Tesamorelin · research summary

Tesamorelin improves fat quality independent of changes in fat quantity.

AIDS (London, England) · 2021. Summary drawn from the study's full text. Each statement is followed by the exact sentence it comes from. This is a research summary, not medical advice.

Study type

Post-hoc analysis of two completed, placebo-controlled, randomized Phase 3 trials
“This analysis used data from two randomized (2:1), Phase 3 trials of tesamorelin vs placebo for the treatment of abdominal fat accumulation in PLWH.”

Subjects

Adults living with HIV with central adiposity who were either tesamorelin responders or placebo-treated
“Participants from two completed, placebo-controlled, randomized trials of tesamorelin for central adiposity treatment in PLWH were included if they had either a clinical response to tesamorelin (VAT decrease ≥8%, ≈70% of participants) or were placebo-treated.”

Sample size

341 participants (193 responders and 148 placebo-treated)
“Participants (193 responders, 148 placebo) were 87% male and 83% Caucasian.”

Duration

26 weeks
“Over 26 weeks, mean (SD) VAT and SAT density increased in tesamorelin-treated participants only.”

Reported findings

Tesamorelin treatment significantly increased visceral and subcutaneous fat density compared to placebo
“Over 26 weeks, mean (SD) VAT and SAT density increased in tesamorelin-treated participants only (VAT: +6.2 (8.7) HU tesamorelin, +0.3 (4.2) HU placebo, p<0.0001; SAT: +4.0 (8.7) HU tesamorelin, +0.3 (4.8) HU placebo, p<0.0001).”
The increase in fat density persisted after controlling for changes in fat area
“The tesamorelin effects persisted after controlling for baseline VAT or SAT HU and area, and VAT (+2.3 HU, 95% CI [4.5, 7.3], p=0.001) or SAT (+3.5 HU, 95% CI [2.3, 4.7], p<0.001) area change.”
Increases in fat density correlated with increases in adiponectin and improved lipid profiles
“Changes in adiponectin and IGF-1 concentrations positively correlated with changes in both VAT and SAT densities (adjusted for changes in VAT and SAT area, respectively) (Table 3).”

Limitations stated by the authors

Limited generalizability due to predominantly male and Caucasian demographics; exclusion of non-responders to tesamorelin
“First, it is limited by the predominately Caucasian and male patient demographic enrolled into the parent clinical trials; consequently, our results may not be generalizable to women or persons of color.”

Source: PubMed 33756511 · DOI 10.1097/QAD.0000000000002897 · all study summaries

Subjects

Adults living with HIV with central adiposity who were either tesamorelin responders or placebo-treated

“Participants from two completed, placebo-controlled, randomized trials of tesamorelin for central adiposity treatment in PLWH were included if they had either a clinical response to tesamorelin (VAT decrease ≥8%, ≈70% of participants) or were placebo-treated.”

Reported findings

Tesamorelin treatment significantly increased visceral and subcutaneous fat density compared to placebo

“Over 26 weeks, mean (SD) VAT and SAT density increased in tesamorelin-treated participants only (VAT: +6.2 (8.7) HU tesamorelin, +0.3 (4.2) HU placebo, p<0.0001; SAT: +4.0 (8.7) HU tesamorelin, +0.3 (4.8) HU placebo, p<0.0001).”

The increase in fat density persisted after controlling for changes in fat area

“The tesamorelin effects persisted after controlling for baseline VAT or SAT HU and area, and VAT (+2.3 HU, 95% CI [4.5, 7.3], p=0.001) or SAT (+3.5 HU, 95% CI [2.3, 4.7], p<0.001) area change.”

Increases in fat density correlated with increases in adiponectin and improved lipid profiles

“Changes in adiponectin and IGF-1 concentrations positively correlated with changes in both VAT and SAT densities (adjusted for changes in VAT and SAT area, respectively) (Table 3).”

Limitations stated by the authors

Limited generalizability due to predominantly male and Caucasian demographics; exclusion of non-responders to tesamorelin

“First, it is limited by the predominately Caucasian and male patient demographic enrolled into the parent clinical trials; consequently, our results may not be generalizable to women or persons of color.”