Tesamorelin — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Growth hormone deficiency and growth-hormone secretagogue pharmacology
Anchor outcome. Peak stimulated growth hormone.
Effect as recorded. IGF-1 rose by a mean of 81 ng/mL, with 34 % of participants exceeding the upper limit of normal at some point; pharmacodynamic.[1,2]
Certainty. Moderate certainty IGF-1 monitoring is required; the proportion exceeding the reference range is the reason.
Contributing trials. TESA-PIVOTAL-1. Full structured abstracts are published for each.
Full evidence extract for growth hormone deficiency and growth-hormone secretagogue pharmacology · Indication assessment
§3.2HIV-associated lipodystrophy and excess visceral adiposity
Anchor outcome. Change in visceral adipose tissue area by computed tomography.
Effect as recorded. Visceral adipose tissue reduced by 15.2 % versus 5.0 % increase with placebo at 26 weeks; estimated difference −20.2 % (95 % CI −25.7 to −14.7).[2,3]
Certainty. Moderate certainty Two pivotal trials in HIV-associated lipodystrophy with computed-tomography endpoints. Downgraded for indirectness when applied to any population outside that indication.
Contributing trials. TESA-PIVOTAL-1 · TESA-PIVOTAL-2. Full structured abstracts are published for each.
Full evidence extract for hiv-associated lipodystrophy and excess visceral adiposity · Indication assessment
§3.3Metabolic dysfunction-associated steatohepatitis
Anchor outcome. Resolution of steatohepatitis without worsening of fibrosis.
Effect as recorded. Liver fat fraction reduced by 4.1 percentage points versus 0.9 with placebo at 12 months in people with HIV and hepatic steatosis; estimated difference −3.2 percentage points (95 % CI −5.5 to −0.9).[3,4]
Certainty. Low certainty Small single trial in a specific population.
Contributing trials. TESA-NAFLD-PH2. Full structured abstracts are published for each.
Full evidence extract for metabolic dysfunction-associated steatohepatitis · Indication assessment
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
- 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
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