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Sermorelin Pre-Surgery Hold Window: What Patients and Clinicians Need to Know

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At a glance

  • Drug / sermorelin acetate, a 29-amino-acid GHRH analogue, not growth hormone [3]
  • FDA status / Geref discontinued 2008; approvals withdrawn June 18, 2009 [2]
  • Current US supply / compounded, not FDA-approved [1]
  • Published hold window before surgery / none established
  • 1-year pediatric data / fasting glucose unchanged, IGF-I not excessively raised [4]

Is there a recommended sermorelin hold window before surgery?

No. Geref's approved uses were treating idiopathic growth hormone deficiency in children and testing the pituitary's ability to secrete growth hormone; it was never approved for adults, anti-aging or weight loss [2]. With Geref's approvals withdrawn, no sermorelin product is FDA-approved, so there is no current approved label that could set a presurgery hold [2]. Sermorelin products in the United States today are compounded, and FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed [1].

What the sermorelin studies measured

The main sermorelin trial was in children. Thorner and colleagues treated 110 previously untreated prepubertal children with growth hormone deficiency for up to 1 year with 30 micrograms per kg subcutaneously at bedtime; 86 were evaluable [4]. Height velocity rose from 4.1 cm/yr at baseline to 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months; 74% were good responders at 6 months [4]. Fasting glucose did not change, IGF-I was not excessively raised, and the drug was well tolerated [4]. The study measured growth and safety outcomes; it did not test a presurgery hold interval.

A pharmacokinetic study in 30 healthy men found that GHRH(1-29)-NH2 was eliminated rapidly after an intravenous dose, yet growth hormone levels stayed raised for about 3 hours [6]. That describes the hormone response in healthy volunteers, not a surgical stop interval.

What the growth hormone trial does and does not show

Takala and colleagues ran two parallel randomized, placebo-controlled trials of high-dose growth hormone in critically ill adults after cardiac surgery, abdominal surgery, trauma or respiratory failure, with 247 patients in Finland and 285 in other European countries [5]. In-hospital mortality was 39% versus 20% in Finland and 44% versus 18% in the multinational trial [5]. These trials did not test sermorelin. They used growth hormone itself at high dose in intensive care, so they cannot establish when to stop sermorelin before surgery [5].

Frequently asked questions

How long before surgery should I stop sermorelin?
No stop date has been established. Sermorelin is not FDA-approved today, so there is no approved sermorelin label that sets a presurgery hold [2].
Is sermorelin the same as growth hormone?
No. It is a 29-amino-acid GHRH analogue that prompts the pituitary to release the body's own growth hormone; it is not growth hormone itself [3].
Wasn't Geref withdrawn for safety reasons?
No. The manufacturer discontinued it and asked FDA to withdraw the applications, and in March 2013 FDA determined Geref was not withdrawn for reasons of safety or effectiveness [2].

References

  1. Official web page. Official web page
  2. Federal Register :: Request Access. Federal Register :: Request Access
  3. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-57. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency
  4. Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, et al. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group. J Clin Endocrinol Metab. 1996;81(3):1189-96. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group
  5. Takala J, Ruokonen E, Webster NR, Nielsen MS, Zandstra DF, Vundelinckx G, et al. Increased mortality associated with growth hormone treatment in critically ill adults. N Engl J Med. 1999;341(11):785-92. Increased mortality associated with growth hormone treatment in critically ill adults
  6. Wilton P, Chardet Y, Danielson K, Widlund L, Gunnarsson R. Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration. Acta Paediatr Suppl. 1993. Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration
Evidence overview for Sermorelin Pre-Surgery Hold Window: What Patients and Clinicians Need to Know