medwireNews: A position statement from three societies, including the European Society of Paediatric Endocrinology (ESPE), supports the safety profile of recombinant human growth hormone (rhGH).
The statement is the result of a 3-day workshop involving ESPE, the GH Research Society and the Pediatric Endocrine Society. The workshop participants reviewed published data on GH safety and as well as information from pharmaceutical company safety databases; industry representatives presented their data but were not involved in voting or writing statements.
The participants concluded that “the safety record of rhGH remains good, supported by evidence from the follow-up of thousands of children and adults over tens of thousands of patient years.”
The report writers – Richard Ross (University of Sheffield, UK) and colleagues – acknowledge that long-term safety data come from observational studies and that there is little data from untreated comparison cohorts. Also, children requiring GH treatment often have complex underlying conditions that may increase the risk of mortality and other adverse events.
Nevertheless, the workshop participants agreed that there is no evidence supporting increased mortality in GH-treated children, or an increased risk of primary or recurring cancer in children.
There was evidence “suggestive” of an increased risk of second primary tumours in GH-treated cancer survivors, but this diminished with longer duration of treatment.
“The general opinion was that the association between GH therapy and risk of second tumors is insufficient to preclude use of rhGH for licensed indications in children”, Ross and team write in the European Journal of Endocrinology.
Many areas had insufficient evidence to support a firm conclusion, such as GH treatment of children with a high underlying cancer risk, all cancer-related outcomes in adults and stroke risk in adults who received GH as children. However, the participants agreed that GH has generally neutral or positive effects on cardiometabolic risk.
There are a number of recognised side effects of GH treatment, such as intracranial hypertension, scoliosis, and altered cortisol and thyroid metabolism, for which the report notes monitoring and management requirements. It also highlights the importance of monitoring children during GH therapy to reduce the risk of GH side effects.
Although concluding that GH has a good safety profile, the workshop participants also state that continuing monitoring of patients is essential both during and after treatment. They add: “This is particularly important with the advent of long-acting GH preparations with very different pharmaco-kinetic and -dynamic profiles compared to daily rhGH injections.”
By Eleanor McDermid, Senior medwireNews Reporter
Eur J Endocrinol 2015; Advance online publication
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