies represent an inherently increased risk in TS patients.
Twenty years of experience in 5220 patients indicates no new rhGH-related safety
signals in the TS population.
