This article is written live from the American Association of Clinical Endocrinologists (AACE) 2017 Annual Meeting in Austin, TX. MPR will be reporting news on the latest findings from leading experts in endocrinology. Check back for more news from AACE 2017.
Use of Somatotropin (recombinant human growth hormone) in adults with growth hormone deficiency significantly raised high-density lipoprotein (HDL) levels at 24 months whereas its effects on other lipid levels “remain inconclusive,” according to Mohita Kumar, MD, from Ferring Pharmaceuticals, Inc. Findings from the analysis were presented at the AACE 2017 Annual Meeting.
Adults with growth hormone deficiency commonly have dyslipidemia. Somatotropin, an agent approved for pediatric growth hormone deficiency, was evaluated in a long-term study for its safety and efficacy in adults. Data from the interim analysis include results from up to 2 years of treatment to assess the impact of somatotropin on lipid concentrations.
The Phase 3b, open-label, multicenter, observational, non-comparative study enrolled patients aged ≥18 years with growth hormone deficiency confirmed by insulin-like growth factor 1 (IGF-1) or blood glucose and peak GH concentration. Of the 98 total patients, 42 had no Somatotropin treatment in the past 12 months and 56 were previously treated patients; 89 patients were included in the efficacy analyses. All study patients were given Somatotropin daily via the Zoma-Jet needle-free injector. Study investigators assessed patients’ fasting total cholesterol (TC), LDL, HDL, and triglyceride (TG) levels every 6 months.
“A lack of evaluable LDL observations did not allow this parameter to be analyzed,” explained Dr. Kumar.
At baseline, lipid parameters were similar between new and switch patients. At Month 24, new patients showed slight reductions and switch patients showed slight increases in TC levels (-4.9% vs. 3.5%; P-value not significant). HDL levels were also significantly higher in both new and switch patient groups (19.9% [P=0.003] vs. 11.1% [P=0.002], respectively).
The newly initiated patients did not exhibit significant changes in TG levels at any timepoint measured but switch patients showed significant increases at Month 6 only (change from baseline 7.6%; P=0.0148).
In general, the effect of Somatotropin on non-HDL parameters “were difficult to interpret from the current analysis, especially without LDL data,” concluded Dr. Kumar.
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