Ipamorelin in growth hormone deficiency and growth-hormone secretagogue pharmacology — evidence extract
The Institute's graded assessment of Ipamorelin 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
- Ipamorelin, subcutaneous
- 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 Ipamorelin in growth hormone deficiency and growth-hormone secretagogue pharmacology.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| IPA-PH1-GH | 1 | Phase 1 ascending dose | — | Single dose | 1998 |
| IPA-PH2-POI | 2 | Randomised, double-blind, placebo-controlled | — | In-hospital | 2011 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | The primary endpoint is patient-reported in a setting where blinding cannot be maintained. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | Serious | The event count falls below the optimal information size. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from 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.
- Raun K, Hansen BS, Johansen NL, Thøgersen H, Madsen K, Ankersen M, Andersen PH. Ipamorelin, the first selective growth hormone secretagogue. European Journal of Endocrinology 1998;139(5):552–561. doi:10.1530/eje.0.1390552 · PMID 9849822
- 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
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
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.