Sermorelin in growth hormone deficiency and growth-hormone secretagogue pharmacology — evidence extract
The Institute's graded assessment of Sermorelin for growth hormone deficiency and growth-hormone secretagogue pharmacology, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Growth hormone deficiency and growth-hormone secretagogue pharmacology
§1.1Question and anchor outcome
- Population
- Insufficient endogenous growth-hormone secretion, or the pharmacological stimulation of the growth-hormone axis, assessed here principally through provocative testing and IGF-1 response.
- Intervention
- Sermorelin, subcutaneous or intravenous
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Peak stimulated growth hormone
Additional outcomes the Institute extracts for this indication: Change in IGF-1 and IGFBP-3; Body composition by DXA; Glucose tolerance.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Sermorelin in growth hormone deficiency and growth-hormone secretagogue pharmacology.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| SERM-DIAGNOSTIC | — | Diagnostic accuracy | — | Single test | — |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | Serious | Too few contributing studies for a formal assessment; the risk cannot be excluded. |
| Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- 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):139–157. doi:10.2165/00063030-199912020-00007 · PMID 18031173
- Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine 2007;357(23):2359–2370. doi:10.1056/NEJMoa072375 · PMID 18052660
- Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. Journal of Clinical Endocrinology & Metabolism 2006;91(3):799–805. doi:10.1210/jc.2005-1536 · PMID 16352683
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.