Effects of Tesamorelin, a Growth Hormone–Releasing Factor, in HIV-Infected Patients With Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial With a Safety Extension

  title={Effects of Tesamorelin, a Growth Hormone–Releasing Factor, in HIV-Infected Patients With Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial With a Safety Extension},
  author={Julian M Falutz and Diane Potvin and Jean-Claude Mamputu and Hani Assaad and Monika Zoltowska and Sophie-{\'E}lise Michaud and Daniel S Berger and Michael S Somero and Graeme J. Moyle and Stephen Brown and Claudia T Martorell and Ralph Turner and Steven K Grinspoon},
  journal={JAIDS Journal of Acquired Immune Deficiency Syndromes},
Background:HIV-infected patients receiving antiretroviral therapy often demonstrate excess visceral fat. A growth hormone-releasing factor, tesamorelin, may selectively reduce visceral fat in this population. We investigated the effects of tesamorelin (GHRH1-44) in HIV-infected patients with central fat accumulation. Methods:A 12-month study of 404 HIV-infected patients with excess abdominal fat in the context of antiretroviral therapy was conducted between January 2007 and October 2008. The… 

Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data.

Treatment with tesamorelin reduces VAT and maintains the reduction for up to 52 wk, preserves abdominal sc adipose tissue, improves body image and lipids, and is overall well tolerated without clinically meaningful changes in glucose parameters.

Predictors of Treatment Response to Tesamorelin, a Growth Hormone-Releasing Factor Analog, in HIV-Infected Patients with Excess Abdominal Fat

Individuals with baseline MetS-NCEP, elevated triglyceride levels, or white race were most likely to experience reductions in VAT after 6 months of tesamorelin treatment, and Metabolic syndrome (MetS-IDF or MetS NCEP) and FRS were significantly associated with VAT at baseline.

Tesamorelin: a review of its use in the management of HIV-associated lipodystrophy.

Current evidence suggests that tesamorelin may be useful for reducing visceral adiposity in patients with HIV-associated lipodystrophy, thereby potentially improving self image.

Spotlight on Tesamorelin in HIV-Associated Lipodystrophy

Current evidence suggests that tesamorelin may be useful for reducing visceral adiposity in patients with HIV-associated lipodystrophy, thereby potentially improving self image.

Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin.

  • T. StanleyJ. Falutz S. Grinspoon
  • Medicine
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2012
In contrast to nonresponders, HIV-infected patients receiving tesamorelin with ≥8% reduction in VAT have significantly improved triglyceride levels, adiponectin levels, and preservation of glucose homeostasis over 52 weeks of treatment.

Growth hormone and tesamorelin in the management of HIV-associated lipodystrophy

Administration of tesamorelin is safe and effective in reducing central fat accumulation among HIV-infected patients, however, this effect is transient, and its association with improved cardiovascular risk remains unclear.

Tesamorelin: A Growth Hormone-Releasing Factor Analogue for HIV-Associated Lipodystrophy

Tesamorelin is effective in improving visceral adiposity and body image in patients with HIV-associated lipodystrophy over 26-52 weeks of treatment and potential limitations for its use include high cost and lack of long-term safety and adherence data.

Recombinant Human Growth Hormone and Rosiglitazone for Abdominal Fat Accumulation in HIV-Infected Patients with Insulin Resistance: A Randomized, Double-Blind, Placebo-Controlled, Factorial Trial

The addition of rosiglitazone abrogated the adverse effects of rhGH on insulin sensitivity and glucose tolerance while not significantly modifying the lowering effect of rh GH on VAT.

Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV

A clinically significant VAT reduction with tesamorelin was associated with improved liver enzymes among HIV-infected patients with abdominal obesity and elevated baseline transaminases.

The Growth Hormone Releasing Hormone Analogue, Tesamorelin, Decreases Muscle Fat and Increases Muscle Area in Adults with HIV

Among those with clinically significant decrease in visceral adipose tissue on treatment, tesamorelin was effective in increasing skeletal muscle area and density, and the impact of these changes in daily life should be further studied.



Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation

Treatment with tesamorelin was generally well tolerated and resulted in sustained decreases in VAT and triglycerides over 52 weeks without aggravating glucose, though effects on VAT are sustained during treatment for 52 weeks, these effects do not last beyond the duration of treatment.

A placebo-controlled, dose-ranging study of a growth hormone releasing factor in HIV-infected patients with abdominal fat accumulation

TH9507 reduced truncal fat, improved the lipid profile and did not increase glucose levels in HIV-infected patients with central fat accumulation and longer-term studies with more patients are needed to determine effects on VAT, treatment durability, and safety.

Metabolic effects of a growth hormone-releasing factor in patients with HIV.

Daily tesamorelin for 26 weeks decreased visceral fat and improved lipid profiles, effects that might be useful in HIV-infected patients who have treatment-associated central fat accumulation.

Growth hormone-releasing hormone in HIV-infected men with lipodystrophy: a randomized controlled trial.

GHRH was well tolerated and effectively increased levels of IGF-1 in HIV-infected men with lipodystrophy and total and regional body composition improved in response to GHRH, with increased lean mass and reduced truncal and visceral fat.

Low-dose physiological growth hormone in patients with HIV and abdominal fat accumulation: a randomized controlled trial.

In HIV-associated abdominal fat accumulation and relative GH deficiency, low-dose GH received for 18 months resulted in significantly reduced visceral fat and truncal obesity, triglycerides, and diastolic BP, but 2-hour glucose levels on glucose tolerance testing were increased.

Metformin in the treatment of HIV lipodystrophy syndrome: A randomized controlled trial.

This study suggests that a relatively low dosage of metformin reduces insulin resistance and related cardiovascular risk parameters in HIV-infected patients with lipodystrophy.

Recombinant Human Growth Hormone to Treat HIV-Associated Adipose Redistribution Syndrome: 12-Week Induction and 24-Week Maintenance Therapy

In patients with HARS, r-hGH induction-maintenance therapy produces greater relative losses of VAT and trunk fat than of subcutaneous fat and also has beneficial effects on the lipid profile.

Effects of Growth Hormone on Abnormal Visceral Adipose Tissue Accumulation and Dyslipidemia in HIV-Infected Patients

R-hGH dosed at 4 mg daily for 12 weeks decreases VAT and cholesterol concentrations in HIV-infected patients with excess VAT and the optimal regimen to sustain these effects awaits determination.

Prospective evaluation of the effects of antiretroviral therapy on body composition in HIV-1-infected men starting therapy

This is the first prospective study demonstrating that treatment with antiretrovirals results in progressive, selective loss of limb fat, making an immune aetiology unlikely.

Effects of metformin and rosiglitazone in HIV-infected patients with hyperinsulinemia and elevated waist/hip ratio

Both treatments improved insulin sensitivity, but neither reduced visceral fat, and rosiglitazone may increase subcutaneous fat in some individuals.