CJC-1295 in growth hormone deficiency and growth-hormone secretagogue pharmacology: tolerability and… — summary of findings
Outcome-by-outcome summary with effect, certainty and the reason for each downgrade.
Templated review frame. This review question was generated by crossing an indication with a compound for which contributing trials exist. Its prose frame is templated and is shared with other questions of the same shape. Its included studies, its summary of findings and its certainty rating are computed from the underlying records and are not templated. The Institute publishes these questions because the alternative is to leave a question the document set can answer unanswered, and it labels them because the alternative is to present a templated frame as an authored one.
§4Summary of findings
§4.1Summary of findings
Table 7. Summary of findings for CJC-1295 in growth hormone deficiency and growth-hormone secretagogue pharmacology….
| Outcome | Participants (studies) | Effect as reported | Certainty | Reason for downgrade |
|---|---|---|---|---|
| Peak stimulated growth hormoneThe outcome the Institute designates as anchor for this indication. | — (2) | Sustained elevation of insulin-like growth factor 1 for one to two weeks after a single dose | Low | risk of bias, publication bias |
| Discontinuation for adverse eventsReported as a summary-of-findings row rather than in a tolerability annex, following a public submission. | — (2) | Reported per contributing trial; see the included-studies table | Low | imprecision |
| Serious adverse eventsEvent counts are low; the estimate is imprecise by construction. | — (1) | Reported per contributing trial; see the included-studies table | Very low | inconsistency, imprecision |
| Any adverse eventAscertained by spontaneous report in the contributing trials. | — (1) | Reported per contributing trial; see the included-studies table | Very low | indirectness, imprecision |
| Change in IGF-1 and IGFBP-3A secondary outcome for this indication. Its hierarchical position within each contributing trial is recorded on that trial's abstract where the Institute holds it. | — (1) | Reported as a secondary outcome in a subset of contributing trials | Very low | risk of bias, imprecision, publication bias |
| Body composition by DXAA secondary outcome for this indication. Its hierarchical position within each contributing trial is recorded on that trial's abstract where the Institute holds it. | — (1) | Reported as a secondary outcome in a subset of contributing trials | Very low | risk of bias, imprecision |
| Certainty ratings describe confidence in the effect estimate for the stated outcome. They are not recommendations and do not transfer between outcomes. | ||||
§4.2Forest plot
§4.3Certainty assessment for the anchor outcome
Table 8. Reasoning recorded against each certainty domain for the anchor outcome.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | Allocation concealment is not described in one contributing report. |
| 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: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from the estimate. | ||
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.
- 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
- 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
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