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Tesamorelin (TSM20)

Name: Tesamorelin (TSM20) - Apex peptid etherapeutic
Price: 175.00 USD
Availability: InStock

Original price was: $471.00.Current price is: $175.00.

Tesamorelin (TSM20)
20mg/vial *10 vials

Category: PEPTIDES

Description
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Tesamorelin

Tesamorelin, a growth hormone-releasing hormone analogue, decreases visceral adipose tissue in people living with HIV, however, the effects on skeletal muscle fat and area are unknown.

Objectives

The goals of this exploratory secondary analysis were to determine the effects of tesamorelin on muscle quality (density) and quantity (area).

Design

Secondary, exploratory analysis of two previously completed randomized (2:1), clinical trials.

Setting

U.S. and Canadian sites.

Participants

People living with HIV and with abdominal obesity. Tesamorelin participants were restricted to responders (visceral adipose tissue decrease ≥8%).

Intervention

Tesamorelin or placebo.

Measurements

Computed tomography scans (at L4-L5) were used to quantify total and lean density (Hounsfield Units, HU) and area (centimeters²) of four trunk muscle groups using a semi-automatic segmentation image analysis program. Differences between muscle area and density before and after 26 weeks of tesamorelin or placebo treatment were compared and linear regression models were adjusted for baseline and treatment arm.

tesamorelin peptide

Tesamorelin responders (n=193) and placebo (n=148) participants with available images were similar at baseline; most were Caucasian (83%) and male (87%). In models adjusted for baseline differences and treatment arm, tesamorelin was associated with significantly greater increases in density of four truncal muscle groups (coefficient 1.56-4.86 Hounsfield units; all p<0.005), and the lean anterolateral/abdominal and rectus muscles (1.39 and 1.78 Hounsfield units; both p<0.005) compared to placebo. Significant increases were also seen in total area of the rectus and psoas muscles (0.44 and 0.46 centimeters²; p<0.005), and in the lean muscle area of all four truncal muscle groups (0.64-1.08 centimeters²; p<0.005).

Conclusions

Among those with clinically significant decrease in visceral adipose tissue on treatment, tesamorelin was effective in increasing skeletal muscle area and density. Long term effectiveness of tesamorelin among people with and without HIV, and the impact of these changes in daily life should be further studied.

Key words: Muscle quality, sarcopenia, frailty, IGF-1, visceral adipose tissue

Introduction

Due to the successes of antiretroviral therapy, persons living with human immunodeficiency virus infection (PLWH) are living longer (1) and experiencing conditions commonly associated with aging (i.e., cardiovascular disease (2, 3, 4), neurocognitive dysfunction (5, 6), physical function impairments (7, 8), and falls (7, 9)). Although multiple factors contribute to the development of these disease processes, an accumulation of visceral adipose tissue (VAT) may play a central role (10, 11, 12). VAT accumulation is associated with HIV (4), antiretroviral therapy (4, 6, 12), and diet and physical activity (6, 12), and may contribute to the low-level, chronic inflammatory state persistent in HIV infection despite virologic suppression. Indeed, several studies have shown strong associations between VAT or central adiposity and cardiovascular disease (10), neurocognitive dysfunction (6, 11), and frailty (13) among PLWH.

what is tesamorelin

In November 2010, the United States Food and Drug Administration approved tesamorelin for the treatment of excessive abdominal fat in PLWH (20). Tesamorelin is a synthetic growth hormone-releasing hormone that acts on the anterior pituitary gland to stimulate the endogenous growth hormone secretion (21). In randomized, controlled, double-blinded studies, tesamorelin decreased VAT by approximately 15% compared to placebo (22, 23, 24). In a separate study, tesamorelin reduced hepatic fat by a relative 40% (25) among PLWH with abdominal fat accumulation, compared to a 27% increase in the placebo arm. Ongoing studies are investigating the long-term safety of tesamorelin and the impact of tesamorelin on cognition, liver inflammation, and diabetic retinopathy in PLWH. The goals of this exploratory secondary analysis were to determine the effects of tesamorelin on muscle quality, as measured by changes in computed tomography (CT)-based trunk muscle density, a biopsy-correlated measurement of skeletal muscle fat (26), and trunk muscle area. We hypothesized that tesamorelin would increase skeletal muscle density (less fat) and skeletal muscle area, supportive of an overall improvement in muscle quality, compared to placebo.

Methods

Participants

This analysis is a secondary, exploratory analysis of two previously completed randomized (2:1), clinical trials of tesamorelin versus placebo among PLWH with abdominal adiposity (22, 23, 24). Details of the study design and primary study outcomes have been previously published (22, 23, 24, 27). In brief, eligible participants from both studies were between 18 and 65 years of age with a CD4+ T-lymphocyte count >100 cells/μL, an HIV-1 RNA <10,000 copies/mL, on stable antiretroviral therapy for at least 8 weeks, and had evidence of excessive abdominal fat accumulation (defined as having waist circumference of ≥95cm and waist to hip ratio ≥0.94 for men and ≥94 cm and waist to hip ratio ≥0.88 for women). The initial study design consisted of a primary efficacy phase of the initial studies (baseline–week 26) and a safety extension phase (week 26–52). A minimum of 8% of VAT change was considered clinically relevant (27), and PLWH with ≥8% in VAT reduction were thus deemed responders. Based on the initial studies, approximately 70% of PLWH with central adiposity that received tesamorelin met responder criteria. For this exploratory analysis, data were restricted to the primary efficacy phase and participants who were receiving either placebo (regardless of response) or were tesamorelin responders, as these patients would be those most likely to receive ongoing therapy in clinical practice (Supplemental Figure).