Metabolic and muscular effects of switching from somatropin to somapacitan in adults with growth hormone deficiency.
Switching from daily growth hormone to once-weekly somapacitan did not significantly change total lean mass but showed improvements in functional outcomes.
Where it sits
this study against the rest of the hgh (somatropin) corpusSummary and findings
This study compared metabolic and functional outcomes in adults with growth hormone deficiency who switched from daily growth hormone to once-weekly somapacitan versus those who continued daily therapy. The primary endpoint, change in total lean mass from baseline to week 52, showed no significant difference between groups. Exploratory outcomes indicated improvements in handgrip strength and physical performance metrics.
Abstract
<h4>Context</h4>Once-weekly somapacitan is approved for treating adults with growth hormone deficiency. Phase 3 trials support its noninferiority to daily growth hormone (GH); however, its effect on comprehensive metabolic outcome, including muscle strength, during routine care, remains unclear.<h4>Objective</h4>To compare the metabolic and functional outcomes in patients who switched from daily GH to somapacitan with those who continued daily GH.<h4>Methods</h4>Prospective, observational, nonrandomized comparative study conducted from baseline to 52 weeks.This study was conducted at a single-center providing routine endocrine management.Fifty-seven adults on growth hormone replacement therapy were self-selected to receive either once-weekly or continued daily GH.Switching from daily GH to once-weekly somapacitan, or continuing daily treatment based on patient preference.The prespecified primary endpoint was the dual-energy X-ray absorptiometry-derived change in total lean mass from baseline to week 52. Exploratory endpoints included body composition, lipid profile, and physical performance.<h4>Results</h4>Baseline and week 52 insulin-like growth factor 1 standard deviation scores distributions were similar between the groups; yet the increase was greater with daily GH than with somapacitan. The primary endpoint showed no between-group difference (mean difference -0.2 kg; 95% CI -1.5 to 1.1). Somapacitan was associated with increased adiposity indices, yet it improved high-density lipoprotein-cholesterol. Exploratory analyses revealed improvements in handgrip strength and Timed Up and Go Test. No new safety concerns were observed.<h4>Conclusion</h4>In routine practice, switching to once-weekly somapacitan was associated with improved functional outcomes, despite less favorable adiposity trajectories, compared with daily therapy. Further studies are required to clarify long-term effects.
Background
This paper addresses the metabolic and functional outcomes of adults with growth hormone deficiency switching from daily growth hormone to once-weekly somapacitan. Prior studies indicated that somapacitan is noninferior to daily growth hormone in controlled settings, but its effects in routine practice on comprehensive metabolic outcomes were not well understood. Understanding these effects is critical for clinicians considering treatment options for growth hormone deficiency.
Methods
The study was a prospective, observational, nonrandomized comparative study conducted over 52 weeks at a single center. Fifty-seven adults on growth hormone replacement therapy self-selected to receive either once-weekly somapacitan or continued daily growth hormone. The primary outcome measure was the change in total lean mass as assessed by dual-energy X-ray absorptiometry.
Results
The primary endpoint showed no significant between-group difference in total lean mass change, with a mean difference of -0.2 kg (95% CI -1.5 to 1.1). While somapacitan was associated with increased adiposity indices, it also led to improvements in high-density lipoprotein-cholesterol. Exploratory analyses indicated improvements in handgrip strength and the Timed Up and Go Test.
Interpretation
The findings suggest that while switching to somapacitan did not significantly improve lean mass compared to daily growth hormone, there were functional improvements noted in physical performance. The lack of significant change in lean mass may limit the clinical relevance of the switch, especially given the increase in adiposity indices. Potential confounds include the observational nature of the study and the small sample size, which may affect the generalizability of the results.
Key findings
- mean difference in total lean mass change -0.2 kg; 95% CI -1.5 to 1.1
- increased adiposity indices with somapacitan
- improved high-density lipoprotein-cholesterol with somapacitan
- improvements in handgrip strength and Timed Up and Go Test
Limitations
- observational and nonrandomized study design
- small sample size n=57
- single-center study
- short follow-up duration of 52 weeks
- no long-term effects reported