Tesamorelin in hiv-associated lipodystrophy and excess visceral adiposity — evidence extract
The Institute's graded assessment of Tesamorelin for hiv-associated lipodystrophy and excess visceral adiposity, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: HIV-associated lipodystrophy and excess visceral adiposity
§1.1Question and anchor outcome
- Population
- Abnormal regional fat distribution with excess visceral adipose tissue, in the setting of HIV infection and antiretroviral therapy.
- Intervention
- Tesamorelin, subcutaneous once daily
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Change in visceral adipose tissue area by computed tomography
Additional outcomes the Institute extracts for this indication: Change in triglycerides; Change in IGF-1; Glucose tolerance.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Tesamorelin in hiv-associated lipodystrophy and excess visceral adiposity.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| TESA-PIVOTAL-1 | 3 | Randomised, double-blind, placebo-controlled | 412 | 26 weeks | 2010 |
| TESA-PIVOTAL-2 | 3 | Randomised, double-blind, placebo-controlled | 404 | 26 weeks | 2010 |
§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 | Serious | A single small trial contributes the whole estimate. |
| Publication bias | No concern | No serious concern identified in this domain. |
| 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.
- 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
- 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
- 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.